Pharmacokinetics of Two Nanoemulsion Formulations of Δ8-Tetrahydrocannabinol in Rats - Michael Tagen; Linda E. Klumpers; Alexey Peshkovsky (AAPS PharmSciTech, 2023)

Thyme Oil–Containing Fluconazole-Loaded Transferosomal Bigel for Transdermal Delivery - Biswarup Das; Amit Kumar Nayak; Subrata Mallick (AAPS PharmSciTech, 2023)

Unlocking the Potential of Bilosomes and Modified Bilosomes: a Comprehensive Journey into Advanced Drug Delivery Trends - Devika Nayak; Mahalaxmi Rathnanand; Vamshi Krishna Tippavajhala (AAPS PharmSciTech, 2023)

Sticking Detection by Repeated Compactions on a Single Tablet - James Thomas; Phuong Bui; Antonios Zavaliangos (AAPS PharmSciTech, 2023)

Systemically Administered Anti-uPAR Antibody Plasma and Lung ELF Pharmacokinetics Characterized by Minimal Lung PBPK Model - Sharad Sharma; Antony Leonard; Kathryn Phoenix; Hsueh Yuan Chang; Jun Wang; Steven Hansel (AAPS PharmSciTech, 2023)

Inhalation Lenalidomide-Loaded Liposome for Bleomycin-Induced Pulmonary Fibrosis Improvement - Zhilin Luo; Liyuan Ji; Hongting Liu; Yao Sun; Conglu Zhao; Xiang Xu; Xiaoting Gu; Xiaoyu Ai; Cheng Yang (AAPS PharmSciTech, 2023)

Study on the Nasal Drug Delivery System of NMD Liposomes In Situ Thermosensitive Gel - Lin Ma; HeYing Mao; Jing Xu; Jingshu Piao; Mingguan Piao (AAPS PharmSciTech, 2023)

Nanoparticle-Based Approaches for Treatment of Hematological Malignancies: a Comprehensive Review - Umme Hani; B. H. Jaswanth Gowda; Nazima Haider; KVRNS Ramesh; Karthika Paul; Sumel Ashique; Mohammed Gulzar Ahmed; Soumya Narayana; Sourav Mohanto; Prashant Kesharwani (AAPS PharmSciTech, 2023)

Effects of Encapsulation of Caesalpinia sappan L. with Cyclodextrins for Bovine Mastitis - Wasana Chaisri; Parichat Suebsakwong; Hataichanok Pandith; Aussara Panya; Kraisorn Taynawa; Surachai Pikulkaew; Witaya Suriyasathaporn; Siriporn Okonogi; Ruttiros Khonkarn (AAPS PharmSciTech, 2023)

Deep Learning for Drug Development: Using CNNs in MIA-QSAR to Predict Plasma Protein Binding of Drugs - Affaf Khaouane; Latifa Khaouane; Samira Ferhat; Salah Hanini (AAPS PharmSciTech, 2023)

HSPiP and QbD Program–Based Analytical Method Development and Validation to Quantify Ketoconazole in Dermatokinetic Study - Afzal Hussain; Mohhammad Ramzan; Mohammad A. Altamimi; Tahir Khuroo (AAPS PharmSciTech, 2023)

Correction to: Innovative Microemulsion Loaded with Unusual Dimeric Flavonoids from Fridericia platyphylla (Cham.) L.G. Lohmann Roots - Jessyane Rodrigues do Nascimento; Beatriz Santiago de Matos Monteiro Lira; Matheus Oliveira do Nascimento; Gláucia Laís Nunes Lopes; Glaucio Monteiro Ferreira; Glécilla Colombelli de Souza Nunes; Renato Sonchini Gonçalves; André Luis Menezes Carvalho; Wagner Vilegas; Cláudia Quintino da Rocha (AAPS PharmSciTech, 2023)

Empowering Precision Medicine: The Impact of 3D Printing on Personalized Therapeutic - Lorca Alzoubi; Alaa A. A. Aljabali; Murtaza M. Tambuwala (AAPS PharmSciTech, 2023)
This review explores recent advancements and applications of 3D printing in healthcare, with a focus on personalized medicine, tissue engineering, and medical device production. It also assesses economic, environmental, and ethical considerations. In our review of the literature, we employed a comprehensive search strategy, utilizing well-known databases like PubMed and Google Scholar. Our chosen keywords encompassed essential topics, including 3D printing, personalized medicine, nanotechnology, and related areas. We first screened article titles and abstracts and then conducted a detailed examination of selected articles without imposing any date limitations. The articles selected for inclusion, comprising research studies, clinical investigations, and expert opinions, underwent a meticulous quality assessment. This methodology ensured the incorporation of high-quality sources, contributing to a robust exploration of the role of 3D printing in the realm of healthcare. The review highlights 3D printing's potential in healthcare, including customized drug delivery systems, patient-specific implants, prosthetics, and biofabrication of organs. These innovations have significantly improved patient outcomes. Integration of nanotechnology has enhanced drug delivery precision and biocompatibility. 3D printing also demonstrates cost-effectiveness and sustainability through optimized material usage and recycling. The healthcare sector has witnessed remarkable progress through 3D printing, promoting a patient-centric approach. From personalized implants to radiation shielding and drug delivery systems, 3D printing offers tailored solutions. Its transformative applications, coupled with economic viability and sustainability, have the potential to revolutionize healthcare. Addressing material biocompatibility, standardization, and ethical concerns is essential for responsible adoption. Graphical Abstract

Ternary Deep Eutectic Solvents System of Colchicine, 4-Hydroxyacetophenone, and Protocatechuic Acid and Characterization of Transdermal Enhancement Mechanism - Huiqing Piao; Wanchen Xie; Shiqi Li; Jiaqi Wang; Chao Liu; Peng Quan; Liang Fang (AAPS PharmSciTech, 2023)

One Platform Comparison of Polymeric and Lipidic Nanoparticles for the Delivery of Amphotericin B - Nandha Joyson; Anchal Pathak; Keerti Jain (AAPS PharmSciTech, 2023)

ApoE3 Anchored Liposomal Delivery of Rivastigmine for Brain Delivery: Formulation, Characterization, and In Vivo Pharmacokinetic Evaluation - Pooja Khairnar; Ajit Singh; Kailash Ahirwar; Rahul Shukla (AAPS PharmSciTech, 2023)

Development of Sustained Release Formulations Based on Lipid-Liquid Crystal to Control the Release of Deoxycholate: In Vitro and In Vivo Assessment - Maryam Kouhjani; Arezoo Saberi; Farzin Hadizadeh; Elham Khodaverdi; Malihe Karimi; Elaheh Gholizadeh; Hossein Kamali; Ali Nokhodchi (AAPS PharmSciTech, 2023)
Subcutaneous injections of phosphatidylcholine (PC), sodium deoxycholate (NADC), and a mixture of them were found to be an effective option for treating cellulite. However, it is noteworthy that the injection of NADC may result in inflammation as well as necrosis in the injection area. The preparation of a sustained release formulation based on lipid-liquid crystal that controls the release of NADC could be a potential solution to address the issue of inflammation and necrosis at the site of injection. To present a practical and validated approach for accurately determining the concentration of NADC in LLC formulations, spectrofluorimetry was used based on the International Council for Harmonization (ICH) Q2 guidelines. Based on the validation results, the fluorometric technique has been confirmed as a reliable, efficient, and economical analytical method for quantifying NADC concentrations. The method demonstrated favorable attributes of linearity, precision, and accuracy, with an r 2 value of 0.999. Furthermore, it exhibited excellent interday and intraday repeatability, with RSD values below 4%. The recovery percentages ranged from 97 to 100%, indicating the method’s ability to accurately measure NADC concentrations. The subcutaneous injection of the LLC-NADC demonstrated a reduction in inflammation and tissue necrosis in skin tissue, along with an increase in fat lysis within 30 days, when compared to the administration of only NADC solution. Moreover, the histopathological assessment confirmed that the use of the LLC formulation did not result in any detrimental side effects for kidney or heart tissue.

Investigations on Compaction Behavior of Kollidon®SR-Based Multi-component Directly Compressed Tablets for Preparation of Controlled Release Diclofenac Sodium - Wasfy M. Obeidat; Ishraq K. Lahlouh; Shadi F. Gharaibeh (AAPS PharmSciTech, 2023)

Nanohybrid Based on (Mn, Zn) Ferrite Nanoparticles Functionalized With Chitosan and Sodium Alginate for Loading of Curcumin Against Human Breast Cancer Cells - Fatemeh Ahmadi; Majid Saeedi; Jafar Akbari; Mohammad Seyedabadi; Pedram Ebrahimnejad; Katayoun Morteza-Semnani; Shahram Ghasemi; Monire Moalem-Banhangi; Amirhossein Babaei; Seyyed Mohammad Hassan Hashemi; Kofi Asare-Addo; Ali Nokhodchi (AAPS PharmSciTech, 2023)
This study reports on the synthesis of Mn 1 − x Zn x Fe 2 O 4 (Mn, Zn ferrite) magnetic nanoparticles (MNPs) as drug delivery carriers for effective therapeutic outcomes. The MNPs were prepared using the coprecipitation method, and their magnetic properties were investigated based on their composition. Among the compositions tested, Mn 0.8 Zn 0.2 Fe 2 O 4 MNPs exhibited superparamagnetic properties with a saturation magnetization moment of 34.6 emu/g at room temperature (25°C). To enhance the water solubility of curcumin (Cur), known for its hydrophobic nature, it was successfully loaded onto alginate (Alg)/chitosan (Chit)@Mn 0.8 Zn 0.2 Fe 2 O 4 nanoparticles (NPs). The nanocomposite was characterized by field emission scanning electron microscopy (FE-SEM) which revealed a particle size of approximately 20 nm. The crystalline structure of the NPs was analyzed using X-ray diffraction, while Fourier-transform infrared (FTIR), energy-dispersive X-ray, and map analysis techniques were employed for further characterization. In terms of drug release, there was an initial burst release of Cur (around 18%) within the first hour, followed by a slower release (approximately 61%) over the next 36 h. The anti-tumor properties of the Cur-loaded NPs were evaluated using the Methyl Thiazol Tetrazolium (MTT) assay and quantitative real-time polymerase chain reaction. The MTT assay confirmed a higher cytotoxic effect of Cur-loaded Alg/Chit@Mn 0.8 Zn 0.2 Fe 2 O 4 NPs on the MCF-7 breast cancer cell line compared to free Cur, highlighting the significance of incorporating Cur into nano-sized carrier systems. Graphical Abstract

Effects of Sodium Salts of Fatty Acids and Their Derivatives on Skin Permeation of Cromolyn Sodium - Olasunkanmi Evelyn Akinbote; Gabrielle Verana; Amruta A. Dandekar; Akeemat O. Tijani; Dhruv Mishra; Ashana Puri; Steven Dinh (AAPS PharmSciTech, 2023)

Quality-by-Design Approach for Investigating the Efficacy of Tacrolimus and Hyaluronic Acid–Loaded Ethosomal Gel in Dermal Management of Psoriasis: In Vitro, Ex Vivo, and In Vivo Evaluation - Nikhil Dadwal; Amisha; Dilpreet Singh; Amrinder Singh (AAPS PharmSciTech, 2023)

Development and Evaluation of Amorphous Solid Dispersion of Riluzole with PBPK Model to Simulate the Pharmacokinetic Profile - Kanchan Bharti; Deepika Deepika; Manish Kumar; Abhishek Jha; Manjit; Akhilesh; Vinod Tiwari; Vikas Kumar; Brahmeshwar Mishra (AAPS PharmSciTech, 2023)

Trends in Formulation Approaches for Sustained Drug Delivery to the Posterior Segment of the Eye - Arpon Biswas; Abhijit Deb Choudhury; Amol Chhatrapati Bisen; Sristi Agrawal; Sachin Nashik Sanap; Sarvesh Kumar Verma; Anjali Mishra; Shivansh Kumar; Rabi Sankar Bhatta (AAPS PharmSciTech, 2023)

Supersaturable Solid Self-microemulsifying Delivery Systems of Astaxanthin via Spray Drying: Effects of Polymers and Solid Carriers - Wai Thet Aung; Peerawas Kopongpanich; Veerakiet Boonkanokwong (AAPS PharmSciTech, 2023)

Development of Subdermal Implants Using Direct Powder Extrusion 3D Printing and Hot-Melt Extrusion Technologies - Derick Muhindo; Eman A. Ashour; Mashan Almutairi; Michael A. Repka (AAPS PharmSciTech, 2023)

The Use of Nanoneedles in Drug Delivery: an Overview of Recent Trends and Applications - Mohamed Rahamathulla; Santhosh Murugesan; D. V. Gowda; Ali H. Alamri; Mohammed Muqtader Ahmed; Riyaz Ali M. Osmani; Sathish Ramamoorthy; Balamuralidhara Veeranna (AAPS PharmSciTech, 2023)

Novel Sprayable Thermosensitive Benzydamine Hydrogels for Topical Application: Development, Characterization, and In Vitro Biological Activities - Muhammet Davut Arpa; Ebrar Elif Kesmen; Sevde Nur Biltekin (AAPS PharmSciTech, 2023)

