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Crystal Polymorphism in Chemical Process Development

Crystal Polymorphism in Chemical Process Development Polymorphism in molecular crystals is a prevalent phenomenon and is of great interest to the pharmaceutical community. The solid-state form is a key quality attribute of a crystalline product. Inconsistencies in the solid phase produced during the manufacturing and storage of drug substances and drug products may have severe consequences. It is essential to understand the solid-state behavior of the drug and to judiciously select the optimal solid form for development. This review highlights the pervasiveness and relevance of polymorphism and describes solid form screening and selection processes. Moreover, case studies on controlling polymorphs from a chemical development perspective are provided. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Annual Review of Chemical and Biomolecular Engineering Annual Reviews

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Publisher
Annual Reviews
Copyright
Copyright © 2011 by Annual Reviews. All rights reserved
ISSN
1947-5438
eISSN
1947-5446
DOI
10.1146/annurev-chembioeng-061010-114224
pmid
22432619
Publisher site
See Article on Publisher Site

Abstract

Polymorphism in molecular crystals is a prevalent phenomenon and is of great interest to the pharmaceutical community. The solid-state form is a key quality attribute of a crystalline product. Inconsistencies in the solid phase produced during the manufacturing and storage of drug substances and drug products may have severe consequences. It is essential to understand the solid-state behavior of the drug and to judiciously select the optimal solid form for development. This review highlights the pervasiveness and relevance of polymorphism and describes solid form screening and selection processes. Moreover, case studies on controlling polymorphs from a chemical development perspective are provided.

Journal

Annual Review of Chemical and Biomolecular EngineeringAnnual Reviews

Published: Jul 15, 2011

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