Solid Form Screenings in Pharmaceutical Development: a Perspective on Current Practices.

Abstract

Solid form screening is a crucial step in new drug development because solid forms of a drug substance significantly affect stability, dissolution and manufacturing processes of its drug products. This perspective introduces solid-state science from a practical standpoint, aiming to reduce knowledge gaps and promote communications among scientists with diverse background. This perspective starts with a concise overview that followed by discussion on timeline and goals of solid form screening. Techniques for solid from identification and characterization are thendiscussed. Subsequently, the perspective presents commonly used methods in solid form screening and introduces criteria and strategies to effectivelyselect a favorable solid form based on screening results. The last section summarizes current practices in pharmaceutical industries and suggests potential opportunities for future research and development.