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Adv. Drug Deliv. Rev. · Feb 2004
ReviewPhase transformation considerations during process development and manufacture of solid oral dosage forms.
- Geoff G Z Zhang, Devalina Law, Eric A Schmitt, and Yihong Qiu.
- Pharmaceutics and New Technology Center, R4P3/AP9, Global Pharmaceutical R&D, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064-6120, USA. Qiu.yihong@abbott.com
- Adv. Drug Deliv. Rev. 2004 Feb 23; 56 (3): 371-90.
AbstractThe 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.
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