Novel Hybrid Polymer-Lipid-Based Formulations for Enhanced Dissolution Rates of Poorly Water-Soluble Drugs: A Quality by Design (QbD) Approach via Hot Melt Extrusion - Siva S. Kolipaka; Laura A. Junqueira; Vivek Garg; Shaumil Bhatt; Vivek Trivedi; Dennis Douroumis (AAPS PharmSciTech, 2026)

Engineering Next-generation Drug Delivery Systems Via 4-D Printing: A Paradigm Shift Toward Precision Medicine - Charmi Dudhat; Shruti Rawal; Mohit Shah; Riya Patel (AAPS PharmSciTech, 2026)

Advanced Bisoprolol Oral Liquid Formulations for Flexible Pediatric and Geriatric Pharmacotherapy - María Alejandra Operto; Marina Antonio; Rubén Maggio; Darío Leonardi; Silvana Vignaduzzo (AAPS PharmSciTech, 2026)

Formulation, Optimization and Characterization of Acetazolamide-Loaded Solid Lipid Nanoparticles for Glaucoma Treatment: In-Vitro and In-Vivo Study - Shuchi Goyal; Ankur; Garima; Rajan Swami; Neeraj Mittal (AAPS PharmSciTech, 2026)

Quality by Design for Bilayer Tablets: Integrating Formulation, Manufacturing, and Process Analytical Technology - Joao D Simão; António J Ribeiro (AAPS PharmSciTech, 2026)

Regulatory and Quality Considerations of Antibody-drug Conjugates - Karen J. Cha; Morris Rosenberg (AAPS PharmSciTech, 2026)

Multi-Omics-Driven Insights into Cancer Biology and Therapeutic Targeting - Deval Koshti; Nikhil Khandale; Jignesh Shah; Darshil Shah; Vrashabh V. Sugandhi; Dilip Maheshwari; Vishal Shah; Sanyog Jain (AAPS PharmSciTech, 2026)

Polymeric Azelaic Acid-loaded Nanocapsules Incorporated into Tragacanth Gum: Development and Biological Evaluation in Alternative Models for the Treatment of Rosacea - Tainara Benin; Graziela Scheuer Gomes; Eduarda Cristina Jacobus Ferreira; Victor de Mello Palma; Aline de Cristo Soares Alves; Fernanda Visioli; Adriana Raffin Pohlmann; Silvia Stanisçuaski Guterres; Luiza Abrahão Frank (AAPS PharmSciTech, 2026)

Use of Benzene-Free Carbomer 980 in the Formulation of Metronidazole Gel 0.75% and Demonstration of Equivalence with Carbomer 940 - Om Sambhaji Shelke; Jie Feng; Zhong Liu; Yulan Chen; Yijie Zhu; Zheng Zhang (AAPS PharmSciTech, 2026)

Retraction Note: Nasal In-Situ Gels of Brij®-Enriched Novasomes as Optimistic Nanovesicular Carriers for Enhancing Anti-Depressant Action of Agomelatine - Tarek M. Ibrahim; Ayman M. Fathi; Nourhan A. Abdulla (AAPS PharmSciTech, 2026)

Retraction Note: Bi-polymeric Spongy Matrices Through Cross-linking Polymerization: Synthesized and Evaluated for Solubility Enhancement of Acyclovir - Saima Asghar; Naveed Akhtar; Muhammad Usman Minhas; Kifayat Ullah Khan (AAPS PharmSciTech, 2026)

Correction: Scrutinizing the Feasibility of Nonionic Surfactants to Form Isotropic Bicelles of Curcumin: a Potential Antiviral Candidate Against COVID-19 - Dina B. Mahmoud; Mohamed Mofreh Bakr; Ahmed A. Al-karmalawy; Yassmin Moatasim; Ahmed El Taweel; Ahmed Mostafa (AAPS PharmSciTech, 2026)

The Role of Contract Manufacturing in Antibody–Drug Conjugate (ADC) Drug Substance Development – Strategies for Successful Engagement - Conor S. Barry (AAPS PharmSciTech, 2026)

A Review on Nanocarrier-Based Strategies for Sunitinib Delivery: Advances in Pharmacokinetic Enhancement and Targeted Theranostics - Mahesha Keerikkadu; Akshay Shetty; Raagul Seenivasan; Praveen Halagali; Vamshi Krishna Tippavajhala; Mahalaxmi Rathnanand (AAPS PharmSciTech, 2026)

A Review on Modular Peptide Anchoring Strategies for Functionalizing Liposomal Nanocarriers: Advancing Non-covalent Design Toward Targeted Cancer Therapy - Adamu Safiyanu Maikifi; Veerakiet Boonkanokwong (AAPS PharmSciTech, 2026)

Vegetable Butter-Based Nanocarriers: Do Nanoparticulation and Quercetin Loading Modulate In vitro Cellular Effects Involved in Wound Healing? - Ana Beatriz Chieco Costa; Regina Gomes Daré; Luciana B. Lopes (AAPS PharmSciTech, 2026)

Hot-Melt Extrusion of Bupropion with Three Ethylcellulose Grades for Pellet Feedstock Preparation and Screw-Based 3D Printing of Sustained-Release Tablets - Chrystalla Protopapa; Laura Andrade Junqueira; Siva Satyanarayana Kolipaka; Sophia Economidou; Dimitris Pappas; Dennis Douroumis; Marilena Vlachou (AAPS PharmSciTech, 2026)

The Preparation and Physicochemical Characterization of a Triple Synergistic Nanoplatform Designed for Targeted Subcutaneous Delivery of Sitagliptin with Potential for β-Cell Preservation - Mo’tasem M. Alsmadi; Rana Obaidat (AAPS PharmSciTech, 2026)

Enhanced Stability and Transdermal Delivery of Semaglutide Using an L-Arginine Based Dissolving Microneedle System - Priyanka Panchal; Snehal Daware; Yi Guo; Ganming Mao; Blase Billack; Pulkit Khatri; Ketan Patel (AAPS PharmSciTech, 2026)

Repurposing Non-oncologic Drugs via Targeted Nanocarriers for Cancer Therapy: Mechanisms, Synergistic Combinations, and Clinical Translation - Nur Aininie Yusoh; Afiq Azil; Ahlam Zaid Alkilani; Mohd Basyaruddin Abdul Rahman; Azren Aida Asmawi; Rosniza Razali; Fatmawati Adam; Nurul Akmarina Mohd Abdul Kamal (AAPS PharmSciTech, 2026)

Targeting Permeability Barriers By Strategic Selection of Thiol Containing Coformer for Novel Cocrystals of Metformin - Mangesh R. Bhalekar; Ashwini R. Madgulkar; Shweta J. Khiratkar (AAPS PharmSciTech, 2026)

Plume Geometry Matters: Investigating the Contribution of Mass-Based Plume Geometry to Aerosol Delivery Efficiency in pMDIs - Daniel Moraga-Espinoza; Eli Eshaghian; Tania F. Bahamondez-Canas; Hugh D. C. Smyth (AAPS PharmSciTech, 2026)

Eigenrate-Based Thermodynamic Decomposition of Competing Release Mechanisms in Polymeric Nano- and Microspheres: The MMIR-S Framework with Arrhenius Dual-Population Burst Kinetics and Log-Normal Polydispersity Averaging - Pitt Supaphol (AAPS PharmSciTech, 2026)

Development and Characterization of Amorphous PVP K30–Phosphatidylcholine Dispersions for the Fixed-Dose Co-Delivery of Hesperetin and Cannabidiol Prepared by Hot-Melt Extrusion - Kamil Wdowiak; Judyta Cielecka-Piontek (AAPS PharmSciTech, 2026)

Charge-Interaction-Mediated Adsorption of Human Growth Hormone on Polymeric Nanoparticles - Rajeshwar Motheram; Rijo John; Jasmin Monpara; Pardeep Gupta (AAPS PharmSciTech, 2026)

In Vitro Release Prediction of Colchicine Transdermal Patch Based on Raman Spectroscopy Imaging and Data-Driven Modeling - Xin Sha; Wenliang Dong; Lisong Zhang; Lian Li; Wenlong Li (AAPS PharmSciTech, 2026)

SeDeM-Guided Design and Optimization of MCC–Calcium Sulfate Co-Processed Excipient (MCCASUL) for Direct Compression Applications - Minal R. Narkhede; Sonal Y. Mhaske (AAPS PharmSciTech, 2026)

Advances in Payload and Linker Designs for ADCs - Samson Gebretnsae (AAPS PharmSciTech, 2026)
Antibody-drug conjugates (ADCs) are a therapeutic approach that embodies the “magic bullet” concept envisioned by Paul Ehrlich. Since their initial clinical potential was recognized in the early 1980s, ADCs have undergone several generations of development to enhance their therapeutic index (Poon KA, et. al. 273(2):298-313, 2013). Recent advancements, particularly in the last third and the beginning of the fourth generation, have primarily focused on discovering new drug modalities and more potent cancer treatments, while also developing new linkers and improving site-specific and conjugation chemistries. The effectiveness and toxicity of ADCs are largely influenced by their overall physicochemical properties, especially hydrophobicity, plasma stability, resistance to payload release, and the efficient release of the payload at the target site (Saber H, et. al. 71(3):444-52, 2015), (Saber H, et. al. 107:104429, 2019). These properties are heavily dictated by the site of conjugation, conjugation chemistry, linkers, and payloads. Most payloads are hydrophobic and cannot undergo significant structural or functional changes without compromising their cytotoxicity. In contrast, linkers can be extensively modified to enhance the physicochemical characteristics of ADCs, improve stability, increase drug-to-antibody ratio (DAR), and reduce aggregation. This review will focus on the latest advancements in potent payloads with novel mechanisms of action, including immune-stimulating agents, protein degraders, radionuclides, light-activated photosensitizers for photoimmunotherapy, and dual-payload ADCs. Additionally, we will explore emerging linkers that offer varying stimuli for trigger payload release and improved release control.

