Chitosan Nanoparticles: Approaches to Preparation, Key Properties, Drug Delivery Systems, and Developments in Therapeutic Efficacy - Wasfy M. Obeidat; Ishraq K. Lahlouh (AAPS PharmSciTech, 2025)

Correction: Nanoparticle Formulations for Intracellular Delivery in Colorectal Cancer Therapy - Burcu Uner; Erdogan Oguzhan Akyildiz; Kubra Kolci; Rengin Reis (AAPS PharmSciTech, 2025)

Finite Dose In Vitro Permeation Testing: Significance of Occluding the Donor compartment, a Case study - Prajwal N. Murthy; Mohammad Moinul Hossain; Santanu Kundu; Srinath Rangappa; Shivakumar H. N. (AAPS PharmSciTech, 2025)

Foam-Based Drug Delivery Systems for Skin Disorders: A Comprehensive Review - Syrsulu Myrzagulova; Zhexenova Azhar N; Mohit Kumar; Devesh Kumar; Akshay Kumar (AAPS PharmSciTech, 2025)

Correction: Gene Therapy: Towards a New Era of Medicine - Mokshit Bhagat; Raj Kamal; Jyoti Sharma; Kirandeep Kaur; Amit Sharma; Thakur Gurjeet Singh; Rohit Bhatia; Ankit Awasthi (AAPS PharmSciTech, 2025)

QbD-Based Development of Fluocinolone Nanocomposite Transdermal Gel: Optimization, Characterization, and Enhanced Anti-hyperpigmentation Efficacy Assessment - Priyanka Rathore; Rishikesh Gupta; Prem Prakash Singh; Anshu Awasthi; Ankita Kishore; Kuldeep K. Bansal; Alok Kumar Mahor (AAPS PharmSciTech, 2025)

Investigation of Curcumin-β-Cyclodextrin Complex Release in Injectable Hyaluronic Acid/Quince Seed Gum Hydrogel - Serdar Kolay; Nilhan Kayaman Apohan; Erdinç Babuç; Gökay Gün (AAPS PharmSciTech, 2025)
Injectable hydrogels play a crucial role in various biomedical applications, serving as fillers in tissue engineering, facilitating cell repair, and contributing to the development of drug delivery systems. This study aims to investigate the release of dissolved curcumin from a new injectable hyaluronic acid/quince seed gum (HA/QSG) hydrogel. Curcumin possesses numerous biological activities, including anti-cancer, antioxidant, antimicrobial, and anti-inflammatory properties. However, due to its very low water solubility, its bioavailability is poor. To address this, curcumin was encapsulated in three inclusion complexes: Cur 1:2 β-CD, Cur 1:4 β-CD, and Cur 1:6 β-CD. These Cur-β-CD inclusion complexes were lyophilized and converted into a water-soluble form. The curcumin, bisdemethoxycurcumin, and desmethoxycurcumin content of the obtained lyophilized Cur-β-CD complexes were analyzed using the HPLC method. HA-QSG hydrogels were loaded with Cur 1:2 β-CD inclusion complex in compositions of 0.75% (w/w), 0.50% (w/w), and 0.25% (w/w). The dissolution profiles of the HA-QSG hydrogels were examined in a pH 6.8 phosphate buffer medium, used as the swelling medium in intra-articular hydrogels. The initial burst of the 0.75% (w/w) hydrogel reached 9% release within the first 15 min, whereas the 0.25% (w/w) hydrogel exhibited only 6% release during the same period. The 0.75%(w/w) and 0.50% (w/w) hydrogels displayed very similar dissolution profiles, with a slightly faster release in the early stages of dissolutions, compared to the 0.25%(w/w) Cur β-CD-HA-QSG hydrogel. The 0.25%(w/w) Cur β-CD-HA-QSG hydrogel demonstrated a relatively slower release rate particularly during the initial stage of dissolution period. However, all three formulations reached approximately 98% release within 24 h. While the 0.75%(w/w) and 0.50%(w/w) curcumin-loaded HA-QSG hydrogels, with their rapid initial release, may be suited for intra-articular applications requiring quick drug availability, the 0.25%(w/w) curcumin-loaded HA-QSG hydrogel, with its slower release, may be more beneficial for sustained intra-articular delivery. Graphical Abstract

Harnessing Exercise-Like Benefits of Protonation prone Liposomal Resveratrol in Differentiated Fat Cells: A Proof-of-Concept Study - Nupur Vasdev; Tanisha Gupta; Anoothi Bain; Dnyaneshwar Kalyane; Suryanarayana Polaka; Rakesh Kumar Tekade (AAPS PharmSciTech, 2025)

Exploration of Conventional and FDM-Mediated 3D Printed Tablets Fabricated Using HME-Based Filaments for pH-Dependent Drug Delivery - Ruchira Patil; Prajakta Bule; Naveen Chella (AAPS PharmSciTech, 2025)

Biogenic Amino Acid Cross-Linked Hyaluronic Acid Nanoparticles Containing Dexamethasone for the Treatment of Dry Eye Syndrome - Ajit Mishra; Jitu Halder; Ivy Saha; Vineet Kumar Rai; Ritu Mahanty; Deepak Pradhan; Priyanka Dash; Chandan Das; Tushar Kanti Rajwar; Bibhanwita Satpathy; Salim Manoharadas; Muralidhar Tata; et al. (AAPS PharmSciTech, 2025)

Development of Complex Generics and Similar Biological Products: An Industrial Perspective of Reverse Engineering - Rajeev Ranjan (AAPS PharmSciTech, 2025)

Treatment of Bleomycin-induced Pulmonary Fibrosis by Intratracheal Instillation Administration of Ellagic Acid-Loaded Chitosan Nanoparticles - Zhilin Luo; Yao Sun; Shihao Cai; Hongting Liu; Conglu Zhao; Xiang Xu; Aiguo Xu; Honggang Zhou; Cheng Yang; Xiaoting Gu; Xiaoyu Ai (AAPS PharmSciTech, 2025)

Engineering pH-Dependent Orally Disintegrating Tablets for Modified Indomethacin Release: A Polymer-Based Approach - Nihad Al-hashimi; Eman Zmaily Dahmash; Mouhamad Khoder; Raid Alany; Amr Elshaer (AAPS PharmSciTech, 2025)
The application of pH-sensitive polymers has been widely explored in pharmaceutical industry because of their versatile properties. This work aims to delay the release of indomethacin (IND), a commonly used anti-inflammatory drug, using a pH-dependent polymer within orally disintegrating tablets (ODTs) and to investigate the effect of the polymer particle size on the ODTs. When developing delayed-release formulations for orally disintegrating tablets (ODTs), it's essential to balance the pellet's matrix properties to maintain integrity and delayed release. Different sizes of Eudragit L100 were used to create IND-containing pellets via extrusion spheronization, which were then embedded into the matrix of ODTs. The particle sizes displayed good elastic properties with low Young's modulus (YM) values, and there was no significant difference between the different sizes (45, 60, 93 µm; p > 0.05). The tensile strength of the pellets was directly proportional to YM ( p Graphical Abstract Graphical illustration for developing delayed release indomethacin loaded Eudragit L100 pellets embedded in orally disintegrating tablets

Integrating Quantitative Methods & Modeling and Analytical Techniques in Reverse Engineering; A Cutting-Edge Strategy in Complex Generic Development - Akash Rajput; Megha Pillai; Jinal Ajabiya; Pinaki Sengupta (AAPS PharmSciTech, 2025)

Novel Methods Developed in Bioequivalence Assays: Patent Review - Brian Sebastian Correa Barrera; Izabel Almeida Alves; Diana Marcela Aragón (AAPS PharmSciTech, 2025)

Co-Delivery of Tacrolimus and Thymoquinone Topically by Nanostructured Lipid Carrier Gel for Enhanced Efficacy Against Psoriasis - Meraj Alam; Md. Rizwanullah; Shahnawaz Ahmad; Ashif Iqubal; Showkat R. Mir; Tae-Geum Kim; Saima Amin (AAPS PharmSciTech, 2025)

Amorphous Solid Dispersion/Salt of Efavirenz: Investigating the Role of Molecular Interactions on Recrystallization and In-vitro Dissolution Performance - Aastha Gadoya; Kiran Dudhat; Sunny Shah; Chetan Borkhataria; Trupesh Pethani; Viral Shah; Nilesh Janbukiya; Saina Jyotishi; Jainabparvin Ansari; Mori Dhaval (AAPS PharmSciTech, 2025)

Quantitative Analysis of Salmon Calcitonin Hydroxyapatite Nanoparticle Permeation to substantiate Non-Invasive Bone Targeting via Sublingual Delivery - Darsheen Kotak; Esha Attar; Bhavik Dalal; Aruna Shankarkumar; Padma Devarajan (AAPS PharmSciTech, 2025)

Development and Optimization of Eberconazole Nanostructured Lipid Carrier Topical Formulations Based on the QbD Approach - Amarnath Reddy Ramireddy; Dilip Kumar Behara (AAPS PharmSciTech, 2025)

Brazilian Green Propolis Extract-Loaded Poly(Ε-Caprolactone) Nanoparticles Coated with Hyaluronic Acid: Antifungal Activity in a Murine Model of Vulvovaginal Candidiasis - Aniely Dos Reis Teixeira; Amanda De Vasconcelos Quaresma; Renata Tupinambá Branquinho; Patrícia Capelari De Oliveira; Jorge Andrés García Suárez; Geraldo Célio Brandão; Ana Paula Moreira Barboza; Marcelo Gonzaga De Freitas Araújo; Juliana Teixeira De Magalhães; Sandra Aparecida Lima De Moura; Gisele Rodrigues Da Silva (AAPS PharmSciTech, 2025)

Unraveling the Effects of Filtration, Process Interruptions, and Post-Process Agitation on Protein Aggregation - Christina Winter; Anna Springer; Jean-Loup Descamps; Joris Hoefinghoff; Salehi Mohammad-Sadegh; Amrit Paudel; Milica Stankovic-Brandl (AAPS PharmSciTech, 2025)

Characterizing the Complex Multi-Step Degradation Kinetics of Amphotericin B in a Microemulsified Drug Delivery System - Sarah R. A. Santos; Éverton N. Alencar; Silvana C. C. Urtiga; Wógenes N. Oliveira; Júlio Abreu Miranda; Lucas Amaral-Machado; Francine J. Azeredo; Lee E. Kirsch; Eryvaldo Sócrates T. Egito (AAPS PharmSciTech, 2025)

Towards Enhanced Solubility of Cannabidiol: Preparation and Evaluation of Cannabidiol Solid Dispersions Using Vacuum Compression Molding - Achref Cherif; Janhavi Deshmukh; Kavish Sanil; Iman Taha; Daniel Treffer; Eman A. Ashour (AAPS PharmSciTech, 2025)
The present study aims to develop and characterize cannabidiol (CBD) solid dispersions using Vacuum Compression Molding (VCM) to enhance the drug solubility and release profile. Solid dispersions of CBD and polymers were processed using VCM at 130 °C for 4 min after a prior physical mixing. Five percent w/w of CBD was used with 5% w/w of poloxamer 188 and 90% w/w of polymeric carrier (Polyethylene Oxide, PEO-N80 or Hydroxypropyl cellulose, HPCEF). Discs were collected and milled to obtain formulations (F1V, F2V). The degradation temperature of CBD was determined using Thermogravimetric Analysis (TGA). The formulations were further characterized using differential scanning calorimetry (DSC), scanning electron microscopy (SEM), and Fourier-Transform Infrared Spectroscopy (FTIR). In vitro dissolution testing of pure CBD and formulations was evaluated using USP apparatus II. TGA showed that CBD degradation occurs after 200 °C. FTIR spectra of formulations indicate potential interactions between the drug and polymers. DSC thermograms of F1V showed a thermal peak at 65 °C that could correspond to PEO-N80. F2V did not show any of the thermal event peaks, which suggests the conversion of the drug to the amorphous state. Images from the SEM showed irregular surfaces for both formulations. The release profile showed an increase in the CBD dissolution rate by 4.75 folds for F1V and 3.63 folds for F2V in four hours. In this study, solid dispersions of CBD formulations were successfully achieved. The VCM technology has proven to be successful in formulating solid dispersions of CBD for early-stage drug development. Graphical Abstract

Eudragit S 100 Assisted Molecular Solid Dispersion of Andrographolide Tendered Augmented Drug Delivery and Apoptosis in Human Colon Cancer, HT-29 Cells - Pawan Devangan; Anamika Sharma; Nitin Wadate; Atul Mourya; Jitender Madan (AAPS PharmSciTech, 2025)

Nanoparticle Formulations for Intracellular Delivery in Colorectal Cancer Therapy - Burcu Uner; Erdogan Oguzhan Akyildiz; Kubra Kolci; Rengin Reis (AAPS PharmSciTech, 2025)

In Vitro Characterization of a Cyclosporine Eluted Polymeric Stent Manufactured by Liquid Crystal Display 3D Technology - Seyed Mohammad-Amin Mousazadeh; Saeideh Allahyari; Ali Nokhodchi (AAPS PharmSciTech, 2025)
Coronary artery blockage, the most common cardiovascular problem, is often treated with drug-eluting stents (DES). This study aims to address the main limitation of traditional angioplasty therapy. Thus, designing, fabricating, and analyzing a novel drug-eluting polymeric stent using liquid crystal display (LCD) technology may potentially represent an innovative approach to DES in the near future. Therefore, a poly (lactic acid) (PLA) based 3D-printed stent was designed using SolidWorks software and fabricated using the liquid crystal display (LCD) method. The cyclosporine-loaded stent was prepared and analyzed using optical microscopy, differential scanning calorimetry (DSC), and Fourier transform infrared spectroscopy (FTIR). Loading efficiency percentage and release characteristics were estimated. The polymeric stent platform was successfully designed and manufactured using PLA resin. Based on the characterization of cyclosporine eluting stent, a loading efficiency of 48.66 ± 5.92% was estimated through the immersion method. The FTIR and DSC results confirmed molecular interactions between cyclosporine and the PLA-based 3D-printed stent compared with physical mixture formulations. A sustained release profile of cyclosporine was also observed where approximately 50% of the drug was released within the first three hours. The sustained-release profile, characterized by the absence of a burst release, holds significant clinical potential by ensuring consistent therapeutic levels, reducing side effects, and potentially improving patient outcomes. Overall, the study highlights the effectiveness of LCD technology in printing the stent platform using PLA resin. The results demonstrated a significant cyclosporine loading with a sustained release profile without any stent coating procedure. Graphical Abstract

