Oral solid dose (OSD) formulations remain a dominant delivery method for pharmaceutical products, representing more than 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 active pharmaceutical ingredients (API) 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, Malvern Panalytical will consider the typical workflow associated with OSD product deformulation and how this is enabled through the application of physicochemical characterisation techniques.
The company will then present case studies that confirm how developing an understanding of the APIs and excipients within a formulation can enable more rapid product development, reducing the time-to-market for new generic products.
This webinar will take place on 9 October from 10:30 (GMT-5:00) to 11:30.
Paul Kippax will present the webinar, which will be of interest to developers of generic versions of oral solid dose drug products, as well as those generally interested in deformulation, establishing bioequivalence and understanding how improved physicochemical analysis methods and techniques can help accelerate these processes.
Malvern Panalytical will take an in-depth look at the workflow associated with the deformulation of oral solid dose products to establish when and how various physicochemical characterisation tools are applied to speed the development of safe and effective drug products.