Design, Development, and Evaluation of SA-F127:TPGS Polymeric Mixed Micelles for Improved Delivery of Glipizide Drug: In-vitro, Ex-vivo, and In-vivo Investigations - Hemil S. Patel; Bhavin A. Vyas; Subhash Tripathi; Rakesh K. Sharma (AAPS PharmSciTech, 2023)

Innovative Microemulsion Loaded with Unusual Dimeric Flavonoids from Fridericia platyphylla (Cham.) L.G. Lohmann Roots - Jessyane Rodrigues do Nascimento; Beatriz Santiago de Matos Monteiro Lira; Matheus Oliveira do Nascimento; Gláucia Laís Nunes Lopes; Glaucio Monteiro Ferreira; Glécilla Colombelli de Souza Nunes; Renato Sonchini Gonçalves; André Luis Menezes Carvalho; Wagner Vilegas; Cláudia Quintino da Rocha (AAPS PharmSciTech, 2023)

QbD-Guided Traditional Chinese Medicine Manufacturing Process: Development and Optimization of Fluid-Bed Granulation and Drying Processes for Xiaochaihu Capsules - Kaixuan Teng; Hao Fu; Gelin Wu; Ping Gong; Yongjian Xie; Peng Zhou; Xingchu Gong; Haibin Qu (AAPS PharmSciTech, 2023)

Development and Validation of a Stability-indicating UPLC-DAD Method for the Simultaneous Determination of Ivermectin and Praziquantel in Pharmaceutical Tablets and Dissolution Media - Ahmed Ibrahim; Fang Wang; R. Gary Hollenbeck; Marilyn N. Martinez; Raafat Fahmy; Stephen W. Hoag (AAPS PharmSciTech, 2023)

Laboratory Performance Testing of Aqueous Nasal Inhalation Products for Droplet/Particle Size Distribution: an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) - William H. Doub; Julie M. Suman; Mark Copley; Adrian P. Goodey; Sana Hosseini; Jolyon P. Mitchell (AAPS PharmSciTech, 2023)
Although nasal inhalation products are becoming more and more important for the delivery of medicines, characterization of these products for quality control and assessment of bioequivalence is complicated. Most of the problems encountered are associated with the assessment of aerodynamic droplet/particle size distribution (APSD). The droplets produced by the various nasal devices are large, and for suspension products, individual droplets may contain multiple drug particles or none at all. Assessment of suspension products is further complicated by the presence of solid excipient particles. These complications make it imperative that the limitations of the instruments used for characterization as well as the underlying assumptions that govern the interpretation of data produced by these instruments are understood. In this paper, we describe various methodologies used to assess APSD for nasal inhalation products and discuss proper use, limitations, and new methodologies on the horizon.

Comparative Drug Solubility Studies Using Shake-Flask Versus a Laser-Based Robotic Method - Elaheh Rahimpour; Milad Moradi; Atefeh Sheikhi-Sovari; Homa Rezaei; Hadis Rezaei; Vahid Jouyban-Gharamaleki; Martin Kuentz; Abolghasem Jouyban (AAPS PharmSciTech, 2023)

Non-contact Laser Interferometer Method to Characterize Tablet Punches: New Methodology to Assess Surface Roughness - Helen Hughes; Michael Leane; Patrick S. Wray; Mike Tobyn (AAPS PharmSciTech, 2023)

Correction: Therapeutic Potential of Nanocarrier-Mediated Delivery of Phytoconstituents for Wound Healing: Their Current Status and Future Perspective - Mohit Kumar; Puja Keshwania; Shruti Chopra; Syed Mahmood; Amit Bhatia (AAPS PharmSciTech, 2023)

Film Coatings Based on Aqueous Shellac Ammonium Salt “Swanlac® ASL 10” and Inulin for Colon Targeting - S. Strich; H. Azehaf; C. Neut; Y. Lellouche-Jacob; N. Medkour; M. Penning; Y. Karrout (AAPS PharmSciTech, 2023)

Bioequivalence Evaluation of Topical Metronidazole Products Using Dermal Microdialysis in New Zealand Rabbits - Sharareh Senemar; Benjamin A. Kuzma; Tannaz Ramezanli; Priyanka Ghosh; Sam G. Raney; Elena Rantou; Grazia Stagni (AAPS PharmSciTech, 2023)

A Comparative Assessment of Cocrystal and Amorphous Solid Dispersion Printlets Developed by Hot Melt Extrusion Paired Fused Deposition Modeling for Dissolution Enhancement and Stability of Ibuprofen - Preethi Mandati; Dinesh Nyavanandi; Sagar Narala; Abdullah Alzahrani; Sateesh Kumar Vemula; Michael A. Repka (AAPS PharmSciTech, 2023)

Development of an Image-based Method for Tablet Microstructure Description and Its Correlation with API Release Rate - Simona Römerová; Ondřej Dammer; Petr Zámostný (AAPS PharmSciTech, 2023)
The performance of a pharmaceutical formulation, such as the drug (API) release rate, is significantly influenced by the properties of the materials used, the composition of the final product and the tablet compression process parameters. However, in some cases, the knowledge of these input parameters does not necessarily provide a reliable description or prediction of tablet performance. Therefore, the knowledge of tablet microstructure is desirable to understand such formulations. Commonly used analytical techniques, such as X-ray tomography and intrusion mercury porosimetry, are not widely used in pharmaceutical companies due to their price and/or toxicity, and therefore, efforts are made to develop a tool for fast and easy microstructure description. In this work, we have developed an image-based method for microstructure description and applied it to a model system consisting of ibuprofen and CaHPO 4 ∙2H 2 O (API and excipient with different deformability). The obtained parameter, the quadratic mean of the equivalent diameter of the non-deformable, brittle excipient CaHPO 4 ∙2H 2 O, was correlated with tablet composition, compression pressure and API release rate. The obtained results demonstrate the possibility of describing the tablet dissolution performance in the presented model system based on the microstructural parameter, providing a possible model system for compressed solid dosage forms in which a plastic component is present and specific API release is required. Graphical Abstract

Polymeric Nanocapsules Containing Ozonated Oil and Terbinafine Hydrochloride as a Potential Treatment Against Dermatophytes - Francielli Lima dos Santos; Júlia Capp Zilles; Andressa Urbano Machado; Morgana Souza Marques; Bárbara Souza da Costa; Irene Clemes Kulkamp Guerreiro; Alexandre Meneghello Fuentefria; Renata Vidor Contri (AAPS PharmSciTech, 2023)

Functionalised Carbon Nanotubes: Promising Drug Delivery Vehicles for Neurovascular Disorder Intervention - Patrick Komane; Pradeep Kumar; Yahya Choonara (AAPS PharmSciTech, 2023)
Neurovascular diseases are linked to the brain’s blood vessels. These disorders are complicated to treat due to the strict selective characteristics of the blood–brain barrier. Consequently, the potency of the pharmacological treatments for these conditions is immensely diminished, leading to a rise in neurovascular-associated morbidity and mortality. Carbon nanotubes are regarded as essential nanoparticles with a promise of treating neurovascular disorders. Current findings have demonstrated the effectiveness of carbon nanotubes as vehicles for ferrying drugs to the site of interest. This review accentuates the theoretical utilisation of carbon nanotubes as drug nanocarriers equipped with the penetrating capability to the blood–brain barrier for treating neurovascular disorders such as ischemic stroke. The success of the carbon nanotube system may result in the development of a new and highly relevant drug delivery procedure. This review will also cover carbon nanotube functionalisation for applications in the biomedical fields, toxicity, in vitro and in vivo drugs and biomolecule delivery, and the future outlook of carbon nanotubes. Graphical Abstract

3D-Printed Capsaicin-Loaded Injectable Implants for Targeted Delivery in Obese Patients - Manjusha Annaji; Nur Mita; Jessica Heard; Xuejia Kang; Ishwor Poudel; Oladiran Fasina; Padmamalini Baskaran; Sai H. S. Boddu; Amit K. Tiwari; Pengyu Chen; Candace C. Lyman; R. Jayachandra Babu (AAPS PharmSciTech, 2023)

Nanofibers of Glycyrrhizin/Hydroxypropyl-β-Cyclodextrin Inclusion Complex: Enhanced Solubility Profile and Anti-inflammatory Effect of Glycyrrhizin - Jitu Halder; Ritu Mahanty; Tushar Kanti Rajwar; Vineet Kumar Rai; Biswakanth Kar; Goutam Ghosh; Goutam Rath (AAPS PharmSciTech, 2023)

A Novel Oral Drugs Delivery System for Borneol Based on HiCap®100 and Maltodextrin: Preparation, Characterization, and the Investigation as an Intestinal Absorption Enhancer - Yuan Chen; Xiaowei Jin; Yanhui Kuang; Sisi Zhang; Chuanping Zhang; Chuyuan Li; Bohong Guo (AAPS PharmSciTech, 2023)

Chitosan/Polylactic Acid Nanofibers Containing Astragaloside IV as a New Biodegradable Wound Dressing for Wound Healing - Zemei Liu; Yuanju Lv; Guangyan Zheng; Wenli Wu; Xin Che (AAPS PharmSciTech, 2023)

Implementing Nanovesicles for Boosting the Skin Permeation of Non-steroidal Anti-inflammatory Drugs - Manar Adel Abdelbari; Ahmed Hassen Elshafeey; Aly Ahmed Abdelbary; Shaimaa Mosallam (AAPS PharmSciTech, 2023)
The consumption of non-steroidal anti-inflammatory drugs (NSAIDs) have increased lately around the world, as they are considered essential and popular drugs for effective reduction of pain and inflammation. They have analgesic, antipyretic, and anti-inflammatory activities; also, it was reported recently that they protect against various critical disorders like heart attacks and cancer. However, oral use of NSAIDs may cause several pulmonary, gastrointestinal, hepatic, cardiovascular, cerebral, and renal complications. Therefore, topical NSAIDs were recommended as a substitute to oral NSAIDs for the treatment of inflammation and pain. Still, the skin permeation of NSAIDs is considered a challenge, as the skin have an effective barrier function. Therefore, this review investigates various advanced vesicular nanocarriers and their applications through the skin, to augment the topical delivery of NSAIDs through stratum corneum over the conventional systems, enhance their effectiveness, and reduce the unwanted side effects. These innovative systems can manage bioavailability, solubility, stability, safety, and efficacy issues present in conventional systems.

Mucoadhesive, Fluconazole-Loaded Nanogels Complexed with Sulfhydryl-β-cyclodextrin for Oral Thrush Treatment - Farwa Muskan Khalid; Muhammad Ijaz; Arshad Mahmood; Muhammad Khurram Waqas; Talib Hussain; Mulazim Hussain Asim; Nadeem Ahmad; Shumaila Arshad; Masood Ur Rehman; Imran Nazir (AAPS PharmSciTech, 2023)

Viability of Lactobacillus acidophilus in Thin-Film Freeze-Dried Powders Filled in Delayed-Release Vegetarian Capsules in a Simulated Gastric Fluid - Jie-Liang Wang; Benjamin Southard; Miguel O. Jara; Yu-Sheng Yu; Haiyue Xu; Justin Kalafat; Robert O. Williams; Zhengrong Cui (AAPS PharmSciTech, 2023)

Design and Evaluation of Continentalic Acid Encapsulated Transfersomal Gel and Profiling of its Anti-arthritis Activity - Muhammad Waseem Akram; Danish Mazhar; Iqra Afzal; Ahmad Zeb; Qurat Ul Ain; Salman Khan; Hussain Ali (AAPS PharmSciTech, 2023)

New Insights into the Applications of 3D-Printed Biomaterial in Wound Healing and Prosthesis - Aayushi Pandey; Pragya; Jovita Kanoujia; Poonam Parashar (AAPS PharmSciTech, 2023)

Formulation and Development of Flurbiprofen Colon-Specific Eudragit Coated Matrix Tablets: Use of a Novel Crude Banana Peel Powder as a Time-Dependent Polymer - Sateesh Kumar Vemula; Bhaskar Daravath; Sridhar Babu Gummadi; Michael Repka (AAPS PharmSciTech, 2023)

Co-administration of Thymoquinone and Propolis in Liposomal Formulations as a Potential Approach for Treatment of Acetic Acid-Induced Ulcerative Colitis: Physiological and Histopathological Analysis - Eman Alaaeldin; Hesham Refaat; Entesar Ali Saber; Neven Makram Aziz; Nehad M. Reda Abdel-Maqsoud; Mohammed Mustafa Abd El Aleem; Maha Yehia Kamel; Fatma M. Mady (AAPS PharmSciTech, 2023)
A severe form of autoimmune-mediated inflammatory bowel disease (IBD) is termed as ulcerative colitis (UC) which ultimately results in significant mucosal damage and ulceration. Herbal remedies may be employed as an alternative for treatment of UC instead of conventional medications such as Sulfasalazine. Promising natural remedies for the treatment of IBD, including colitis, are propolis extract (PP) and thymoquinone (TQ). This study is aimed at assessing the potential of liposomal formulations of TQ and Egyptian PP in combination therapy on improving their therapeutic efficacy against ulcerative colitis in order to maximize the potential of their beneficial clinical effects. Clinical, biochemical, and histological evaluations of colonic mucosal damage and inflammation were evaluated. The results exhibited a significant increase in tissue MDA, TNFα, and nitrite levels with activation of caspase-3 in the acetic acid-induced colitis group, which is predominantly downregulated in the treatment groups. The prepared formulations of TQ and PP revealed liposomal vesicles in a nanoscale size (192 ± 20.3 and 98.2 ± 20.3 nm, respectively) and accepted stability indicated with a zeta potential of 19.3 ± 0.11 and 17.1 ± 0.25 mV, respectively. They showed an entrapment efficiency of 85.3 ± 12.6% and 69.3 ± 11.8%, respectively. At comparable doses, combination therapy with thymoquinone liposomes and propolis liposomes considerably outperformed free TQ and free PP in reducing inflammation of UC as shown in the present study by clinical, biochemical, and histological evaluations.