Enhanced Transdermal Delivery of Piroxicam via Nanocarriers, Formulation, Optimization, Characterization, Animal Studies and Randomized Double-Blind Clinical Trial - Moein Masjedi; Mohammad Ali Helforoush; Katayoun Rohani Rad; Soliman Mohammadi-Samani; Talieh Montahaei; Zarindokht Helforoush; Afshin Amini (AAPS PharmSciTech, 2025)

A New Screening Strategy for Flavonoid Components to Obtain a Satisfactory Co-Amorphous System with Piperine - Jiawei Han; Wen Sun; Yongxu Yao; Shuo Li; Zhimin Yue; Weitao Fang; Xiaoqian Liu; Jue Wang; Jiaxin Chen (AAPS PharmSciTech, 2025)

Dual Drug Loaded Topical Cubosomal Gel Against Candida Albicans: An In Vitro and In Vivo Proof of Concept - A. Gowri Nath; Klaudi K. Vaiphei; Ankaj Kumar; Sargun Basrani; Ashwini Jadhav; Rudra Chakravarti; Dipanjan Ghosh; Kuldeep K. Bansal; Arvind Gulbake (AAPS PharmSciTech, 2025)

Nano-Based Hydrogel for Cutaneous Sesamol Delivery in UVB-Induced Skin Injury - Vinicius Costa Prado; Kauani Moenke; Natháli Schopf Pegoraro; Camila Parcianello Saccol; Daniele Rubert Nogueira-Librelotto; Giancarlo Cervo Rechia; Sara Marchesan Oliveira; Letícia Cruz (AAPS PharmSciTech, 2025)

Sodium Cholate-Mediated Ion-Pairing for Skin Delivery of Methylene Blue: Physicochemical Characterization and Influence on Skin Barrier and Skin Penetration - Elizabeth Baraçal Tavares; Maria Clara Evangelista Paiva; Giovana Duarte Lobo; Tereza Silva Martins; Wilson Dias Segura; Maria Teresa Junqueira Garcia (AAPS PharmSciTech, 2025)

Delving Into Nanoparticle Systems for Enhanced Drug Delivery Technologies - Nimra Abaidullah; Khalid Muhammad; Yasir Waheed (AAPS PharmSciTech, 2025)

Recent Advances in Antiviral Drug Delivery Strategies - Dhwani Rana; Arvee Prajapati; Bharathi Karunakaran; Lalitkumar Vora; Derajram Benival; Anil B. Jindal; Rikin Patel; Vishvesh Joshi; Ashutosh Jamloki; Ujashkumar Shah (AAPS PharmSciTech, 2025)

Innovative Drug Development Approach to Address the Transition to Low Global Warming Potential Propellant Using Hydrofluoroalkane-152a, for Triple Combination Pressurized Metered-Dose Inhaler Products Targeting Small Airways - A. Matturro; E. Zambelli; E. Cuoghi; D. Copelli; F. Usberti; A. Fioni; L. Labadini (AAPS PharmSciTech, 2025)
Recent and emerging environmental policies have boosted the investigation of pressurized metered-dose inhalers (pMDI) that have a minimal impact on climate change. There is a current move away from existing hydrofluorocarbon (HFC)-based propellants, specifically the hydrofluoroalkane (HFA)-134a and HFA-227ea based pMDI products that are approved for the treatment of asthma and chronic obstructive pulmonary disease (COPD), towards those that use low global warming potential (LGWP) propellants. Changing the propellant to, for example, the less environmentally-damaging HFA-152a, is a focus for many manufacturers. In this paper, we report an innovative approach to developing new pMDI drug products with a LGWP propellant. Moreover, proof of the hypothesis that products containing the current propellant and those using a LGWP propellant can achieve equivalent performance is reported, by showing comparability of a triple combination pMDI (Trimbow®) formulated using the LGWP HFA-152a propellant compared with HFA-134a. This paper will present the use of in silico mathematical modelling, leveraging on Chiesi proprietary Modulite® principles to predict and validate in vitro performances of the drug product under development. Validation is carried out using realistic aerodynamic particle size distribution (rAPSD), a novel approach that offers a more accurate prediction of aerosol distribution by incorporating variations compared to the standard aerodynamic particle size distribution (APSD). Additional in vitro testing validates the prediction of in silico models and confirms good comparability in terms of aerodynamic performance between HFA-152a and HFA-134a, which translates in vivo as evidenced by the preliminary pharmacokinetics (PK) in animal models and the formal clinical PK bioequivalence (BE) studies. (Rony et al. in Pulm Pharmacol Ther 85, 2024). Graphical Abstract

Microemulsions Improve the Cutaneous Co-Localization of Lipoic Acid and Quercetin and Antioxidant Effects in Cutaneous Cells and Tissue - Mariana de Sousa Silva; Julia S. Passos; Regina G. Daré; Jessica R. Nunes; Patricia P. Adriani; Luciana B. Lopes (AAPS PharmSciTech, 2025)

Cellular Uptake and Trafficking of Lipid Nanocarriers Using High-Resolution Electron Microscopy - Thilo Faber; Alf Lamprecht (AAPS PharmSciTech, 2025)
Lipid based nanocarriers are a commonly used drug delivery system with cargos ranging from small molecules to complex RNA-based therapies. There are several hypotheses how such carriers can enter the cell, in which organelles they reside, and how they cross or escape the endo-lysosomal system. To provide additional insights, the cell-nanocarrier interplay was visualized exemplarily with lipid-based nanocarriers and macrophage-like cultured cells (J774A.1 cells) using high resolution electron microscopy. Nanocarrier uptake into J774A.1 cells was detectable after the first 15 min by intracellular accumulation of electron-dense material. These accumulations were identified as lysosomes and lipid droplets, indicating complete degradation and a subsequent formation of storage organelles as early as 15 min. Inhibition of lysosomal acid lipase did not block lipid droplet formation, but rather resulted in accumulation of lipid droplets within lysosomes. This suggests that other cellular lipases already degrade acylglycerols before they reach lysosomes. Chloroquine co-treatment allowed visualization of nanocarriers inside endosomal vesicles, multivesicular bodies, and lysosomes. Graphical Abstract

Electrospinning: A New Frontier in Peptide Therapeutics - Jeyanthi L.; Sivadharshini Kamaraj; Ruckmani Kandasamy; Shanmugarathinam Alagarsamy (AAPS PharmSciTech, 2025)

Biomimetic Nanoparticle Based Targeted mRNA Vaccine Delivery as a Novel Therapy for Glioblastoma Multiforme - Tanvir Ahmed; Kazi Tasnuva Alam (AAPS PharmSciTech, 2025)

Oral pH-Sensitive Solid Self-Microemulsion of Norcantharidin Wrapped in Colon-Coated Capsule for Selective Therapy of Colorectal Carcinoma - Xia Liu; Wenyou Fang; Wenjie Lu; Mingchao Xu; Zijun Wu; Dan Su; Lingzhen Ding; Qing Zhang; Jinguang Ouyang; Tianming Wang; Lingfeng Sun; Song Gao; et al. (AAPS PharmSciTech, 2025)

Nanocrystals for Intravenous Drug Delivery: Composition Development, Preparation Methods and Applications in Oncology - Wanjiao Chen; Jingyi Huang; Yankun Guo; Xinyv Wang; Zhizhe Lin; Ruting Wei; Jianming Chen; Xin Wu (AAPS PharmSciTech, 2025)

Hansen Solubility Parameters, Computational, and Thermodynamic Models for Tofacitinib Citrate Solubility in Neat Mono Solvents, and GastroPlus Based Predicted In Vivo Performance of Subcutaneous Solution in Humans - Iman Ehsan; Mudassar Shahid; Subramanian Natesan; Abdul Faruk; Ashwani Kumar Sood; Tasneem Khan (AAPS PharmSciTech, 2025)

Materials Compatibility Considerations for the Transition to Low Global Warming Potential Propellants for Pressurized Metered Dose Inhalers - Dan Dohmeier; Atish Sen; Alessandro Cavecchi; João Matos; Richard Lostritto; Lee Nagao (AAPS PharmSciTech, 2025)
Pressurized metered dose inhalers (pMDI) are a vital therapy for the treatment of lung diseases such as asthma and chronic obstructive pulmonary disease (COPD). In pMDI, the propellants used to deliver the drug to the lungs are hydrofluorocarbons (HFC). However, the current HFCs in use have large global warming potential (GWP). In order to reduce or eliminate the use of propellants with large global warming potential, efforts are underway within the pharmaceutical industry to transition to the use of low GWP propellants in pMDI, while maintaining their effectiveness in treating disease. The current switch from higher GWP propellants mirrors the switch from chlorofluorocarbon (CFC) propellants to HFCs undertaken in the 1990’s, which was driven by ozone depletion concerns. In this paper, the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) discusses aspects of the switch to low GWP propellants from the perspective of materials compatibility of pMDI components with low GWP propellants. Leveraging the learnings and advances in pMDI component materials implemented following the switch from CFCs, industry is well positioned to make the change. This paper describes the utility of the low GWP propellants being developed for use in pMDI and the learnings from the previous transition that are being leveraged by industry. The current state of development will be described, including a review of available literature supporting the transition to low GWP propellants.

Development of Mucoadhesive Vaginal Films for Metronidazole Delivery Using Methacryloylated, Crotonoylated, and Itaconoylated Gelatin Blends with Poly(vinyl alcohol) - Elvira O. Shatabayeva; Daulet B. Kaldybekov; Zarina A. Kenessova; Rysgul N. Tuleyeva; Sarkyt E. Kudaibergenov; Vitaliy V. Khutoryanskiy (AAPS PharmSciTech, 2025)
Purpose This work reports the development and characterisation of polymeric films composed of gelatin or its chemically modified derivatives (crotonoylated, itaconoylated, and methacryloylated gelatins) blended with polyvinyl alcohol (PVA). Metronidazole served as an antimicrobial drug in these formulations. Methods The films were produced by casting aqueous solutions of polymers, followed by solvent evaporation. Their structure and physicochemical characteristics were studied using Fourier transform infrared spectroscopy, scanning electron microscopy, and mechanical testing. The thickness of the films, their folding endurance, the surface pH, and transparency were also evaluated. The mucoadhesive performance of the films was evaluated through an ex vivo detachment technique involving freshly excised sheep vaginal tissues. In vitro cumulative drug release studies were conducted using Franz diffusion cells. Results The results demonstrate that incorporating unsaturated functional groups into gelatin improves its mucoadhesive properties compared to native gelatin. The drug release experiments conducted in vitro showed that the cumulative release from pure gelatin/PVA films was found to be 49 ± 2%, whereas modified gelatins/PVA (70:30) films released ~ 64–71%. Conclusion These findings suggest that modified gelatins could serve as effective excipients in designing mucoadhesive formulations for vaginal administration, with potential applications extending to other transmucosal drug delivery systems. Graphical Abstract

Optimization of Capecitabine-Loaded Niosomes Using Factorial Design: An Approach for Enhanced Drug Release and Cytotoxicity in Breast Cancer - Vidya Sabale; Ashwini Ingole; Rutuja Pathak; Prafulla Sabale (AAPS PharmSciTech, 2025)

Computational Design and Optimization of Multi-Compound Multivesicular Liposomes for Co-Delivery of Traditional Chinese Medicine Compounds - Mengjie Rui; Yali Su; Haidan Tang; Yinfeng Li; Naying Fang; Yingying Ge; Qiuqi Feng; Chunlai Feng (AAPS PharmSciTech, 2025)

Experimental and Theoretical Investigation of the Formation of Daidzein Ion-pair Compounds: Solubility, Hydrogen Bonds, Stability - Zhaoyang Zhang; Sheng Wang; Qianlei Wang; Qian Ye; Wenjuan Wang (AAPS PharmSciTech, 2025)

Unveiling the Potential of Nanosuspension Formulation Strategy for Improved Oral Bioavailability of Gefitinib - Parvez Sayyad; Shikha Jha; Reena Sharma; Vivek Yadav; Sanyog Jain (AAPS PharmSciTech, 2025)

Current Status and Future Prospects of Lyotropic Liquid Crystals as a Nanocarrier Delivery System for the Treatment of Cancer - Raj Baldha; G. S. Chakraborthy; Sachin Rathod (AAPS PharmSciTech, 2025)

Current Developments in the Delivery of Gastro-Retentive Drugs - Kamal Shah; Disha Singh; Rutvi Agrawal; Akash Garg (AAPS PharmSciTech, 2025)

Rodent Diets Incorporated with Live Biotherapeutic Products (LBPs): An Innovative Dosing Strategy to Support Preclinical Animal Studies on LBP Intervention - Haixi Cui; Yongrong Zhang; Hua Yu; R. Gary Hollenbeck; Lydia Nyasae; Yihan Wang; Yiguang Han; Zhiyong Yang; Hanping Feng; Stephen W. Hoag (AAPS PharmSciTech, 2025)

Development of a Dermal Nanoemulsion with Antioxidants Derived from Rice Residues Using an HLD Theory Approach - Paola Vargas-Escobar; Patricia Quintero-Rincón; Oscar Flórez-Acosta (AAPS PharmSciTech, 2025)
Agricultural waste, such as rice straw, has become increasingly valuable as biocomposites in various industries. For cosmetic and pharmaceutical sectors, these biocomposites have improved active substance incorporation and waste reduction, which is pivotal for mitigating environmental impact. This study reports the encapsulation of a protein derivative derived from rice straw within a nanoemulsion for skin care applications, emphasizing stability and efficacy. Protein hydrolysates were produced by extracting proteins in an alkaline medium, followed by precipitation at the isoelectric point. The hydrolysates were enzymatically treated with Alcalase® at 80 °C and pH 10 for 45 min to generate antioxidant-rich formulations. Utilizing Hydrophilic-Lipophilic Deviation (HLD) theory, oil-in-water (O/W) emulsions were formulated by adjusting variables to achieve an HLD near zero. Sunflower oil and surfactants were combined, stirred at 70 °C, and homogenized using a rotor–stator. The final formulation's stability and permeability were evaluated through fluorescence microscopy, particle size analysis, zeta potential measurements, and accelerated stability assays. Nanoemulsion ENE37 showed high stability with 47.25 nm size, PDI 0.21, and excellent dispersion, maintaining integrity without phase separation. Hydrolyzed protein into ENE37 (NE37-HP) improved stability, increasing zeta potential and preventing aggregation while maintaining structure without phase inversion. NE37-HP exhibited shear-thinning behavior and good diffusion capacity, achieving 20.14 μg/cm 2 .h. The HLD theory and ternary diagrams are valuable methodological tools for formulating stable nanoscale emulsions. Additionally, this dosage form, containing protein hydrolysates derived from rice straw, demonstrated potential for adequate dermal absorption in humans. Graphical Abstract

