Recent Advances in Amorphous Solid Dispersions: Preformulation, Formulation Strategies, Technological Advancements and Characterization

Dear Colleagues,

The majority of new chemical entities in development are crystalline in nature, and thus suffer from poor solubility and bioavailability. Over the last two decades, amorphous solid dispersions (ASDs) have been utilized as a promising technology to improve the solubility and bioavailability of poorly soluble drugs, thus attending to unmet therapeutic needs with poorly soluble drugs. Reports indicate that around 48 new drug products developed using ASD technology were approved by the FDA between 2013 and 2023.

Formulating an ASD into a stable drug product and commercialization involve a lot of challenges which include recrystallization, polymorphism of drug, poor absorption, manufacturing, and scale-up in real time industrial setup. Lately, a few medical conditions have required a high dose of drugs for clinical response; thus, improving patient compliance has become the need of the hour in order to reduce the pill burden. In this aspect, ASDs can be valuable in formulation development, despite facing the unique challenge of high drug load. To overcome these challenges, various excipients (surfactants and lipids) have been explored along with polymeric carriers in ASD technology.

Recent advances pertinent to ASDs elucidate novel manufacturing technologies, chemical modifications of polymers, improvised manufacturing, and characterization techniques in pharmaceutical applications. Therefore, this Special Issue invites both reviews and original articles emphasizing innovative ASD formulation development, approaches to overcome challenges in manufacturing ASD’s, and  recent developments in the characterization of ASDs. Suitable topics for submission include, but are not limited to, the following:

• Formulating high-drug-load ASDs;
• Novel techniques in manufacturing ASDs;
• Characterization of ASDs;
• Preformulation and material sparing techniques for ASDs;
• Role of ASDs in navigating molecules from bench to market;
• Risk assessment and QBD-based formulation development of ASDs;
• Overcoming the manufacturing and scale-up challenges of ASDs;
• Downstream processing of ASDs;
• Application of lipids, surfactants, and mesoporous silica in conjunction with ASDs

Dr. Pavan Kumar Nukala
Dr. Pradeep Kumar Bolla
Guest Editors

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