Emerging Applications of Hydroxypropyl Methylcellulose Acetate Succinate: Different Aspects in Drug Delivery and Its Commercial Potential - Manisha Choudhari; Shantanu Damle; Ranendra Narayan Saha; Sunil Kumar Dubey; Gautam Singhvi (AAPS PharmSciTech, 2023)

Deep Eutectic Solvents Based on L-Arginine and 2-Hydroxypropyl-β-Cyclodextrin for Drug Carrier and Penetration Enhancement - Jianhua Lv; Pan Wu; Yaru Fang; Wenchang Zhang; Dongwen Liu; Mi Wu; Lei Shang; Huaiguo Li; Yan Zhao (AAPS PharmSciTech, 2023)

Development of Delayed Release Oral Formulation Comprising Esomeprazole Spray Dried Dispersion Utilizing Design of Experiment As An Optimization Strategy - Kaushika Patel; Jaymin Patel; Shreeraj Shah (AAPS PharmSciTech, 2023)

Metronidazole-Loaded Camphor-Based In Situ Forming Matrix for Periodontitis Treatment - Kritamorn Jitrangsri; Nutdanai Lertsuphotvanit; Ngamsil Kabthong; Thawatchai Phaechamud (AAPS PharmSciTech, 2023)

Quantitative Determination of (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate (Ketone Ester) and Its Metabolites Beta-hydroxybutyrate, 1-3-Butanediol, and Acetoacetate in Human Plasma Using LC-MS - Nimishraj Panse; Matthew Halquist; Phillip M. Gerk (AAPS PharmSciTech, 2023)

Percutaneous absorption and Skin accumulation of Lorazepam-Diphenhydramine- Haloperidol Carbopol gel in Porcine Ear Skin - Rabin Neupane; Sai H. S. Boddu; Moawia M. Al-Tabakha; Shery Jacob; R. Jayachandra Babu; Amit K. Tiwari (AAPS PharmSciTech, 2023)

Curcumin/Fusidic Acid Bitherapy Loaded Mixed Micellar Nanogel for Acne Vulgaris Treatment: In Vitro and In Vivo Studies - Raghda Abdel-monem; Eman S. El-leithy; Ahmed Adel Alaa-Eldin; Rania S. Abdel-Rashid (AAPS PharmSciTech, 2023)
The combination of herbal drugs with a topical antibacterial for managing a chronic disease like acne vulgaris has emerged lately to settle side effects and bacterial multidrug resistance. Mixed micelles (MMs) incorporated into nanogel were explored for hybrid delivery of curcumin (Cur) and fusidic acid (FA) combination presenting a multi-strategic treatment. Curcumin-fusidic acid–loaded mixed micelles (Cur-FA-MMs) were assessed for size, surface charge, compatibility, in vitro release, and encapsulation. The selected formula was further loaded into nanogel and investigated for viscosity, ex vivo permeation, and in vivo potential. Cur-FA-MMs exhibited uniform nanosized spherical morphology, and negative surface charge affording high encapsulation for both drugs with a biphasic in vitro release over a period of 48h and good colloidal stability. The attained Cur-FA-MM-loaded nanogel had optimum viscosity with remarkable permeation coefficient values nearly 2-fold that related to plain nanogel. The pharmacodynamic effect of Cur on FA was pronounced by the significant improvement of the skin’s degree of inflammation, epidermal hypertrophy, and congestion in animals treated with Cur-FA-MM-loaded nanogel. In conclusion, micellar nanogel could enable the progressive effect of Cur (an antioxidant with reported antibiotic activity) on FA (antibiotic) and decrease the risk of emerging antibiotic resistance by enhancing the solubility and permeation of Cur. Graphical Abstract

A (Traditional Chinese Medicine) TCM-Inspired Doxorubicin Resistance Reversing Strategy: Preparation, Characterization, and Application of a Co-loaded pH-Sensitive Liposome - Xueyan Zhang; Hua Liu; Na Li; Jiayang Li; Meng Wang; Xiaoliang Ren (AAPS PharmSciTech, 2023)

Exploring Sorafenib and Simvastatin Combination for Ferroptosis-Induced Cancer Treatment: Cytotoxicity Screening, In Vivo Efficacy, and Safety Assessment - Kaushik Kuche; Vivek Yadav; Meet Patel; Rohan Ghadi; Sanyog Jain (AAPS PharmSciTech, 2023)

Development and In Vitro Evaluation of Crizotinib-Loaded Lipid–Polymer Hybrid Nanoparticles Using Box–Behnken Design in Non-small Cell Lung Cancer - Pelinsu Korucu Aktas; Ipek Baysal; Samiye Yabanoglu-Ciftci; Betul Arica (AAPS PharmSciTech, 2023)

Nanovesicular-Mediated Intranasal Drug Therapy for Neurodegenerative Disease - Shalu Singh; Rahul Shukla (AAPS PharmSciTech, 2023)

Quality-by-Design-Based Development of Rivaroxaban-Loaded Liquisolid Compact Tablets with Improved Biopharmaceutical Attributes - Pranav Shah; Heta Desai; Bhavin Vyas; Manisha Lalan; Madhur Kulkarni (AAPS PharmSciTech, 2023)

Development of a Novel Histatin-5 Mucoadhesive Gel for the Treatment of Oral Mucositis: In Vitro Characterization and In Vivo Evaluation - Shiva Golshani; Alireza Vatanara; Saeed Balalaie; Zeinab Kadkhoda; Mohammad Abdollahi; Mohsen Amin (AAPS PharmSciTech, 2023)

Effects of Additives on the Physical Stability and Dissolution of Polymeric Amorphous Solid Dispersions: a Review - Jinghan Li; Yihan Wang; Dongyue Yu (AAPS PharmSciTech, 2023)

Novel Meta-iodobenzylguanidine and Etoposide Complex: Physicochemical Characterization and Mathematical Modeling of Anticancer Activity - Omowumi Akinjole; Kathryn Menta; Abdullah Alsalhi; Majid Bani-Yaghoub; Bi-Botti Celestin Youan (AAPS PharmSciTech, 2023)

Author Correction: Formulation and Evaluation of Chitosan-PLGA Biocomposite Scaffolds Incorporated with Quercetin Liposomes Made by QbD Approach for Improved Healing of Oral Lesions - Neha Manish Munot; Yashwant Dattatraya Shinde; Pranav Shah; Abhinandan Patil; Sandeep B. Patil; Somnath D. Bhinge (AAPS PharmSciTech, 2023)

The In Vitro, In Vivo, and PBPK Evaluation of a Novel Lung-Targeted Cardiac-Safe Hydroxychloroquine Inhalation Aerogel - Mo’tasem M. Alsmadi; Mays M. Jaradat; Rana M. Obaidat; Mohammad Alnaief; Rabab Tayyem; Nasir Idkaidek (AAPS PharmSciTech, 2023)

Preparation and Characterization of 3D-Printed Dose-Flexible Printlets of Tenofovir Disoproxil Fumarate - Canberk Kayalar; Ziyaur Rahman; Eman M. Mohamed; Sathish Dharani; Tahir Khuroo; Nada Helal; Mathew A. Kuttolamadom; Mansoor A. Khan (AAPS PharmSciTech, 2023)

siRNA-Based Novel Therapeutic Strategies to Improve Effectiveness of Antivirals: An Insight - Krittika Chatterjee; Sagheerah Lakdawala; Sheikh Shahnawaz Quadir; Dinesh Puri; Dinesh Kumar Mishra; Garima Joshi; Sanjay Sharma; Deepak Choudhary (AAPS PharmSciTech, 2023)

Fabrication and Evaluation of Anticancer Potential of Eugenol Incorporated Chitosan-Silver Nanocomposites: In Vitro, In Vivo, and In Silico Studies - Hamid Saeed Shah; Sumera Zaib; Muhammad Sarfraz; A. Alhadhrami; Mohamed M. Ibrahim; Aamir Mushtaq; Faisal Usman; Memoona Ishtiaq; Muhammad Sajjad; Hafiz Muhammad Mazhar Asjad; Umar Farooq Gohar (AAPS PharmSciTech, 2023)

Integrating Artificial Intelligence with Quality by Design in the Formulation of Lecithin/Chitosan Nanoparticles of a Poorly Water-Soluble Drug - Marwa H. S. Dawoud; Islam S. Mannaa; Amira Abdel-Daim; Nabila M. Sweed (AAPS PharmSciTech, 2023)
The aim of the current study is to explore the potential of artificial intelligence (AI) when integrated with Quality by Design (QbD) approach in the formulation of a poorly water-soluble drug, for its potential use in carcinoma. Silymarin is used as a model drug for its potential effectiveness in liver cancer. A detailed QbD approach was applied. The effect of the critical process parameters was studied on each of the particle size, size distribution, and entrapment efficiency. Response surface designs were applied in the screening and optimization of lecithin/chitosan nanoparticles, to obtain an optimized formula. The release rate was tested, where artificial neural network models were used to predict the % release of the drug from the optimized formula at different time intervals. The optimized formula was tested for its cytotoxicity. A design space was established, with an optimized formula having a molar ratio of 18.33:1 lecithin:chitosan and 38.35 mg silymarin. This resulted in nanoparticles with a size of 161 nm, a polydispersity index of 0.2, and an entrapment efficiency of 97%. The optimized formula showed a zeta potential of +38 mV, with well-developed spherical particles. AI successfully showed high prediction ability of the drug’s release rate. The optimized formula showed an enhancement in the cytotoxic effect of silymarin with a decreased IC50 compared to standard silymarin. Lecithin/chitosan nanoparticles were successfully formulated, with deep process and product understanding. Several tools were used as AI which could shift pharmaceutical formulations from experience-dependent studies to data-driven methodologies in the future. Graphical abstract

Application of Design of Experiment in the Optimization of Apixaban-Loaded Solid Lipid Nanoparticles: In Vitro and In Vivo Evaluation - Safaa E. Ramadan; Sanaa A. El-Gizawy; Mohamed A. Osman; Mona F. Arafa (AAPS PharmSciTech, 2023)
Solid lipid nanoparticles (SLnPs) are usually utilized as lipid-based formulations for enhancing oral bioavailability of BCS class IV drugs. Accordingly, the objective of this work was to investigate the effect of formulation and processing variables on the properties of the developed SLnPs for oral delivery of apixaban. Randomized full factorial design (2 4 ) was employed for optimization of SLnPs. With two levels for each independent variable, four factors comprising both formulations and processing factors were chosen: the GMS content (A), the Tween 80 content (B), the homogenization time (C), and the content of poloxamer 188 used (D). The modified hot homogenization and sonication method was employed in the formulation of solid lipid nanoparticles loaded with apixaban (APX-SLnPs). The size of APX-SLnPs formulations was measured to lie between 116.7 and 1866 nm, polydispersity index ranged from 0.385 to 1, and zeta potential was discovered to be in the range of − 12.6 to − 38.6 mV. The entrapping efficiency of APX-SLnPs formulations was found to be in the range of 22.8 to 96.7%. The optimized formulation was evaluated in vivo after oral administration to rats. Oral administration of APX-SLnPs resulted in significant prolongation in bleeding time compared with both positive and negative control. This indicates the ability of this system to enhance drug therapeutic effect either by increasing intestinal absorption or trans-lymphatic transport. So, this study highlighted the capability of SLnPs to boost the pharmacological effect of apixaban. Graphical Abstract

A Bacteriophage-Loaded Microparticle Laden Topical Gel for the Treatment of Multidrug-Resistant Biofilm-Mediated Burn Wound Infection - Deepa Dehari; Aiswarya Chaudhuri; Dulla Naveen Kumar; Meraj Anjum; Rajesh Kumar; Akshay Kumar; Dinesh Kumar; Gopal Nath; Ashish Kumar Agrawal (AAPS PharmSciTech, 2023)