Evaluation of Physicochemical, Microstructure Parameters (Q3) and Performance Attributes of Commercial Ketoprofen Gels - Şeyma İşkin; Emine Kahraman; Sevgi Güngör (AAPS PharmSciTech, 2025)
In vitro methods for quality and equivalence assessment of semi-solid products applied to the skin have increasingly garnered attention because in vivo bioequivalence studies is high cost, complexity, and time-consuming. Regulatory authorities established draft guidelines that outline a modular framework demanding qualitative, quantitative, microstructure and product performance equivalence to support generic products. In line with these guidelines, our study aimed to evaluate the relationship between microstructure and performance attributes in both originator and generic semi-solid products applied to the skin. In this context, reference and three generics of ketoprofen gel were selected as models for semi-solid formulations. Microstructure of all products was assessed regarding pH, specific gravity, drying rate, formulation rheology and potential drug polymorphism. Additionally, performance attributes of products were evaluated using in vitro release testing and in vitro permeation testing. Polymorphism and drying rate data showed no significant difference in microstructure of ketoprofen gels. All tested products exhibited pseudo-plastic flow behavior with thixotropic characteristic. However, differences in pH, specific gravity and viscosity values at low shear stress were observed between reference product and generic products, according to EMA guidance. Although IVRT outcomes did not entirely align with Q3 attributes, IVRT results for reference product versus Generic Product-I and Generic Product-II met the acceptance limits according to FDA guidance, which differs from EMA's assessment. Furthermore, in vitro release rate results were consistent with IVPT data. Consequently, it can be concluded that microstructure of semi-solid products applied to the skin may not consistently correlate with performance attributes due to various alternations influenced by manufacturing process parameters and/or formulation components. Graphical Abstract

Investigating the Influence of Crospovidone’s Manufacturer Variability on Dissolution Profiles of Hydrochlorothiazide Tablets - Arash Yavari; Seyed Kazem Sadjady; Elham Moniri; Ali Nokhodchi; Fatemeh Haghighat Talab (AAPS PharmSciTech, 2025)

Characterization of Interpolyelectrolyte Complexes Based on Eudragit® RL and Oppositely Charged Eudragit® Polyanions as a Novel Matrix System for Colon-specific Drug Delivery - Rouslan I. Moustafine; Natalia N. Porfiryeva; Shamil F. Nasibullin; Alexander Y. Sitenkov; Aleksandra V. Sitenkova; Venera R. Timergalieva; Vera A. Kemenova (AAPS PharmSciTech, 2025)

Fabrication, Characterization, and Pharmacokinetics of Phospholipid-Based Naturosomal Nanocarriers for Enhanced Oral Solubility and Bioavailability of Naringin - Vijay Metkari; Rohit Shah; Nitin Salunkhe; Shailendra Gurav (AAPS PharmSciTech, 2025)

Machine Learning-Based Prediction of Drug Solubility in Lipidic Environments: The Sol_ME Tool for Optimizing Lipid-Based Formulations with a Preliminary Apalutamide Case Study - Swayamprakash Patel; Ami Kalasariya; Jagruti Desai; Mehul Patel; Ashish Patel; Umang Shah (AAPS PharmSciTech, 2025)

Intranasal Delivery of Paclitaxel-Loaded Ligand Conjugated Polymeric Nanoparticles for Targeted Brain Delivery - Vishawambhar Deshmukh; Mahaveer Narwade; Kavita Rai Gajbhiye (AAPS PharmSciTech, 2025)

Long-Term Stabilized and Highly Soluble Bezafibrate-Gliclazide Co-Amorphous Binary System - Jorge Cruz-Angeles; Luz María Martínez; Alice M López López; Paulina Cabada-Aguirre; Marcelo Videa; Alejandra Flores (AAPS PharmSciTech, 2025)

Developing Soluplus®-Based Microparticle Amorphous Solid Dispersions with High Drug Loading for Enhanced Celecoxib Dissolution via Electrospraying - Fan Fan; Feng Zhou; Jiayu Zhang; Junhui Yang; Kai Zhuang; Yudong Shan; Lei Jiang; Jiantao Zhang (AAPS PharmSciTech, 2025)

Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications - Ankit Monga; Gagan; Pragya Jamwal; Sumit Sharma; Amanpreet Kaur (AAPS PharmSciTech, 2025)

Valsartan Loaded Solid Self-Nanoemulsifying Delivery System to Enhance Oral Absorption and Bioavailability - Lusi Chen; Xin Zhang; Jiayu Xie; Tao Xiao; Huiying Zhong; Haibing He; Guoqing Zhang; Hongfei Liu (AAPS PharmSciTech, 2025)

Design and Process Considerations for Preparation of Modified Release Ivermectin and Praziquantel Tablets by Wet Granulation - R. Gary Hollenbeck; Raafat Fahmy; Marilyn N. Martinez; Ahmed Ibrahim; Stephen W. Hoag (AAPS PharmSciTech, 2025)

Development and In-Vitro Tuning of Piperine Containing Solid Lipid Microparticles for the Treatment of Rheumatoid Arthritis - Muneeba Aziz; Sajid Bashir; Rai Muhammad Sarfraz; Hira Ijaz; Asif Mahmood; Zulcaif; Bilal Haroon; Milad A. Mezher; Mohamed M. Salem; Sami Al Zahrani; Mounir M. Bekhit (AAPS PharmSciTech, 2025)

Human Plasma-Derived Exosomes: A Promising Carrier System for the Delivery of Hydroxyurea to Combat Breast Cancer - Wajeeha Khalid; Afeefa Aslam; Nadeem Ahmed; Muhammad Sarfraz; Jawad Akbar Khan; Sabeeh Mohsin; Muhammad Shahid Riaz Rajoka; Imran Nazir; Muhammad Imran Amirzada (AAPS PharmSciTech, 2025)

Transethosomes: A Comprehensive Review of Ultra-Deformable Vesicular Systems for Enhanced Transdermal Drug Delivery - Raagul Seenivasan; Praveen Halagali; Devika Nayak; Vamshi Krishna Tippavajhala (AAPS PharmSciTech, 2025)
The transdermal route is one of the effective routes for delivering drugs. It also overcomes many limitations associated with oral delivery. One of the limitations of this route is the drug’s poor skin permeability—stratum corneum, the skin’s outermost layer that also acts as a barrier for the drug to penetrate. Traditional liposomal formulation is utilized to overcome these limitations. However, these liposomes also have certain difficulty in delivering drugs across the barriers. Ultra-deformable vesicles are novel vesicular structures that are flexible and stable, they can easily bypass the skin barriers more efficiently and thus enhance bioavailability. These vesicles consist of ethosomes, transethosomes, and transferosomes. Transethosomes are more advanced than other vesicular systems because they contain ethanol, phospholipids, and edge activators, making them more deformable and easier to penetrate deeper skin membranes. These vesicular systems can be prepared by various methods, such as cold, hot, and thin film hydration. Characterization of transethosomes includes vesicular size, zeta potential, polydispersity index and encapsulation efficiency, stability, and drug release studies. These vesicular systems can be utilized to deliver a variety of medications transdermally, including analgesics, antibiotics, and arthritis medications. Despite their promising potential, ethanol-based formulations present several problems requiring additional study. This review aims to describe various vesicular structures that have been used to overcome the barrier for the transdermal delivery of drugs and also describe brief composition, method of preparation, characterization, mechanism of penetration of transethosomes, as well as highlighted various applications of transethosomes in medicine, clinical trials and patents.

Microfluidic Approach for Enhanced Paeoniflorin Transdermal Delivery: A Comparative Study on Different Chips and Mixing Dynamics - Qifei Gu; Wuqing Xiao; Yingyin Zhu; Wanling Zhong; Xue Sui; Yongchao Liu; Jie Zhang; Huichao Wu; Rui Zhou (AAPS PharmSciTech, 2025)
Paeoniflorin is a natural pharmaceutical ingredient with a widely biological activity. However, as a hydrophilic drug, the problem of low transdermal rate limits its clinical application. To overcome this shortage, LUVs were used as biocompatible carriers of paeoniflorin in this study. We prepared paeoniflorin-loaded large unilamellar vesicles (LUVs) with W/O/W structure by microfluidics. We used four kinds of chips to prepare paeoniflorin LUVs and explored the effects of the chip structures on LUVs properties applying both experiments and numerical simulations. The difference of fluid mixing mechanisms was analyzed among four different channels, including straight and curved structures. Then we evaluated the differences in skin permeability among the three groups, paeoniflorin aqueous solution group, drug-loaded liposome group and blank liposome & drug mixture group, using the abdominal skin of male mice. The results showed that the structure of the microfluidic channel was a key factor affecting the flow rate and mixing efficiency. The mixing efficiency further affected the liposome size. The mixing efficiency of curved channel was not better than that of a straight channel due to the low flow rate and long mixing time. By the results of transdermal experiments, LUVs could reduce the transdermal time and increase the total transdermal amount. LUVs effectively improved the transdermal absorption efficiency of paeoniflorin. In conclusion, paeoniflorin LUVs with highly efficient transdermal were successfully prepared by using microfluidics. We explored the underlying fluid dynamics that lead to variations in the preparation with different chip structures. The transdermal effect of the LUVs was verified. Graphical Abstract

A New and Safe Delivery of Sildenafil Citrate Co-Evaporate Loaded Emulgels for the Cure of Certain Male Sexual Dysfunctions - Shaaban K. Osman; Abobakr M. Yassin; Taher M. Yassin; Ahmed M. Mohammed; Ahmed M. Abdelsalam; Wael A. Mahdi; Sultan Alshehri; Mohamed A. El Hamd; Ahmed A. H. Abdellatif; Mohammed A. Amin; Emad A. Taha (AAPS PharmSciTech, 2025)

A Novel Facile and Efficient Prophylaxis Avenue of Chitosan Oligosaccharide/PLGA Based Polydatin Loaded Nanoparticles Against Bleomycin-Induced Lung Inflammation in Experimental Rat Model - Ahmed Nashaat Alnagar; Amira Motawea; Randa A. Zaghloul; Mamdouh Eldesoqui; Irhan Ibrahim Abu Hashim (AAPS PharmSciTech, 2025)
Lung inflammation is a hallmark of several respiratory diseases. Despite the great effectiveness of the synthetic antiinflammatory agents, they cause potential side effects. Polydatin (PD), a natural phytomedicine, has antioxidant and antiinflammatory effects. Its clinical applications are hindered due to poor aqueous solubility, low bioavailability, and rapid metabolism by first-pass effect. Herein, we report the development of a novel chitosan oligosaccharide-coated PD-loaded Poly dl-lactide-co-glycolide nanoparticles (COS-coated PD/PLGA NPs) against a bleomycin-induced pulmonary inflammation in a rat model. The NPs exhibited a small particle size of 188.57 ± 5.68 nm and a high zeta potential of + 18.13 ± 2.75 mV with spherical architecture and sustained release pattern of PD. In vivo studies in bleomycin-induced lung inflammation in a rat model revealed the superior prophylactic activity of COS-coated PD/PLGA NPs over the free drug (PD) as demonstrated by histopathological and immunohistochemical analyses, alongside biochemical assays evaluating oxidative stress biomarkers and inflammatory cytokine levels. Overall, the optimized COS-coated PD/PLGA NPs formulation offers a promising prophylactic platform against many respiratory diseases. Graphical Abstract

Development of CPAP Overlay Interfaces for Efficient Administration of Aerosol Surfactant Therapy to Preterm Infants - Hasan Jubaer; Sarah Strickler; Dale Farkas; Caleb Dalton; Mohammad A. M. Momin; Kelley M. Dodson; Michael Hindle; Worth Longest (AAPS PharmSciTech, 2025)
The administration of surfactant aerosol therapy to preterm infants receiving continuous positive airway pressure (CPAP) respiratory support is highly challenging due to small flow passages, relatively high ventilation flow rates, rapid breathing and small inhalation volumes. To overcome these challenges, the objective of this study was to implement a validated computational fluid dynamics (CFD) model and develop an overlay nasal prong interface design for use with CPAP respiratory support that enables high efficiency powder aerosol delivery to the lungs of preterm infants when needed (i.e., on-demand) and can remain in place without increasing the work of breathing compared with a baseline CPAP interface. Realistic in vitro experiments were first conducted to generate baseline validation data, and then the CFD model, once validated, was used to explore key design parameters across a range of preterm infant nose-throat geometries and aerosol delivery conditions. The most important factors for efficient aerosol delivery were shown to be (i) maintaining the aerosol delivery flow rate below the tracheal flow rate (to minimize CPAP line loss) and (ii) concentrating the aerosol within the first portion of the inhalation waveform. An optimized design was shown to deliver approximately 37–60% of the nominal dose through the system and to the lungs with low intersubject variability (1050–2200 g infants) across two modes of device actuation (automated and manual) with room for further improvement. Ergonomic curvatures and streamlining of the prong geometries were also found to reduce work of breathing and flow resistance compared with a commercial alternative. Graphical Abstract

Pediatric Formulation Optimization Using a Rational Design: Exploring Amorphous Solid Dispersion Technology with Terbinafine Hydrochloride as a Case Study - Izabelle Amorim Ferreira Boza; Stéfani Laise da Silva; Nicolly Bittencourt Guedes; Giovana Carolina Bazzo; Hellen Karine Stulzer (AAPS PharmSciTech, 2025)

Dosage Optimization Using Physiologically Based Pharmacokinetic Modeling for Pediatric Patients with Renal Impairment: A Case Study of Meropenem - Najia Rahim; Muhammad Sarfraz; Abubakar Bello; Syed Baqir Shyum Naqvi (AAPS PharmSciTech, 2025)

