Ann Newman, Seventh Street Development Group
The solid form of an active pharmaceutical ingredient (API) used in development has become an important aspect of drug development based on possible issues with manufacturability, solubility, bioavailability, and stability differences between materials. A variety of solid forms can be investigated in screening studies, including polymorphs, salts, cocrystals, amorphous, and amorphous dispersions. The next step after finding the forms is collecting relevant data to choose the best form for the targeted dosage form and development plan. This usually includes more in-depth experiments with solubility, physical and chemical stability, and possible process induced transformations during API crystallization or formulation. This talk will discuss properties to consider when choosing a form, as well as methods used in the industry for comparison. Case studies that illustrate the selection process will be presented, and examples of using different forms in various types of formulations for lifecycle management will also be discussed.