In Silico Screening as a Tool to Prepare Drug-Drug Cocrystals of Ibrutinib-Ketoconazole: a Strategy to Enhance Their Solubility Profiles and Oral Bioavailability - Divya Dhatri Kara; Pragathi Devanand Bangera; Chetan Hasmukh Mehta; Katikala Tanvi; Mahalaxmi Rathnanand (AAPS PharmSciTech, 2023)
Ibrutinib (IBR) is a biopharmaceutical classification system (BCS) class II drug and an irreversible Bruton’s tyrosine kinase (BTK) inhibitor. IBR has an extremely low oral bioavailability due to the activity of the CYP3A4 enzyme. The current intention of the research was to enhance solubility followed by oral bioavailability of IBR using the hot melt extrusion (HME) technique by formulating drug-drug cocrystals (DDCs). Ketoconazole (KET) is an active CYP3A4 inhibitor and was selected based on computational studies and solubility parameter prediction. Differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FT-IR), powder X-ray diffraction (PXRD), thermogravimetric analysis (TGA), proton nuclear magnetic resonance ( 1 H NMR), and scanning electron microscopy (SEM) evaluations were employed for estimating the formation of IBR-KET DDCs. The IBR-KET DDC system was discovered to have a hydrogen bond (H-bond) and π-π-stacking interactions, in accordance with the computational results. Further, IBR-KET DDCs showed enhanced solubility, stability, powder dissolution, in vitro release, and flow properties. Furthermore, IBR-KET-DDCs were associated with enhanced cytotoxic activity in K562-CCL-243 cancer cell lines when compared with IBR and KET alone. In vivo pharmacokinetic studies have shown an enhanced oral bioavailability of up to 4.30 folds of IBR and 2.31 folds of KET through IBR-KET-DDCs compared to that of the IBR and KET suspension alone. Thus, the prepared IBR-KET-DDCs using the HME technique stand as a favorable drug delivery system that augments the solubility and oral bioavailability of IBR along with KET. Graphical abstract

Impact of the Drug Loading Method on the Drug Distribution and Biological Efficacy of Exosomes - Dulla Naveen Kumar; Aiswarya Chaudhuri; Dinesh Kumar; Sanjay Singh; Ashish Kumar Agrawal (AAPS PharmSciTech, 2023)

3D-to-4D Structures: an Exploration in Biomedical Applications - Kadambari Borse; Pravin Shende (AAPS PharmSciTech, 2023)

A Pediatric Upper Airway Library to Evaluate Interpatient Variability of In Silico Aerosol Deposition - Emily L. Kolewe; Saurav Padhye; Ian R. Woodward; Yu Feng; Jenna W. Briddell; Catherine A. Fromen (AAPS PharmSciTech, 2023)
The airway of pediatric patients’ changes through development, presenting a challenge in developing pediatric-specific aerosol therapeutics. Our work aims to quantify geometric variations and aerosol deposition patterns during upper airway development in subjects between 3.5 months–6.9 years old using a library of 24 pediatric models and 4 adult models. Computational fluid–particle dynamics was performed with varying particle size (0.1–10 μm) and flow rate (10–120 Lpm), which was rigorously analyzed to compare anatomical metrics (epiglottis angle ( θ E ), glottis to cricoid ring ratio (GC-ratio), and pediatric to adult trachea ratio ( H -ratio)), inhaler metrics (particle diameter, $${d}_{p}$$ d p , and flow rate, Q ), and clinical metrics (age, sex, height, and weight) against aerosol deposition. Multivariate non-linear regression indicated that all metrics were all significantly influential on resultant deposition, with varying influence of individual parameters. Additionally, principal component analysis was employed, indicating that $${d}_{p}$$ d p , Q , GC-ratio, θ E , and sex accounted for 90% of variability between subject-specific deposition. Notably, age was not statistically significant among pediatric subjects but was influential in comparing adult subjects. Inhaler design metrics were hugely influential, thus supporting the critical need for pediatric-specific inhalable approaches. This work not only improves accuracy in prescribing inhalable therapeutics and informing pediatric aerosol optimization, but also provides a framework for future aerosol studies to continue to strive toward optimized and personalized pediatric medicine. Graphical Abstract

Optimization of In Situ Gel-Forming Chlorhexidine-Encapsulated Polymeric Nanoparticles Using Design of Experiment for Periodontitis - Phuvamin Suriyaamporn; Nitjawan Sahatsapan; Prasopchai Patrojanasophon; Praneet Opanasopit; Mont Kumpugdee-Vollrath; Tanasait Ngawhirunpat (AAPS PharmSciTech, 2023)

Towards Formulation of Highly Acidic Active Ingredients: Development of Clinically Effective Concentrated Trichloroacetic Acid Gel for Wart Management - Abdelrahman M. Helmy; Shimaa Shehata Ahmed; Ramy M. El Sabaa; Hossam M. Abdel-Wahab; Sara A. Abouelmagd (AAPS PharmSciTech, 2023)

Flexible New Dosage Forms Containing Carvedilol for the Treatment of Patients with Cardiovascular Disorders: Development, Stability, Palatability, and Microbiological Studies - María Alejandra Operto; Rubén Maggio; Darío Leonardi; Silvana Vignaduzzo (AAPS PharmSciTech, 2023)

Development and Pharmacokinetic Evaluation of Two Parenteral Formulations of Albendazole Using Prodrug and Cosolvent Approaches - José Becerril-Vega; Alicia Hernández-Campos; Iliana González-Hernández; Miguel Flores-Ramos; Rafael Castillo; Gerardo Leyva-Gómez; Lourdes Mayet-Cruz; Helgi Jung-Cook (AAPS PharmSciTech, 2023)
Albendazole is a broad-spectrum anthelmintic drug used for parasitic infections. In addition, due to its mechanism of action, it has been studied as an anticancer agent. However, poor and highly variable bioavailability are limiting factors for its use in systemic illnesses. The present study aimed to develop two parenteral formulations of albendazole and to compare its pharmacokinetic profile with the conventional oral administration. Parenteral formulations were developed using two different approaches: a phosphonooxymethylated prodrug and cosolvents. For the albendazole prodrug, once synthetized, its solubility and hydrolysis with alkaline phosphatase were evaluated. A factorial design of experiments was used for the cosolvent formulation. Stability and hemolytic activity were assessed. A pharmacokinetic study was performed on New Zealand rabbits. Both formulations were administered intravenously, and the prodrug was also administered intramuscularly. Results were compared with those obtained after the oral administration of albendazole. A 20,000-fold and 6000-fold increase in albendazole solubility was found with the prodrug and cosolvent formulations, respectively. Both parenteral formulations displayed higher albendazole plasma concentrations for the first 2 h compared with oral administration, even when the oral dose was doubled. The absolute bioavailability of oral albendazole was 15.5% while for the intramuscular administration of the prodrug was 102.6%. Both parenteral formulations showed a significant decrease in the formation of albendazole sulfoxide (ANOVA p Graphical abstract

Exploring Penetration Ability of Carbonic Anhydrase Inhibitor–Loaded Ultradeformable Bilosome for Effective Ocular Application - Vishnumaya S. Nair; Vaibhavi Srivastava; Valamla Bhavana; Rati Yadav; Naveen Rajana; Shashi Bala Singh; Neelesh Kumar Mehra (AAPS PharmSciTech, 2023)

Development of Lipid Polymer Hybrid Drug Delivery Systems Prepared by Hot-Melt Extrusion - Fritz Eduardo Kasbaum; Danilo Monteiro de Carvalho; Laís de Jesus Rodrigues; Gleidson Cardoso; Ludmila Alvim Gomes Pinho; Felipe Terra Martins; Marcilio Cunha-Filho; Stephânia Fleury Taveira; Ricardo Neves Marreto (AAPS PharmSciTech, 2023)

Therapeutic Potential of Nanocarrier-Mediated Delivery of Phytoconstituents for Wound Healing: Their Current Status and Future Perspective - Mohit Kumar; Puja Keshwania; Shruti Chopra; Syed Mahmood; Amit Bhatia (AAPS PharmSciTech, 2023)

Preclinical Investigation of Transdermal Route for Enhanced Bio-performance of Duloxetine HCl - Rajiv Kumar; V. R. Sinha; Lalita Dahiya; Amita Sarwal (AAPS PharmSciTech, 2023)

Retraction Note: Development and Evaluation of Icariin-Loaded PLGA-PEG Nanoparticles for Potentiation the Proapoptotic Activity in Pancreatic Cancer Cells - Nabil A. Alhakamy (AAPS PharmSciTech, 2023)

Pulmonary Fibrosis: Unveiling the Pathogenesis, Exploring Therapeutic Targets, and Advancements in Drug Delivery Strategies - Kirti Aggarwal; Sandeep Arora; Kalpana Nagpal (AAPS PharmSciTech, 2023)

Recent Update on Nanoemulsion Impregnated Hydrogel: a Gleam into the Revolutionary Strategy for Diffusion-Controlled Delivery of Therapeutics - Jatin Rathee; Sakshi Malhotra; Manisha Pandey; Neha Jain; Shreya Kaul; Gaurav Gupta; Upendra Nagaich (AAPS PharmSciTech, 2023)

Contemporary Techniques and Potential Transungual Drug Delivery Nanosystems for The Treatment of Onychomycosis - Wessam H. Abd-Elsalam; Samar M. Abouelatta (AAPS PharmSciTech, 2023)
The humanoid nail is considered an exceptional protective barrier that is formed mainly from keratin. Onychomycosis is the cause of 50% of nail infections that is generally caused by dermatophytes. Firstly, the infection was regarded as a cosmetic problem but because of the tenacious nature of onychomycosis and its relapses, these infections have attracted medical attention. The first line of therapy was the oral antifungal agents which were proven to be effective; nevertheless, they exhibited hepato-toxic side effects, alongside drug interactions. Following, the opportunity was shifted to the topical remedies, as onychomycosis is rather superficial, yet this route is hindered by the keratinized layers in the nail plate. A potential alternative to overcome the obstacle was applying different mechanical, physical, and chemical methods to boost the penetration of drugs through the nail plate. Unfortunately, these methods might be expensive, require an expert to be completed, or even be followed by pain or more serious side effects. Furthermore, topical formulations such as nail lacquers and patches do not provide enough sustaining effects. Recently, newer therapies such as nanovesicles, nanoparticles, and nanoemulsions have emerged for the treatment of onychomycosis that provided effective treatment with possibly no side effects. This review states the treatment strategies such as mechanical, physical, and chemical methods, and highlights various innovative dosage forms and nanosystems developed in the last 10 years with a focus on advanced findings regarding formulation systems. Furthermore, it demonstrates the natural bioactives and their formulation as nanosystems, and the most relevant clinical outcomes. Graphical Abstract

Formulation Intervention to Overcome Decreased Kinetic Solubility of a Low Tg Amorphous Drug - Mangesh S. Bordawekar; Madhu Pudipeddi; Colleen E. Ruegger; Sundeep S. Dhareshwar (AAPS PharmSciTech, 2023)

Correction to: Salix subserrata Bark Extract-Loaded Chitosan Nanoparticles Attenuate Neurotoxicity Induced by Sodium Arsenate in Rats in Relation with HPLC–PDA-ESI–MS/MS Profle - Daila I. Hamdan; Nora Tawfeek; Riham A. El-Shiekh; Heba M. A. Khalil; Mohamed Y. Mahmoud; Alaa F. Bakr; Dalia Zaafar; Nawaal Farrag; Michael Wink; Assem Mohamed El-Shazly (AAPS PharmSciTech, 2023)

Photothermal Therapy Mediated Hybrid Membrane Derived Nano-formulation for Enhanced Cancer Therapy - Xia Cao; Tianwen Deng; Qin Zhu; Jianping Wang; Wenwan Shi; Qi Liu; Qintong Yu; Wenwen Deng; Jiangnan Yu; Qilong Wang; Gao Xiao; Ximing Xu (AAPS PharmSciTech, 2023)

Formulation and Evaluation of Chitosan-PLGA Biocomposite Scaffolds Incorporated with Quercetin Liposomes Made by QbD Approach for Improved Healing of Oral Lesions - Neha Manish Munot; Yashwant Dattatraya Shinde; Pranav Shah; Abhinandan Patil; Sandeep B. Patil; Somnath D. Bhinge (AAPS PharmSciTech, 2023)

Telmisartan-Loaded Lactosylated Chitosan Nanoparticles as a Liver Specific Delivery System: Synthesis, Optimization and Targeting Efficiency - Mohamed Nasr; Ahmed Y. Kira; Sameh Saber; Ebtessam A. Essa; Sanaa A. El-Gizawy (AAPS PharmSciTech, 2023)
Hepatocellular carcinoma (HCC) has a significant economic impact and a high mortality rate. Telmisartan (TLM) is a potential therapy for HCC, but it has a limited scope in drug delivery due to unpredictable distribution and poor bioavailability. The objective of this study was to prepare, design, and in vitro evaluate lactose-modified chitosan nanoparticles (LCH NPs) as a liver-targeted nanocarrier for TLM with the potential to offer a promising HCC therapy. The combination of chitosan with lactose was successfully attained using the Maillard reaction. TLM-LCH NPs were prepared, characterized, and optimized with the developed 2 3 full factorial design. The optimized formulation (F1) was in vitro and in vivo characterized. LCH was synthesized with an acceptable yield of 43.8 ± 0.56%, a lactosylation degree of 14.34%, and a significantly higher aqueous solubility (6.28 ± 0.21 g/L) compared to native chitosan (0.25 ± 0.03 g/L). In vitro characterization demonstrated that, F1 had a particle size of 145.46 ± 0.7 nm, an entrapment efficiency of 90.21 ± 0.28%, and a surface charge of + 27.13 ± 0.21 mV. In vitro TLM release from F1 was most consistent with the Higuchi model and demonstrated significantly higher release at pH 5.5. Moreover, a significantly higher ratio of liver to plasma concentration was observed with TLM-LCH NPs compared to plain TLM and unmodified TLM-NPs. The obtained results nominate TLM-LCH NPs as a promising carrier for enhancing liver targeting of TLM in treatment of HCC. Graphical abstract