Pharmaceutical Salts: Comprehensive Insights From Fundamental Chemistry to FDA Approvals (2019–2023) - Mori Dhaval; Kiran Dudhat; Aastha Gadoya; Sunny shah; Trupesh Pethani; Nilesh Jambukiya; Ajay Patel; Chintan Kalsariya; Jainabparvin Ansari; Chetan Borkhataria (AAPS PharmSciTech, 2025)

Correction: From Bench to Bedside: ROS-Responsive Nanocarriers in Cancer Therapy - Abhishek Chauhan; Raj Kamal; Rohit Bhatia; Thakur Gurjeet Singh; Ankit Awasthi (AAPS PharmSciTech, 2025)

Silica Nanoparticles: A Promising Vehicle for Anti-Cancer Drugs Delivery - T. Naga Aparna; Rohit Kumar; Shah Raj Ali; Dhaval J. Patel; Kazi Julekha; Touseef Begum; Jyoti Bala; Pawan Kumar (AAPS PharmSciTech, 2025)

Understanding Microemulsions and Nanoemulsions in (Trans)Dermal Delivery - Jasmine Musakhanian; David W. Osborne (AAPS PharmSciTech, 2025)
Continuously explored in pharmaceuticals, microemulsions and nanoemulsions offer drug delivery opportunities that are too significant to ignore, namely safe delivery of clinically relevant drug doses across biological membranes. Their effectiveness as drug vehicles in mucosal and (trans)dermal delivery is evident from the volume of published literature. Commonly, their ability to enhance skin permeation is attributed to dispersion size, a characteristic closely related to solubilization capacity. However, the literature falls short on distinctions between microemulsions and nanoemulsions for definitions, behavior, or specific differences in their mechanisms of action in (trans)dermal delivery. The focus is typically on surfactant/cosurfactant ratio and droplet size but the role of mesostructures or the effect of cosolvent (C sol ), oil (O) or water (W) on permeation profile remain poorly explained. Towards a deeper understanding of these vehicles in (trans)dermal drug delivery, this review begins with their conceptual and practical distinctions before delving into the published works for less obvious but potentially important underlying mechanisms; notably composition and the competitive positioning of system constituents in the resulting microstructures and subsequent effect(s) these may have on skin structures and drug permeability. For practical purposes, this review focuses on formulation systems based on ternary diagrams with commonly accepted non-ionic surfactants, cosurfactants, cosolvents, and oils used in pharmaceutical applications. Graphical Abstract

Concerns Regarding the Use of Kirchhoff’s Laws in Pharmacokinetics - Svein Øie (AAPS PharmSciTech, 2025)
Over the last two years the idea that the principles presented in Kirchhoff’s circuit and voltage laws also pertain to pharmacokinetics (1–3). It is claimed that these principles make the elimination in the liver and kidney more straight forward to model and provide a rationale for understanding why sometimes during bioavailability studies one arrives at bioavailability values greater than 100%. In this paper it will be shown that these claims are based on incorrect translations of the Kirchhoff’s Laws to pharmacokinetics.

Advancements in Transdermal Drug Delivery Systems: Harnessing the Potential of Macromolecular Assisted Permeation Enhancement and Novel Techniques - Pratikeswar Panda; Tejaswini Mohanty; Rajaram Mohapatra (AAPS PharmSciTech, 2025)

Inclusion Complex of Nimodipine with Sulfobutylether-β-cyclodextrin: Preparation, Characterization, In Vitro and In Vivo Evaluation - Jiahui Liu; Meichai Li; Yongjie Huang; Xinyu Wang; Youfa Xu; Zhiqin Fu; Zhizhe Lin; Jianming Chen; Xin Wu (AAPS PharmSciTech, 2025)

New Ionic Liquid Forms of Antituberculosis Drug Combinations for Optimized Stability and Dissolution - Hanan E. Rasmy; Sara A. Abouelmagd; Elsayed A. Ibrahim (AAPS PharmSciTech, 2025)
Isoniazid (INH) and rifampicin (RIF) are the two main drugs used for the management of tuberculosis. They are often used as a fixed drug combination, but their delivery is challenged by suboptimal solubility and physical instability. This study explores the potential of active pharmaceutical ingredient-ionic liquids (API-ILs) to improve the physicochemical and pharmaceutical properties of INH and RIF. Antitubercular drugs, INH, or RIF, were paired with different counter ions (ascorbic acid (AsA), citric acid (CA), tartaric acid (TA), benzoic acid (BA), salicylic acid (SA), and p-amino salicylic acid (PAS)) using the solvent evaporation method. INH and RIF API-ILs were formed successfully using AsA and CA counter ions. IL formation was examined and analyzed using Fourier transform infrared (FTIR) spectroscopy, x-ray powder diffraction (XRPD), and polarized optical microscopy (POM). XRPD and POM confirmed their amorphous nature, while FTIR analysis demonstrated the contribution of hydrogen bonding to IL formation. IL formation enhanced the storage stability of the INH + RIF mixture in the presence of CA. Moreover, RIF-CA IL significantly increased the rate and extent of RIF dissolution. An effect that is unattainable with the RIF/CA physical mixture. Thus, API-IL formation not only enhances RIF dissolution but also facilitates the preparation of stable, compatible INH-RIF combinations. Graphical Abstract

Mechanistic Insights Underlying the Drug Release and Skin Permeation of Guanfacine Transdermal Patch with Various Acrylic Pressure-Sensitive Adhesives - Zhiyuan Hou; Jianing Lin; Xiangcheng Zhao; Jinsong Ding (AAPS PharmSciTech, 2025)

Menthol-based Novel Ultra-Deformable Vesicle: Formulation, Optimization and Evaluation of an Antifungal Drug - Hema Manjushree; Devika Nayak; Praveen Halagali; Mahalaxmi Rathnanand; Roshan Tawale; Koteshwara Ananthmurthy; Jesil Mathew Aranjani; Vamshi Krishna Tippavajhala (AAPS PharmSciTech, 2025)
The current study aims to establish a novel ultra-deformable vesicular system to enhance the drug penetration across the skin by preparing the ketoconazole-loaded menthosomes. It was achieved through regular thin-film evaporation & hydration techniques. To examine the effect of formulation parameters on menthosome characteristics, a 2 3 full factorial design was used using Design-Expert® software. The optimized batch exhibited a vesicle size (107.6 nm), a polydispersity index (PDI) (0.248), entrapment efficiency (% EE) (76.9%), and a zeta potential (-33.7 mV). Results from ex vivo skin permeation studies and in vitro drug release demonstrated enhanced improved skin permeation and drug release compared to other formulations. An in vitro antifungal and in vivo pharmacodynamic study, elucidated the enhanced effectiveness of the optimized formulation against Candida albicans . In summary, menthosomes could serve as a potent vehicle to enhance drug penetration via the skin to improve its antifungal activity. Graphical Abstract

Tea Saponins: a Novel Stabilizer for Enhancing the Oral Bioavailability of Albendazole Nanocrystals - Sumin Lan; Kexi Chen; Liqiang Feng; Panle Sima; Xiaoyao Ji; Feihua Wu; Yining Lin (AAPS PharmSciTech, 2025)

Investigation of the Thermal Stability and Hydrolytic Degradation Kinetics of Poly(Lactide-co-Glycolide) Melts - Beibei Chen; Mark A. Costello; Louise Kuehster; Nathaniel A. Lynd; Bin Qin; Yan Wang; Feng Zhang (AAPS PharmSciTech, 2025)

Therapeutic Potential of Microneedle Assisted Drug Delivery for Wound Healing: Current State of the Art, Challenges, and Future Perspective - Devesh Kumar; Shubham Pandey; Jailani Shiekmydeen; Mohit Kumar; Shruti Chopra; Amit Bhatia (AAPS PharmSciTech, 2025)

In Silico and Experimental Evidence for the Stabilization of rhEPO by Glycine, Glutamic Acid and Lysine - Yoshio Aldo Alarcón-López; Pablo Aguirre-Vidal; Hugo Víctor Vásquez-Valadez; Alejandro Manuel Hernández-Serda; Alfonso Luis Cárdenas-Granados; Carlos E. Espinosa de la Garza; Néstor O. Pérez; Enrique Angeles; Víctor Pérez Medina Martínez (AAPS PharmSciTech, 2025)

Use of Remote Regulatory Assessment (RRA) for Site Evaluations during the COVID-19 Pandemic: The USFDA’s Office of Study Integrity and Surveillance (OSIS) Perspective - Tahseen Mirza; Nicola Fenty-Stewart; Clint Mitchell; Brian Folian; Sean Kassim (AAPS PharmSciTech, 2025)

Multi-Layered Microneedles Loaded with Microspheres - Andrew R. Tadros; Xin Dong Guo; Mark R. Prausnitz (AAPS PharmSciTech, 2025)

Amorphous Solid Dispersions of Glycyrrhetinic Acid: Using Soluplus, PVP, and PVPVA as the Polymer Matrix to Enhance Solubility, Bioavailability, and Stability - Meng-yu Zhao; Xian-bao Shi; Jin-hua Chang; Ru-xing Wang; Jian-yu Zhou; Pei Liu (AAPS PharmSciTech, 2024)

Gene Therapy: Towards a New Era of Medicine - Mokshit Bhagat; Raj Kamal; Jyoti Sharma; Kirandeep Kaur; Amit Sharma; Thakur Gurjeet Singh; Rohit Bhatia; Ankit Awasthi (AAPS PharmSciTech, 2024)

Formulation, Development, and Characterization of AMB-Based Subcutaneous Implants using PCL and PLGA via Hot-Melt Extrusion - Kshitij Chitnis; Nagarjuna Narala; Sateesh Kumar Vemula; Sagar Narala; Sivaram Munnangi; Michael A. Repka (AAPS PharmSciTech, 2024)
The hot-melt extrusion process is currently considered a prominent manufacturing technique in the pharmaceutical industry. The present study is intended to develop amlodipine besylate (AMB)-loaded subcutaneous implants to reduce the frequency of administration, thus improving patient compliance during hypertension management. AMB subcutaneous implants were prepared using continuous hot-melt extrusion technology using poly(caprolactone) and poly(lactic-co-glycolic acid) with dimensions of 3.70 cm (length) by 2.00 mm (diameter). The implants were characterized for thermal characteristics, drug-excipient incompatibilities, surface morphology, fracturability, in vitro drug release, and stability studies. Differential scanning calorimetry study confirmed the drug's crystalline state within the fabricated implants, while textural analysis demonstrated good fracturability in the lead formulation. Scanning electron microscopy revealed the smooth surface morphology of the lead subcutaneous implant. The lead formulation showed an extended drug release profile over 30 days (~ 2.25 mg per day) and followed zero-order release kinetics (R 2 value to 0.9999) with a mean dissolution time of 14.96 days. The lead formulation remained stable for 30 days at accelerated stability conditions of 40°C and 75% relative humidity. In conclusion, developing hot-melt extruded implants could be an alternative to the conventional amlodipine besylate (AMB) formulation. Graphical Abstract

Eco-friendly Nanostructured Liquid Crystals Loaded with Clove Oil as a Sustainable Approach for Managing Infected Burn Wounds - Sally A. EL-Zahaby; Ming Ming Wen; Ibrahim A. Abdelwahab; Yasmine M. Shahine; Sherien A. Abdelhady; Gihan A. Elbatouti (AAPS PharmSciTech, 2024)
Infections are a leading complication in patients with burns. Effective antimicrobial treatment with regenerative tissue healing is required. Utilizing components derived from plant origin such as natural oils as a sustainable and eco-friendly approach for managing disease is highly required nowadays. The aim of the current study is to assess the antibacterial and wound-healing activity of clove oil and its novel eco-friendly nanostructured liquid crystals (Eco-friendly-NLCs) formulation in treating infected burn wounds. A 2 3 full factorial design was used to optimize the Eco-friendly-NLCs. Clove oil and its novel nano-formulation were characterized and subjected to in vitro and in vivo assessments for their efficacy. Twenty rats were used experimentally. The optimum Eco-friendly-NLCs had 189.2 ± 1.9 nm, -22.8 ± 0.7 mV and 0.308 as values for particle size, zeta potential and polydispersity index. Transmission electron microscope images showed discrete spherical shape NLCs with no aggregations. The microbiological and pharmacological results revealed a superior efficacy regarding clove loaded Eco-friendly-NLCs in inhibiting bacterial growth (inhibition zone of 38 mm), significantly reducing inflammatory biomarker levels ( p Graphical Abstract

Advancements in Ocular Modelling and Simulations: Key Considerations and Case Studies - Mohammed Shareef Khan; Aditya Murthy; Tausif Ahmed (AAPS PharmSciTech, 2024)

Establishment of Biopredictive Dissolution and Bioequivalence Safe Space Using the Physiologically Based Biopharmaceutics Modeling for Tacrolimus Extended-Release Capsules - Fulin Bi; Tong Yuan; Baohong Zhang; Jixia Li; Yan Lin; Jin Yang (AAPS PharmSciTech, 2024)

Contemplating Novel W/O Emulsion Based Gel for Anti-Psoriatic Activity of Tofacitinib in Imiquimod-Induced Balb/C Mice Model - Ashwini Aratwar; Indrani Maji; Shrilekha Chilvery; Srushti Mahajan; Mayur Aalhate; Ujala Gupta; Chandraiah Godugu; Pankaj Kumar Singh (AAPS PharmSciTech, 2024)

From Bench to Bedside: ROS-Responsive Nanocarriers in Cancer Therapy - Abhishek Chauhan; Raj Kamal; Rohit Bhatia; Thakur Gurjeet Singh; Ankit Awasthi (AAPS PharmSciTech, 2024)

Mupirocin-Doped α-Cellulose Nanopaper for Wound Dressing: Development, In Vitro Characterization and Antimicrobial Studies - Nivedita Pant; Sarika Wairkar (AAPS PharmSciTech, 2024)

A Novel Self-Assembled Paclitaxel Nanodispersion Facilitates Rapid In-Vitro/In-Vivo Dissociation and Protein Binding - Ajay J. Khopade; Malay D. Shah; Bhushan Borole (AAPS PharmSciTech, 2024)

Impact of Storage on In Vitro Permeation and Mucoadhesion Setup Experiments Using Swine Nasal Mucosa - Jaiza Samara Macena de Araújo; Gabriela Gama Xavier Augusto; Aylla Mesquita Pestana; Francisco Carlos Groppo; Flávia Sammartino Mariano Rodrigues; Pedro Duarte Novaes; Michelle Franz-Montan (AAPS PharmSciTech, 2024)

