ABSTRACT
The essential component of a solid dose form is, of course, the active pharmaceutical ingredient (API), and most drug substances are still administered via the solid dose form (1). It is a truism that one cannot develop such a dosage form without determining the scope of excipients that might be used in the formulation; but before one can begin to comprehend the scope of these studies, one must first catalog and understand the chemical and physical properties of the bulk drug substance. The acquisition of a sufficiently detailed body of information regarding the properties of an API allows a formulator to set up drug-excipient compatibility studies, rationally design formulations, and ultimately cope with unanticipated crises.
