Advances in Solid and Semi-Solid Dosage Form Design for Enhanced Biopharmaceutical Performance

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Biopharmaceutics".

Deadline for manuscript submissions: 30 November 2025 | Viewed by 1531

Special Issue Editors


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Guest Editor
Division of Pharmaceutical Sciences, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY 11201, USA
Interests: pharmaceutical 3D printing; bioprinting; hot melt extrusion; additive manufacturing; continuous manufacturing; spray drying; twin-screw granulation; amorphous solid dispersions; solubility and bioavailability enhancement of poorly soluble drugs; tailored drug release strategies; solid oral dosage forms; implants; ocular formulations; colon-targeted drug delivery; personalized medicine; smart dosage forms

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Guest Editor
Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Debrecen, Nagyerdei Körút 98, H-4032 Debrecen, Hungary
Interests: gastroretention; dosage form design; in vivo bioavability; cyclodextrin; cyclodextrin polymer
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Special Issue Information

Dear Colleagues,

The development of solid and semi-solid dosage forms represents a cornerstone of modern pharmaceutical sciences, offering advantages such as stability, ease of administration, and cost-effective manufacturing. However, challenges such as poor solubility, low bioavailability, inconsistent drug release, and regulatory complexities continue to drive innovation in formulation and drug delivery technologies. The need for advanced formulation strategies and innovative manufacturing techniques has never been greater. These approaches could be transformative in enhancing therapeutic efficacy, patient compliance, and commercial viability.

This Special Issue will highlight cutting-edge research and technological advancements in solid and semi-solid dosage form design to improve biopharmaceutical properties. We invite the submission of original research articles and comprehensive reviews that explore novel approaches to enhancing drug solubility, bioavailability, and controlled release, as well as advanced manufacturing methods that align with modern regulatory and quality-by-design (QbD) principles.

The rapid evolution of pharmaceutical formulation sciences necessitates continuous research to optimize drug delivery, enhance patient compliance, and meet regulatory standards. This Special Issue will provide a platform for researchers, industry professionals, and regulatory experts to share their latest breakthroughs, challenges, and perspectives in the field of solid and semi-solid dosage forms.

We encourage contributions from academia, industry, and regulatory agencies that showcase interdisciplinary advancements and real-world applications. Your research will help shape the future of pharmaceutical development and improve therapeutic outcomes.

We look forward to receiving your valuable contributions.

Dr. Abdullah Alzahrani
Dr. Ádám Haimhoffer
Guest Editors

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Keywords

  • solid dosage forms (tablets, capsules, pellets)
  • novel formulation strategies
  • bioavailability enhancement
  • amorphous solid dispersions
  • lipid-based formulations
  • pharmaceutical cocrystals
  • excipient functionality and drug release
  • 3D printing in pharmaceuticals
  • hot melt extrusion (HME)
  • spray drying in drug formulation
  • co-processing techniques
  • controlled and sustained drug release
  • targeted drug delivery systems
  • in vitro/in vivo correlation (IVIVC)
  • quality-by-design (QbD) in pharmaceutics

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Published Papers (2 papers)

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Research

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24 pages, 4329 KB  
Article
Bioavailability Enhancement of Curcumin by PEG-Based Gastroretentive System: Development and In Vitro Evaluation
by Orsolya Csendes, Gábor Vasvári, Ádám Haimhoffer, László Horváth, Monika Béresová, Attila Bényei, Ildikó Bácskay, Pálma Fehér, Zoltán Ujhelyi and Dániel Nemes
Pharmaceutics 2025, 17(9), 1166; https://doi.org/10.3390/pharmaceutics17091166 - 5 Sep 2025
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Abstract
Background/Objectives: Increasing the bioavailability of poorly absorbed drugs is a continuous challenge in modern pharmaceutical technology. This is due to the problematic nature of BCS class IV active pharmaceutical ingredients: these drugs possess poor solubility and membrane permeability. Moreover, many undergo immediate efflux [...] Read more.
Background/Objectives: Increasing the bioavailability of poorly absorbed drugs is a continuous challenge in modern pharmaceutical technology. This is due to the problematic nature of BCS class IV active pharmaceutical ingredients: these drugs possess poor solubility and membrane permeability. Moreover, many undergo immediate efflux and/or rapid systemic metabolism after absorption. This project aimed to improve the bioavailability of BCS class IV drugs by formulating gastroretentive self-emulsifying systems using curcumin as a model drug. Methods: The base of the systems was created by melting emulsifying agents, dissolution retardants, and PEGs together. Curcumin was added after the mixture was cooled slightly. Aqueous dispersions of several compositions were characterized by dynamic light scattering. After screening these results, the viscosities of the selected formulations were evaluated. Dissolution retardants were selected and added to the most superior samples, and their dissolution profiles were compared. Gastroretention of the final formulation was achieved by dispersing air in the molten system through melt foaming; internal structure was assessed by microCT, and physicochemical properties by PXRD and DSC. Cytotoxicity was measured in Caco-2 cells using MTT and Neutral Red assays, and transcellular transport was also studied. Results: Based on these results, a homogeneous gastric floating system was developed. We observed an advantageous cytotoxic profile and increased bioavailability. Conclusions: Overall, we were able to create a self-emulsifying gastroretentive formulation displaying extended release and gastric retention with a low amount of cost-efficient excipients. Full article
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33 pages, 6726 KB  
Review
Recent Techniques to Improve Amorphous Dispersion Performance with Quality Design, Physicochemical Monitoring, Molecular Simulation, and Machine Learning
by Hari Prasad Bhatta, Hyo-Kyung Han, Ravi Maharjan and Seong Hoon Jeong
Pharmaceutics 2025, 17(10), 1249; https://doi.org/10.3390/pharmaceutics17101249 - 24 Sep 2025
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Abstract
Amorphous solid dispersions (ASDs) represent a promising formulation strategy for improving the solubility and bioavailability of poorly water-soluble drugs, a major challenge in pharmaceutical development. This review provides a comprehensive analysis of the physicochemical principles underlying ASD stability, with a focus on drug–polymer [...] Read more.
Amorphous solid dispersions (ASDs) represent a promising formulation strategy for improving the solubility and bioavailability of poorly water-soluble drugs, a major challenge in pharmaceutical development. This review provides a comprehensive analysis of the physicochemical principles underlying ASD stability, with a focus on drug–polymer miscibility, molecular mobility, and thermodynamic properties. The main manufacturing techniques including hot-melt extrusion, spray drying, and KinetiSol® dispersing are discussed for their impact on formulation homogeneity and scalability. Recent advances in excipient selection, molecular modeling, and in silico predictive approaches have transformed ASD design, reducing dependence on traditional trial-and-error methods. Furthermore, machine learning and artificial intelligence (AI)-based computational platforms are reshaping formulation strategies by enabling accurate predictions of drug–polymer interactions and physical stability. Advanced characterization methods such as solid-state NMR, IR, and dielectric spectroscopy provide valuable insights into phase separation and recrystallization. Despite these technological innovations, ensuring long-term stability and maintaining supersaturation remain significant challenges for ASDs. Integrated formulation design frameworks, including PBPK modeling and accelerated stability testing, offer potential solutions to address these issues. Future research should emphasize interdisciplinary collaboration, leveraging computational advancements together with experimental validation to refine formulation strategies and accelerate clinical translation. The scientists can unlock the full therapeutic potential with emerging technologies and a data-driven approach. Full article
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