Pharmacokinetic Prediction of Immediate- and Extended-Release Tablets for Patients with Liver Disease Using Whole Body Physiologically-Based Pharmacokinetic Modeling for the Antipsychotic Drug Quetiapine - Ji-Hun Jang; Seung-Hyun Jeong (AAPS PharmSciTech, 2024)

Mesogenic Architectures for Advanced Drug Delivery: Interrogating Lyotropic and Thermotropic Liquid Crystals - Induja Govindan; Angeeta Paul; Annamalai Rama; Anjana A. Kailas; K. A. Abutwaibe; Thamizharasan Annadurai; Anup Naha (AAPS PharmSciTech, 2024)
The possibility of precisely regulating and targeting drug release with mesophase or Liquid crystal drug delivery systems has drawn much attention recently. This review offers a thorough investigation of liquid crystal drug delivery systems with an emphasis on their mesogenic architecture. It describes the various liquid crystal forms such as thermotropic and lyotropic liquid crystals and their applicability in advanced drug delivery. Liquid crystals are used as excellent carriers due to their distinctive characteristics, such as stimuli-responsive drug delivery and sustained release patterns. Comprehending the materials that form mesophase provides insight into their distinct physiochemical characteristics and their use in drug delivery. This review highlights the important role lyotropic and thermotropic liquid crystals play in drug delivery, underscoring their considerable potential. The transition of thermotropic liquid crystals from their conventional technological applications to drug delivery has been studied. Nonetheless, a few challenges still need to be addressed, including formulation strategy refinement, regulating release rates, maximising the loading of hydrophilic drugs, and storage stability. In the pharmaceutical field, addressing these issues will open the door to a revolutionary paradigm that will revolutionise therapeutic outcomes and improve patient care. Graphical Abstract

Isoquercitrin Loaded PEGylated Long Circulating Liposomes Improve Bone Mass and Reduce Oxidative Stress After Osteoporosis - Liangju Sheng; Fuping Gao; Zhe Lan; Bin Zong; Qilong Wang (AAPS PharmSciTech, 2024)

Cyclodextrin Drugs in Liposomes: Preparation and Application of Anticancer Drug Carriers - Lanni Feng; Ruting Wei; Jiali Wu; Xinmei Chen; Yan Wen; Jianming Chen (AAPS PharmSciTech, 2024)

Investigation of Minipigs as the Optimal Non-rodent Pre-clinical Species: Exploring Plasma Protein Binding of Marketed Cardiovascular Drugs Across Species - Subodh Mondal; Ritika Uppal; Satish CS (AAPS PharmSciTech, 2024)

Bifunctional Oxaliplatin (IV) Prodrug Based pH-Sensitive PEGylated Liposomes for Synergistic Anticancer Action Against Triple Negative Breast cancer - Lavkesh Bhute; Sayali Dighe; Oly Katari; Vivek Yadav; Sanyog Jain (AAPS PharmSciTech, 2024)

Physiologically Based Biopharmaceutics Modeling Coupled with Biopredictive Dissolution in Development of Bioequivalent Formulation for Mesalamine Enteric Coated Tablet: A Tough Nut to Crack - Sivacharan Kollipara; Pankaj Kumar Prabhat; Paramita Saha; Saurabh Gupta; Venkat Ramana Naidu; Tausif Ahmed (AAPS PharmSciTech, 2024)

Unveiling Swelling and Erosion Dynamics: Early Development Screening of Mirabegron Extended Release Tablets - Ana S. Sousa; J. Serra; C. Estevens; R. Costa; António J. Ribeiro (AAPS PharmSciTech, 2024)
Although the development of extended release (ER) matrices has been extensively investigated, understanding the most appropriate mechanism of drug release to achieve the desired release remains a cost- and time-consuming challenge in the early stages of formulation development. This study aimed to investigate the early stage of developing ER hydrophilic matrix tablets containing mirabegron as a model drug, focusing on the effects of polymer type, diluent type, and polymer amount on critical quality attributes (CQAs), namely, tablet swelling and erosion behavior. A full factorial design was employed to explore the interactions of control factors through multivariate regression analysis, emphasizing the application of quality by design (QbD) principles. The swelling and erosion performances of 72 formulations were evaluated. The swelling data were fitted to the Vergnaud model. Finally, in vitro drug release profiles were investigated for four of the formulations studied. The polymer type, diluent type, and polymer amount had distinct effects on the swelling and erosion behavior of the ER matrix tablets. Compared with those with isomalt (G720) or dextrate (DXT), formulations with polyethylene glycol 8000 (P8000) consistently exhibited greater swelling. Additionally, higher molecular weight was correlated with increased swelling within the same polymer type. Hydroxypropylmethylcellulose (HPMC) and polyethylene oxide (PEO)-based formulations showed higher swelling rates, while polyvinyl alcohol (PVA-80) displayed the highest erosion percentage. The findings highlight the significance of incorporating early-stage screening designs to maximize efficiency and optimize time and resource. This approach enables the development of a comprehensive understanding of drug release mechanisms from ER matrix tablets. Graphical abstract

Advancements in Exosome Proteins for Breast Cancer Diagnosis and Detection: With a Focus on Nanotechnology - Mohamed J. Saadh; Afrah Majeed Ahmed Al-Rihaymee; Mandeep Kaur; Abhishek Kumar; Ahmed Faisal Mutee; Ghufran Lutfi Ismaeel; Shirin Shomurotova; Mahmood Hasen Shuhata Alubiady; Hamza Fadhel Hamzah; Zainab Abbas Abd Alhassan; Tuqa S. Alazzawi; Khursheed Muzammil; et al. (AAPS PharmSciTech, 2024)

The Comparison between Pilot-Grade Spray Dryer and Laboratory-Grade Spray Dryer: Structure, Powder Properties and Application for Direct Compaction - Zhe Li; Wanghai Peng; Fucai Chen; Lin Zhu; Abid Naeem; Weifeng Zhu; Yongmei Guan; Yi Feng; Yanni Wu; Xiao Lin; Liangshan Ming (AAPS PharmSciTech, 2024)

User-Friendliness Evaluation of Handling pMDI with Various Add-on Devices in Asthmatic Patients - Ahmed M. Abdelfattah; Rania M. Sarhan; Yasmin M. Madney; Ahmed F. Mady; Mohamed E. A. Abdelrahim; Hadeer S. Harb (AAPS PharmSciTech, 2024)
The objective of this study was to assess the use of pMDI alone and pMDI with different spacers in asthmatic patients and to identify any associations between errors in handling the device for the first time and the sessions needed to reach the correct handling method, considering patient demographics and clinical characteristics. A total of 150 Asthmatic patients were crossed over to handle pMDI alone and with add-on inhalable devices (Aerochamber plus, Tips Haler, Able, Dispozable and Aer-8) randomly, without receiving verbal or demonstrative instruction (baseline assessment). The assessment of the inhaler technique was performed using checklists that had been set beforehand. Subsequently, the proper utilization of the inhaler was exhibited, and the patient's inhaler usage was reassessed. The demonstration was repeated until an optimal technique was attained. The number of counselling attempts required to achieve successful management, together with patient demographics and clinical factors, were documented. The mean percentage of total errors at baseline shows that pMDI alone is significantly higher than pMDI attached to add-on devices (53.90 ± 9.71, 32.54 ± 13.93, 24.53 ± 14.93, 21.6 ± 14.48, 25.14 ± 10.99, 27.47 ± 10.28) for pMDI alone, Aerochamber plus, Tips Haler, Able, Dispozable and Aer-8 respectively at p Graphical Abstract

Advancements in Antiviral Therapy: Favipiravir Sodium in Nasal Formulation - Priti Darne; Shankar Vidhate; Somesh Shintre; Somnath Wagdare; Dhiraj Bhamare; Nisha Mehta; Vishal Rajagopalan; Sriram Padmanabhan (AAPS PharmSciTech, 2024)

Long-Circulating and Targeted Liposomes Co-loading Cisplatin and Mifamurtide: Formulation and Delivery in Osteosarcoma Cells - Bo Li; Qianhui Zhao; Hanyu Yang; Xueyuying Wang; Zhijun Zhang; Yanling Gong; Xu Wan (AAPS PharmSciTech, 2024)

Albumin and Polysorbate-80 Coated Sterile Nanosuspensions of Mebendazole for Glioblastoma Therapy - Himaxi Patel; Akanksha Patel; Mukti Vats; Ketan Patel (AAPS PharmSciTech, 2024)

Predicting the Thermodynamic Solubility and Stability of Co-crystals and Eutectics of Febuxostat by using a Thermodynamic Model involving Flory Huggins Interaction Parameter - Moksh Jagia; Arvind K. Bansal; Sarsvatkumar Patel (AAPS PharmSciTech, 2024)

The Role of Amphiphilic Compounds in Nasal Nanoparticles - Thinh To Quoc; Krisztina Bíró; Ágota Pető; Dóra Kósa; Ádám Haimhoffer; István Lekli; Ádám Pallér; István Bak; Alexandra Gyöngyösi; Pálma Fehér; Ildikó Bácskay; Zoltán Ujhelyi (AAPS PharmSciTech, 2024)
Nasal medications hold significant importance and are widely utilized due to their numerous advantageous properties, offering a compelling route for both local and systemic therapeutic effects. Nowadays, the development of nasal particles under 1 micrometer is in the focus of much scientific research. In our experiments, the use of innovative nanotechnology to increase the effectiveness of the active substance was of paramount importance. Our aim was to create solid nanoparticles that enable targeted and effective delivery of the active ingredient into the body. The innovation of this experimental series lies not only in highlighting the importance of amphiphilic compounds in enhancing penetration, but also in the fact that while most nasally administered formulations are in liquid form, our formulation is solid. Liquid formulations frequently suffer from the disadvantage of possible leakage during administration, which can reduce the bioavailability of the active ingredient. In our experiments we created novel drug delivery systems of finely divided powders, which, thanks to the penetration enhancers, can be successfully administered. These enhancers facilitate the swift disintegration and penetration of the particles through the membrane. This represents a new direction in nasal drug delivery methods. The results of our trials are promising in the development of innovative pharmaceutical products and outline the role of amphiphilic compounds in more efficient utilization and targeted application of active substances. According to our results it can be concluded that this innovative approach not only addresses the common issues associated with liquid nasal formulations but also paves the way for more stable and effective delivery methods. The use of finely divided powders for nasal delivery, enabled by penetration enhancers, represents a major breakthrough in the field, providing a dependable alternative to conventional liquid formulations and ensuring improved therapeutic results. Graphical Abstract

The Role of Phase Separation and Local Mobility in the Stabilization of a Lyophilized IgG2 Formulation - Ashley Lay-Fortenbery; Ryan E. Holcomb; Charles S. Henry; Mark Cornell Manning; Eric J. Munson (AAPS PharmSciTech, 2024)

Correction: Croscarmellose Sodium as Pelletization Aid in Extrusion-Spheronization - Finn Siebel; Peter Kleinebudde (AAPS PharmSciTech, 2024)

The Neoteric Paradigm of Biomolecule-Functionalized Albumin-Based Targeted Cancer Therapeutics - Swati Gunjkar; Ujala Gupta; Rahul Nair; Priti Paul; Mayur Aalhate; Srushti Mahajan; Indrani Maji; Manish K. Chourasia; Santosh Kumar Guru; Pankaj Kumar Singh (AAPS PharmSciTech, 2024)

Vesicular Carriers for Improved Oral Anticoagulation Competence of Rivaroxaban: In Vitro and In Vivo Investigation - Samar H. Faheim; Gamal M. El Maghraby; Amal A. Sultan (AAPS PharmSciTech, 2024)
Rivaroxaban is an anticoagulant for avoidance and therapy of thromboembolic disorders. Unfortunately, oral bioavailability of rivaroxaban is compromised with dose increments. Accordingly, the aim was to test nano-vesicular lipid systems for improved oral anticoagulation activity of rivaroxaban. Rivaroxaban loaded niosomes, bilosomes and spanlastic formulations were prepared. The prepared systems were assessed in terms of particle size, zeta potential, transition electron microscopic features (TEM), entrapment efficiency, in-vitro drug release, and in-vivo anticoagulation performance in rats. The prepared vesicular systems exposed spherical negatively charged vesicles with mean particle size values between 136.6 nm to 387.9 nm depending on the composition. Rivaroxaban was efficiently entrapped in the vesicular systems with entrapment efficiency values ranging from 92.4% to 94.0%. Rivaroxaban underwent sustained release from the fabricated vesicular systems. The in vivo performance of the tested preparation revealed significant enhancement of the anticoagulation parameters. This was manifested from the prolonged clotting time, and prothrombin time. Moreover, the cut tails of the examined rats receiving the formulated nano-systems exposed a lengthy tail bleeding time compared to those receiving the un-processed rivaroxaban aqueous dispersion. In Conclusion, niosomes, bilosomes and spanlastic nano-dispersions have a potential to overwhelm the oral anticoagulation efficiency of rivaroxaban with spanlastic ranked as best. Graphical Abstract

Correction: Investigations on the Impacts of Drugs or Excipients with Different Physicochemical and Compaction Properties on the Disintegration Behavior of Kollidon®SR-Based Binary Controlled Release Matrix Tablets - Wasfy M. Obeidat; Shadi F. Gharaibeh (AAPS PharmSciTech, 2024)

Chitosan-Based Nanoformulations: Preclinical Investigations, Theranostic Advancements, and Clinical Trial Prospects for Targeting Diverse Pathologies - Seema Yadav; Abhishek Singh; Narahari N. Palei; Prateek Pathak; Amita Verma; Jagat Pal Yadav (AAPS PharmSciTech, 2024)

