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Polymorphic transformations during pharmaceutical processing

Otsuka, M. Hasegawa, H. Matsuda, Y., Effect of polymorphic transformation during the extrusion-granulation process on the pharmaceutical properties of carbamazepine granules Chem. Pharm. Bull. 1997, 45, 894-898. [Pg.360]

Polymorphic transformation can take place during pharmaceutical processing, such as particle size reduction, wet granulation, drying, and even during the compaction process.f Tests employed to determine crystal... [Pg.3642]

Zhang, G.G. Law, D. Schmitt, E.A. Qiu, Y. Bauer, M. Bauer, J. Spanton, S. Henry, R. Quick, J. Dziki, W. Porter, W. Morris, J. Highleyman, L. Phase transformation considerations during process development and manufacture of solid oral dosage forms [Crystallization and solid state properties of molecules of pharmaceutical interest] Ritonavir an extraordinary example of conformational polymorphism Ritonavir manufacturing problems. Adv. Drug. Deliv. Rev. 2004, 56 (3), 371-390. [Pg.854]

Polymorphism is ubiquitous in the pharmaceutical industry. The approval of a new drug substance by the USFDA requires that all data on polymorphs of the lead molecule be documented. In general, a given substance can have any number of polymorphs but, under given experimental conditions, only one polymorph will be stable and all other polymorphs will be metastable. Since the presence of a metastable polymorph during processing often leads to phase transformation to the more stable polymorph, it is desirable to choose the thermodynamic polymorph for drug development. [Pg.2303]


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