ABSTRACT
Historically, preformulation evolved in the late 1950s and early 1960s as a result of a shift in emphasis in industrial pharmaceutical product development. Up until the mid1950s, the general emphasis in product development was to develop elegant dosage forms and organoleptic considerations far outweighed such (as yet unheard of) considerations as whether a dye used in the preparation might interfere with stability or with bioavailability. In fact, pharmacokinetics and biopharmaceutics were in their infancy, and although stability was a serious consideration, most analytical methodology was such that even gross decomposition often went undetected. It was, in fact, improvement in analytical methods that spurred the first programs that might bear the name “preformulation.” Stability-indicating methods would reveal instabilities not previously known, and reformulation of a product would be necessary. When faced with the problem of attempting to sort out the component of incompatibility in a 10component product, one might use many labor hours. In developing new products, therefore, it would be logical to check, ahead of time, which incompatibilities the drug exhibited (testing it against common excipients). This way the disaster could be prevented in advance.