Magnesium Stearate Fatty Acid Composition, Lubrication Performance and Tablet Properties - Natalia Veronica; Paul Wan Sia Heng; Celine Valeria Liew (AAPS PharmSciTech, 2024)
Magnesium stearate (MgSt) is a common tablet lubricant. As variations in MgSt properties are known to influence tablet attributes, the impact of MgSt fatty acid composition, particularly the significance of the stearate and palmitate contents, and its effects on tablet properties warrant further investigation. This study investigated the effect of MgSt with different stearate and palmitate contents but comparable physical properties (e.g. particle size, crystallinity, specific surface area and morphology) on lubrication performance and resulting tablet quality attributes, including mechanical strength, disintegratability and drug release. The influence of MgSt concentration and blending duration on the resulting tablet properties was also examined. Tablets produced using the lower stearate content MgSt had slightly higher tensile strength. The effect of MgSt stearate content was more apparent in the disintegration time and drug release, whereby MgSt of lower stearate content resulted in tablets with longer disintegration time and slower drug release. The lower stearate content also resulted in a lower lubrication performance, leading to a lesser reduction in tablet ejection force. As expected, a longer blending time of the tablet formulation blend with MgSt yielded tablets with reduced tensile strength, shorter disintegration time and slower drug release. Tablets with higher MgSt concentration showed a greater reduction in tensile strength, longer disintegration time and faster drug release. The study findings reinforced observations by other researchers and provided a better understanding of the fatty acid composition effects of MgSt on lubrication performance and the resulting tablet properties. Graphical Abstract

Formononetin-Loaded Self-Microemulsion Drug Delivery Systems for Improved Solubility and Oral Bioavailability: Fabrication, Characterization, In Vitro and In Vivo Evaluation - Zhihui Zou; Yuanyuan Xue; Michael Adu-Frimpong; ChengWei Wang; Zhou Jin; Ying Xu; Jiangnan Yu; Ximing Xu; Yuan Zhu (AAPS PharmSciTech, 2024)

Strap-on Buoyant Device to Enhance Gastrointestinal Tract Retention of Felodipine Osmotic Pump Tablets - Qijia Ni; Zeru Li; Libumo Baqing; Tianfu Li; Huipeng Xu; Falan Li; Ningning Peng; Caifen Wang; Jianhua Lu; Zhigang Wang; Kai Wang; Chao Jiang; et al. (AAPS PharmSciTech, 2024)

An Overview of Film-Forming Emulsions for Dermal and Transdermal Drug Delivery - Aideé Morales-Becerril; Liliana Aranda-Lara; Keila Isaac-Olive; Alejandra Ramírez-Villalva; Blanca Ocampo-García; Enrique Morales-Avila (AAPS PharmSciTech, 2024)

Technological Strategies Applied to Pharmaceutical Systems for Intranasal Administration of Drugs Intended for Neurological Treatments: A Review - Maria Vitoria Gouveia Botan; Jéssica Bassi da Silva; Marcos Luciano Bruschi (AAPS PharmSciTech, 2024)

An Adaptive Approach in Polymer-Drug Nanoparticle Engineering using Slanted Electrohydrodynamic Needles and Horizontal Spraying Planes - Amna Ali; Saman Zafar; Manoochehr Rasekh; Tahir Ali Chohan; Francesca Pisapia; Neenu Singh; Omar Qutachi; Muhammad Sohail Arshad; Zeeshan Ahmad (AAPS PharmSciTech, 2024)

Non-Invasive Techniques of Nose to Brain Delivery Using Nanoparticulate Carriers: Hopes and Hurdles - Mansi Butola; Nidhi Nainwal (AAPS PharmSciTech, 2024)

Understanding of Wetting Mechanism Toward the Sticky Powder and Machine Learning in Predicting Granule Size Distribution Under High Shear Wet Granulation - Yanling Jiang; Kangming Zhou; Huai He; Yu Zhou; Jincao Tang; Tianbing Guan; Shuangkou Chen; Taigang Zhou; Yong Tang; Aiping Wang; Haijun Huang; Chuanyun Dai (AAPS PharmSciTech, 2024)

Development of Predictive Statistical Model for Gaining Valuable Insights in Pharmaceutical Product Recalls - Jayshil A. Bhatt; Kenneth R. Morris; Rahul V. Haware (AAPS PharmSciTech, 2024)

In Situ Forming Hydrogel Reinforced with Antibiotic-Loaded Mesoporous Silica Nanoparticles for the Treatment of Bacterial Keratitis - Mohammad Mohammadi; Shokoufeh Rahmani; Zohre Ebrahimi; Ghazal Nowroozi; Fatemeh Mahmoudi; Mohsen Shahlaei; Sajad Moradi (AAPS PharmSciTech, 2024)

Development of Minodronic Acid-Loaded Dissolving Microneedles for Enhanced Osteoporosis Therapy: Influence of Drug Loading on the Bioavailability of Minodronic Acid - Beibei Yang; Zeshi Jiang; Xiaoqian Feng; Jingxin Yang; Chao Lu; Chuanbin Wu; Xin Pan; Tingting Peng (AAPS PharmSciTech, 2024)

Effects of Glass Bead Size on Dissolution Profiles in Flow-through Dissolution Systems (USP 4) - Hiroyuki Yoshida; Keita Teruya; Yasuhiro Abe; Takayuki Furuishi; Kaori Fukuzawa; Etsuo Yonemochi; Ken-ichi Izutsu (AAPS PharmSciTech, 2024)

Self-Nanoemulsifying/ Self-Assembled Cubic Nanoparticles Lyophilized Tablet: A Novel Biphasic Release Approach to Enhance the Bioavailability of a Lipophilic Drug - Michael M. Farag; Wessam El-Sebaie; Emad B. Basalious; Omaima N. El-Gazayerly (AAPS PharmSciTech, 2024)
This study aimed to prepare a combined self-nanoemulsifying and self-assembled cubic nanoparticles (SNE/SAC) lyophilized tablet eliciting biphasic release pattern escorted with enhanced bioavailability for drugs hampered with slow dissolution and poor absorption. The antimuscarinic Darifenacin hydrobromide (DRF) was selected as a model drug used to treat overactive bladder-associated nocturia. The DRF-SNE/SAC lyophilized tablet was prepared so that upon reconstitution a mixture of DRF-loaded cubic nanoparticles and nanoemulsion dispersion is obtained. The nanoemulsion portion is responsible for the fast release followed by controlled release of the remaining dose loaded in cubic nanoparticles. A comparative pharmacokinetic study adopting randomized crossover design in male albino rabbits versus marketed product Frequefenacine® tablet was performed. Half of the dose (52.05% ± 4.21%) was rapidly released in the first 4 h followed by sustained release of the remaining drug where (90.16% ± 8.85%) was released in 24 h. The tested system showed 2.45 folds higher % relative bioavailability and 1.57 folds higher C max with 1.62 longer residence time relative to reference product. The results endow the ability of the developed DRF-SNE/SAC lyophilized tablet to be considered as a propitious approach for the treatment of overactive bladder-associated nocturia without midnight dose administration. Graphical Abstract

Demystifying the Potential of Embelin-Loaded Nanoformulations: a Comprehensive Review - Layba Noor; Abdul Hafeez; Md. Azizur Rahman; Km Khushboo Vishwakarma; Archita Kapoor; Nargis Ara; Rabia Aqeel (AAPS PharmSciTech, 2024)

Systematic Approach in the Development of Chitosan Functionalized Iloperidone Nanoemulsions for Transnasal Delivery, In Vitro and In Vivo Studies - Niserga D. Sawant; Pratima A. Tatke; Namita D. Desai (AAPS PharmSciTech, 2024)

Paroxetine Loaded Nanostructured Lipid Carriers Based In-situ Gel for Brain Delivery via Nasal Route for Enhanced Anti-Depressant Effect: In Vitro Prospect and In Vivo Efficacy - Kiran Akbar; Masood Ur Rehman; Fawad Ali Shah; Sidra Younas; Jamelah S. Al-Otaibi; Haroon Khan (AAPS PharmSciTech, 2024)

Effect of Liquid Load Level and Binder Type on the Tabletability of Mesoporous Silica Based Liquisolids - Jan Appelhaus; Kristina E. Steffens; Karl G. Wagner (AAPS PharmSciTech, 2024)
Mesoporous silica offers an easy way to transform liquids into solids, due to their high loading capacity for liquid or dissolved active ingredients and the resulting enhanced dissolution properties. However, the compression of both unloaded and loaded mesoporous silica bulk material into tablets is challenging, due to poor/non-existing binding capacity. This becomes critical when high drug loads are to be achieved and the fraction of additional excipients in the final tablet formulation needs to be kept at a minimum. Our study aimed to investigate the mechanism of compression and tabletability dependent on the Liquid Load Level of the silica and type of filler/binder in binary tabletting mixtures. To this end, Vivapur® 101, FlowLac® 90, Pearlitol® 200 SD and tricalcium citrate tetrahydrate were selected and mixed with Syloid® XDP 3050 at various Liquid Load Levels. Compaction characteristics were analysed using the StylOne® Classic 105 ML compaction simulator. Additionally, the Overall Liquid Load (OLL) was defined as a new critical quality attribute for liquisolid tablets. The Overall Liquid Load allows straightforward, formulation-relevant comparisons between various fillers/binders, liquid components, and silica types. Results indicate strong binding capacity and high plasticity of the fillers/binders as key components for successful high liquid load silica tablet formulation. A volumetric combination of 30% Vivapur® 101 and 70% 0.75 mL/g loaded Syloid® XDP 3050 proved to be the most effective mixture, achieving an Overall Liquid Load of 36–41% [ v / v ] and maintaining a tensile strength of 1.5 N/mm 2 with various liquid vehicles. Graphical Abstract

Development of a Single Vial Mass Flow Rate Monitor to Assess Pharmaceutical Freeze Drying Heterogeneity - Tiffany Yu; Richard Marx; Michael Hinds; Nicholas Schott; Emily Gong; Seongkyu Yoon; William Kessler (AAPS PharmSciTech, 2024)

Effect of Fluid Paraffin on the Formulation Properties of Pressure Sensitive Adhesive Formulations Containing Diclofenac Sodium - Kaede Osanai; Shunsuke Aoki; Chihiro Otsuka; Hirotaka Watanabe; Haruhiko Hikichi; Takayuki Terukina; Hiromu Kondo (AAPS PharmSciTech, 2024)

Discriminative Power of the Flow through Cell Dissolution Tester in Predicting the In Vivo Performance of Pentoxifylline SR Product under Fed and Fasting Conditions - Nesrin F. Taha; Laila H. Emara (AAPS PharmSciTech, 2024)
This study explored, for the first time the role of different designs of the Flow-Through-Cell (FTC, USP IV) dissolution Tester in predicting the in-vivo performance of Pentoxifylline (PTX) sustained-release (SR) market product, under fed & fasting conditions. Release studies of Trental ® SR 400 mg (Sanofi, Egypt), were carried-out in the FTC under different conditions, including: different volumes / compositions of release media, variable FTC flow patterns as well as applying open / closed loop configuration setups. Pharmacokinetic (PK) data, obtained from literature, were converted to in-vivo fraction-absorbed [F A ] using Wagner-Nelson (WN) method. A 1:1 IVIVC was investigated by comparing PTX fraction-dissolved [F D ] under different FTC release designs versus calculated [F A ]. Predicted PK parameters were evaluated, and compared with actual data, with estimation of prediction-error (PE%). The suggested FTC design; a closed-loop setup, with turbulent-flow pattern of the dissolution medium; provided the most acceptable PTX release according to USP labeled limits (USP 27). Also, results showed that PTX release was pronouncedly increased in a finite-volume of gradient-buffer system rather than water, which guarantee complete resemblance to GIT environment. This release design presented the most predictive IVIVC model with PTX in-vivo performance under fasting / fed states, with acceptable PE% values in terms of C max and AUCs. A suggested FTC design is proposed as an alternative dissolution model in the official USP-monograph for PTX SR products. Graphical Abstract

Surfactant-Assisted Wet Granulation-Based Matrix Tablets without Exceptional Additives: Prolonging Systemic Exposure of Model BCS Class II Ketoprofen - Rahat Shamim; Sana Shafique; Khalid Hussain; Nasir Abbas; Sana Ijaz; Nadeem Irfan Bukhari (AAPS PharmSciTech, 2024)

Moxifloxacin HCl -loaded Cellulose Acetate Butylate In Situ Forming Gel for Periodontitis Treatment - Warakon Thammasut; Catleya Rojviriya; Pornsit Chaiya; Thawatchai Phaechamud; Sucharat Limsitthichaikoon (AAPS PharmSciTech, 2024)

Remote Regulatory Assessments of Bioavailability/Bioequivalence Study Conduct by the Office of Study Integrity and Surveillance - Monica Javidnia; Hasan A. Irier; Sean Kassim; Seongeun Julia Cho (AAPS PharmSciTech, 2024)

Material-Sparing Approach to Predict Tablet Capping Under Processing Compression Conditions Based on Mechanical and Molecular Properties Derived from Compaction Simulation and Crystal Structural Analysis - Pratap Basim; Harsh S. Shah; Robert Sedlock; Bhavin V. Parekh; Rutesh H. Dave (AAPS PharmSciTech, 2024)

Development of a Versatile High-through-put Oligonucleotide LC–MS Method to Accelerate Drug Discovery - Changhong Yun; Hyun Chong Woo; Ditte Lovatt; Craig A. Parish; Daniel S. Spellman; Honglue Shen (AAPS PharmSciTech, 2024)

New Insight for Enhanced Topical Targeting of Caffeine for Effective Cellulite Treatment: In Vitro Characterization, Permeation Studies, and Histological Evaluation in Rats - Shahinaze A. Fouad; Taher A. Badr; Ahmed Abdelbary; Maha Fadel; Rehab Abdelmonem; Bhaskara R. Jasti; Mohamed El-Nabarawi (AAPS PharmSciTech, 2024)
Cellulite (CLT) is one of the commonly known lipodystrophy syndromes affecting post-adolescent women worldwide. It is topographically characterized by an orange-peel, dimpled skin appearance hence, it is an unacceptable cosmetic problem. CLT can be modulated by surgical procedures such as; liposuction and mesotherapy. But, these options are invasive, expensive and risky. For these reasons, topical CLT treatments are more preferred. Caffeine (CA), is a natural alkaloid that is well-known for its prominent anti-cellulite effects. However, its hydrophilicity hinders its cutaneous permeation. Therefore, in the present study CA was loaded into solid lipid nanoparticles (SLNs) by high shear homogenization/ultrasonication. CA-SLNs were prepared using Compritol® 888 ATO and stearic acid as solid lipids, and span 60 and brij™35, as lipid dispersion stabilizing agents. Formulation variables were adjusted to obtain entrapment efficiency (EE > 75%), particle size (PS via shunt diffusion. CA-SLN-4 incorporated into Noveon AA−1® hydrogel (CA-SLN-Ngel) showed accepted physical/rheological properties, and in vitro release profile. Histological studies showed that CA-SLN-Ngel significantly reduced mean subcutaneous fat tissue (SFT) thickness with 4.66 fold ( p = 0.035) and 4.16 fold ( p = 0.0001) compared to CA-gel, at 7th and 21st days, respectively. Also, significant mean SFT thickness reduction was observed compared to untreated group with 4.83 fold ( p = 0.0005) and 3.83 fold ( p = 0.0043), at 7th and 21st days, respectively. This study opened new avenue for CA skin delivery via advocating the importance of skin appendages. Hence, CA-SLN-Ngel could be a promising nanocosmeceutical gel for effective CLT treatment. Graphical Abstract

