Accelerating the deformulation workflow for oral solid dosage forms
White Paper Dec 15, 2014
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.
The FDA’s Critical Path Opportunities for Generic Drugs  guides the workflow associated with generic development, and emphasizes the need to adopt a Quality by Design (QbD) approach. QbD calls for the development of a sound understanding, and robust control, of all the variables that impact product and process behavior. This creates a need for extensive information gathering from the outset. The guidance clearly recognizes the role of analytical technology in delivering relevant information, and calls for advances in the analytical technology used in characterizing drug substances and products.
In this white paper Dr Deborah Huck-Jones and Dr Paul Kippax examine the deformulation workflow, demonstrating the value of the technique of Morphologically Directed Raman Spectroscopy (MDRS) within this context. Case studies illustrate the relevance of MDRS data.