Review of role of physical properties of crystals in dosage forms performance

Crystallization is often employed for purifying a drug substance in pharmaceutical industry and, in addition, plays an important role in defining the stability and drug release properties of the final dosage forms. Advances of chemical synthesis have achieved control over drug identity and purity, but control over the physical form and crystallinity remains poor. It should be considered that even minor change in crystallization condition can produce significant change in the crystal and powder physical properties such as particle size, shape, and defect structure. These effects have been recognized as the major batch-to-batch and source variation problems leading to inconsistency of the final dosage forms properties. The purpose of this review is to indicate the importance of physical properties of the crystals and their roles in the performance of dosage forms.