Advancements in Colon-Targeted Drug Delivery: A Comprehensive Review on Recent Techniques with Emphasis on Hot-Melt Extrusion and 3D Printing Technologies - Nouf D. Alshammari; Rasha Elkanayati; Sateesh Kumar Vemula; Esraa Al Shawakri; Prateek Uttreja; Mashan Almutairi; Michael A. Repka (AAPS PharmSciTech, 2024)
This review investigates the progression and effectiveness of colon-targeted drug delivery systems, offering a comprehensive understanding of the colon's anatomy and physiological environment. Recognizing the distinctive features of the colon is crucial for successfully formulating oral dosage forms that precisely target specific areas in the gastrointestinal tract (GIT) while minimizing side effects through mitigating off-target sites. This understanding forms the basis for designing effective targeted drug delivery systems. The article extensively examines diverse approaches to formulating drugs for colonic targeting, highlighting key polymers and excipients in their production. Special emphasis is given to innovative approaches such as hot-melt extrusion (HME) and three-dimensional printing (3D-P), renowned for their accuracy in drug release kinetics and intricate dosage form geometry. However, challenges arise regarding material standardization and the complex network of regulatory clearances required to confirm safety and effectiveness. The review provides insights into each application’s advantages and potential challenges. Furthermore, it sheds light on the local diseases that necessitate colon targeting and the available marketed products, providing an overview of the current state of colon-targeted drug delivery systems. Additionally, the review emphasizes the importance of testing drugs in a controlled in vitro environment during the development phase. It also discusses the future directions for successful development in this field. By integrating knowledge across anatomy, formulation techniques, and assessment methodologies, this review is a valuable resource for researchers navigating the dynamic field of colonic drug delivery. Graphical Abstract

Rosuvastatin Flexible Chitosomes: Development, In Vitro Evaluation and Enhancement of Anticancer Efficacy Against HepG2 and MCF7 Cell Lines - Nermin E. Eleraky; Abeer S. Hassan; Ghareb M. Soliman; Mohammed M. H. Al-Gayyar; Mohamed A. Safwat (AAPS PharmSciTech, 2024)

Investigations on the Impacts of Drugs or Excipients with Different Physicochemical and Compaction Properties on the Disintegration Behavior of Kollidon®SR-Based Binary Controlled Release Matrix Tablets - Wasfy M. Obeidat; Shadi F. F. Gharaibeh (AAPS PharmSciTech, 2024)

Docetaxel-tethered di-Carboxylic Acid Derivatised Fullerenes: A Promising Drug Delivery Approach for Breast Cancer - Charu Misra; Jasleen Kaur; Manish Kumar; Lokesh Kaushik; Deepak Chitkara; Simran Preet; Muhammad Wahajuddin; Kaisar Raza (AAPS PharmSciTech, 2024)

Correction: Microbicidal Polymer Nanoparticles Containing Clotrimazole for Treatment of Vulvovaginal Candidiasis - María del Rocío Lara-Sánchez; Adriana Ganem-Rondero; María Guadalupe Nava-Arzaluz; Andrea Angela Becerril-Osnaya; Laura Abril Pérez-Carranza; Sergio Alcalá-Alcalá; Néstor Mendoza-Muñoz; Elizabeth Piñón-Segundo (AAPS PharmSciTech, 2024)

Correction: Synthesis of Quarternized Chitosans and Their Potential Applications in the Solubility Enhancement of Indomethacin by Solid Dispersion - Sasikarn Sripetthong; Sirinporn Nalinbenjapun; Abdul Basit; Chitchamai Ovatlarnporn (AAPS PharmSciTech, 2024)

An Exploration of Dissolution Tests for Inhalation Aerosols - Min Wang; Zhaoying Fang; Kunhao Yang; Xiaowei Guo; Shangyang Li; Ali Liu (AAPS PharmSciTech, 2024)

Prolonged Skin Retention of Luliconazole from SLNs Based Topical Gel Formulation Contributing to Ameliorated Antifungal Activity - Manjot Kaur; Gurbir Singh; Riya Shivgotra; Manpreet Singh; Shubham Thakur; Subheet Kumar Jain (AAPS PharmSciTech, 2024)

“Enhancing Oral Drug Absorption: Overcoming Physiological and Pharmaceutical Barriers for Improved Bioavailability” - Rashmi Maurya; Akash Vikal; Preeti Patel; Raj Kumar Narang; Balak Das Kurmi (AAPS PharmSciTech, 2024)

Naringenin Nanocrystals Mitigate Rotenone Neurotoxicity in SH-SY5Y Cell Line by Modulating Mitophagy and Oxidative Stress - Vaibhavi Giradkar; Akshada Mhaske; Rahul Shukla (AAPS PharmSciTech, 2024)

HPMC-Zein Film-forming Gel Loaded with 5-Fluorouracil Coupled with CO2 Laser Dermabrasion for Managing Stable Vitiligo - Heba A. Abou-Taleb; Mohamed S. Mohamed; Gamal M. Zayed; Lamiaa N. Abdelaty; Mahmoud A. Makki; Hazem L. Abdel-Aleem; Mohamed A. El-Mokhtar; Helal F. Hetta; Nidaa Abdullah; Mohammed S. Saddik (AAPS PharmSciTech, 2024)

Novel Sustained Release Azithromycin Resinate Fabricated by One-Pot Ion-exchange Performed in Hydro-alcoholic Solution - Hongyu Liang; Meihui Zhao; Shaoning Wang; Da Wang; Jingxin Gou; Yanjie Bai; Mingyue Shen; Junfeng Wang; Yujie Cheng; Ning Ge; Yi Zhao; Jie Zeng; et al. (AAPS PharmSciTech, 2024)

Development of Sinomenine Hydrochloride Sustained-release Pellet With Multiple Release Characteristics - Sijun Wu; Guoming Zhou; Xi Wang; Xiaoyang Zhang; Shubo Guo; Yongqiang Ma; Hai Liu; Wenlong Li (AAPS PharmSciTech, 2024)

Investigation of Mirabegron-loaded Nanostructured Lipid Carriers for Improved Bioabsorption: Formulation, Statistical Optimization, and In-Vivo Evaluation - Pranav Shah; Mansi Patel; Yashwini Kansara; Bhavin Vyas; Pintu Prajapati; Madhulika Pradhan; Sanyog Jain (AAPS PharmSciTech, 2024)

Development of a Temperature and pH Dual-Sensitive In-Situ Gel for Treating Allergic Conjunctivitis - Yanpeng Zhu; Yinghui Liu; Yongyue Wang; Tingting Chen; Xuerui Ma; Ji Li; Dongkai Wang (AAPS PharmSciTech, 2024)

Development and Characterization of Olaparib-Loaded Solid Self-Nanoemulsifying Drug Delivery System (S-SNEDDS) for Pharmaceutical Applications - Yuseon Shin; Mikyung Kim; Chaeyeon Kim; Hyewon Jeon; Jain Koo; Jimin Oh; Soyoung Shin; Yu Seok Youn; Chaemin Lim; Kyung Taek Oh (AAPS PharmSciTech, 2024)

Surface Solid Dispersion of Ketoconazole on Trehalose Dihydrate using Spray Drying to Achieve Enhanced Dissolution Rate - Wanlop Weecharangsan; Robert J. Lee (AAPS PharmSciTech, 2024)

Monitoring of Isothermal Crystallization and Time–Temperature Transformation of Amorphous Felodipine: The Time-Domain Nuclear Magnetic Resonance Method - A. Pajzderska; M. A. Gonzalez; M. Jarek; J. Wąsicki (AAPS PharmSciTech, 2024)
The isothermal crystallization process of felodipine has been investigated using the time-domain Nuclear Magnetic Resonance (NMR) method for amorphous bulk and ground samples. The obtained induction and crystallization times were then used to construct the time–temperature-transformation (TTT) diagram, both above and below the glass transition temperature (T g ). The Nose temperature was found equal to 363 K. Furthermore, the dynamics of crystalline and amorphous felodipine were compared across varying temperatures. Molecular dynamics simulations were also employed to explore the hydrogen-bond interactions and dynamic properties of both systems. Graphical Abstract

Preparation and In Vitro Evaluation of Montelukast Sodium-Loaded 3D Printed Orodispersible Films for the Treatment of Asthma - Ece Özcan-Bülbül; Yağmur Kalender; Ayça Bal-Öztürk; Neslihan Üstündağ-Okur (AAPS PharmSciTech, 2024)

Development, Pharmacokinetics and Antimalarial Evaluation of Dose Flexible 3D Printlets of Dapsone for Pediatric Patients - Adnan A. Khan; Tahir Khuroo; Eman M Mohamed; Sathish Dharani; Kayalar Canberk; Xiaoyu Zhang; Lamba Omar Sangaré; Mathew A. Kuttolamadom; Allison C. Rice-Ficht; Ziyaur Rahman (AAPS PharmSciTech, 2024)

PEGylated pH-Responsive Liposomes for Enhancing the Intracellular Uptake and Cytotoxicity of Paclitaxel in MCF-7 Breast Cancer Cells - Harsh P. Nijhawan; Pooja Shyamsundar; Bala Prabhakar; Khushwant S. Yadav (AAPS PharmSciTech, 2024)

Exploring Co-Amorphous Formulations Of Nevirapine: Insights From Computational, Thermal, And Solubility Analyses - Kayque Almeida dos Santos; Luíse Lopes Chaves; Daniela Nadvorny; Mônica Felts de La Roca Soares; José Lamartine Soares Sobrinho (AAPS PharmSciTech, 2024)

Efficient Delivery of Gold Nanoparticles and miRNA-33a Via Cationic PEGylated Niosomal Formulation to MCF-7 Breast Cancer Cells - Seyedeh Melika Ahmadi; Mohammad Seyedabadi; Pedram Ebrahimnejad; Mozhgan Abasi; Ali Nokhodchi (AAPS PharmSciTech, 2024)
To overcome the challenges associated with the co-delivery of AuNPs (gold nanoparticles) and miRNA as an anti-breast cancer combination therapy, niosomal systems were developed using Span 60, cholesterol, and a cationic lipid (CTAB), and the formulations were optimized using Box-Behnken experimental design. The niosomal formulations with the smallest size were selected for further optimization of size, surface charge, entrapment efficiency, and stability. To achieve this, AuNPs and DSPE-PEG2000 (2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[amino(polyethylene glycol)-2000)were added to the formulation. The optimized niosomal formulation could effectively encapsulate AuNPs with an entrapment efficiency of 34.49% ± 0.84 and a spherical particle size of 153.6 ± 4.62 nm. The incorporation of PEG and CTAB led to notable enhancements in the overall characteristics of the delivery system. To evaluate the effectiveness of the combination therapy, various assessments such as cytotoxicity, apoptosis, and gene expression properties were conducted. The results demonstrated that the combination delivery using the new C-PEG-Nio-AuNPs (cationic pegylated niosomal gold nanoparticles) system and miRNA had the lowest IC50, the highest apoptosis rate, and the most significant upregulation of miRNA and BAX/BCL2 expression in MCF-7 cell growth. In conclusion, this innovative co-delivery approach represents a promising breakthrough in the development of therapeutic agents for breast cancer treatment. By combining multiple therapeutic agents within a single delivery system, this method has the potential to enhance treatment efficacy, reduce side effects, and improve patient outcomes. Graphical Abstract

Nanotechnology-driven Microemulsion Based Intranasal Delivery to Neurotechnology-driven Neuralink: Strategies to Improve Management of Neurodegenerative Disorders - Pragya; Shradha Bisht; Poonam Parashar (AAPS PharmSciTech, 2024)

Torsemide Crystalline Salts with a Significant Spring-Parachute Effect - Xuezhen Deng; Weimin Shi; Kun Qian; Jie Yang; Siyu Yuan; Hong Li (AAPS PharmSciTech, 2024)

The Tiny Big Difference: Nanotechnology in Photoprotective Innovations – A Systematic Review - José Adão Carvalho Nascimento Júnior; Anamaria Mendonça Santos; Ana Maria Santos Oliveira; Alcimary Bispo Santos; Adriano Antunes de Souza Araújo; Diana Marcela Aragón; Luiza Abrahão Frank; Mairim Russo Serafini (AAPS PharmSciTech, 2024)

Concomitant Delivery of Pirarubicin and Salinomycin Synergistically Enhanced the Efficacy of Cancer Therapy and Reduced the Risk of Cancer Relapse - Mohd Anees; Priya Gupta; Harshdeep Kaur; Surender Kharbanda; Harpal Singh (AAPS PharmSciTech, 2024)

Development and Evaluation of Solidified Supersaturated SNEDDS Loaded with Triple Combination Therapy for Metabolic Syndrome - Abdelrahman Y. Sherif; Doaa Hasan Alshora; Mohamed Abbas Ibrahim; Adel Jreebi (AAPS PharmSciTech, 2024)

A Comparative Mathematical Analysis of Drug Release from Lipid-Based Nanoparticles - Pedram Porbaha; Ramin Ansari; Mohammad Reza Kiafar; Rahman Bashiry; Mohammad Mehdi Khazaei; Amirhossein Dadbakhsh; Amir Azadi (AAPS PharmSciTech, 2024)

Oral Bioavailability Enhancement of Poorly Soluble Drug by Amorphous Solid Dispersion Using Sucrose Acetate Isobutyrate - Eman M. Mohamed; Sathish Dharani; Tahir Khuroo; Mohammad T. H. Nutan; Phillip Cook; Rajendran Arunagiri; Mansoor A. Khan; Ziyaur Rahman (AAPS PharmSciTech, 2024)

