Assuming you have chosen the optimal API form for development, the focal point now turns to scale, control, quality and protection.  Regulatory guidance requires an understanding of all relevant forms in your system and that API and drug product processes are under control.  This requires you understand the impact of API and drug product processing on API form.  Additionally, solid forms can significantly impact lifecycle management with respect to freedom to operate and patent protection/extension.

Activities related to solid state properties in early clinical development include:

     •     Full polymorph screening and understanding

     •     Chemical and physical stability

     •     Crystallization

          •     Controlling crystal form and particle attributes – key on yield, productivity, and scale

     •     Form Changes in API and drug product

          •     Choosing the best technology for the appropriate API and drug product