ABSTRACT

Selection of appropriate excipients for formulation of drug substances is vitally important in ensuring fi nal product stability and effi cacy ( 1 ). As formulation scientists, it is imperative that we develop pharmaceutical products that have acceptable chemical and physical stability during the time period of their distribution, storage, and use. It is not uncommon that an API (active pharmaceutical ingredient) will be stable as bulk drug but unstable when blended with the excipients required for formulation of dosage forms. Therefore, understanding the reactivity of the API in the solid state when mixed with excipients is critical to commercial formulation development.