Twin-Screw Melt Granulation with Mannitol: High-Drug-Loaded Immediate-Release Tablets of Caffeine - Elzbieta Maria Buczkowska; Kirils Kukuls; Zoltán Márk Horváth; Alīna Jaroslava Frolova; Līga Pētersone; Suha Dadou; Valentyn Mohylyuk (AAPS PharmSciTech, 2026)

Correction: Carbohydrate-Functionalized Liposomal Nanocarriers: Design Strategies for Receptor-Mediated Organ Targeting and Advanced Theranostic Applications - Jayaraj Beliraya; Raagul Seenivasan; Praveen Halagali; Mahalaxmi Rathnanand; Vamshi Krishna Tippavajhala (AAPS PharmSciTech, 2026)

Chloramphenicol Application Onto the Eyelid: Transfersomes for Enhanced Skin Delivery - Larysa Grygor’yeva; Manuela Colla Carvalheiro; Joana Marto; Sandra Simões (AAPS PharmSciTech, 2026)

Development of Resveratrol/Curcumin Dual-Loaded Chitosan/Sericin Hydrogel Films for Wound Healing: A Comparison Of Shrimp- and Crab-Sourced Chitosan - Bui Thi Phuong Thuy; Phuong T. M. Ha; Nguyen Thi Ngoc Quyen; Nguyen Thi Kim Ngan; Ngoc Yen Nguyen; Nguyen Trong Tuan; Huynh Vu Thanh Luong; Tran Thi Bich Quyen; Trieu Phu Hau; Duy Toan Pham (AAPS PharmSciTech, 2026)

Amphotericin B-cholesterol Co-encapsulated Polymeric Nanoparticles in Protein Hydrogel-based Injectable Depot System for Long-acting Drug Delivery - Sanat Kumar Dash; Rashmi Ghosh; Anil B. Jindal (AAPS PharmSciTech, 2026)

Process Development of Site-Specific Antibody–Drug Conjugates - Brian O’Mara; Shantanu Guha (AAPS PharmSciTech, 2026)

Solvent‑Free Bioerodible Ophthalmic Inserts for Mangiferin Delivery: Physicochemical Characterization and In Vivo Evaluation - Nam V. Dao; Tu V. Le; Anh Q. Vo (AAPS PharmSciTech, 2026)

Oil-in-water Emulsion as a Strategy for Taste Masking of Cannabinoid Extract - Juliana Feitoza Brasil; Luiza Aparecida Luna Silvério; Claudete da Costa-Oliveira; Leonardo Costalonga Rodrigues; Maria Helena Gonçalves; Leonardo Mathias Leidens; Carla Daniela Boeira; Jose Luiz Costa; Antonio Riul Junior; Priscila Gava Mazzola (AAPS PharmSciTech, 2026)

Rapid Identification of Counterfeit Biopharmaceuticals using Portable Fourier Transform Infrared Spectroscopy - Vineela Peruri; Rishika Trivedi; Drashti Trivedi; Arunima Garg; Anurag S. Rathore (AAPS PharmSciTech, 2026)

Matrix Metalloproteinase-9-Responsive Lipid-Core Micelles for Proof-of-Concept Enzyme-Triggered Cardiomyocyte Association - Wai-Houng Chou; Jafet Ortiz-Quintero; Sergio Bedoya; Lorena García; Javier O. Morales (AAPS PharmSciTech, 2026)

Functional Hybrid Wound Scaffolds for Controlled Drug Delivery and Smart Wound Management: A Decade of Progress - Riya Patel; Shreeraj Shah; Bhupendra Prajapati (AAPS PharmSciTech, 2026)

From Parenteral to Oral Delivery: Facile Formulation of Oral Gemcitabine Nanospanlastics for Enhanced Bioavailability and Anticancer Activity in Murine Breast Cancer Model - Safaa E. Ramadan; Suleiman S. Eltokhy; Sanaa A. El-Gizawy; Yusuf A. Haggag (AAPS PharmSciTech, 2026)

Comparison of Chitosan-Poloxamer Nanoparticles and Poloxamer-based In-Situ Forming Gel for Nose-to-Brain Delivery of Cetrorelix: In Vitro and Pharmacokinetic Studies in Rats - Soheil Tafazzoli Mehrjardi; Mohsen Tafaghodi; Davood Yari; Hossein Kamali; Ali Nokhodchi (AAPS PharmSciTech, 2026)

Antibody–Drug Conjugates Drug Product Formulation and Process Development, Scalability and Stability Considerations - Léa Sorret; Mamiko Ninomiya; Nils Hillebrandt; David Schmitt; Arundhati Chattopadhyay; Orla McGarvey (AAPS PharmSciTech, 2026)
Antibody–drug conjugates (ADCs) combine the target specificity of monoclonal antibodies with the potency of cytotoxic small molecules, offering enhanced therapeutic potential. However, their inherent structural complexity, arising from the interplay of antibody, linker, and payload, introduces unique challenges for drug product (DP) development, stability, and scalability requiring tailored approaches to maintain the quality target product profile throughout the product lifecycle. This review summarizes key formulation and process development considerations for ADCs, with an emphasis on aspects that are particularly distinctive for ADC drug products. Critical degradation risks, such as photo- and heat-induced degradation, are discussed in the context of formulation screening, formulation excipients and primary packaging selection, and DP process design. Basic considerations on analytical tools used to identify and monitor critical quality attributes are provided. Lyophilization strategies, essential for the stability of commercialized ADCs, are recommended using Design of Experiments and modeling approaches. Furthermore, robust DP process control strategies during scale-up are reviewed with a focus on lyophilization, the application of Quality by Design (QbD) principles, and risk-based methodologies to address ADC‑specific challenges. Finally, the review explores the transition from early development to late-phase clinical and commercial stages, underscoring the need for evolving control strategies. Overall, it provides an overview of current practices and challenges in ADC formulation and DP process development, offering strategies to navigate these complexities based on literature and insights from approved ADCs.

Design of Ion-Pairing Azithromycin liposome for Local Pulmonary Delivery with Prolonged Lung Retention - Mengtong Wu; Siqi Li; Hongbing Liu; Tian Yin; Jian Zhao; Tao Wu; Yu Su; Muse Ji; Yu Zhang (AAPS PharmSciTech, 2026)

Carbohydrate-Functionalized Liposomal Nanocarriers: Design Strategies for Receptor-Mediated Organ Targeting and Advanced Theranostic Applications - Jayaraj Beliraya; Raagul Seenivasan; Praveen Halagali; Mahalaxmi Rathnanand; Vamshi Krishna Tippavajhala (AAPS PharmSciTech, 2026)

Exploring Synergistic Potential of Sorafenib and Atorvastatin to Launch Apoptosis and Ferroptosis-driven Mixed Cell Death Mechanism in Colorectal Cancer - Vivek Yadav; Sayali Dighe; Pratik Dhake; Sanyog Jain (AAPS PharmSciTech, 2026)

Understanding the Impact of Particle Size and Crystal Habit of Mesalamine Drug Substances on Their Packing, Wetting, and Dissolution Behaviour: A Science-based Approach for Selection of API Vendor - Prakash Kumar Sirvi; Ayush Rohila; Sakshi Kunjir; Sadhana Dhyagala; Ankit Kumar; Rajkumar Malayandi (AAPS PharmSciTech, 2026)

Safe Handling and Clinical Administration of Antibody Drug Conjugates: Occupational Safety, Material Compatibility, and the Integration of CSTDs into Workflows - Lara Nonis; Yaser Alkhatib; Balasubramanian Sivakumar; Mattias Paulsson; Josef Hartl; Stanley Kwok; Léa L. Sorret (AAPS PharmSciTech, 2026)

Comments on “Methodological Concern Regarding the In Vitro Release Assessment Performed Using a Dialysis Method with a PBS/ethanol (1:1, v/v) Medium” - Sophia Hatziantoniou (AAPS PharmSciTech, 2026)

Comparative Study of Rotigotine Release and Permeation from the Neupro® Transdermal Patch: An In Vitro-In Vivo Correlation - Thamara de Carvalho Mendes; Hellen Regina Oliveira de Almeida; Lucio Mendes Cabral; Alice Simon; Valeria Pereira de Sousa (AAPS PharmSciTech, 2026)

Formulation, Characterization, and Optimization of Ascorbic Acid-Loaded Chitosan Nanoparticles: Investigating the Impact of pH and Ionic Crosslinking Parameters - Wasfy M. Obeidat; Abdolelah Jaradat (AAPS PharmSciTech, 2026)

In vitro Evaluation of Hydroxypropyl-β-cyclodextrin Effects on Rhein Flux Across Microneedle-pretreated Skin - Kamchai Saepang; Puwich Chaikhumwang; Benjaporn Buranrat; Tasana Pitaksuteepong; Supavadee Boontha (AAPS PharmSciTech, 2026)

Quality-by-design-based fabrication of betaxolol hydrochloride-loaded nano-ocular carrier via ternary phase mapping of solid/liquid lipids and BBD modeling for enhanced transcorneal flux and IOP-lowering effect - Nishant Kumar; Anoop Kumar; Sokindra Kumar (AAPS PharmSciTech, 2026)

Effects of Different Carriers on the Stability and Pharmacokinetic Performance of Cucurbitacin B Solid Dispersions - Siri Huang; Qian Wu; Yabo Ren; Hefei Xue; Xigang Liu (AAPS PharmSciTech, 2026)

Safety and Efficacy of Inhaled Natural Product Powders That Enhance Mucociliary Clearance - Dale J. Christensen; Zachary Warnken; Daria Stoltz; Matthew Beerman; Norman Amparado; Michael Grass; Nicholas Haft; Juan Sabater (AAPS PharmSciTech, 2026)

Development and Characterization of Ginsenoside-Aconitum Lipidic Cubic Nanoparticle-Loaded Dissolving Microneedles for Enhanced Transdermal Anti-inflammatory Therapy - Yang Liu; Yaqian Wang; Sinan Wu; Xiali Zhu; Jie Yang; Yongyan Jia (AAPS PharmSciTech, 2026)

Formulation, Optimization and In vivo Evaluation of Freeze-Dried Nanocapsules for Enhancing the Oral Delivery of Valsartan - Asmaa H. Abdelhameed; Usama Farghaly; Zeinab M. Fathalla; Gamal Zayed (AAPS PharmSciTech, 2026)

Managing Dissolved Air Throughout Freeze–Thaw Process to Reduce Aggregation of Human Serum Albumin - Neela Nahar Nazmun; Huy M. Dao (AAPS PharmSciTech, 2026)

Identifying Optimal Drug Loading in Stable Amorphous Solid Dispersion Formulations: A Rheological Approach - Sagar Narala; Fengyuan Yang; Kapish Karan; Michael Kogan; Ian Pierce; Osama M. Musa (AAPS PharmSciTech, 2026)

