ABSTRACT

Preformulation, the cornerstone of science-based formulation development, should always be an integral part of all new drug development projects to facilitate the progression of formulation optimization on a sound scientific basis precept by precept. Needless to say, as a prelude to formulation, it should pave the way for the formulation scientist to successfully formulate stable dosage forms for clinical trials in record time. In other words, prior to embarking on the product development, the formulator should have a clear understanding of the physicochemical properties of the drug substance under consideration. In short, preformulation is considered as a rate-limiting step in the overall planning of new drug development activities.