The goal of formulation is to incorporate an identified drug substance into a successful pharmaceutical product. The regulatory framework for OSD products highlights the need to comprehensively characterize the drug substance and any excipients both individually and when blended to achieve this goal.
In the new whitepaper the potential role of different analytical techniques is discussed with reference to each step of the formulation process. The techniques explored include: laser diffraction particle size analysis, for the control of excipient milling processes and final tablet spray coating; gel permeation/size exclusion chromatography for the characterization of controlled release excipients; and Morphologically Directed Raman Spectroscopy (MDRS) for polymorph detection and assessment of the impact of processing steps on the properties of the drug substance.
For more information on how Malvern’s instruments can help with all aspects of OSD formulation download the paper at: http://www.malvern.com/osdtoolkit.