Bridging Therapeutics and Nanotechnology in Dry Eye Disease: A Review of Risk Factors, Drug Delivery Barriers, and Recent and Future Endeavors for Disease Management - Mayar Salama; Islam M. Adel; Randa Tag; Ahmed R. Fares (AAPS PharmSciTech, 2026)

Palatability-by-Design for Oral Drug Products: A Unified Framework for Evaluation and Optimization - Qiaorui Li; Junzhe Xi; Zhenda Liu; Yingying Mu; Lijie Zhao; Lan Shen (AAPS PharmSciTech, 2026)

Engineering Bilosomal Nanocarriers for Targeted Delivery of Resveratrol: Rational Design, Radiotracking Insights and Cytotoxic Assessment - Khaled M. Attallah; Shymaa Hatem; Marwa Eid Sayyed (AAPS PharmSciTech, 2026)

Formulation Development of Topical Inserts Containing Doxycycline and Doxycycline Combined with Tenofovir Alafenamide and Elvitegravir for the Prevention of Sexually Transmitted Infections - Vivek Agrahari; M. Melissa Peet; Jasmin Monpara; Rijo John; Sriramakamal Jonnalagadda; Pardeep K. Gupta; Meredith R. Clark; Gustavo F. Doncel (AAPS PharmSciTech, 2026)

Development and Evaluation of Tofacitinib Tablets with Comparative Dissolution and Pharmacokinetic Studies in Beagle Dogs - Deokkyu Lee; Jain Koo; Hyewon Jeon; Jaehyun Cheong; Dongmin Park; Kyung Taek Oh (AAPS PharmSciTech, 2026)

Design, Optimization and Pharmacokinetic Profiling of BCS Class II Drug Loaded Oral Self Nanoemulsifying System - Ayon Dutta; Swarupananda Mukherjee; Biswajit Basu; Durgesh Ranjan Kar (AAPS PharmSciTech, 2026)

PEGylated Flavonoid Aspasomes as a Brain-Targeted Nano-Vesicular Platform for Enhanced Neuroprotection in Stress-Induced Cognitive Dysfunction - Amal Fathy Aladoly; Maha M. Amin; Heba Nasr Shalaby; Ahmed F. Mohamed; Mohamed Y. Zakaria (AAPS PharmSciTech, 2026)

Impact of Amino Acid Excipients on icIEF Method Development in Protein Therapeutics: A Formulation-Aware Analytical Framework - Pragya Manandhar; Nicole Payung; Siddharth Sapa; Matthew Myers; Zaneta Maijorovaite; Haichen Nie (AAPS PharmSciTech, 2026)

From Digital Design to Dosage Performance: Material-Process-Geometry Interactions in 3D-Printed Oral Tablets - Aarya Rajendra Menkudale; Prerana V. Poojary; Swohinee Sarkar; Shaila Angela Lewis (AAPS PharmSciTech, 2026)

The Application of Machine Learning in the Development of Co-Amorphous Dry Powder Inhalation - Ziling Zhou; Xian Chen; Yuxin Liu; Rongjiao Zheng; Junxiang Huang; Xin Pan; Chuanbin Wu; Junhuang Jiang (AAPS PharmSciTech, 2026)

Understanding the Influence of Molarity, Buffer Capacity, and pH on Product-specific Guidance Dissolution Method for Developing a Discriminatory Dissolution Method for the Development of Mesalamine Products - Ankit Kumar; Sakshi Kunjir; Prakash Kumar Sirvi; Ayush Rohila; Sadhana Dhyagala; Rajkumar Malayandi (AAPS PharmSciTech, 2026)

Mesoporous Silica Nanoparticles for Ocular Drug Delivery: Synthesis, Functionalization, and Safety Insights - Lajja Patel; Tejal Mehta (AAPS PharmSciTech, 2026)

Advancement in Sodium Alginate-Based Drug Delivery Systems: Applications and Future Prospects - Anjali Kumari; Bonthu Varunteja; Satyajit Mohanty; Anjali Mishra; Nayan Gupta; Tuhin Mukherjee; Bhawna Sharma; Nikita Nayak; Anwesha Sahu; Ashok Pattnaik; Pranav Kumar Prabhakar; Uttam Kumar Mishra (AAPS PharmSciTech, 2026)

Cyclodextrins: Synthesis, Pharmaceutical Applications, Drug Delivery Systems and Safety Perspectives - Aman Kumar; Ravi Raj Pal; Preeti Patel; Atul Jain; Nitin Sharma; Umesh Kumar Patil; Balak Das Kurmi (AAPS PharmSciTech, 2026)

Development of a New Aerosol Delivery System for Administering Aerosol Surfactant Therapy to Preterm Infants Through a Laryngeal Mask Airway - Sarah C. Strickler; Caleb J. Dalton; Felicia G. Hall; Dale R. Farkas; Mohammad A. M. Momin; Robert M. DiBlasi; Michael Hindle; P. Worth Longest (AAPS PharmSciTech, 2026)

A Quality-by-Design Approach Based Formulation, Optimization, In Vitro and Ex Vivo Evaluation of Delafloxacin-Loaded Ethosomal Gel - Deesha Jain; Devaraj Yallappa; Modhusmita Gogoi; Kunal Gonage; Sapan Borah; Aakanchha Jain (AAPS PharmSciTech, 2026)

Hybrid Photometric–Geometric 3D Reconstruction Framework for Manufacturing-Oriented Assessment of Tablet Surface CQAs under PAT/RTRT - Phakdee Sukpornsawan; Jakkarin Suksawatchon; Watcharaphong Chaemsawang; Somchart Chokchaitam; Ureerat Suksawatchon (AAPS PharmSciTech, 2026)

Liposome-Based Drug Delivery Systems: Mechanisms, Preparation Strategies, Clinical Status, and Therapeutic Applications - Abdul Shadab; Md. Faheem Haider; Mohammad Abohassan (AAPS PharmSciTech, 2026)

Emerging and Prospective Engineering Technologies Enabling Microneedle Based Vaccine Therapeutics - N. Ahmad; N. A. Jalil; R. Benziane; H. Iqbal; S. J. Rana; T. AbuAin; A. Al-Asiri; A. T. Kola-Mustapha; M.S. Arshad; Z. Ahmad (AAPS PharmSciTech, 2026)

Integrative Perspectives on Pirfenidone: Mechanistic Insights, Pharmacodynamics, and Emerging Therapeutic Strategies for Fibrotic Disorders - Abhidnya Kudterkar; Sarika Wairkar (AAPS PharmSciTech, 2026)

Formulation-Based Repurposing of Mifepristone Using a Drug-Eluting Intrauterine Insert for Localized Uterine Fibroid Therapy: A Preclinical Study - Riya Patel; Alkesh Patel; Gayatri Patel (AAPS PharmSciTech, 2026)

Smart In Situ-Forming Ocular Therapeutics for Dry Eye Disease: Bridging Biomaterials, Nanotechnology, and Clinical Translation - Adiba Rahman; Poonam Kushwaha; Bipasha Ray; Sapna Yadav (AAPS PharmSciTech, 2026)

Influence of pH, Buffering Capacity, Ionic Strength, Bile Salts, and Model Drugs on Micellization Behaviour of Salcaprozate Sodium in Physiological Range pH Buffers - Sideequl Akbar; Anumol Joseph; Adarsh Malgave; Ankit Kumar; Priyambada Bej; Rajkumar Malayandi (AAPS PharmSciTech, 2026)

Efficient Loading of Rabeprazole Sodium via Porous Anion Exchange Resin for Enteric Delivery - Hongfei Liu; Luyuan Cai; Yutian Dou; Yingshu Feng; Caleb Kesse Firempong; Guoqing Zhang; Haibing He (AAPS PharmSciTech, 2026)

Combining of Spray Drying and Dry Granulation to Prepare Orodispersible Tablets: Influence of Spray-Dried Particle Size on Tablet Properties - Thao Tranová; Jan Loskot; Petr Koukal; Jitka Mužíková (AAPS PharmSciTech, 2026)

Optimizing Particle Size of pH Modifiers Enhances Dissolution of Weakly Basic Drugs - Kejia Wu; Yupeng Feng; Zherui Zhang; Junyao Jiao; Weiwei Zhang; Dandan Wei; Haibing He; Yu Zhang; Tian Yin; Zhihong Bao; Yanjiao Wang; Xing Tang (AAPS PharmSciTech, 2026)

Formulation Design of a Hot-melt Extrusion-Based Amorphous Solid Dispersion to Optimize Palatability of Berberine Hydrochloride with In Vitro and In Vivo Evaluation - Jiayu Zhang; Shengyu Zhang; Chunxue Wang; Binxin Cai; Hongxuan Yang; Kai Zhuang; Nitin Swarnakar; Sandip Tiwari; Feng Zhou; Wenxi Wang; Yang Zhou; Jiantao Zhang (AAPS PharmSciTech, 2026)

Thermo-Sensitive Polymeric Networks for Next-Generation Wound Management: A Review - Akshay Kumar; Prachee Nirmale; Suresh Babu Kondaveeti; Arpan Kumar Tripathi; Jailani Shiekmydeen; Sagar Nanaso Salunkhe; Gurjeet Singh Thakur; Mohit Kumar (AAPS PharmSciTech, 2026)

DoE-Optimized Chitosan-Coated pH-Sensitive Liposomes for Targeted Nose-to-Brain Delivery of Temozolomide - Ashish Jain; Harsh P. Nijhawan; Khushwant S. Yadav (AAPS PharmSciTech, 2026)

Can a Lipid-Containing Co-Processed Excipient Overcome Compression Challenges Associated with a Cohesive and Viscoelastic API? - Ivana Aleksić; Teodora Glišić; Slobodanka Ćirin-Varađan; Jelena Đuriš (AAPS PharmSciTech, 2026)

TPGS Modified Phospholipid-free and Cholesterol-free Ethosomes Enhance Chemical Stability and Transdermal Permeation Of Retinol - Fanjun Xu; Meiting Li; Hang Ruan; Teng Guo; Zhi Wang; Nianping Feng; Yongtai Zhang (AAPS PharmSciTech, 2026)