Transdermal Delivery of Estradiol Simultaneously Possessing Rapid Release and Sustained Release Effect - XiaoFei Tang; Huaiying Qin; Jianhua Yang; XiaoYun Zhang (AAPS PharmSciTech, 2023)

Physico-chemistry and Cytotoxicity of Tenofovir-Loaded Acid Phosphatase-Responsive Chitosan Nanoparticles - Albert Nguessan Ngo; James Murowchick; Andrea Drew Gounev; Todor K. Gounev; Bi-Botti Celestin Youan (AAPS PharmSciTech, 2023)

Core Shell Lipid-Polymer Hybrid Nanoparticles for Oral Bioavailability Enhancement of Ibrutinib via Lymphatic Uptake - Mitali Patel; Ayushi Desai; Vrushti Kansara; Bhavin Vyas (AAPS PharmSciTech, 2023)

Detection and Identification of an Unknown Impurity in Ephedrine HCl 5 mg/mL Cyclic Olefin Syringes: Formulation Development - Ellen A. Kok; Daphne den Besten-Bertholee; Stefan van Berkel; Karin H. M. Larmené-Beld (AAPS PharmSciTech, 2023)

Degradants of Tenofovir Disoproxil Fumarate Under Forced Yet Mild Thermal Stress: Isolation, Comprehensive Structural Elucidation, and Mechanism - Mahesh Ranga; Arun Kumar Modini; Anil Kumar Nallajarla; Raju Doddipalla; Muralidharan Kaliyaperumal; Anandarup Goswami (AAPS PharmSciTech, 2023)

Cellular and Non-cellular Antioxidant Properties of Vitamin E–Loaded Metallic-Quercetin/Polycaprolactone Nanoparticles for the Treatment of Melanogenesis - Nasreen Ramzan; Muhammad Azeem; Khalid Mahmood; Shahid Shah; Fazal Rahman Sajid Chughtai; Muhammad Hanif; Nabeela Ameer; Zakia Bashir; Farhan Siddique; Muhammad Qaisar (AAPS PharmSciTech, 2023)

Hydrogel Containing Silibinin-Loaded Pomegranate Oil-Based Nanocapsules for Cutaneous Application: In Vitro Safety Investigation and Human Skin Biometry and Permeation Studies - Marila C. L. Marchiori; Cristina Rigon; Fernanda da S. Jardim; Laura M. Giuliani; Priscila M. Copetti; Michele R. Sagrillo; Aline F. Ourique; Letícia Cruz (AAPS PharmSciTech, 2023)

Can the Oral Bioavailability of the Discontinued Prostate Cancer Drug Galeterone Be Improved by Processing Method? KinetiSol® Outperforms Spray Drying in a Head-to-head Comparison - Stephen A. Thompson; Urvi Gala; Daniel A. Davis; Sandra Kucera; Dave Miller; Robert O. Williams (AAPS PharmSciTech, 2023)

Solvent-Free Loading of Vitamin A Palmitate into β-Cyclodextrin Metal-Organic Frameworks for Stability Enhancement - Ying Zhang; Jiacai Chen; Zaiyong Zhang; Huajie Zhu; Wuzhen Ma; Xiangyu Zhao; Manli Wang; Caifen Wang; Weidong Chen; Abid Naeem; Jiwen Zhang; Tao Guo; et al. (AAPS PharmSciTech, 2023)

Rapid Microwave-Assisted Synthesis of pH-Sensitive Carbon-Based Nanoparticles for the Controlled Release of Doxorubicin to Cancer Cells - Koranat Dechsri; Cheewita Suwanchawalit; Padungkwan Chitropas; Tanasait Ngawhirunpat; Theerasak Rojanarata; Praneet Opanasopit; Supusson Pengnam (AAPS PharmSciTech, 2023)

Augmented Transdermal Delivery of Curcumin for the Effective Management of Plaque Psoriasis – Design, Formulation, Characterisation, and In Vivo Studies - Bhumika Kumar; Pravat Kumar Sahoo (AAPS PharmSciTech, 2023)

Strategizing Spray Drying Process Optimization for the Manufacture of Redispersible Indomethacin Nanoparticles Using Quality-by-Design Principles - Vishal Rathod; Bhavin Gajera; Anusha Pinninti; Irfan A. Mohammed; Rutesh H. Dave (AAPS PharmSciTech, 2023)

Development of Child-Friendly Lisdexamfetamine Chewable Tablets Using Ion Exchange Resin as a Taste-Masking Carrier Based on the Concept of Quality by Design (QbD) - Chunmei Zhu; Jinmin Chen; Limin Shi; Qing Liu; Chunfeng Liu; Fuli Zhang; Haoxiang Wu (AAPS PharmSciTech, 2023)

Formulation of Resveratrol-Loaded Polycaprolactone Inhalable Microspheres Using Tween 80 as an Emulsifier: Factorial Design and Optimization - Riya Mahar; Arpita Chakraborty; Nidhi Nainwal (AAPS PharmSciTech, 2023)

Inhaled Adjunct Therapy with Second-Line Drug Candidates for Dose Reduction in Chemotherapeutic Regimens for Multi-drug-Resistant Tuberculosis - Sonia Verma; Nils-Jorgen K. Dal; Ashish Srivastava; Reena Bharti; D. V. Siva Reddy; Hasham Shafi Sofi; Trisha Roy; Khushboo Verma; Sunil K. Raman; Lubna Azmi; Lipika Ray; Madhav N. Mugale; et al. (AAPS PharmSciTech, 2023)

Retraction Note: Fluvastatin-Loaded Emulsomes Exhibit Improved Cytotoxic and Apoptosis in Prostate Cancer Cells - Nabil A. Alhakamy; Shaimaa M. Badr-Eldin; Hibah M. Aldawsari; Anas Alfarsi; Thikryat Neamatallah; Solomon Z. Okbazghi; Usama A. Fahmy; Osama A. A. Ahmad; Basma G. Eid; Wael Ali Mahdi; Adel F. Alghaith; Sultan Alshehri; et al. (AAPS PharmSciTech, 2023)

Retraction Note: Optimization of Thymoquinone-Loaded Coconut Oil Nanostructured Lipid Carriers for the Management of Ethanol-Induced Ulcer - Usama A. Fahmy; Ahmed L. Alaofi; Zuhier A. Awan; Hani M. Alqarni; Nabil A. Alhakamy (AAPS PharmSciTech, 2023)

An Intragastric Delivery Device Employing FDM Technology: 3D-Printed Tablet Containing Green Developed Mosapride-Saccharin Co-crystals - Omnya Mahmoud Amin; Hesham Nassereldin EL Qady; Marwa Adel Abd El-Fattah (AAPS PharmSciTech, 2023)
Mosapride citrate (MC) is a poorly soluble short half-life drug with more pronounced absorption in the stomach. The present study aimed to incorporate MC co-crystals with enhanced solubility into 3D-printed floating tablets. MC co-crystals were prepared via the green method using Saccharin sod. as a co-former at a (1:1) molar ratio. The prepared co-crystals were assessed for solubility, FTIR, thermal behavior, and SEM. Then, it was incorporated into zero % infill 3D-printed tablets of different configurations at two thickness levels by the FDM printing technique. Printed tablets were evaluated for dimensions, weight deviation, friability, and in vitro floating behavior. Drug release and kinetic of the MC release were also assessed. Solubility study of the co-crystals showed a significant ( p value In vitro drug release exhibited variable extended release profiles with different lag times depending on the configuration indicating that the tablet’s wall thickness and surface area were the factors manipulated to control drug release. Kinetic analysis of the release data displayed intermediate kinetics between zero-order and diffusional kinetics. The intragastric extended release profile for MC co-crystals of improved solubility could be successfully, economically, and quickly developed utilizing the 3D printing technique. Graphical Abstract

Naringenin-Capped Silver Nanoparticles Amalgamated Gel for the Treatment of Cutaneous Candidiasis - Chantibabu Katta; Arbaz Sujat Shaikh; Nagesh Bhale; Vaskuri G. S. Sainaga Jyothi; Venkata Rao Kaki; Amol G. Dikundwar; Pankaj Kumar Singh; Renu Shukla; Krishnaveni Mishra; Jitender Madan (AAPS PharmSciTech, 2023)

In Vitro Prototyping of a Nano-Organogel for Thermo-Sonic Intra-Cervical Delivery of 5-Fluorouracil-Loaded Solid Lipid Nanoparticles for Cervical Cancer - Samson A. Adeyemi; Zardad Az-Zamakhshariy; Yahya E. Choonara (AAPS PharmSciTech, 2023)
Solid lipid nanoparticles (SLNs) are used extensively to achieve site-specific drug delivery with improved bioavailability and reduced toxicity. This work focused on a new approach to provide site-specific stimuli-responsive delivery of SLNs loaded within thermo-sonic nano-organogel (TNO) variants to deliver the model chemotherapeutic agent 5-FU in treating cervical cancer. Pharmaceutically stable nanospherical SLNs comprising poly-L-lactic acid (PLA), palmitic acid (PA), and polyvinyl alcohol (PVA) were prepared and incorporated into TNO variants augmented by external thermal and ultrasound stimuli for release of 5-FU in the cervix. Results revealed that rate-modulated 5-FU release was achieved from SLNs (particle size =450.9 nm; PDI =0.541; zeta potential =−23.2 mV; %DL =33%) within an organogel upon exposure to either a single (thermo-) and/or both (thermo-sonic) stimuli. 5FU was released from all TNO variants with an initial burst on day 1 followed by sustained release over 14 days. TNO 1 provided desirable release over 15 days (44.29% vs. 67.13% under single (T) or combined (TU) stimuli, respectively). Release rates were primarily influenced by the SLN:TO ratio in tandem with biodegradation and hydrodynamic influx. Biodegradation by day 7 revealed that variant TNO 1 (1:5) released 5FU (46.8%) analogous to its initial mass than the other TNO variants (i.e., ratios of 2:5 and 3:5). FT-IR spectra revealed assimilation of the system components and corroborative with the DSC and XRD analysis (i.e., in ratios of PA:PLA 1:1 and 2:1). In conclusion, the TNO variants produced may be used as a potential stimuli-responsive platform for the site-specific delivery of chemotherapeutic agents such as 5-FU to treat cervical cancer.

Preliminary Study on the Development of Caffeine Oral Solid Form 3D Printed by Semi-Solid Extrusion for Application in Neonates - Agnès Roche; Noelia M. Sanchez-Ballester; Adrien Aubert; Jean-Christophe Rossi; Sylvie Begu; Ian Soulairol (AAPS PharmSciTech, 2023)

Aerosolization Performance of Immunoglobulin G by Jet and Mesh Nebulizers - Kyung Hwa Chang; Bong Joo Park; Ki Chang Nam (AAPS PharmSciTech, 2023)
Recently, many preclinical and clinical studies have been conducted on the delivery of therapeutic antibodies to the lungs using nebulizers, but standard treatment guidelines have not yet been established. Our objective was to compare nebulization performance according to the low temperature and concentration of immunoglobulin G (IgG) solutions in different types of nebulizers, and to evaluate the stability of IgG aerosols and the amount delivered to the lungs. The output rate of the mesh nebulizers decreased according to the low temperature and high concentration of IgG solution, whereas the jet nebulizer was unaffected by the temperature and concentration of IgG. An impedance change of the piezoelectric vibrating element in the mesh nebulizers was observed because of the lower temperature and higher viscosity of IgG solution. This affected the resonance frequency of the piezoelectric element and lowered the output rate of the mesh nebulizers. Aggregation assays using a fluorescent probe revealed aggregates in IgG aerosols from all nebulizers. The delivered dose of IgG to the lungs in mice was highest at 95 ng/mL in the jet nebulizer with the smallest droplet size. Evaluation of the performance of IgG solution delivered to the lungs by three types of nebulizers could provide valuable parameter information for determination on dose of therapeutic antibody by nebulizers. Graphical abstract

