Why is the Study of Crystals Important in Meeting Registration Regulations?

Question

Accepted Answer

• Regulatory agencies require thorough screening of drug polymorphs and mandate that pharmaceutical companies select a validated choice form or a specified mixture. The U.S. FDA and the NMPA address this requirement in the drug declaration, necessitating research on drug polymorphism and the provision of corresponding data.

• The development of any new drug requires a comprehensive and systematic polymorph screening to identify as many crystal forms as possible. Subsequently, various solid-state methods are employed to conduct detailed research and evaluation of these forms to determine the most suitable crystalline forms for development.

• Once the optimal crystal form is selected, the next steps involve developing a chemical process capable of consistently producing this crystal form and ultimately optimizing the crystallization process according to formulation requirements for solid state API properties. This ensures that the resulting crystal form exhibits desired physical properties such as crystal appearance, particle size distribution, and specific surface area.

• This method to quality assurance through experimental design can only be achieved with a comprehensive and profound understanding of the drug crystal form.