Besifloxacin-Loaded Nanostructured Lipid Carrier for Ocular Delivery: Formulation Optimization, In Vitro Characterization, and Safety Assessment - Mirla Anali Bazan Henostroza; Jéssica Fagionato Masiero; Carolina Falaschi Saponi; Danielle Costa Vargas Redondo; Raimar Löbenberg; Gabriel Lima Barros de Araujo; Nádia Araci Bou-Chacra (AAPS PharmSciTech, 2026)

Recent Advances in Surface-Engineered Polymeric Nanoparticles for Targeted Paclitaxel Delivery in Breast Cancer Therapy - Mahak Fatima; Fahad AlQahtani; Prashant Kesharwani (AAPS PharmSciTech, 2026)

Stability Assessment of FDA Approved Varenicline Tartrate Products for Critical Quality Attributes – N-Nitroso Varenicline, Solid Form, and Dissolution - Mariame A. Hassan; Gereziher Sibhat; Indra K. Reddy; Mansoor A. Khan; Ziyaur Rahman (AAPS PharmSciTech, 2026)

Comprehensive Modalities for Cataract Management: Preventive, Surgical, and Non-Surgical Approaches Using Conventional and Nanotechnology-Based Therapies - Aya Hussein; Maha El-Kayal; Rehab Nabil Shamma; Asmaa F. Khafaga; Nihal Farid Younes (AAPS PharmSciTech, 2026)

Functional Reclassification of Lipid-Based Drug Delivery Systems and Advances in Formulation Strategies and Manufacturing Challenges - Pranal Chhetri (AAPS PharmSciTech, 2026)

Harnessing Hybrid Niosomes for Improved Oral Bioavailability of an Anticoagulant: Design, Optimization and In-Vivo Pharmacokinetics and Pharmacodynamics Evaluations - Remonda Raafat Ragheb; Rodayana Atef; Kareem Abdou; Sadek Ahmed; Ahmed M. Fatouh (AAPS PharmSciTech, 2026)

Continuous Manufacturing of Controlled-Release Metoprolol Succinate Tablets by Novel Hot-Melt Fragmentation Technology - Rajat Radhakrishna Rao; Naitik Jain; Vinay Rao; Indu Bhushan; Srinivas Mutalik (AAPS PharmSciTech, 2026)

Polymer Drug Conjugate: A Revolution in Drug Delivery - Chandan Kumar Singh; Pran Kishore Deb (AAPS PharmSciTech, 2026)

Enhancing Doxorubicin Bioavailability via Dissolving Microneedles: Roles of Drug Loading and Administration Force - Beibei Yang; Huanhuan Pan; Chunxian Zhou; Jingxin Yang; Wentao Wu; Wenjing Tang; Xin Pan; Chuanbin Wu; Tingting Peng (AAPS PharmSciTech, 2026)

Albumin Nanoparticle-Based Delivery of Oxaliplatin-Oleic Acid Prodrug for Enhanced Breast Cancer Therapy - Oly Katari; S. Lokesh; Brojendra Nath Saren; Vivek Yadav; Kaushik Kuche; Sanyog Jain (AAPS PharmSciTech, 2026)

Artificial Intelligence-Guided Optimization of Hyaluronic Acid-Coated Liposomal Linagliptin for Targeted Management of Polycystic Ovary Syndrome - Marwa H. S. Dawoud; Aml H. Zaghloul; Karen S. Zakhari; Mai I. Mahmoud; Zeinab M. Elnagdy; Nyera H. El-Shafei; Mai A. Zaafan (AAPS PharmSciTech, 2026)

Unveiling the Potential of Plant-derived Exosomes: A Comprehensive Review - Srishty Jaiswal; Mitali Sethi; Rafquat Rana; Shourya Tripathi; Arun Kumar Trivedi; Manish K. Chourasia (AAPS PharmSciTech, 2026)

Methodological Concern Regarding the In Vitro Release Assessment Performed Using a Dialysis Method with a PBS/ethanol (1:1, v/v) Medium - Sophia G. Antimisiaris (AAPS PharmSciTech, 2026)

From Liquid to Solid: Formulation and Characterization of Testosterone-Loaded S-SMEDDS Pellets Using a 24 Factorial Design - Ohary de Sousa Borges; Julia Ornelas Kramer; Henrique Pascoa; Yanka Machado de Paula Santos; Leticia Silva Oliveira Freitas; Eliana M. Lima; Luís Antônio Dantas Silva; Danielle Guimarães A. Diniz (AAPS PharmSciTech, 2026)

Advances in Nanoparticle-Based Vitamin Delivery Systems for Precision Nutrition and Improved Bioavailability - Sathvik Chennamsetty; Mahesha Keerikkadu; Akshay Shetty; Mahalaxmi Rathnanand (AAPS PharmSciTech, 2026)

Design and Development of Prolong-acting Intelligent Nano-depot (PaIND) for Improving Patient Adherence - Hardik Rana; Shreya Gohel; Prachi Rabari; Dhruvixa Patel; Vaishali Thakkar; Tejal Gandhi (AAPS PharmSciTech, 2026)

3D Printed Vaginal Rings For Contraceptive Applications: Materials, Mechanisms, and Opportunities - Riya Patel; Paranshi Jadeja; Shailvi Shah; Shreeraj Shah; Bhupendra Prajapati (AAPS PharmSciTech, 2026)

Microneedle-Assisted Delivery of Biologics: From Large Molecules to Cancer Vaccines - Salma Younas; Mohit Kumar; Ramsha Khalid; Kirthana Gopal; Akshay Kumar; Pornanong Aramwit; Syed Mahmood (AAPS PharmSciTech, 2026)

Supersaturated Lipid-Based Formulations of Moderately Lipophilic Neutral Drug: Impact of Formulation type, Colloidal Behaviour and Precipitation Inhibition on In Vitro-In Vivo Performance - Kajal Guleria; Shubham Debaje; Abhay T. Sangamwar (AAPS PharmSciTech, 2026)

Effective Brain Targeting Using the Self-Emulsifying Drug Delivery Systems - Shruti Gawde; Yogeshwar Bachhav; Maushmi S. Kumar (AAPS PharmSciTech, 2026)

Formulation and Characterization of Amisulpride-Poly (Lactic-Co-Glycolic Acid) Nanoparticles Coated with Chitosan for Intranasal Delivery - Mai S. Khanfar; Sumieh Y. Alaboud; Raida W. Khalil; Ruba S. Darweesh (AAPS PharmSciTech, 2026)

Development of In Situ Gelling Liquid Extended Release System for Oral Delivery of Abiraterone Acetate - Mohamed M. Shehata; Mona F. Arafa; Ahmed E. Goda; Gamal M. El Maghraby (AAPS PharmSciTech, 2026)

Design, Optimization, and In Vitro Evaluation of Lactoferrin-Coated Brexpiprazole-Loaded Nanostructured Lipid Carriers for Brain Targeting - Jaimini Parmar; Pranav Shah; Dipika Chavda; Mahavir Bhupal Chougule (AAPS PharmSciTech, 2026)

Licofelone-Loaded Poly(d,l-Lactide-Co-Glycolide) Nanoparticles to Enhance Therapeutic Action: A Novel Approach for the Topical Management of Irritant Contact Dermatitis - Khaled E. Abuelella; Shaimaa Mosallam; Amira A. El-Gazar; Ahmed Hassen Elshafeey; Sara M. Soliman (AAPS PharmSciTech, 2026)

Innovative Nanocarriers of Sorafenib in the Optimisation of Therapeutic Outcome: Challenges and Applications in Breast Cancer - Nishtha Chaurawal; Amalia Ruiz Estrada; Klaus Pors; Kaisar Raza; Muhammad Wahajuddin (AAPS PharmSciTech, 2026)

Inhalable Therapeutics in Lung Cancer: Overcoming Barriers for Effective Treatment - Himanshu Paliwal; Tejas Rangbhal; Pratiksha Khedkar; Akanksha Kasture; Pratik Kharche; Sachin S. Gaikwad; Bhupendra G. Prajapati (AAPS PharmSciTech, 2026)

Analytical Development and Testing Strategy of Antibody–Drug Conjugates - Weijun Li (AAPS PharmSciTech, 2026)

Engineered Novel Brijaluronic Terpesomes for Brain-Targeted Quercetin Delivery: Optimization, Ex Vivo and Radiokinetics - Sadek Ahmed; Khaled M. Attallah; Marwa Eid Sayyed (AAPS PharmSciTech, 2026)

Engineered Lecithin-Polymer Hybrid Micelles for Enhanced Gallic Acid Delivery: Response Surface Optimization and Preclinical Evaluation - Nabila M. Sweed; Mahitab H. Elbishbishy; Mai A. Zaafan (AAPS PharmSciTech, 2026)

Personalized 3D-Printed Finger Splints Derived from CT Data Incorporating Multi-Drug Bilayer Nanofiber Delivery Systems - Ahmed M. Mortada; Alaa Y. Darwesh; Iman E. Taha; Thirupathi R. Anekalla; Nourhan Mostafa; Mohammed Maniruzzaman (AAPS PharmSciTech, 2026)

Effect of Polymer-stabilized Liquid–liquid Phase Separation on the Permeability Across the Corneal Barrier - C. C. Sruthi; Gayathri Ramachandran; Indhu Annie Chacko; M. Sabitha; M. S. Sudheesh (AAPS PharmSciTech, 2026)

Controlled Release of Thermosensitive Hydrogel Incorporating Betaxolol-Loaded Resin Microspheres for Glaucoma Therapy - Hongfei Liu; Zhen Zhang; Xinyi Tang; Yingshu Feng; Caleb Kesse Firempong; Haibing He; Guoqing Zhang (AAPS PharmSciTech, 2026)

Polymer-Surfactant Stabilized Amorphous Nanosuspension of Pazopanib: Box-Behnken Optimization and In-vivo Evaluation - Vanshul Saini; Ashish Hankare; Prakash Amate; Mehak Juneja; Mahesh Kashyap; Abhay T. Sangamwar (AAPS PharmSciTech, 2026)

Nanoformulations in Acne Therapy: Translational Opportunities and Barriers for Next-Generation Topical Treatments - Mohd Faiz Mustaffa; Nur Shareena Maisarah Mohd Ghazali; Syed Haroon Khalid; Khuriah Abdul Hamid (AAPS PharmSciTech, 2026)

