Dr. Gregory A. Stephenson presented this talk discussing the critical importance of understanding solid form selection and the influence of it on early development programs and ends with an audience question and answer session.
Rarely does a pharmaceutical compound exist in a single solid-state form. As a result, early in a compound’s life one seeks to identify the physical forms that are viable for development into a pharmaceutical product. This process typically involves screening different crystalline salt forms, if the compound is ionizable, followed by screening for different polymorphic forms of the salt or unionized form of the compound. Form selection is a critical step in a compound’s development life as it influences the rapidity and ease with which a compound is developed.
Polymorphic form impacts product yield, purity, and its ability to be processed into a product. One often must balance different physical properties, such as lower solubility for enhanced physical or chemical stability. Hence, the selection process requires sound judgement, involving a comparison of high quality characterization data of the different forms and evaluation of their impact on the overall process and its critical process parameters. Thorough and efficient solid-form screening, characterization, and selection are critical to the successful development and approval of a new drug substance, as they impact many elements of the product’s chemistry and its manufacturing processes.
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