Highlights on Cell-Penetrating Peptides and Polymer-Lipid Hybrid Nanoparticle: Overview and Therapeutic Applications for Targeted Anticancer Therapy - Pragathi Devanand Bangera; Divya Dhatri Kara; Katikala Tanvi; Vamshi Krishna Tippavajhala; Mahalaxmi Rathnanand (AAPS PharmSciTech, 2023)
Polymer-lipid hybrid nanoparticles (PLHNs) have been widely used as a vehicle for carrying anticancer owing to its unique framework of polymer and lipid combining and giving the maximum advantages over the lipid and polymer nanoparticle drug delivery system. Surface modification of PLHNs aids in improved targeting and active delivery of the encapsulated drug. Therefore, surface modification of the PLHNs with the cell-penetrating peptide is explored by many researchers and is explained in this review. Cell-penetrating peptides (CPPs) are made up of few amino acid sequence and act by disrupting the cell membrane and transferring the cargos into the cell. Ideally, we can say that CPPs are peptide chains which are cell specific and are biocompatible, noninvasive type of delivery vehicle which can transport siRNA, protein, peptides, macromolecules, pDNA, etc. into the cell effectively. Therefore, this review focuses on the structure, type, and method of preparation of PLHNs also about the uptake mechanism of CPPs and concludes with the therapeutic application of PLHNs surface modified with the CPPs and their theranostics. Graphical Abstract

A Combined In-Vitro and GastroPlus® Modeling to Study the Effect of Intestinal Precipitation on Cinnarizine Plasma Profile in a Fasted State - Siddharth S. Kesharwani; Fady Ibrahim (AAPS PharmSciTech, 2023)

Non-systemic Approaches for Ductal Carcinoma In Situ: Exploring the Potential of Ultra-flexible Combisomes as a Novel Drug Delivery Strategy—a Review - Cynthia Lizzie Lobo; Amitha Shetty; Manohar M; Akhilesh Dubey; Sally A. El-Zahaby (AAPS PharmSciTech, 2023)

Darifenacin Self-assembled Liquid Crystal Cubic Nanoparticles: a Sustained Release Approach for an Overnight Control of Overactive Bladder - Michael M. Farag; Wessam El-Sebaie; Emad B. Basalious; Omaima N. El-Gazayerly (AAPS PharmSciTech, 2023)
The current study is regarding the development and characterization of Darifenacin-loaded self-assembled liquid crystal cubic nanoparticles (LCCN). An anhydrous approach was used for the preparation of these cubic nanoparticles using a hydrotropic agent (propylene glycol), with minimal energy input. Upon dispersion in aqueous medium, the system was successfully transformed to cubosomal nanoparticles counterpart as depicted by transmission electron micrographs. A Box-Behnken design was used to optimize formulation variables, namely A: amount of GMO, B: amount of Pluronic F127, C: amount of PG, and D: amount of HPMC. The design has generated 29 formulae which were tested regarding drug content uniformity, dispersibility in water, particle size, zeta potential, polydispersity index, and in vitro release behavior. The numerical optimization algorithms have generated an optimized formula with high desirability ≈ 1. The optimized formula displayed small particle size, good homogeneity, and zeta potential along with controlled in vitro release profile and ex vivo permeation through rabbit intestine. Thus, self-assembled LCCN might offer an alternative anhydrous approach for the preparation of cubosomal nanoparticles with controlled release profile for a possibly better control of overactive bladder syndrome which tremendously affect the overall life quality. Graphical Abstract

Liposomal Nanodrug Based on Norcantharidin Derivative for Increased in Vivo Activity - Hailong Kuang; Peipei Wang; Yuhang Wang; Jinbo Li; Jiang Yu; Lirui Jia; Shuo Li; Yan Ma; Hongzhuo Liu; Zhonggui He; Yongjun Wang (AAPS PharmSciTech, 2023)

Drug-Excipient Compatibility Study Through a Novel Vial-in-Vial Experimental Setup: A Benchmark Study - Sonali Jain; Ravi P. Shah (AAPS PharmSciTech, 2023)

Enhancement of Valsartan Oral Bioavailability by Preparing a Microwave-Irradiated Inclusion Complex with Sulfobutyl Ether β-Cyclodextrin Using a Central Composite Face Design for Optimising Process Parameters - Venkata Ramana Maddula; Rama Sekhara Reddy Dachuru (AAPS PharmSciTech, 2023)

A Review on Physicochemical Properties of Polymers Used as Filaments in 3D-Printed Tablets - AbdAlmonem Doolaanea; NurFaezah Latif; Shubham Singh; Mohit Kumar; Mohamad Faizal Safa’at; Mulham Alfatama; Raihana Edros; Amit Bhatia (AAPS PharmSciTech, 2023)

Evaluating the Effect of Microcrystalline Cellulose Variations on Tablet Quality of Natural Plant Product Using a Design of Experiment Approach - Haiyue Zhao; Chuting Shi; Zhenda Liu; Lijie Zhao; Lan Shen (AAPS PharmSciTech, 2023)

Preparation of Sustained Release Formulation of Verapamil Hydrochloride Using Ion Exchange Resins - Hussein Allaboun; Khouloud A. Alkhamis; Suhair S. Al-Nimry (AAPS PharmSciTech, 2023)

Achillea wilhelmsii–Incorporated Chitosan@Eudragit Nanoparticles Intended for Enhanced Ulcerative Colitis Treatment - Hassan Maleki; Maryam Doostan; Mohammad Hosein Farzaei; Parisa Seifi; Shahram Miraghaee; Mahtab Doostan (AAPS PharmSciTech, 2023)

Emerging Advances in Nanocarriers Approaches in the Effective Therapy of Pain Related Disorders: Recent Evidence and Futuristic Needs - Nishtha Chaurawal; Mohak Kataria; Muniramiah Vinod Kumar; Narayan Prasad Mishra; Vijay G. Goni; Kaisar Raza (AAPS PharmSciTech, 2023)

Dapsone-Loaded Mixed Micellar Gel for Treatment OF Acne Vulgaris - Monica RP Rao; Sushant Deshpande; Padmanabh Deshpande (AAPS PharmSciTech, 2023)

Topical Nanotherapeutics for Treating MRSA-Associated Skin and Soft Tissue Infection (SSTIs) - Sriravali Karnam; Anil B. Jindal; Charu Agnihotri; Bhim Pratap Singh; Atish T. Paul (AAPS PharmSciTech, 2023)

Influence of Poloxamer on the Dissolution and Stability of Hot-Melt Extrusion–Based Amorphous Solid Dispersions Using Design of Experiments - Ashay Shukla; Nagi Reddy Dumpa; Rishi Thakkar; Abhishek Shettar; Eman Ashour; Suresh Bandari; Michael A. Repka (AAPS PharmSciTech, 2023)

Correction: Biomimetic Antidote Nanoparticles: A Novel Strategy for Chronic Heavy Metal Poisoning - Hao Wang; Qing Yao; Wenquan Zhu; Yang Yang; Chunsheng Gao; Xiaoyang Chu; Cuiyan Han (AAPS PharmSciTech, 2023)

Nanostructured Lipid Carrier–Based Gel for Repurposing Simvastatin in Localized Treatment of Breast Cancer: Formulation Design, Development, and In Vitro and In Vivo Characterization - Popat S. Kumbhar; Arehalli S. Manjappa; Rohit R. Shah; Sameer J. Nadaf; John I. Disouza (AAPS PharmSciTech, 2023)

Plaster Gel Loaded with Silver Nanoparticle-Mediated Ganoderma applanatum: from Fabrication to Evaluation - Pattwat Maneewattanapinyo; Chaowalit Monton; Wiwat Pichayakorn; Nattakan Dangmanee; Thaniya Wunnakup; Jirapornchai Suksaeree (AAPS PharmSciTech, 2023)

Comparison of Protein Particle Formation in IgG1 mAbs Formulated with PS20 Vs. PS80 When Subjected to Interfacial Dilatational Stress - Coleman Vaclaw; Kimberly Merritt; Valerie P. Griffin; Neal Whitaker; Madhushree Gokhale; David B. Volkin; Maria O. Ogunyankin; Prajnaparamita Dhar (AAPS PharmSciTech, 2023)

Predicting Glass-Forming Ability of Pharmaceutical Compounds by Using Machine Learning Technologies - Junhuang Jiang; Defang Ouyang; Robert O. Williams (AAPS PharmSciTech, 2023)

Lipid-Based Nanocarriers in the Treatment of Glioblastoma Multiforme (GBM): Challenges and Opportunities - Tanisha Gupta; Rakesh K. Sahoo; Himani Singh; Sumeet Katke; Akash Chaurasiya; Umesh Gupta (AAPS PharmSciTech, 2023)

PEGylated Erlotinib HCl Injectable Nanoformulation for Improved Bioavailability - Hardik Bhargave; Harsh Nijhawan; Khushwant S. Yadav (AAPS PharmSciTech, 2023)

Inclusion Complex of Ibuprofen-β-Cyclodextrin Incorporated in Gel for Mucosal Delivery: Optimization Using an Experimental Design - Chandraprabha Upadhyay; Anisha D’Souza; Pratikkumar Patel; Vivek Verma; Kamal Kumar Upadhayay; Meenakshi Bharkatiya (AAPS PharmSciTech, 2023)

A Novel Alginate Film Based on Nanocoating Approach for Enteric-Release Tablets - Bao Ngoc Tran; Khanh-Ly Tran; Thach-Tung Nguyen; Lan-Phuong T. Bui; Chien Ngoc Nguyen (AAPS PharmSciTech, 2023)

Inhalable Nanoparticle-based Dry Powder Formulations for Respiratory Diseases: Challenges and Strategies for Translational Research - Ho Wan Chan; Stephanie Chow; Xinyue Zhang; Yayi Zhao; Henry Hoi Yee Tong; Shing Fung Chow (AAPS PharmSciTech, 2023)

Development of Photoprotective Formulations: Influence of Formulation Composition on the SPF and Mechanical Properties - Gabriela Maria D’Angelo Costa; Patrícia Maria Berardo Gonçalves Maia Campos (AAPS PharmSciTech, 2023)

Structural Changes in Liposomal Vesicles in Association with Sodium Taurodeoxycholate - Deepak Kumar; Abhishek Suna; Debes Ray; Vinod K. Aswal; Pratap Bahadur; Sanjay Tiwari (AAPS PharmSciTech, 2023)

Best Practices and Guidelines (2022) for Scale-up and Technology Transfer in Freeze Drying Based on Case Studies. Part 2: Past Practices, Current Best Practices, and Recommendations - Serguei Tchessalov; Evgenyi Shalaev; Bakul Bhatnagar; Steven Nail; Alina Alexeenko; Feroz Jameel; Jayasree Srinivasan; Michael Dekner; Ekneet Sahni; Stefan Schneid; Petr Kazarin; Orla McGarvey; et al. (AAPS PharmSciTech, 2023)
Scale-up and transfer of lyophilization processes remain very challenging tasks considering the technical challenges and the high cost of the process itself. The challenges in scale-up and transfer were discussed in the first part of this paper and include vial breakage during freezing at commercial scale, cake resistance differences between scales, impact of differences in refrigeration capacities, and geometry on the performance of dryers. The second part of this work discusses successful and unsuccessful practices in scale-up and transfer based on the experience of the authors. Regulatory aspects of scale-up and transfer of lyophilization processes were also outlined including a topic on the equivalency of dryers. Based on an analysis of challenges and a summary of best practices, recommendations on scale-up and transfer of lyophilization processes are given including projections on future directions in this area of the freeze drying field. Recommendations on the choice of residual vacuum in the vials were also provided for a wide range of vial capacities. Graphical Abstract

Designing Optimum Drug Delivery Systems Using Machine Learning Approaches: a Prototype Study of Niosomes - Aliasgar F. Shahiwala; Samar Salam Qawoogha; Nuruzzaman Faruqui (AAPS PharmSciTech, 2023)

The Effect of Design and Size of the Fluid-Bed Equipment on the Particle Size-Dependent Trend of Particle Coating Thickness and Drug Prolonged-Release Profile - Teja Brezovar; Grega Hudovornik; Matjaž Perpar; Matevž Luštrik; Rok Dreu (AAPS PharmSciTech, 2023)
The focus of the current work is to study and demonstrate the impact of the design, the scale, and settings of fluid-bed coating equipment on the differences in pellet coating thickness, which in case of prolonged-release pellets dictates the drug release. In the first set of coating experiments, the pellet cores were coated with the Tartrazine dye with the aim of estimating the coating equipment performance in terms of coating thickness distribution, assessed through color hue. In the second set, drug-layered pellets were film-coated with prolonged-release coating and dissolution profile tests were performed to estimate the thickness and uniformity of the coating thickness among differently sized pellets. In both study parts, film coating was performed at the laboratory and the pilot scale and essentially two types of distribution plate and different height adjustments of the draft tube were compared. The dye coating study proved to be extremely useful, as the results enable process correction and the optimal use of the process equipment in combination with the appropriate process parameters. Preferential film coating of larger drug-containing pellets was confirmed on the laboratory scale, while on the pilot scale, it was possible to achieve preferential coating of smaller pellets using rational alternatives of settings, which is desirable in terms of particle size-independent drug release profile of such prolonged-release dosage forms.

