Deformulation and the Development of Generic Drugs

Maintaining a competitive edge in the generic drug market requires a constant flow of new products. Cost and speed to market are key, with significant financial benefits for the first-to-file in territories such as the United States of America.

Launch of a successful generic requires developers to show comparability to the innovator Reference Listed Drug (RLD) in dosage form, route of administration, quality and performance characteristics, and intended use. Achieving this can be complex, especially as many drug products contain active pharmaceutical ingredients (APIs) with poor solubility or have a narrow therapeutic window. Successful achieving rapid product development requires formulators to ‘decode’ the critical material attributes of both the active pharmaceutical ingredient (API) and excipients within the RLD – a process often referred to as reverse engineering or deformulation. Physicochemical analysis has a key role to play here: you cannot fully understand the formulation without it.

In this webinar we are joined by Dr Arvind K. Bansal, Professor at the National Institute of Pharmaceutical Education and Research (NIPER), to consider the role of innovator product characterization strategies in accelerating formulation development of generic products. The benefit of such studies in simplifying regulatory approval process and reducing the risk of late-stage has also been highlighted, with specific reference to the development of Oral Solid Dose products.

Who should attend?

• Researchers considering the requirements for formulation characterization and optimization.
• Formulation scientists engaged in developing candidate generic drug product formulations.
• Analytical scientists engaged in supporting in vitro bioequivalence studies.
• Laboratory managers looking to understand the techniques required to support deformulation and in vitro bioequivalence assessments.