Floating-Mucoadhesive Gastro-Retentive Tablets for Enhanced Oral Delivery of Glimepiride: Formulation, Optimization, and Controlled Release - Ankita Basak; Soumyadip Ghosh; Dharmajit Pattanayak; Saumya Das (AAPS PharmSciTech, 2026)

Levofloxacin Inhalation Solution: Superior Efficacy and Minimized Hepatotoxicity Against Chronic Pseudomonas Aeruginosa-Induced Pulmonary Infection - Langui Xie; Yue Zhou; Min Yang; Mingmei Wang; Jingna Xu; Yuqi Sun; Xiao Yue; Shihao Cai; Xia Zhao; Chuanbin Wu; Xuejuan Zhang (AAPS PharmSciTech, 2026)

Dapagliflozin Loaded Bilosomes Gel for Transdermal Delivery: Formulation, Optimization, Physicochemical Characterization, and In Vivo Evaluation - Omar Awad Alsaidan; Ameeduzzafar Zafar; Dibyalochan Mohanty; Mohd Yasir; Md Ali Mujtaba; Mohammad Khalid (AAPS PharmSciTech, 2026)

Stimuli-Responsive Carbon Nanotubes for On-Demand Cancer Therapy: A Review - Mahendran Radha; Ragini Shubham Chaudhari; Mayuresh Kashinath Raut; Mallepally Mamatha; Disha Arora; Akhilesh Patel; Shamim Shamim; Pawan Kumar (AAPS PharmSciTech, 2026)

Rapid and Efficient Aerosol Delivery During 60 L/min High Flow Nasal Cannula Therapy—In Vitro Development of a Novel Dry Powder Delivery Platform - Casey Grey; Ghali Aladwani; Anya Maradiaga; Dale Farkas; Nathan Perkins; Aamer Syed; Michael Hindle; P. Worth Longest (AAPS PharmSciTech, 2026)
High flow therapy (HFT) delivers heated and humidified gas at flow rates up to 60 L/min to hypoxemic subjects, but is not conducive to simultaneous administration of pharmaceutical aerosols. Aerosol losses occur due to circuit wall impaction, environmental loss and particle growth from high humidity; resulting in poor lung delivery efficiency. This study compares two strategies for delivering dry powder aerosols during 60 L/min humidified HFT: a circuit connector (HFT-CC) which integrates directly into the standard HFT flow pathway, and an interface connector (HFT-IC) designed to bypass delivery line losses by directly injecting aerosol into the nasal prongs. Experiments were conducted using an anatomically-realistic in vitro adult nasal airway model with physiological breathing patterns, albuterol sulfate excipient enhanced growth (AS-EEG) dry powder formulation, air-jet aerosolization engine, and custom air actuation system. The HFT-CC approach improved lung delivery to 25.6% compared to existing published data (12.8%) but was limited by losses in the circuit tubing and nasal interface. The HFT-IC approach with a split nasal interface achieved 45.1% lung delivery (HFT-IC3), nearly a fourfold improvement from previously published results, by isolating aerosol flow from HFT flow and eliminating upstream losses. While nose-throat (NT) deposition in HFT-IC3 remained high (39.6%), this approach presents an attractive target for future computational and experimental optimization. These findings prove that efficient dry powder aerosol lung delivery during 60 L/min humidified HFT is achievable, laying the groundwork for translational advances in the efficient delivery of pulmonary therapies such as surfactants, antibiotics, anti-inflammatories, and antivirals during ventilatory support.

Nanocarriers, Smart Biomaterials and Emerging Therapeutics for Psoriasis: Current Progress and Future Directions - Noha F. Ghazi; Nada F. Abo El-Magd; George Bebawy (AAPS PharmSciTech, 2026)

Moisture-Proof Herbal Extract Pellets Prepared via Asymmetric Liquid Layering Technology Combined with Mesoporous Silica and Magnesium Stearate - Shilin Ma; Yupeng Feng; Panao Yuan; Yunlong Xu; Ping Shao; Lifeng Lin; Zimin Wang; Ling Han; Xing Tang (AAPS PharmSciTech, 2026)

Development of Biocompatible Nanocarriers for Antiretrovirals Based on Polylactide and Chitosan - Vedha Hari B. Narayanan; Artur Lewandowski; Ramya Devi Durai; Paweł Wawrzyniak; Samson Folami; Lisa Weber; Hannah Sabeth Schwarzer-Sperber; Marek Brzeziński; Roland Schwarzer (AAPS PharmSciTech, 2026)

Design of a Thermoresponsive Nose-to-Brain Neuromaterial for the Release of Naturally Derived Extracellular Vesicles Delivering Teriflunomide for Multiple Sclerosis - Naznin Bhom; Poornima Ramburrun; Khonzisizwe Somandi; Yahya E. Choonara (AAPS PharmSciTech, 2026)
Multiple sclerosis is a neuroinflammatory disease characterized by demyelination and progressive neurological decline. Teriflunomide, a first-line immunomodulatory agent, faces limitations due to oral route of administration and systemic toxicity. To overcome these challenges, we developed a nose-to-brain delivery system comprising teriflunomide-loaded ginger-derived extracellular vesicles (G-EVs) embedded in an in situ nasal gel. G-EVs were isolated via serial centrifugation and double filtration and characterized for particle size (103.5 ± 1.09 nm) and zeta potential (-17.3 ± 0.32 mV) confirming nanoscale uniformity. Teriflunomide was loaded into G-EVs with an entrapment efficiency of 63.24 ± 0.75%. In vitro release studies revealed a biphasic drug release profile; an initial burst release of 3% in 24 h followed by sustained release over 21 days. The cytotoxicity of the G-EVs, loaded G-EVs and the drug was found to be non-toxic at lower concentrations ( in vitro studies. The loaded G-EVs were added to the nasal gel and SEM was performed to confirm uniformity. This formulation could offer a synergistic platform for brain drug delivery, combining the biocompatibility of naturally-derived EVs with the thermoresponsive nasal gel.

Cannabinoid Oral Mucosal Delivery: Approaches to Formulation, Fabrication, and Permeation Enhancement - Anushree Nagaraj; Ali Seyfoddin (AAPS PharmSciTech, 2026)

Evaluating Dextrose-Derived Interference in Low-Concentration Monoclonal Antibody Quantification for Clinical In-Use Studies - Rakesh Dachineni; Nida Naseer; Matthew Myers; Zaneta Maijorovaite; Haichen Nie (AAPS PharmSciTech, 2026)

Solubility-Permeability-Matrix Interplay in Percutaneous Absorption Exemplified by Theophylline - Sophia Engel; Jozef Al-Gousous; Christiane Grünewald; Claire Jacob; Peter Langguth (AAPS PharmSciTech, 2026)

Bi-Layered Tablets as a Novel Platform for Wound Healing and Synergistic Combination Therapy - Kranthi Gattu; Andrew Ramirez; Hua Zhu; Ketan Patel; Shanzhi Wang; Hyunah Cho (AAPS PharmSciTech, 2026)

DoE-based Development of Transdermal Risedronate-laden Cubosomes: In Vitro Characterization, Drug Deposition, and In Vivo Permeation in Rats - Amrendra J. Gautam; Sarika Wairkar (AAPS PharmSciTech, 2026)

Breaking the Barrier of Brain Disease Therapeutics: Advocating Targeted Drug Delivery for Improved Neuro-Resident Interventions - Brian Timothy Kariithi; Pradeep Kumar; Yahya Essop Choonara (AAPS PharmSciTech, 2026)
This paper provides an expert review of extant research into commercially utilized targeted drug delivery systems for brain therapeutics, with Glioblastoma Multiforme (GBM), Parkinson’s Disease (PD), Alzheimer’s Disease (AD) and Major Depressive Disorder (MDD), as case studies. While the paper highlights the progress made in developing effective drug delivery solutions, a common denominator across much of the research is the singular challenge posed by the Blood Brain Barrier (BBB) against the bulk of drug delivery options and treatments. The paper identifies critical pathways and transporting effective therapeutics through the barrier, and calls for further innovation into nano-systems, gels, and wafers with BBB-beating properties. The paper calls for the modernization of manufacturing regulatory systems, as well as increased preclinical studies and clinical trials to establish the utility of such nano-systems. Ultimately, the paper vouches for fast-tracking and even exemption of promising delivery solutions from phase IV studies but instead to accurately assess and evaluate the solutions' efficacy in a “real world" setting.

Design and Optimization of Indomethacin Nanocrystals using Machine Learning and Molecular Dynamics Simulations - Jianlu Qu; Chaoliang Jia; Yaobin Chen; Haibin Qu; Wenlong Li (AAPS PharmSciTech, 2026)

Stearylamine-Coated Cationic Phyto-Microemulsions Enhance Resveratrol Ocular Delivery for Glaucoma Therapy: Experimental and Preclinical Insights - Jothimani Rajeswari; Karthikeyan Kesavan; Alpana Ram (AAPS PharmSciTech, 2026)

Developing and Evaluating Stable Microemulsion Systems for Potential Intranasal and Transdermal Application of Omeprazole - Heba Hamid Hussein; Jamal ِِAlyoussef Alkrad; Loay Kahled Hassouneh; Aktham Mestareehi; Hatim S. AlKhatib; Shereen M. Assaf; Eman Zmaily Dahmash (AAPS PharmSciTech, 2026)

Rational Design of Amiodarone Co-crystals: A Synergistic Strategy Combining Computational Prediction, Precipitation-Inhibiting Polymers, and Formulation Optimisation - Rahul Jha; Smit Patel; Arzoo Sekhani; Heena A. Parmar; Nimeet Desai; Pranav Shah (AAPS PharmSciTech, 2026)

Liposomal Amodiaquine for Localized Therapy of Non-Small Cell Lung Cancer (NSCLC) - Meghana Mokashi; Mimansa Goyal; Naveen Rajana; Vivek Gupta (AAPS PharmSciTech, 2026)

Advancing Rare Cancer Therapeutics: Osimertinib-Loaded Inhaled PLGA Nanoparticles for Mesothelioma Treatment - Mural Quadros; Naveen Rajana; Vivek Gupta (AAPS PharmSciTech, 2026)

Modelling of Rheological Properties of Pharmaceutical Powder Mixtures for Direct Compression: A Statistical Approach - Pavlína Komínová; Michaela Gajdošová; David Smrčka; Petr Zámostný (AAPS PharmSciTech, 2026)