Evaluation of In-Die Compression Data for a Deeper Understanding of Altered Excipient Properties upon Temperature Rise - Hanna Dorothea Grumann; Stefan Klinken; Peter Kleinebudde (AAPS PharmSciTech, 2023)
The thermodynamic analysis of tablet formation includes the thermal and mechanical analysis during compression. The aim of this study was to evaluate alterations of force–displacement data upon temperature rise as an indicator for changed excipient properties. The tablet press was equipped with a thermally controlled die to imitate the heat evolution from tableting on an industrial scale. Six predominantly ductile polymers with a comparably low glass transition temperature were tableted at temperatures ranging from 22-70°C. Lactose served as a brittle reference with a high melting point. The energy analysis included the net and recovery work during compression, from which the plasticity factor was calculated. The respective results were compared to the changes in compressibility obtained via Heckel analysis. Elevated temperatures reduced the necessary work for plastic deformation for the ductile polymers, which was reflected in decreasing values for the net work of compaction and the plasticity factor. The recovery work slightly increased for the maximum tableting temperature. Lactose showed no response to temperature variations. Changes in the net work of compaction showed a linear correlation to the changes in yield pressure, which could be correlated to the glass transition temperature of a material. It is therefore possible to detect material alterations directly from the compression data, if the glass transition temperature of a material is sufficiently low. Graphical Abstract

Self-Double-Emulsifying Drug Delivery System Enteric-Coated Capsules: A Novel Approach to Improve Oral Bioavailability and Anti-inflammatory Activity of Panax notoginseng Saponins - Yaru Wang; Yunxia Shang; Fengyu Tang; Kun Qiu; Xiaohui Wei; Zhengtao Wang (AAPS PharmSciTech, 2023)

Development of 3D DLP Printed Sustained Release Ibuprofen Tablets and Their Pharmacokinetic Evaluation in Rats - Keb Mosley-Kellum; Arvind Bagde; Shawn Spencer; Satyanarayan Dev; Mandip Singh (AAPS PharmSciTech, 2023)

RETRACTED ARTICLE: Loteprednol-Loaded Nanoformulations for Corneal Delivery by Quality-by-Design Concepts: Optimization, Characterization, and Anti-inflammatory Activity - Burcu Uner; Samet Ozdemir; Cetin Tas; Melike Uner; Yildiz Ozsoy (AAPS PharmSciTech, 2023)

Assessment of Tribo-charging and Continuous Feeding Performance of Direct Compression Grades of Isomalt and Mannitol Powders - Michela Beretta; Julia Kruisz; Theresa R. Hörmann-Kincses; Viktoria Magosi; Meishan Guo; Majid Naderi; Sarah Heupl; Johann Kastner; Martin Spoerk; Amrit Paudel (AAPS PharmSciTech, 2023)
Tribo-charging is often a root cause of mass flow deviations and powder adhesion during continuous feeding. Thus, it may critically impact product quality. In this study, we characterized the volumetric (split- and pre-blend) feeding behavior and process-induced charge of two direct compression grades of polyols, galenIQ™ 721 (G721) for isomalt and PEARLITOL ® 200SD (P200SD) for mannitol, under different processing conditions. The feeding mass flow range and variability, hopper end fill level, and powder adhesion were profiled. The feeding-induced tribo-charging was measured using a Faraday cup. Both materials were comprehensively characterized for relevant powder properties, and their tribo-charging was investigated for its dependence on particle size and relative humidity. During split-feeding experiments, G721 showed a comparable feeding performance to P200SD with lower tribo-charging and adhesion to the screw outlet of the feeder. Depending on the processing condition, the charge density of G721 ranged from -0.01 up to -0.39 nC/g, and for P200SD from -3.19 up to -5.99 nC/g. Rather than differences in the particle size distribution of the two materials, their distinct surface and structural characteristics were found as the main factors affecting their tribo-charging. The good feeding performance of both polyol grades was also maintained during pre-blend feeding, where reduced tribo-charging and adhesion propensity was observed for P200SD (decreasing from -5.27 to -0.17 nC/g under the same feeding settings). Here, it is proposed that the mitigation of tribo-charging occurs due to a particle size-driven mechanism. Graphical abstract

Construction of Imatinib Controlled Release Film-Forming System Based on Drug Ion-Pair and Oligomeric Ionic Liquids for the Long Local Therapy of Cutaneous Melanoma - Junzhu Wang; Han Sun; Wenxuan Jia; Yilin Song; Peng Quan; Liang Fang; Chao Liu (AAPS PharmSciTech, 2023)

Folic Acid–Chitosan Oligosaccharide Conjugates Decorated Nanodiamond as Potential Carriers for the Oral Delivery of Doxorubicin - Dandan Liu; Yupei Su; Jixuan Chen; Hao Pan; Weisan Pan (AAPS PharmSciTech, 2023)

Enhanced Optimal Parameter-Based Nebulizer Design for Flow Analysis of Fluticasone Propionate - Vinoth N; Bhaskara Rao Lokavarapu (AAPS PharmSciTech, 2023)

Long Acting Ionically Paired Pamoate-based Suspension of Lurasidone: An exploration of Size Effects on in vitro Dissolution and in vivo Pharmacokinetic Behaviors - Shuo Li; Ying He; Dianjun Sun; Zhaomeng Wang; Jiang Yu; Jianying Ye; Zhonggui He; Yongjun Wang (AAPS PharmSciTech, 2023)

Evaluation and Screening of Biopharmaceuticals using Multi-Angle Dynamic Light Scattering - Ashutosh Sharma; Jason Beirne; Dikshitkumar Khamar; Ciaran Maguire; Ambrose Hayden; Helen Hughes (AAPS PharmSciTech, 2023)

Microfluidic Generation of Near-Infrared Photothermal Vitexin/ICG Liposome with Amplified Photodynamic Therapy - Xia Cao; Qi Liu; Michael Adu-Frimpong; Wenwan Shi; Kai liu; Tianwen Deng; Hui Yuan; Xuedi Weng; Yihong Gao; Qingtong Yu; Wenwen Deng; Jiangnan Yu; et al. (AAPS PharmSciTech, 2023)

Estimating Shelf Life Through Tolerance Intervals Extended to Nonlinear Response Trends - James Schwenke; Walter Stroup; Michelle Quinlan; Patrick Forenzo (AAPS PharmSciTech, 2023)

Correction to: PhysioCell®—a Novel, Bio-relevant Dissolution Apparatus: Hydrodynamic Conditions and Factors Influencing the Dissolution Dynamics - Marcela Staniszewska; Michał Romański; Justyna Dobosz; Bartosz Kołodziej; Uladzimir Lipski; Grzegorz Garbacz; Dorota Danielak (AAPS PharmSciTech, 2023)

Tocotrienols-enriched Self-nanoemulsifying Drug Delivery System Enhances the Antileukemic Activity of All-trans Retinoic Acid but not Electrocardiogram Alterations Evoked by Its Combination with Arsenic Trioxide - Gabriel Silva Marques Borges; Pierre Sicard; Cristina de Mello Gomides Loures; Fernanda Gontijo Cristina Evangelista; Camila Campos Sales; Adriano de Paula Sabino; Christian Fernandes; Lucas Antônio Miranda Ferreira; Sylvain Richard (AAPS PharmSciTech, 2023)

Impact of Solid-State Properties on the Aerosolization Performance of Spray-Dried Curcumin Powders - Qian Zhang; Yongquan Li; Linghui Li; Yushan Cheng; Fangkun Yu; Rui Li; Shuguang Hou (AAPS PharmSciTech, 2023)

Correction to: Recent Advances in the Applications of Additive Manufacturing (3D Printing) in Drug Delivery: a Comprehensive Review - Derick Muhindo; Rasha Elkanayati; Priyanka Srinivasan; Michael A. Repka; Eman A. Ashour (AAPS PharmSciTech, 2023)

99mTc-Labeled, Colistin Encapsulated, Theranostic Liposomes for Pseudomonas aeruginosa Infection - Merve Karpuz; Aybala Temel; Emre Ozgenc; Yamac Tekintas; Gulsah Erel-Akbaba; Zeynep Senyigit; Evren Atlihan-Gundogdu (AAPS PharmSciTech, 2023)

Continuous Manufacturing of Oil in Water (O/W) Emulgel by Extrusion Process - V. Anusha Echanur; Anusha V. Matadh; S. G. Pragathi; S. Sarasija; Yeoh Thean; Abu Zayed Badruddoza; Jaymin Shah; Vijay Kulkarni; Srinivas Ajjarapu; N. M. Reena; H. N. Shivakumar; S. Narasimha Murthy (AAPS PharmSciTech, 2023)

Antibacterial-Anti-Inflammatory-Bone Restoration Procedure Achieved by MIN-Loaded PLGA Microsphere for Efficient Treatment of Periodontitis - Jiansong Zhao; Ying Wei; Jian Xiong; Hongbing Liu; Gaoshuai Lv; Jingyi Zhao; Haibing He; Jingxin Gou; Tian Yin; Xing Tang; Yu Zhang (AAPS PharmSciTech, 2023)

Formulation and Characterization of Buccal Films Containing Valsartan with Additional Support from Image Analysis - Blaž Grilc; Tjaša Felicijan; Timeja Planinšek Parfant; Odon Planinšek (AAPS PharmSciTech, 2023)

Good Practices for the Laboratory Performance Testing of Aqueous Oral Inhaled Products (OIPs): an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) - Jolyon P. Mitchell; I. Carter; J. D. Christopher; M. Copley; W. H. Doub; A. Goodey; C. J. Gruenloh; B. B. Larson; S. Lyapustina; R. B. Patel; S. W. Stein; J. D. Suman (AAPS PharmSciTech, 2023)

Enhanced Transdermal Delivery of N-Acetylcysteine and 4-Phenylbutyric Acid for Potential Use as Antidotes to Lewisite - Amruta A. Dandekar; Deepal Vora; Jihee Stephanie Yeh; Ritesh Kumar Srivastava; Mohammad Athar; Ajay K. Banga (AAPS PharmSciTech, 2023)

Direct Tableting on a Continuous Manufacturing Line—Impact of Mixing Parameters, Material Densities, and Drug Load on Subsequent Process Parameters and Tablet Quality - Marius J. Kreiser; Christoph Wabel; Karl G. Wagner (AAPS PharmSciTech, 2023)
The continuous manufacturing (CM) of solid oral dosage forms has received increased attention in recent years and has become a leading technology in the pharmaceutical industry. A model has been developed based on process data from two design of experiments (DoEs), where the impact of the mixer process parameters, throughput (THR), hold up mass (HUM), impeller speed (IMP), and the input raw material bulk density (BD i ), on the continuous process and the resulting drug product has been investigated. These statistical models revealed equations, describing process parameter interactions for optimization purposes. For the exit valve opening width (EV) at the bottom of the continuous mixer (CMT), the combination of high throughput (30 kg/h) and low impeller speed (300 rpm) resulted in optimal process conditions. Apparent bulk density of the blend (BD) within the process, fill depth (FD), and tensile strength (TS) were mainly impacted by input bulk density (BD i ) of the tableting mixture, emphasizing the role of material attributes on the continuous manufacturing process. The apparent bulk density itself was, other than from the input bulk density, equally dependent from THR and IMP in opposite deflections. However, process parameters (THR and IMP) revealed a minor impact on the apparent BD compared to the input bulk density. FD was impacted mainly by THR ahead of IMP and the TS by IMP and THR to a similar extend, in opposite deflections. A simplified linear model to estimate the input bulk density revealed satisfactory prediction quality when included in the derived statistical model equations.

