General considerations for the prescription and process development of chemical generic compound bilayer tablets
SHUAI Yaping
ZHAO Na
SUN Yuanpeng
XIE Yan
ZHANG Junlin
Abstract：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.
Keywords：Compound bilayer tabletsParticle size distributionPrescription and process development
Publication Date：2026-02-28
Online Publishing Date：2026-03-25(First online date of this platform, not the publication date of the document)
Pages：6( 182-187 )