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Amorphous solid dispersions: Utilization and challenges in preclinical drug development within AstraZeneca
Akosua B Anane-Adjei1, Esther Jacobs1, Samuel C Nash1
1Advanced Drug Delivery, Pharmaceutical Sciences, R&D AstraZeneca, Granta Park, Cambridge CB21 6GH, UK.
Abstract:
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.
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