*We regret to announce that this webinar will be postponed until later in the year*
Oral Solid Dose (OSD) formulations remain the dominant delivery method for pharmaceutical products, representing over 60% of global pharmaceutical sales. As such, they remain an important target for generic product developers. The process of deformulation and subsequent in vitro bioequivalence assessment is often viewed as being simpler for these products than other complex dosage forms. However, many of the targets for generic development relate to drug substances which have low solubility or a narrow therapeutic window. Successful product development therefore depends upon understanding and controlling the critical material attributes of both the APIs and excipients. Here, physicochemical analysis has a key role to play, not only in confirming the API form, but also in understanding its interaction with functional excipients within the formulation.
In this webinar, we will consider the typical workflow associated with OSD product deformulation and how this is enabled through the application of physicochemical characterization techniques. We will then present case studies which confirm how developing understanding of the API and excipients within a formulation can enable more rapid product development, reducing the time to market for new generic products.