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Analytical Strategies that Support OSD Formulation: A new Whitepaper from Malvern Instruments
A new whitepaper from Malvern Instruments provides detailed guidance on the analytical technologies that help to accelerate oral solid dosage (OSD) product formulation to a successful conclusion.
‘Analytical techniques with a place in the oral solid dosage formulation toolkit’ reviews the regulatory and QbD framework associated with OSD formulation and demonstrates how Malvern systems can be used to generate the data required.
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.