A new whitepaper from Malvern Instruments on oral solid dose (OSD) deformulation demonstrates how the analytical technique of morphologically directed Raman spectroscopy (MDRS) can be used to accelerate development of generic products to a successful conclusion.
Deformulation, the unpicking and investigation of a reference labelled drug (RLD), enables generic developers to understand the features of a product that define its clinical performance.
‘Accelerating the deformulation workflow for oral solid dosage forms’ reviews the current regulatory landscape associated with generic development and considers workflow for preparing OSD product abbreviated new drug applications (ANDAs).
Case studies demonstrate the breadth and value of information generated by MDRS within this context.
MDRS enables component specific data to be obtained for multi-component samples, which is made possible by systems such as the Morphologi G3-ID.
The instrument combines automated analytical imaging, which can be used to gather statistically relevant size and shape data, with Raman spectroscopy, that enables component identification.
Case studies in the whitepaper show how MDRS can be applied to efficiently identify and quantify the components in an RLD, determine the polymorphic form of an active pharmaceutical ingredient, and to gain insight into manufacturing methods used.
This information supports successful deformulation and development of generics with well-understood performance and robust bioequivalence.