From Concept to Medicine - A Comprehensive Drug Development Journey

159 - Innovations in Crystallization Techniques for Active Pharmaceutical Ingredients (S11E9)


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This episode delves into the innovative approaches and considerations in the crystallization of active pharmaceutical ingredients (APIs). The discussion covers topics such as continuous crystallization, which leads to steady states with tight controls, which allow for more steady manufacturing, particle size control for the proper medication intake by the patients, and the development of robust and scalable salt formation processes. There is a discussion as to what each facet of these controls offers, how the new procedures are better than old, as well as the analytical testing that goes into it.

The solid state, polymorph and solubility of all facets are discussed. The discussion of solubility also takes lead way into how salt optimization needs to be done, how all the testing and results play out in all forms. The best and hows are answered about a long standing and complex method. In the end, the deep dive goes back to the analytical testing to bring to head where the innovations of medicine are going.

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From Concept to Medicine - A Comprehensive Drug Development JourneyBy Jim Mitchell

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