Modification of Crystal Habit and Its Role in Dosage Form Performance

Abstract

Crystallization is often employed for purifying a drug substance. Use of different solvents and processing conditions may change the crystal habit, besides altering the polymorphic state. Furthermore, altered habit may result from crystal growth during storage. Hence, there is a need to understand the factors influencing crystal habit and to evaluate critically its role in the performance of dosage forms. Establishing the physicotechnical properties of different habits of a drug will help to recognize lot-to-lot variations in raw materials and to ensure reproducibility of dosage form performance.