Considerations on pharmaceutical research of co-crystal drugs
MA Jun-wei
LIU Juan
REN Lian-jie
Abstract：Developing co-crystals is a technical approach to improve the solubility,stability,and solid-state characteristics of drugs,which shows significant value in drug development.Several co-crystal drugs have been marketed both domestically and internationally.However,regulatory frameworks for co-crystals differ between the U.S.Food and Drug Administration(FDA)and the European Medicines Agency(EMA).China currently lacks specific technical requirements for co-crystals.This paper references the current regulatory landscape for co-crystal drugs and combines insights from practical review work to discuss the pharmaceutical research of co-crystals from aspects including elucidation of structure,key physicochemical property studies,process development and control,and co-crystal quality studies.
Keywords：co-crystalspharmaceutical researchelucidation of structure
Publication Date：2025-11-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2366-2371 )