ABSTRACT
A significant portion of this book is devoted to the concepts involved in formulating drug products in their various forms. Physical, chemical, and biological properties all must be given due consideration in the selection of components and processing steps for that dosage form. The final product must be one that meets not only the requirements placed on it from a bioavailability standpoint, but also the practical mass production criteria of process and product reproducibility. In the current regulatory climate, formulation and process justification is a requirement for preapproval inspections for all new drug applications. In fact, development reports for both formulation and process are reviewed during these inspections. It is in the best interest of the pharmaceutical scientist to understand the theoretical formulation and target processing parameters, as well as the ranges for each excipient and processing parameter. Optimization techniques provide both a depth of understanding and an ability to explore and defend ranges for formulation and processing factors. With a rational approach to the selection of the several excipients and manufacturing steps for a given product, one qualitatively selects a formulation. It is at this point that optimization can become a useful tool to quantitate a formulation that has been qualitatively determined. Optimization is not a screening technique.