Transcellular Transport Behavior of the Intact Polymeric Mixed Micelles with Different Polymeric Ratios - Wenting Wu; Quan Ding; Zhiwei Zhou; Wenliang Kuang; Lipeng Jiang; Peng Liu; Weiping Ai; Weifeng Zhu (AAPS PharmSciTech, 2023)

An Innovative Approach for Formulation of Rutin Tablets Targeted for Colon Cancer Treatment - Aliaa Ismail; Ebtesam El-Biyally; Wedad Sakran (AAPS PharmSciTech, 2023)
The aim of this study was the improvement of rutin solubility along with targeting its release to colon for effective treatment of colon cancer. Five formulations of compression-coated tablets were prepared with the same core composition including rutin-polyvinyl pyrrolidone K30 solid dispersion (rutin-PVP K30 SD) but differ in being coated with either frankincense alone or different combinations of frankincense with gelatin. The superior formula was selected based on the in vitro drug release then further evaluated in terms of physical properties and in vivo performance in dogs using X-ray. Moreover, in vitro cytotoxicity of rutin, rutin-PVP K30 SD, frankincense, and a mixture of rutin-PVP K30 SD with frankincense in a ratio representing their concentrations in the selected formula was assessed against human colon cancer (HCT-116) cell lines using sulforhodamine B assay . The formula (F4) with the coat consisted of 65%w/w frankincense and 35%w/w gelatin achieved acceptable in vitro controlled drug release. In vivo X-ray in dogs confirmed that F4 tablet could remain intact in the stomach and small intestine until reaching the colon. In vitro cytotoxicity revealed that mixture of rutin-PVP K30 SD with frankincense was more effective in arresting cancer cell growth than rutin or frankincense alone. Moreover, stability studies revealed that F4 tablets were physically and chemically stable. Thus, improving rutin solubility using solid dispersion technique and formulating it into frankincense-based compression-coated (F4) tablets would be a successful approach for colonic delivery of rutin with potential of improving therapeutic efficacy. Graphical Abstract

Ocular Drug Delivery: a Comprehensive Review - Sadek Ahmed; Maha M. Amin; Sinar Sayed (AAPS PharmSciTech, 2023)
The human eye is a sophisticated organ with distinctive anatomy and physiology that hinders the passage of drugs into targeted ophthalmic sites. Effective topical administration is an interest of scientists for many decades. Their difficult mission is to prolong drug residence time and guarantee an appropriate ocular permeation. Several ocular obstacles oppose effective drug delivery such as precorneal, corneal, and blood-corneal barriers. Routes for ocular delivery include topical, intravitreal, intraocular, juxtascleral, subconjunctival, intracameral, and retrobulbar. More than 95% of marketed products exists in liquid state. However, other products could be in semi-solid (ointments and gels), solid state (powder, insert and lens), or mixed ( in situ gel). Nowadays, attractiveness to nanotechnology-based carries is resulted from their capabilities to entrap both hydrophilic and lipophilic drugs, enhance ocular permeability, sustain residence time, improve drug stability, and augment bioavailability. Different in vitro , ex vivo, and in vivo characterization approaches help to predict the outcomes of the constructed nanocarriers. This review aims to clarify anatomy of the eye, various ocular diseases, and obstacles to ocular delivery. Moreover, it studies the advantages and drawbacks of different ocular routes of administration and dosage forms. This review also discusses different nanostructured platforms and their characterization approaches. Strategies to enhance ocular bioavailability are also explained. Finally, recent advances in ocular delivery are described. Graphical Abstract

An Overview of Taste-Masking Technologies: Approaches, Application, and Assessment Methods - Shuqin Hu; Xiaoxuan Liu; Shuangshuang Zhang; Danyi Quan (AAPS PharmSciTech, 2023)

PhysioCell — a Novel, Bio-relevant Dissolution Apparatus: Hydrodynamic Conditions and Factors Influencing the Dissolution Dynamics - Marcela Staniszewska; Michał Romański; Justyna Dobosz; Bartosz Kołodziej; Uladzimir Lipski; Grzegorz Garbacz; Dorota Danielak (AAPS PharmSciTech, 2023)

Facile Technology for Extemporaneous Preparation of Long-Acting Injectable Microparticulate Suspensions at the Patient Side - Sukhada S. Shevade; Maharukh T. Rustomjee; Padma V. Devarajan (AAPS PharmSciTech, 2023)

Liposomal Doxorubicin: the Sphingomyelin/Cholesterol System Significantly Enhances the Antitumor Efficacy of Doxorubicin - Xianmin Meng; Hongxia Zhang; Lingyan Chen; Mingqi Wang; Kaituo Zhang; Xinrong Liu; Yihui Deng; Yanzhi Song (AAPS PharmSciTech, 2023)

Recent Advances in the Applications of Additive Manufacturing (3D Printing) in Drug Delivery: A Comprehensive Review - Derick Muhindo; Rasha Elkanayati; Priyanka Srinivasan; Michael A. Repka; Eman A. Ashour (AAPS PharmSciTech, 2023)

Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective - Sivacharan Kollipara; Adithya Karthik Bhattiprolu; Rajkumar Boddu; Tausif Ahmed; Siddharth Chachad (AAPS PharmSciTech, 2023)

Synthesis of Submicrometric Chitosan Particles Loaded with Calcium Phosphate for Biomedical Applications - Diana Pereira Lopes; Selma Regina Muniz Freitas; Carina Baptiston Tanaka; Giovanne Delechiave; Lucia Nobuco Takamori Kikuchi; Roberto R. Braga; Jamie J. Kruzic; Maria Stella Moreira; Leticia Cristina Cidreira Boaro; Luiz Henrique Catalani; Flávia Gonçalves (AAPS PharmSciTech, 2023)

Vitamin D3-Loaded Nanoemulsions as a Potential Drug Delivery System for Autistic Children: Formulation Development, Safety, and Pharmacokinetic Studies - Marwa Hasanein Asfour; Sameh Hosam Abd El-Alim; Ahmed Alaa Kassem; Abeer Salama; Amr Sobhi Gouda; Walaa Samy Nazim; Neveen Hassan Nashaat; Maha Hemimi; Nagwa Abdel Meguid (AAPS PharmSciTech, 2023)
The aim of the current study is the development of a vitamin D 3 (VD3)-loaded nanoemulsion (NE) formulation to improve VD3 oral bioavailability for management of vitamin D inadequacy in autistic children. Eight NE formulations were prepared by high-speed homogenization followed by ultrasonication. Four vegetable oils were employed along with two concentrations of Span 20 as the emulsifier. Glycerol, fructose, and mango flavor were included as viscosity modifier, sweetening, and flavoring agents, respectively. The prepared VD3-loaded NE formulations exhibited high drug content (> 98%), droplet size (DS) ranging from 61.15 to 129.8 nm with narrow size distribution, zeta potential values between − 9.83 and − 19.22 mV, and acceptable pH values (4.59–5.89). Storage stability showed that NE formulations underwent coalescence and phase separation during 6 months at room temperature, whereas at refrigerated conditions, formulations showed slight creaming. The optimum formulation (VD3-NE6) revealed a non-significant DS growth at refrigerated conditions and spherical morphology under transmission electron microscopy. VD3-NE6 did not produce any toxic effects to rats treated orally for 3 months, where normal blood picture and kidney and liver functions were observed compared to control rats. Also, serum calcium, oxidative stress, and apoptosis biomarkers remained within normal levels, indicating the safety of the optimum formulation. Furthermore, evaluation of VD3-NE6 oral bioavailability depicted a significant increase in AUC 0–72 and C max with decreased T max compared to plain VD3. The optimum formulation demonstrated improved stability, safety, and oral bioavailability indicating the potential for successful management of vitamin D deficiency in autistic children.

A Hematological and Histopathological Study on Diphenhydramine Nasal Nano-gel and Nano-emulgel for the Management of Allergic Rhinitis in Animal Model - Hina Javed; Syed Nisar Hussain Shah; Furqan Muhammad Iqbal; Nida Javed; Benish Saeed (AAPS PharmSciTech, 2023)

Correction: Extracellular Vesicles Derived from a Human Brain Endothelial Cell Line Increase Cellular ATP Levels - Kandarp M. Dave; Wanzhu Zhao; Catherine Hoover; Anisha D’Souza; Devika S Manickam (AAPS PharmSciTech, 2023)

Nitroso Impurities in Drug Products: An Overview of Risk Assessment, Regulatory Milieu, and Control Strategy - Naseem A. Charoo; Sathish Dharani; Mansoor A. Khan; Ziyaur Rahman (AAPS PharmSciTech, 2023)

Mitigating Drug Stability Challenges Through Cocrystallization - Jamshed Haneef; Mohd Amir; Nadeem Ahmed Sheikh; Renu Chadha (AAPS PharmSciTech, 2023)

Dermaplaning for Transdermal Drug Permeation Enhancement: A Qualitative and Quantitative Assessment - Akeemat O. Tijani; Dorcas Frempong; Jagroop Kaur; Sophia Sergent; Kara Shaw; Rebecca Lessaint; Maryam Al Shawi; Gabrielle Verana; Ashana Puri (AAPS PharmSciTech, 2023)

Preparation of Conotoxin-Encapsulated Chitosan Nanoparticles and Evaluation of Their Skin Permeability - Haigang Li; JiPeng Yao; Yong Guo; JingJing Huo; Haijuan Zhang; Zengtao Zhang; Jinlong Zhao; Chun Zhang (AAPS PharmSciTech, 2023)

Preparation of Free-Flowing Spray-Dried Amorphous Composites Using Neusilin® - Zhixing Lin; Kai Zheng; Mohammad A. Azad; Rajesh N. Davé (AAPS PharmSciTech, 2023)

Core–Shell Type Lipidic and Polymeric Nanocapsules: the Transformative Multifaceted Delivery Systems - Arti Mehandole; Nikita Walke; Srushti Mahajan; Mayur Aalhate; Indrani Maji; Ujala Gupta; Neelesh Kumar Mehra; Pankaj Kumar Singh (AAPS PharmSciTech, 2023)

Twin Screw Melt Granulation: Alternative Approach for Improving Solubility and Permeability of a Non-steroidal Anti-inflammatory Drug Ibuprofen - Dinesh Nyavanandi; Sagar Narala; Preethi Mandati; Abdullah Alzahrani; Praveen Kolimi; Ahmed Almotairy; Michael A. Repka (AAPS PharmSciTech, 2023)

Solubility Enhancement and Inhalation Delivery of Cyclodextrin-Based Inclusion Complex of Delamanid for Pulmonary Tuberculosis Treatment - Suyash M. Patil; Druva Sarika Barji; Tejashri Chavan; Kinjal Patel; Andrew J. Collazo; Vasudha Prithipaul; Aaron Muth; Nitesh K. Kunda (AAPS PharmSciTech, 2023)

Andrographolide-Soya-L-α-Phosphatidyl Choline Complex Augmented Solubility and Drug Delivery in Leishmania donovani, a Causative Agent for Cutaneous and Visceral Leishmaniasis - Purva Pingle; Atul Mourya; Madhulika Namdeo; Katta Chanti Babu; Harithasree Veerabomma; Radheshyam Maurya; Pankaj Kumar Singh; Neelesh Kumar Mehra; Saurabh Srivastava; Jitender Madan (AAPS PharmSciTech, 2023)

Recommended Best Practices in Freeze Dryer Equipment Performance Qualification: 2022 - Arnab Ganguly; Lisa Hardwick; Serguei Tchessalov; Steven L. Nail; Dan Dixon; Frank Kanka; Anthony Guidinas; T. N. Thompson; Cindy Reiter; Zakaria Yusoff; Ted Tharp; Joseph Azzarella; et al. (AAPS PharmSciTech, 2023)
Best practices for performing freeze dryer equipment qualification are recommended, focusing on identifying methods to quantify shelf thermal uniformity (also known as “shelf surface uniformity”), equipment capability, and performance metrics of the freeze dryer essential to the pharmaceutical Quality by Design paradigm. Specific guidelines for performing shelf temperature mapping, freeze dryer equipment limit testing (the capability curve), and condenser performance metrics have been provided. Concerning shelf temperature mapping and equipment capability measurements, the importance of paying attention to the test setup and the use of appropriate testing tools are stressed. In all the guidelines provided, much attention has been paid to identifying the balance between obtaining useful process knowledge, logistical challenges associated with testing in the production environment vs that at laboratory scale, and the frequency of the testing necessary to obtain such useful information. Furthermore, merits and demerits of thermal conditions maintained on the cooled surfaces of the freeze dryer condenser have been discussed identifying the specific influence of the condenser surface temperature on the process conditions using experimental data to support the guidelines. Finally, guidelines for systematic leak rate testing criteria for a freeze dryer are presented. These specific procedural recommendations are based on calculations, measurements, and experience to provide useful process and equipment knowledge. Graphical Abstract

Polymeric Nanogel for Oral Delivery of the Chemotherapeutic Agent: Fabrication and Evaluation Alongside Toxicological Studies and Histopathological Examination - Humaira Sultana; Muhammad Naeem Aamir; Asadullah Madni; Masood ur Rehman; Afifa Shafiq; Jafir Hussain Shirazi; Sidra Hassan; Sumaira (AAPS PharmSciTech, 2023)

A Novel Approach for the Availability and Ocular Delivery of Tenoxicam Potassium: Synthesis, Characterization, and In Vivo Application - Shaaban K. Osman; Taher M. Yassin; Ahmed M. Mohammed; Abdallah M. Alfayomy; Ahmed A. Abdellatif; Wael A. Mahdi; Sultan Alshehri; Mohamed A. El Hamd; Hatem Sarhan; Mohammed A. Ibrahim (AAPS PharmSciTech, 2023)

Optimization of Process and Formulation Variables for Semha–Pinas Extract Effervescent Tablets Using the Box–Behnken Design - Jirapornchai Suksaeree; Chaowalit Monton; Laksana Charoenchai; Natawat Chankana; Thaniya Wunnakup (AAPS PharmSciTech, 2023)

Inclusion Complex of Clomiphene Citrate with Hydroxypropyl-β-Cyclodextrin for Intravenous Injection: Formulation and Stability Studies - Manjusha Annaji; Nur Mita; Ishwor Poudel; Qi Wang; Brittany Tipton; R. Jayachandra Babu; Candace C. Lyman (AAPS PharmSciTech, 2023)

3D Printing as a Technological Strategy for the Personalized Treatment of Wound Healing - Denise Tiemi Uchida; Marcos Luciano Bruschi (AAPS PharmSciTech, 2023)

Dissolving Microneedle Arrays as a Hepatitis B Vaccine Delivery System Adjuvanted by APC-Targeted Poly (Lactic-co-Glycolic Acid) (PLGA) Nanoparticles - Xiaoling Zheng; Jiahuan Zhu; Caihong Zheng; Zeng Tan; Zhonghua Ji; Jin Tao; Yunchun Zhao; Zhuwa Ji; Ying Hu (AAPS PharmSciTech, 2023)