The isolated perfused lung: a bridge between in vitro and in vivo studies of inhaled medicinal products - Virginia Patterlini; Fabio Sonvico; Alessandro Fioni; Francesca Buttini (AAPS PharmSciTech, 2026)

Retraction Note: Chitosan Nanoparticles of Gamma-Oryzanol: Formulation, Optimization, and In vivo Evaluation of Anti-hyperlipidemic Activity - Tejal Rawal; Neha Mishra; Abhishek Jha; Apurva Bhatt; Rajeev K. Tyagi; Shital Panchal; Shital Butani (AAPS PharmSciTech, 2026)

Comparative Kinetic Modeling and Mathematical Analysis of Monoterpene Release from Nanocarrier Systems - Morteza Maleki; Maryam Mehrabi; Masomeh Mehrabi; Soroor Sadegh Malvajerd (AAPS PharmSciTech, 2026)

Radiopharmaceuticals: Status, Regulatory Landscape and Future Perspective - Heena Maithania; Rijo John; Raghunandhan Painoori; Jasmin Monpara; Shankar Swaminathan; Rahul Kalhapure (AAPS PharmSciTech, 2026)

Fortified Long-acting Ocular Gel Laden with Nanoformulated Dexamethasone for Dry Eye Therapy - Aya A. Refaat; Sarah Yahia; Ibrahim M. El-Sherbiny (AAPS PharmSciTech, 2026)

Bridging Gaps in Fungal Keratitis Management: Novel Diagnostics, Drug Delivery Systems, and Gene Therapies - Riya Shivgotra; Bindu Soni; Hossamaldeen Bakrey; Parminder Kaur; Subheet Kumar Jain (AAPS PharmSciTech, 2026)

Multi-Objective Spray Drying Process Optimization via BBD-ANN-AGWO Framework: Case of Andrographolide Amorphous Solid Dispersions - Guangpu Fang; Changhao Jia; Zhiqi Guan; Fan Li; Zheng Li; Wenlong Li (AAPS PharmSciTech, 2026)

An Affordable and Simple Novel Approach to Obtain the Heat Transfer Coefficient (Kv) for Primary Drying Models Without Product Temperature Sensors - C. A. Amor; A. Nardi-Ricart; J. R. Ticó; D. Samarkanova; M. Miñarro Carmona (AAPS PharmSciTech, 2026)

Breaking Barriers: Intranasal Microemulsions for the Efficient Nose-to-brain Delivery of Glycyrrhetinic Acid - Sara R. Gad; Mina Y. George; Riham I. El-Gogary; Rania M. Hathout (AAPS PharmSciTech, 2026)

Use of Incurred Sample Reproducibility Data to Support Long Term Stability of Therapeutic Antibodies in Clinical Bioanalytical Methods - Catherine L. Brockus; Likitha Venkatesh (AAPS PharmSciTech, 2026)

Overcoming the Challenges of Viscous Simulated Fed State Media with a Computerized Numerical Control Tablet Disintegration and Dissolution Tester - Valentin Stahl; Muhammad Farooq Umer; Jozef Al-Gousous; Thomas Nawroth; Wei-Jhe Sun; Fang Wu; Wenlei Jiang; Zongming Gao; Peter Langguth (AAPS PharmSciTech, 2026)

Appropriateness of Dissolution Methods on Evaluation of Digoxin Product Quality - Rizwan Shaikh; Swaroop J. Pansare; Bhanu P. Dongala; Sunil K. Thota; Mohammad T. H. Nutan; Daniela Z. Bazan; Mansoor A. Khan; Ziyaur Rahman (AAPS PharmSciTech, 2026)

Reverse Engineering of Branded Mesalamine Prolonged Release Granules for Synthesis of QTPP and FMEA: A Systematic Approach for Oral Complex Generic Product Development - Sadhana Dhyagala; Ankit Kumar; Prakash Kumar Sirvi; Sakshi Kunjir; Ayush Rohila; Rajkumar Malayandi (AAPS PharmSciTech, 2026)

Fraisinib in a Shell: Liposomal Encapsulation of a GARS1 Inhibitor for Controlled Anticancer Delivery - Stefano Boetti; Ilaria Andreana; Barbara Rolando; Federico Cesano; Maela Manzoli; Paola Milla; Chiara Riganti; Franz H. Kohnke; Camillo Rosano; Silvia Arpicco (AAPS PharmSciTech, 2026)

Evaluation of Critical Quality Attributes of Topical Foam Formulations - Srinath Rangappa; Srinivas Ajjarapu; Vijay Kumar Shankar; Anandavalli Varadarajan; Santanu Kundu; S. Narasimha Murthy (AAPS PharmSciTech, 2026)

Modulation of Phase Inversion Dynamics and Buccal Permeation in Borneol-Based In Situ Forming Matrices by Triacetin - Setthapong Senarat; Nutdanai Lertsuphotvanit; Warakon Thammasut; Thawatchai Phaechamud; Sucharat Limsitthichaikoon (AAPS PharmSciTech, 2026)

Tricalcium Citrate Tetrahydrate TB as Filler in Direct Compression of Minitablets - Maike Hafels; Amelie Mattusch; Karl G. Wagner; Kristina E. Steffens (AAPS PharmSciTech, 2026)

From Anatomy to Application: A Comprehensive Review of Nanovesicular Systems for Otic Drug Delivery - Manar Adel Abdelbari (AAPS PharmSciTech, 2026)

High-Contrast X-Ray Computed Tomography for Quantifying Amorphous Content in Melt-Quenched Acetaminophen - Tamaki Miyazaki; Yoshihiro Takeda; Kazuki Ito; Kazuki Omoto; Daisuke Ando; Tatsuo Koide; Yoji Sato (AAPS PharmSciTech, 2026)

Harnessing Novel Tetra-Synergistic Bilosomes for Effective Otomycosis Management: Integrated In-Vitro, Microbiological and In-vivo Studies - Abdurrahman M. Fahmy; Osama Saher; Heba Attia; Michael M. Farag; Sadek Ahmed (AAPS PharmSciTech, 2026)
This study introduces and statistically optimizes novel Tetra-Synergistic Bilosomes (TSB), an advanced nano-platform for topical delivery of voriconazole (VOR) in otomycosis therapy. The term “Tetra-Synergistic” reflects the incorporation of four complementary components: Cremophor® EL, sodium deoxycholate, Brij® 58, and Brij® S2, working in synergy to enhance therapeutic efficacy. TSB was fabricated using the thin-film hydration method and optimized through a 2 3 D-optimal design. Three formulation factors were investigated: Cremophor® EL: VOR ratio, sodium deoxycholate: cholesterol ratio, and Brij® 58: Brij® S2 ratio, with the optimization goal of maximizing EE%, minimizing vesicular size, and maintaining ZP within the acceptable stability range. The model demonstrated excellent predictability, achieving a desirability value of 0.888. The optimized TSB exhibited high EE% (91.6%), a suitably small VS (217.9nm), and stable ZP (− 24.1mV). FTIR confirmed VOR entrapment, while TEM revealed nano-sized spherical vesicles. Moreover, TSB displayed a biphasic In-vitro release profile and remained stable for three months under refrigeration. Importantly, microbiological evaluation confirmed the superior antifungal performance of TSB. Compared with VOR suspension, TSB showed a larger inhibition zone, a lower minimum inhibitory concentration (MIC) and minimum fungicidal concentration (MFC), and a faster fungicidal effect, eradicating fungal growth in 33% less time. Ex-vivo permeation studies revealed a 2.18-fold enhancement ratio, supported by confocal laser scanning microscopy confirming deeper tissue penetration. Histopathological analysis further validated the safety of topical application without any tissue damage. Collectively, these results establish TSB as a pioneering, microbiologically potent, and clinically promising nano-vesicular system for the effective management of otomycosis.

The PAH-AM-PEG-ApoE@siRNA Nanocarrier Delivery System for Polo-like Kinase 1 Inhibition Suppresses Glioma Progression - Feng Su; Shengnan Lu; Junli Zhang; Yu Zhang; Yaoyao Zhang; Ling Cheng; Jing Li; Ying Li; Guangwei He; Lifang Yin (AAPS PharmSciTech, 2026)
The poor efficacy of chemotherapy for glioma is mainly due to the difficulty of drug penetration through the blood–brain barrier (BBB), as well as the difficulty of drug concentration in the tumor tissue to reach the effective therapeutic level. The emerging tumor-targeted delivery technology can facilitate the precise enrichment of drugs in the tumor site. Apolipoprotein E (ApoE(159–167) 2 ) binds to low-density lipoprotein receptor-related protein 1 (LRP-1) on the blood–brain barrier and helps it to specifically cross the BBB. Based on this, in this study, poly (ethylene glycol) (PEG) dimerized with ApoE(159–167) 2 was used for the modification of PAH-AM, and amphiphilic PAH-AM-PEG-ApoE nanocarriers were successfully prepared. Among them, the PEG modification could effectively prolong the retention time of the nanoparticles in vivo and reduce the toxic side effects, while the ApoE(159–167) 2 polypeptide could specifically penetrate the blood–brain barrier for intracerebral targeted delivery by binding to LRP-1. The nanocarrier further binds to small interfering RNA (siRNA) targeting PLK1 , a key cell cycle factor, by electrostatic interaction to construct the nano-delivery system PAPA@siPLK1. In vitro experiments showed that the nanoparticles significantly inhibited the proliferation of U87MG glioma cells, induced apoptosis, and specifically silenced the mRNA and protein expression of PLK1 . The results of in vivo animal experiments showed that PAPA@siPLK1 could effectively inhibit tumor growth and had potential brain permeability; The PAPA@siPLK1 nanocarrier delivery system developed in this study achieves PLK1 gene silencing through efficient siRNA delivery, providing an important basis for novel therapeutic strategies for glioma.

