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Michel BAUER: Director, International Analysis Department Sanofi-Synthélabo
INTRODUCTION
This article focuses on the consequences of polymorphism in the pharmaceutical field. As explained in the previous article , two crystalline forms can differ sufficiently in Gibbs free enthalpy (at a given pressure and temperature) for differences in solubility, dissolution kinetics and chemical reactivity to have significant consequences on drug bioavailability and stability. This explains why health authorities require a thorough study of this phenomenon, which must be presented in registration dossiers (including those for generic products). Examples and a list of important references are provided to enable the reader to delve deeper into this field. A special study on the influence of crystalline facies and agglomeration/aggregation states is also described. Finally, a brief examination of the consequences of polymorphism in the food and dye industries is offered.
For a complete study of the subject, readers are invited to consult the two previous issues:
Crystallization and polymorphism. Description of the phenomenon
Crystallization and polymorphism. Physical chemistry of polymorphism
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Crystallization and polymorphism
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