Business & Regulation Drug Delivery, Formulation, Standards & Regulation

Accelerating the deformulation workflow for oral solid dosage forms

In this white paper we examine the deformulation workflow, demonstrating the value of the technique of Morphologically Directed Raman Spectroscopy (MDRS) within this context.

05/07/2015

Oral Solid Dosage (OSD) forms still represent a significant share of the pharmaceutical market. As a result, they remain an important target for generic product developers. OSD products tend to be viewed as simpler to reverse engineer compared to those with more complex delivery mechanisms, such as Orally Inhaled and Nasal Drug Products (OINDPs). However, deformulation - the unpicking and rationalization of those characteristics of a Reference Listed Drug (RLD) that deliver its performance - still requires significant effort, especially when considering modified or sustained release OSD products. In addition, the development of a new generic can be an intensely competitive process, with multiple companies chasing the opportunity to be first to file in the US in order to claim a highly valuable period of exclusivity. Optimizing the deformulation workflow to accelerate submission and secure regulatory approval is therefore an important goal.

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