Topical 915–3985 MHz Microwave Sweep-Assisted Retention of Nanoemulsified α-Tocopherol for Dermatitis Treatment - Mohd Saufi Harun; Tin Wui Wong (AAPS PharmSciTech, 2026)

Enhanced Oral Bioavailability of Felodipine via Solid Self-microemulsion Delivery System - Ying Zheng; Lusi Chen; Yingshu Feng; Caleb Kesse Firempong; Dongli Li; Guoqing Zhang; Hongfei Liu (AAPS PharmSciTech, 2026)

Physicochemical Characterization and In Vitro Evaluation of Novel Liposomal and Proliposomal Doxorubicin Formulations in Accordance with FDA Guidance - Gülbeyaz Yıldız Türkyılmaz; Mine Diril; H. Yeşim Karasulu (AAPS PharmSciTech, 2026)
Doxorubicin (Dox) is a widely used chemotherapeutic agent, but its clinical application is limited by severe dose-dependent toxicities, particularly cardiotoxicity. To overcome these challenges, two novel formulations—liposomal doxorubicin (Dox-Lip) and proliposomal doxorubicin (Dox-P-Lip) —were developed and systematically compared with the reference listed drug (RLD), focusing on physicochemical comparability and in vitro bioequivalence in accordance with FDA guidance. Dox-Lip was prepared using alternative lipid compositions and a modified pH gradient–based active loading method, while Dox-P-Lip was obtained by lyophilization of the liposomal formulation. Characterization studies included encapsulation efficiency (EE%), lipid content, drug-to-lipid ratio, internal pH, morphology, bilayer phase behavior, PEG surface density, particle size, zeta potential, and PEG layer thickness determined using the Fixed Aqueous Layer Thickness (FALT) model. In vitro drug release was evaluated under simulated plasma, variable pH and temperature, and ultrasound exposure. Both formulations exhibited high encapsulation efficiencies (EE%) exceeding 90%, comparable to those of the RLD. Moreover, these formulations demonstrated approximately 2.1-fold thicker PEG layers, indicating improved steric stabilization. Although these formulations exhibited slightly higher leakage under stress conditions, the encapsulation efficiency (EE%) consistently remained above 90%, confirming their structural integrity. Overall, the novel formulations demonstrated physicochemical similarity and stability relative to the RLD, supporting their potential as bioequivalent and clinically viable liposomal Dox alternatives. Graphical Abstract

Analysis of the Correlation Between Membrane Permeability in RPMI 2650 Cells and Human Nasal Absorption - Tokio Morita; Toshiaki Tsuchitani; Hiroyuki Yoshida; Naomi Tomita; Yoji Sato (AAPS PharmSciTech, 2026)

In Vitro Permeation Testing of Sunscreens using Reconstructed Human Skin versus Human Cadaver Skin Models - Kartik R. Roy; Apipa Wanasathop; Lijing Xu; Jiang Wang; Sergio G. Coelho; Steven A. Adah; Theresa M. Michele; Patrick J. Faustino; Muhammad Ashraf; Xiaoming Xu; Yang Yang (AAPS PharmSciTech, 2026)

Quality by Design Integration of Design of Experiments for Tablet Formulation Optimization and Process Validation - Jirapornchai Suksaeree; Chaowalit Monton; Pattwat Maneewattanapinyo (AAPS PharmSciTech, 2026)

Recent Trends in the Development and Clinical Translation of Polymer-based Targeted Therapeutic Nanoparticle - Chandan Kumar Singh; Ratnali Bania; Satyendra Deka; Monika Dwivedi; Anroop B. Nair; Trishna Bal; Prasenjit Maity; Pran Kishore Deb (AAPS PharmSciTech, 2026)

Delivery Strategies and Clinical Significance of Oral Colon-targeted Drug Delivery Systems - Kailash Bansal; Amit Mukharya; Anil B. Jindal (AAPS PharmSciTech, 2026)

Process Optimisation, Pharmaceutical Characterisation, and in vitro Activity of Mesalamine Nanocrystals in PMA-differentiated THP-1 cell Lines in the Late Inflammatory and Profibrotic Phase - Sonam Sharma; Sakshi Kunjir; Sadhana Dhyagala; Abhishek Sahu; Subramanian Natesan; Rajkumar Malayandi (AAPS PharmSciTech, 2026)

AI-enabled, QbD-aligned Predictive, and Sustainable Design of Natural Polymer-based Drug Delivery Systems - Jirapornchai Suksaeree; Pattwat Maneewattanapinyo; Chaowalit Monton (AAPS PharmSciTech, 2026)

Nanocrystallization and Microencapsulation of Natural Pigments for Improved Dissolution and Stability - Zhitao Cai; Hanyan Gong; Sishu Li; Yu Zhang; Tian Yin; Haibing He; Jingxin Gou; Yanjiao Wang; Xing Tang (AAPS PharmSciTech, 2026)

3D Printing of Hydrocortisone-loaded Eudragit RS Tablets: Influence of Plasticizers and Their Concentration on the Printability of Filaments - Hooman Hatami; Marzieh Mohammadi; Fatemeh Sadeghi; Hadi Afrasiabi Garekani; Abbas Akhgari; Ali Nokhodchi (AAPS PharmSciTech, 2026)
Although FDM is one of the prominent 3D printing technologies, and it has been widely investigated in pharmaceutical sciences, the printability of filaments remains a challenge. Therefore, our primary objective was to evaluate the effect of PEG 400, PEG 4000 and triethyl citrate at different concentrations (10%, 15% and 20% w/w) on the printability behavior of hydrocortisone-loaded Eudragit RS filaments. In this study, physical mixtures and their filaments were produced using a hot melt extruder and the properties of the filaments were examined by DSC, XRD, FESEM, FTIR, MFI and mechanical tests. Release behavior and hardness properties of the 3D-printed tablets were also evaluated. DSC and XRD results showed that the drug converted from crystalline to amorphous during hot melt extrusion and remained so during the 3D printing. FTIR results showed no chemical interactions between the drug and other excipients during hot melt extrusion and 3D printing. FESEM results of filaments showed that triethyl citrate-containing filaments had rougher surfaces, which makes them more suitable for 3D printing, while PEG-contained filaments had smoother surfaces. Mechanical tests showed that filaments containing triethyl citrate were stronger and tougher and had moderate ductility and stiffness. Overall, these filaments showed a good balance between these mechanical characteristics, which makes them a suitable candidate for 3D printing. Release studies showed that regardless of plasticizer type, the concentration of the plasticizer determines the extent of drug release. MFI test showed that formulations containing TEC presented a melt flow closer to 30 g/10 min compared to other formulations. Therefore, it can be deduced that TEC improves printability by enhancing melt flow better than the other two plasticizers (PEG 400 and PEG 4000). Based on the results, it can be concluded that triethyl citrate in 15% concentration is the best plasticizer for the production of hydrocortisone-loaded Eudragit RS tablets. Graphical Abstract

Specification Limit Normalization for Nonparametric Process Capability Analysis and Its Application in Cleaning Validation with AI-Enabled Monitoring Models - Xiande Yang; Wendy Lou; Mohamed Chan (AAPS PharmSciTech, 2026)
In pharmaceutical manufacturing, equipment is often used for multiple products following a single standard cleaning process regardless of the previously manufactured product. Despite this, residue levels are frequently non-detectable. Regulatory guidelines, such as the EMA Q&A on HBELs, mandate cleaning and visual inspection after each use, with analytical testing required after product changeovers unless otherwise justified. Consequently, cleaning validation (CV) data is typically left-censored, limited in sample size, and subject to multiple upper specification limits (USLs). These realities limit the applicability of traditional parametric capability indices and reduce the robustness of nonparametric methods. Moreover, they hinder the effective use of historical CV data in AI applications, which depend on large, standardized datasets for model training. To address these challenges, we propose a USL-normalization method that standardizes all residue measurements to a unified USL_Pct = 100. This transformation enables the aggregation of USL-heterogeneous datasets and supports robust nonparametric analysis. The cleaning process CQA (critical quality attribute) level upper capability index Ppu is calculated using the KDEDPonUSLND algorithm (kernel density estimation derived percentiles on USL-normalized data), which demonstrates improved robustness compared to traditional approaches. The cleaning process level Ppu is evaluated using either CQAWWC (CQA-wise worst case) or CQAWP (CQA-wise pooling) strategies, both integrated with the KDEDPonUSLND algorithm. The resulting CQAWWC_BAKEDPonUSLND and CQAWP_BAKEDPonUSLND models support an AI-driven CV Stage 3 Continued Cleaning Process Verification/Monitoring system, aligned with regulatory expectations. Graphical Abstract

Scientific and Regulatory Standards for Dissolution Similarity: a Statistical Game of Matchmaking Neither Force to Pass or Nor Fail to Pass - Dharmaraj More; Bhagyesh Trivedi; Ajay Khopade (AAPS PharmSciTech, 2026)

High Shear Wet Granulation Process Common Deficiencies Observed in Recently Submitted New and Abbreviated Drug Applications - Lixia Cai; Haitao Li; Hang Guo; Steve Y. Rhieu; Zhouxi Wang; Feiyan Jin; Qiang Han (AAPS PharmSciTech, 2026)

Structurally Modified Cyclodextrins in Topical Nanotechnology: Advancing Barrier-Penetrating Drug Delivery Strategies for Psoriasis Management - Hrishikesh Khude; Pravin Shende (AAPS PharmSciTech, 2026)

Correction: Amphotericin B-Loaded Bigel: Characterization and in vivo Antileishmanial Evaluation in BALB/c Mice Infected with Leishmania amazonensis - Rosilene Ribeiro de Sousa; Matheus Oliveira do Nascimento; Leandro Josuel da Costa Santos; Francisco Gesley de Sousa Abreu; André Luiz Pinheiro de Moura; Daniele Costa Lopes; Karla Germana dos Reis Bacelar; Rita de Cássia Vianna de Carvalho; Paulline Paiva Mendes de Souza Leal; Charllyton Luis Sena da Costa; Vitória de Cássia Coelho Rodrigues; Fernando Aécio de Amorim Carvalho; et al. (AAPS PharmSciTech, 2026)

