Amorphous Formulations and Solid-State Strategies to Improve Oral Drug Performance: Bridging Enabling Technologies, Biopharmaceutics, and Patient-Centric Product Design
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".
Deadline for manuscript submissions: 31 July 2026 | Viewed by 29
Special Issue Editors
2. Center for Pharmacology and Drug Research & Development, Semmelweis University, Üllői út 26, H-1085 Budapest, Hungary
Interests: solubility; high-throughput screening; nanoprecipitation; amorphous formulations; in vitro–in vivo prediction; PAMPA permeability; site-specific absorption modeling; solid-state characterization; excipient interactions
Special Issues, Collections and Topics in MDPI journals
2. Center for Pharmacology and Drug Research & Development, Semmelweis University, Üllői Str. 26., 1085 Budapest, Hungary
Interests: drug delivery systems; solid dosage forms; multiparticulate dosage forms; patient-centered formulation; pellets; excipients; machine vision
Special Issue Information
Dear Colleagues,
Poor aqueous solubility remains a major barrier in drug discovery and pharmacotherapy. Limited dissolution can reduce clinical response and drives early attrition; many development candidates fail because adequate exposure cannot be reached with practical oral doses. One widely used strategy is to generate amorphous drug forms, where loss of long-range order removes lattice-energy constraints and can increase apparent solubility and dissolution rate.
This benefit comes with liabilities. Amorphous materials can recrystallize, undergo phase separation, or change during storage under heat and humidity. Formulation and manufacture pose challenges, including in terms of polymer selection, process choices such as spray drying or hot-melt extrusion, scale-up, and definition of critical quality attributes for regulatory submissions.
The number of marketed oral products based on amorphous drugs is limited, yet FDA approvals over the past decade (48 ASD-containing products) and recent reviews point to rising R&D activity, with open questions regarding stability mechanisms, clinically relevant testing, and links between solid-state and in vivo performance. An additional and increasingly relevant dimension is patient-centric product design—how enabling solid-state and ASD approaches can translate into oral dosage forms that improve acceptability and adherence in real-world use. Importantly, patient centricity has emerged as a distinct and impactful development direction in its own right, and advances in ASD science are opening new routes to tailor drug products for specific patient needs (e.g., swallowability, dosing convenience, and consistent performance across use conditions) without compromising biopharmaceutical robustness.
This Special Issue brings together researchers working on amorphous formulations and solid-state strategies that improve dissolution and oral drug performance. We welcome original research and review articles covering topics across preformulation, processing, characterization, stability, and biopharmaceutics, including contributions that connect these technologies to patient-centric oral dosage form design.
Dr. Réka Angi
Dr. Nikolett Kállai-Szabó
Guest Editors
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Keywords
- amorphous solid dispersion
- solid-state characterization
- dissolution
- solubility
- physical stability
- polymer excipients
- spray drying
- hot-melt extrusion
- patient-centric formulation
- geriatric/pediatric formulation
- medication adherence
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