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Polymorphism and Crystallization of Active Pharmaceutical Ingredients (APIs)

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Abstract:

Active pharmaceutical ingredients (APIs), frequently delivered to the patient in the solid-state as part of an approved dosage form, can exist in such diverse solid forms as polymorphs, pseudopolymorphs, salts, co-crystals and amorphous solids. Various solid forms often display different mechanical, thermal, physical and chemical properties that can remarkably influence the bioavailability, hygroscopicity, stability and other performance characteristics of the drug. Hence, a thorough understanding of the relationship between the particular solid form of an active pharmaceutical ingredient (API) and its functional properties is important in selecting the most suitable form of the API for development into a drug product. In past decades, there have been significant efforts on the discovery, selection and control of the solid forms of APIs and bulk drugs. This contribution discusses the thermodynamics and kinetics of polymorphic systems, the characterization of polymorphs, and the transformation between polymorphs. The major techniques for polymorph discovery and control developed in the past years are discussed as well.

Keywords: Crystallization; active pharmaceutical ingredients (APIs); control; discovery; polymorphism; pseudopolymorphism

Document Type: Research Article

DOI: https://doi.org/10.2174/092986709787549299

Affiliations: Department of Chemical and Biochemical Engineering, The University of Western Ontario, London, Ontario, N6A 5B9, Canada.

Publication date: 2009-03-01

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  • Current Medicinal Chemistry covers all the latest and outstanding developments in medicinal chemistry and rational drug design. Each issue contains a series of timely in-depth reviews written by leaders in the field covering a range of the current topics in medicinal chemistry. Current Medicinal Chemistry is an essential journal for every medicinal chemist who wishes to be kept informed and up-to-date with the latest and most important developments.
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