Breaking Barriers in Alzheimer’s Disease: the Role of Advanced Drug Delivery Systems - Devank Shekho; Ritika Mishra; Raj Kamal; Rohit Bhatia; Ankit Awasthi (AAPS PharmSciTech, 2024)

PLGA Nanoparticles Based Mucoadhesive Nasal In Situ Gel for Enhanced Brain Delivery of Topiramate - Vidhi Tanna; Amisha Vora; Pranav Shah; Anroop B. Nair; Jigar Shah; Sujata P. Sawarkar (AAPS PharmSciTech, 2024)

Design and Evaluation of Inorganic/Organic Hybrid Bio-composite for Site-Specific Oral Delivery of Darifenacin - Wafa Ishaq; Attia Afzal; Muhammad Farooq; Muhammad Sarfraz; Sherjeel Adnan; Hammad Ahmed; Muhammad Waqas; Zainab Safdar (AAPS PharmSciTech, 2024)
Benign hyperplasia (BHP) is a common disorder that affects men over the age of 60 years. Transurethral resection of the prostate (TURP) is the gold standard for operative treatment, but a range of drugs are also available to improve quality of life and to reduce BHP-associated urinary tract infections and complications. Darifenacin, an anti-muscarinic agent, has been found effective for relieving symptoms of overactive bladder associated with BHP, but the drug has poor solubility and bioavailability, which are major challenges in product development. An inorganic/organic bio-composite with gastric pH-resistant property was synthesized for the targeted oral delivery of Darifenacin to the lower gastrointestinal tract (GIT). This development was accomplished through co-precipitation of calcium carbonate in quince seed-based mucilage. The FTIR, XRD, DSC, and TGA results showed good drug-polymer compatibility, and the SEM images showed calcite formation in the quince hydrogel system. After 72 h, the drug release of 34% and 75% were observed in acidic (0.1N HCl) and 6.8 pH phosphate buffer, respectively. A restricted/less drug was permeated through gastric membrane (21.8%) as compared to permeation through intestinal membrane (65%.) The developed composite showed significant reduction in testosterone-induced prostatic hyperplasia (2.39 ± 0.12***) as compared to untreated diseased animal group. No sign of organ toxicity was observed against all the developed composites. In this study, we developed an inorganic–organic composite system that is highly biocompatible and effective for targeting the lower GIT, thereby avoiding the first-pass metabolism of darifenacin. Graphical Abstract

Design and Evaluation of Microemulsion-Based Drug Delivery Systems for Biofilm-Based Infection in Burns - Avirup Biswas; Jesil Mathew A; Shaila Angela Lewis; Selvaraj Raja; Arpita Paul; Kajal Ghosal; Syed Mahmood; Mohd Danish Ansari (AAPS PharmSciTech, 2024)
Normal skin is the first line of defense in the human body. A burn injury makes the skin susceptible to bacterial infection, thereby delaying wound healing and ultimately leading to sepsis. The chances of biofilm formation are high in burn wounds due to the presence of avascular necrotic tissue. The most common pathogen to cause burn infection and biofilm is Pseudomonas aeruginosa. The purpose of this study was to create a microemulsion (ME) formulation for topical application to treat bacterial burn infection. In the present study, tea tree oil was used as the oil phase, Tween 80 and transcutol were used as surfactants, and water served as the aqueous phase. Pseudo ternary phase diagrams were used to determine the design space. The ranges of components as suggested by the design were chosen, optimization of the microemulsion was performed, and in vitro drug release was assessed. Based on the characterization studies performed, it was found that the microemulsion were formulated properly, and the particle size obtained was within the desired microemulsion range of 10 to 300 nm. The I release study showed that the microemulsion followed an immediate release profile. The formulation was further tested based on its ability to inhibit biofilm formation and bacterial growth. The prepared microemulsion was capable of inhibiting biofilm formation. Graphical Abstract

Fabrication of Luteolin Nanoemulsion by Box-Behnken Design to Enhance its Oral Absorption Via Lymphatic Transport - Liangxing Tu; Ju Wang; Yongbing Sun; Yang Wan (AAPS PharmSciTech, 2024)

Skin Penetration and Permeation Properties of Transcutol® in Complex Formulations - Jasmine Musakhanian; David W. Osborne; Jean-David Rodier (AAPS PharmSciTech, 2024)
Percutaneous delivery is explored as alternative pathway for addressing the drawbacks associated with the oral administration of otherwise efficacious drugs. Short of breaching the skin by physical means, the preference goes to formulation strategies that augment passive diffusion across the skin. One such strategy lies in the use of skin penetration and permeation enhancers notably of hydroxylated solvents like propylene glycol (PG), ethanol (EtOH), and diethylene glycol monoethyl ether (Transcutol ® , TRC). In a previous publication, we focused on the role of Transcutol ® as enhancer in neat or diluted systems. Herein, we explore its’ role in complex formulation systems, including patches, emulsions, vesicles, solid lipid nanoparticles, and micro or nanoemulsions. This review discusses enhancement mechanisms associated with hydroalcoholic solvents in general and TRC in particular, as manifested in multi-component formulation settings alongside other solvents and enhancers. The principles that govern skin penetration and permeation, notably the importance of drug diffusion due to solubilization and thermodynamic activity in the vehicle (formulation), drug solubilization and partitioning in the stratum corneum (SC), and/or solvent drag across the skin into deeper tissue for systemic absorption are discussed. Emphasized also are the interplay between the drug properties, the skin barrier function and the formulation parameters that are key to successful (trans)dermal delivery. Graphical Abstract

Development of a Stable Lyophilized Cyclophosphamide Monohydrate Formulation Using Non-Aqueous Solvents - Shaik Riyaz Ahammad; Damodharan Narayanasamy (AAPS PharmSciTech, 2024)

Exploring the Dissolution, Solid-state Properties, and Long-term Storage Stability of Cryoprotectant-free Fenbendazole Nanoparticles - Giselle Bedogni; Lina Vargas Michelena; Katia Seremeta; Nora Okulik; Claudio Salomon (AAPS PharmSciTech, 2024)

Gastroretentive Delivery Approach to Address pH-Dependent Degradation of (+)- and (-)-Phenserine - Pratishtha Verma; Leyla Rezaei; Ramprakash Govindarajan; Nigel H. Greig; Maureen D. Donovan (AAPS PharmSciTech, 2024)

Microbicidal Polymer Nanoparticles Containing Clotrimazole for Treatment of Vulvovaginal Candidiasis - María del Rocío Lara-Sánchez; Adriana Ganem-Rondero; María Guadalupe Nava-Arzaluz; Andrea Angela Becerril-Osnaya; Laura Abril Pérez-Carranza; Sergio Alcalá-Alcalá; Néstor Mendoza-Muñoz; Elizabeth Piñón-Segundo (AAPS PharmSciTech, 2024)
Vulvovaginal candidiasis (VVC) alters the innate cervicovaginal immunity, which provides an important barrier against viruses and other infections. The incidence of this disease has not decreased in the last 30 years, so effective treatments are still needed. Nanoparticles (NPs) of cellulose acetate phthalate (CAP) and clotrimazole (CLZ) were prepared by the emulsification-diffusion method. NPs were characterized using dynamic light scattering, atomic force microscopy and differential scanning calorimetry; their release profile was determined by the dialysis bag technique and mucoadhesion was evaluated with the mucin-particle method. The growth inhibition study of Candida albicans was carried out using the plate counting technique. Finally, accelerated physical stability tests of NPs were carried out, both in water and in SVF. The CAP-CLZ NPs had an average diameter of 273.4 nm, a PDI of 0.284, smooth surfaces and spherical shapes. In vitro release of CLZ from the CAP NPs was categorized with the Weibull model as a matrix system in which initial release was rapid and subsequently sustained. The inhibition of C. albicans growth by the CAP-CLZ NPs was greater than that of free CLZ, and the CAP-only NPs had a microbicidal effect on C. albicans . The NPs showed poor mucoadhesiveness, which could lead to studies of their mucopenetration capacities. An accelerated physical stability test revealed the erosion of CAP in aqueous media. A nanoparticulate system was developed and provided sustained release of CLZ, and it combined an antifungal agent with a microbial polymer that exhibited antifungal activity against C. albicans . Graphical Abstract

Isolation, Purification of Phenolic Glycoside 1 from Moringa oleifera Seeds and Formulation of Its Liposome Delivery System - Feng Shi; Mingjie Gong; Michael Adu-Frimpong; Xia Jiang; Xiaowen Wang; Qinyang Hua; Tingyuan Li; Jiaying Li; Jiangnan Yu; Elmurat Toreniyazov; Xia Cao; Qilong Wang; et al. (AAPS PharmSciTech, 2024)

Antipsoriatic Effect of Silymarin NLCs Based Gel: In Vitro and In Vivo Activity - Faijmahmad Momin; Vijay Kevlani; Shruti Rawal; Riya Patel; Sheetal Acharya; Shreeraj Shah (AAPS PharmSciTech, 2024)

Improvement of Bioavailability of Sildenafil Citrate Through Taste Masked Orodispersible Film for Pulmonary Hypertension Management - Vivek Mewada; Jigar Shah; Shery Jacob; Hiral Shah; Sai H. S. Boddu; Anroop B Nair (AAPS PharmSciTech, 2024)

A Semi-Mechanistic Physiologically Based Biopharmaceutics Model to Describe Complex and Saturable Absorption of Metformin: Justification of Dissolution Specifications for Extended Release Formulation - Adithya Karthik Bhattiprolu; Sivacharan Kollipara; Rajkumar Boddu; Anand Arumugam; Sohel Mohammed Khan; Tausif Ahmed (AAPS PharmSciTech, 2024)

Design and Evaluation of Ophthalmic Thermosensitive In Situ Gel of Compound Salvia - Yanqiu Long; Fang Lei; Jie Hu; Zhiyun Zheng; Shuangying Gui; Ning He (AAPS PharmSciTech, 2024)

Thermally-Induced Supersaturation Approach for Optimizing Drug Loading and Biopharmaceutical Properties of Supersaturated Lipid-Based Formulations: Case Studies with Ibrutinib and Enzalutamide - Arvind Sirvi; Akash Janjal; Kajal Guleria; Mahesh Chand; Abhay T. Sangamwar (AAPS PharmSciTech, 2024)

Tailored Sticky Solutions: 3D-Printed Miconazole Buccal Films for Pediatric Oral Candidiasis - Konstantina Chachlioutaki; Anastasia Iordanopoulou; Orestis L. Katsamenis; Anestis Tsitsos; Savvas Koltsakidis; Pinelopi Anastasiadou; Dimitrios Andreadis; Vangelis Economou; Christos Ritzoulis; Dimitrios Tzetzis; Nikolaos Bouropoulos; Iakovos Xenikakis; et al. (AAPS PharmSciTech, 2024)

Physicochemical Stimuli-Mediated Precipitation Approach for the Modulation of Rifampicin’s Dissolution and Oral Bioavailability - Vineet Kumar Rai; Deepak Pradhan; Jitu Halder; Tushar Kanti Rajwar; Ritu Mahanty; Ivy Saha; Priyanka Dash; Chandan Dash; Saroj Kumar Rout; Jameel Al-Tamimi; Hossan Ebaid; Salim Manoharadas; et al. (AAPS PharmSciTech, 2024)

The Artificial Intelligence-Powered New Era in Pharmaceutical Research and Development: A Review - Phuvamin Suriyaamporn; Boonnada Pamornpathomkul; Prasopchai Patrojanasophon; Tanasait Ngawhirunpat; Theerasak Rojanarata; Praneet Opanasopit (AAPS PharmSciTech, 2024)

Novel First-Generation Dissolution Models to Investigate the Release and Uptake of Oral Lymphotropic Drug Products - Malaz Yousef; Chulhun Park; Nadia Bou Chacra; Neal M. Davies; Raimar Löbenberg (AAPS PharmSciTech, 2024)

A Systematic Investigation of Process Parameters for Small-Volume Aqueous Suspension Production by the Use of Focused Ultrasonication - Nadina Zulbeari; René Holm (AAPS PharmSciTech, 2024)
Aqueous suspensions containing crystalline drug in the sub-micron range is a favorable platform for long-acting injectables where particle size can be used to obtain a desired plasma-concentration profile. Stabilizers are added to the suspensions and screened extensively to define the optimal formulation composition. In the initial formulation screening the amount of drug compound can be limited, necessitating milling methods for small-volume screening predictable for scale-up. Hence, adaptive focused ultrasound was investigated as a potential milling method for rapid small-volume suspensions by identifying the critical process parameters during preparation. Suspensions containing drug compounds with different mechanical properties and thereby grindability, i.e., cinnarizine, haloperidol, and indomethacin with brittle, elastic, and plastic properties, respectively, were investigated to gain an understanding of the manufacturing with adaptive focused acoustics as well as comparison to already established milling techniques. Using a DoE-design, peak incident power was identified as the most crucial process parameter impacting the milling process for all three compounds. It was possible to decrease the sizes of drug particles to micron range after one minute of focused ultrasound exposure which was superior compared to other milling techniques ( e.g., non-focused ultrasound exposure). The addition of milling beads decreased the drug particle sizes even further, thus to a lower degree than other already established milling techniques such as milling by dual centrifugation. This study thereby demonstrated that adaptive focused ultrasonication was a promising method for rapid homogenization and particle size reduction to micron range for different compounds varying in grindability without altering the crystalline structure. Graphical Abstract

Preparation, Characterization and Evaluation of Nintedanib Amorphous Solid Dispersions with Enhanced Oral Bioavailability - Shuyin Liu; Hui Chen; Feng Zhou; Sandip Tiwari; Kai Zhuang; Yudong Shan; Jiantao Zhang (AAPS PharmSciTech, 2024)

Beyond Skin Deep: Phospholipid-Based Nanovesicles as Game-Changers in Transdermal Drug Delivery - Mohamed A. Akl; Muhammad Alaa Eldeen; Abdulsalam M. Kassem (AAPS PharmSciTech, 2024)

Lidocaine HCl-Loaded Polyelectrolyte Complex -Poloxamer Thermoresponsive Hydrogel: In Vitro- In Vivo Anesthetic Evaluations for Tooth Socket Wound Delivery - Nuttawut Supachawaroj; Sucharat Limsitthichaikoon (AAPS PharmSciTech, 2024)