By Dr. Dhananjay Singare, Senior Principal Scientist, Piramal
Creating a drug product with the highest level of safety and efficacy requires chemists to have a deep understanding of the physical and chemical properties of its active pharmaceutical ingredient (API). By doing so, they can develop a “composition” that ensures compatibility between the API and excipients, which enhances the quality of product and makes it safe for use. This development of a formulation is typically done using one of two approaches: the traditional method that includes an empirical approach (often referred to as One Variable At A Time, or OVAT) or Quality by Design (QbD). It is critical that drug manufacturers understand the differences between these methods, in order to mitigate risk and preserve product performance.