Amorphous solid dispersions: Utilization and challenges in preclinical drug development within AstraZeneca

[Display omitted] The poor aqueous solubility of many active pharmaceutical ingredients (APIs) dominates much of the early drug development portfolio and poses a major challenge in pharmaceutical development. Polymer-based amorphous solid dispersions (ASDs) are becoming increasingly common and offer...

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Published inInternational journal of pharmaceutics Vol. 614; p. 121387
Main Authors Anane-Adjei, Akosua B., Jacobs, Esther, Nash, Samuel C., Askin, Sean, Soundararajan, Ramesh, Kyobula, Mary, Booth, Jonathan, Campbell, Andrew
Format Journal Article
LanguageEnglish
Published Netherlands Elsevier B.V 25.02.2022
Subjects
Crystallization
Drug Compounding
Drug Development
Polymers
Solubility
Water
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Summary:[Display omitted] The poor aqueous solubility of many active pharmaceutical ingredients (APIs) dominates much of the early drug development portfolio and poses a major challenge in pharmaceutical development. Polymer-based amorphous solid dispersions (ASDs) are becoming increasingly common and offer a promising formulation strategy to tackle the solubility and oral absorption issues of these APIs. This review discusses the design, manufacture, and utilisation of ASD formulations in preclinical drug development, with a key focus on the pre-formulation assessments and workflows employed at AstraZeneca.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-3
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ObjectType-Review-1
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2021.121387