Targeting Polymorphs and Hydrates in Manufacturing of APIs

来源 :中国上海第七届国际新药发明科技年会 | 被引量 : 0次 | 上传用户:lkm6839257
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  Successful manufacture of an active pharmaceutical ingredient (API) in a correct form requires a thorough understanding of API properties and in-depth knowledge of crystallization and downstream processing unit operations,as well as significant scale up efforts.Whenever practicable,for API manufacture,a seeded,cooling crystallization is typically considered as the most reasonable approach.The supersaturation profile has a profound effect on the nucleation and growth processes and the resulting CSD of API and its control during crystallization is necessary.In the four common batch crystallization operations:cooling crystallization,reactive crystallization,antisolvent crystallization,and evaporative crystallization-subsequent control of the crystal growth stage may be realized by employing appropriate time-profiles for cooling rate,reagent addition rate,antisolvent addition rate,and evaporation rate,repectively.
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