化学仿制药复方双层片处方工艺开发一般考虑OA

Compound bilayer tablets have been widely concerned in the development of novel solid formulations because of its advantages including enhancing drug efficacy,reducing side effects and improving patient compliance by combining medications or adjusting the rate of drug release.This review summarized the key points in prescription screening and process development of chemical generic compound bilayer tablets,combining the literature patents,relevant domestic and foreign drug laws and regulations.This included the characteristics of active pharmaceutical ingredients,the selection of ex-cipients,the design of multi-strengths prescription,the development of bilayer process and batch amplification,etc.,in order to provide a reference for generic compound bilayer tablets drug development.