Skin Penetration of Caffeine and Cafestol using Liposomes: Exploring the Benefits of a Combined Delivery System - Nubul Albayati; Amitkumar Virani; Sesha Rajeswari Talluri; Bozena Michniak-Kohn (AAPS PharmSciTech, 2026)
Bioactive compounds in green coffee beans, such as caffeine (CF) and cafestol (CA), possess potential pharmaceutical benefits, including antioxidant and anti-inflammatory properties, but face challenges in skin penetration. This study developed a novel liposomal system combining CF and CA for the first time, formulated with either Lipoid S 75 or Phospholipon® 90 G and cholesterol (80:20 ratio), aiming to enhance skin penetration of CF and CA by encapsulating them into liposomes dermal application. Formulations with 1% CF and either 0.13% or 0.07% CA were developed and tested for skin permeation utilizing Franz diffusion cells with human cadaver skin. Receptor compartment samples were collected at 2, 4, 8, 12, and 24 h and the amount of CF penetrated (µg/cm 2 ) was quantified using a validated HPLC method. The skin distribution in dermal and epidermal layers of both compounds were also assessed. Results showed that formulation F9 (1% CF, 0.13% CA) significantly improved skin penetration, doubling CF levels in the dermis and increasing CA levels by 5.5-fold in the dermis and 35-fold in the epidermis, despite lower CF permeability compared to the control. F9 also demonstrated high encapsulation efficiency and confirmed safety in cytotoxicity studies. These findings suggest that liposomal formulations of combining CF and CA are promising for topical applications and merit further clinical investigation. Graphical Abstract

Characterization of Eudragit Nanoparticle-Tailored β-Cyclodextrin/Thiolated Sodium Alginate/Polyethyleneglycol Polymer Hybrid as a Potential Bone Tissue Engineering Scaffold - Jiyaur Rahaman; Dhrubojyoti Mukherjee (AAPS PharmSciTech, 2026)

Surface Modification of Zinc Undecylenate with Nanoparticle Fluconazole Using Low-Pressure RF Plasma-Assisted CVD: A New Generation Antifungal Compound - Namık Bilici; Ferhat Bozduman (AAPS PharmSciTech, 2026)

Carvedilol Pharmaceutical Cocrystals: Preparation, Advanced Characterization and Dissolution Behavior - Angelica Sharapova; Marina Ol’khovich; Svetlana Blokhina (AAPS PharmSciTech, 2026)

Challenges and Opportunities of Drug Delivery for Treatment of Alzheimer’s Disease - Marwa Adel Abd El-Fattah (AAPS PharmSciTech, 2026)
Alzheimer’s disease (AD) is a neurodegenerative disorder characterized by progressive deterioration in cognitive functions. It represents a global health concern with increasing prevalence and devastating outcomes for the quality of life that could ultimately lead to death. AD is associated with deposition of β-amyloid (Aβ) plaques and intracellular buildup of tau proteins forming neurofibrillary tangles (NFTs), which are the main characteristics for AD brain tissues. Approved AD therapy is based mainly on symptomatic relief, and conventional medicaments often fail due to either low bioavailability, limited solubility, or failure to cross blood–brain barrier (BBB). The complexity in AD pathophysiology opens windows for many therapeutic options. So, lecanemab was recently approved by FDA as the first disease-modifying therapy. However, drug delivery to the brain remains challenging due to the nature of BBB. Hence, more extensive research is essential to develop disease-modifying therapies and also to find drug delivery strategies to ensure simplified administration and successful brain delivery. This review article summarizes AD pathogenesis with the corresponding treatment targets. It emphasizes innovative drug delivery strategies and novel formulation approaches to deliver medicines across BBB. The use of recent advancements in drug delivery to deliver medicaments across BBB are highlighted, with focus given to novel drug delivery systems and formulation of nanoparticles for brain targeting. The use of nutraceuticals, gene therapy, and stem cell therapy are is covered. Graphical Abstract

Human Serum Albumin-Lipid Nanocapsules of Duvelisib for Hematological Cancers: Characterization, In-Vitro Cell-Culture, Toxicity and Pharmacokinetic Studies - Srushti Mahajan; Mayur Aalhate; Anamika Sharma; Suman Karadagatla; Santosh Kumar Guru; Pankaj Kumar Singh (AAPS PharmSciTech, 2026)

Preparation and Evaluation of Candesartan Cilexetil Solid Supersaturated Self-nanoemulsion Containing Phospholipids - Kai Zheng; Tianyi Wang; Hao Chen; Yuyang Zhao; Fucong Jia; Xinggang Yang (AAPS PharmSciTech, 2026)

Fabrication of Second-Generation Acalabrutinib Nanocrystals by Employing the Nano-Edge Method for Improving the Physico-Chemical Properties and Forecasting their In-Silico Pharmacokinetic Behaviour - Bharath M; Ujala Gupta; Anish Dhuri; Tanmoy Kanp; Khushi Rode; Sharon Munagalasetty; Vasundhra Bhandari; Soumyadip Mukherjee; Arvind Gulbake; Pankaj Kumar Singh (AAPS PharmSciTech, 2026)

HPMC Substitution Influences the Buoyancy and Release in Gastroretentive Floating Tablets - Li Ying Kam; Jia Woei Wong; Kah Hay Yuen (AAPS PharmSciTech, 2026)

Biopolymeric Zein Protein Nanoparticles for Oral Vildagliptin Delivery: Fabrication, Statistical Optimization, and In Vivo Pharmacokinetics and Pharmacodynamics Insights - Asmaa Ashraf Nemr; Abdelhamid Ibrahim Elshafey; Amir Ibrahem Mohamed Ali; Mona Mohamed Elkhatib; Mahmoud Teaima; Mohamed A. El-Nabarawi; Mai Ahmed Tawfik (AAPS PharmSciTech, 2026)
Vildagliptin (VLD) is a powerful oral hypoglycemic agent used in the management of type II diabetes. The goal of the current research was to develop VLD-loaded zein protein-based nanoparticles (VLD-ZP NPs) for enhancing their oral hypoglycemic effect, achieving a sustained release profile, and addressing the issues associated with rapid metabolism and side effects. A 2 3 full factorial design was utilized to assess the influence of independent formulation variables on the observed responses. The independent variables considered were VLD-to-zein weight ratio (X 1 ), ethanol-to-water volume ratio (X 2 ), and stirring time (X 3 ). The dependent responses evaluated were particle size (Ps), zeta potential (Zp), entrapment efficiency (EE), and percent of drug release after 2H (Q 2H ) and 8H (Q 8H ). The optimized VLD-ZP NPs formula (F04), with a desirability value of 0.94, exhibited a small Ps (149.64 ± 1.4nm), low Q 2H (23.97 ± 2.1%), high Zp (− 37.67 ± 1.8mV), high EE (68.67 ± 2.3%), and sustained Q 8H release (62.57 ± 2.4%). Further investigations of F04 confirmed sustained drug release, spherical vesicle morphology through TEM, and effective entrapment via DSC and X-ray diffraction. In vivo pharmacokinetic studies revealed that C max and AUC 0-12H of F04 were enhanced by 1.25-fold and 1.8-fold compared to the marketed VLD product. Also, t 1/2 and MRT were extended by 1.84-fold and 1.56-fold, respectively. These findings indicated improved oral bioavailability and prolonged residence time of VLD. Additionally, the in vivo pharmacodynamic study revealed that F04 provided markedly superior and sustained hypoglycemic effects over the marketed VLD product, with higher R max , longer TR ½ , and a 2.8-fold increase in AUC (0-24H) . Graphical Abstract

Pharmacokinetics of Inhaled Clofazimine Dry Powder in Healthy Mice - Prachi Agrawal; Kinnari Arte; Justin A. Tolman (AAPS PharmSciTech, 2026)
Clofazimine (CFZ), an old and highly lipophilic antimycobacterial drug, is a second-line agent for the treatment of multi-drug-resistant tuberculosis (MDR-TB) and has demonstrated antitubercular efficacy when administered to the lung as different inhalation dry powder formulations. While its efficacy has been established, consensus has not been identified regarding the lung dose, pharmacokinetic (PK) properties, and biodistribution following inhalation. This study aimed to establish the biodistribution and inhaled PK of CFZ dry powder inhalation (DPI) formulation after single and multiple doses in healthy mice. Following a single low or high inhaled dose in healthy mice, lung concentrations of CFZ were ~ 20 folds higher than the corresponding plasma concentrations. Administering eight consecutive inhaled doses (twice weekly) maintained high and sustained lung concentrations (28 to 69 times higher than plasma concentrations), remaining significantly above the minimum inhibitory concentration (MIC: 0.6 – 2.0 μg/mL) of the free drug. Notably, CFZ concentrations in the lungs and plasma showed no discernable elimination phase up to four weeks post-dosing, with prolonged retention. Biodistribution studies indicated preferential CFZ retention in lung and spleen tissue following both single and multiple inhaled doses. In conclusion, these results suggest the novel dry powder inhaled CFZ formulation can produce high therapeutic concentration in lung tissues for extended periods of time after single and multiple doses, thereby, underscoring the potential of using inhaled CFZ as the treatment of MDR-TB. Graphical Abstract

Implementing QbD for Nano-Pharmaceuticals and Complex Formulations to Achieve Predictable and High-Quality Outcomes - Rohan Panwar; Anuradha Mishra; Abhisar Sahu; Syed Naved Quadri; M. Z. Abdin; Saman Fatima (AAPS PharmSciTech, 2026)

Admixture Compatibility Studies in Parenteral Formulations: Packaging, Device, and Regulatory Perspectives - Chetana Eknure; Vishvesh Joshi; Yogeshwar Bachhav (AAPS PharmSciTech, 2026)

Optimization of Ionic Liquid Based NLC for Nose-To-Brain Delivery of Tetrabenazine Hydrochloride - Namdeo R. Jadhav; Sonali R. Yede; Asha S. Jadhav; Megha N. Mane; Prathamesh S. Patil; Suhas S. Mohite (AAPS PharmSciTech, 2026)

Development, Stability, and Clinical Efficacy of an Oil-in-Serum Formulation with Olive Extract Standardized in Hydroxytyrosol for Post-Inflammatory Hyperpigmentation Treatment - B. J. Navarro; L. Kakuda; P. M. B. G. Maia Campos (AAPS PharmSciTech, 2026)

Development of Diclofenac Acid Encapsulated Transferosomal gel with Enhanced Antioxidant and Anti-Inflammatory Activities for the Management of Musculoskeletal Pain - Subhrasima Nayak; Arka Karmakar; Sampada Shinde; Lalit Kumar (AAPS PharmSciTech, 2026)

Smart Stings of Nature: Harnessing Microneedles Assisted Targeted Phytoconstituent Delivery for Dermatological Disorders - Akshay Kumar; Suresh Babu Kondaveeti; Arpan Kumar Tripathi; Mohit Agrawal; Thakur Gurjeet Singh; Devesh Kumar; Mohit Kumar (AAPS PharmSciTech, 2026)