Pre-formulation

Pre-formulation is defined broadly as the physicochemical characterization of an active pharmaceutical ingredient (API).  The data on compound properties collected during the pre-formulation stage inform future directions of a drug development program.  The issues addressed include solubility of an API relative to expectations of the drug development team, compatibility with excipients, short term solution and solid state stability, and other concerns.  In general, a systematic and comprehensive pre-formulation study is a prerequisite for developing a successful and robust formulation.  Proper attention to the pre-formulation stage of a drug development program can save a great deal of time and effort as the API is progressed toward clinical trials.

WLI routinely designs and performs pre-formulation studies for its clients.  WLI appreciates that the scope of pre-formulation work, indeed any project, must be adapted to a client’s current needs, financial constraints, and business and scientific plan.  The design of pre-formulation studies is customized further based on projected mode of administration and estimated dosing requirements