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Facilitating DS/DP development through integrated solid-state and crystallization development

Bing-Shiou Yang Boehringer Ingelheim, Ridgefield, CT Abstract Crystallization is an important and economic unit operation for the purification of pharmaceutical API. It also serves as the key step to define the required quality attribute of the API (e.g. solid form, particle size distribution) that would impact the subsequent processing (e.g. filtration, drying, milling) and drug product performance (e.g. dissolution, content uniformity). To successfully bring a compound into the market, an integrated approach to link the development of API solid form, isolation and dosage form is essential to ensure the robust delivery of the desired drug product quality, throughout the scale. Thorough understanding of the solid form of a compound would significant facilitate the design of proper crystallization, resolve process challenges, and enhance the control of the API quality attributes. This presentation will use several examples in development or manufacturing to illustrate the concepts, including producing small particle size of API for enhance dissolution, producing the desired form for a compound with complex solid form landscape and identifying root-case of out-of-specification via solid form understanding, etc.
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