Journal
ADVANCED DRUG DELIVERY REVIEWS
Volume 56, Issue 3, Pages 371-390Publisher
ELSEVIER
DOI: 10.1016/j.addr.2003.10.009
Keywords
phase transformation; pharmaceutical processing; solid oral dosage forms; polymorph; hydrate; amorphous; mechanism
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The quality and performance of a solid oral dosage form depends on the choice of the solid phase, the formulation design, and the manufacturing process. The potential for process-induced solid phase transformations must be evaluated during design and development of formulations and manufacturing processes. This article briefly reviews the basic principles of polymorphism, defines the classes of phase transformation and the underlying transformation mechanisms, and discusses respective kinetic factors. The potential phase transformations associated with common unit operations employed in manufacturing solid oral dosage forms are highlighted. Specific examples are given to illustrate the importance of solid phases, and process-induced phase transitions in formulation and process development. (C) 2004 Elsevier B.V. All nights reserved.
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