固体口服制剂的相转化研究进展

Outlines of phase transformation considerations in solid oral formulations

固体口服制剂的相转化研究对选择工艺流程和研发新产品有重要意义。根据相转化机制,固相相变可以分为3种类型:多晶型的转化(polymorphic transition),水化与脱水(hydration／dehydration),玻璃化相与结晶(vitrification／crystallization)的相互转化。固体口服新制剂研究中应重视药物多晶型和无定形现象,预防和防治固相处方设计与工艺流程选择中发送的相转化。

Phase transformation considerations during process development and manufacture of solid oral dosage forms play important roles in the formulation design and process selection. According to phase transformation mechanisms, solid phase transformation were classified as 3 types： polymorphie transition, hydration/dehydration, vitrification/crystallization. This report proposes recommendations for monitoring and controlling polymorphs, amorphous and potential phase transformation during pharmaceutical processing.