A new whitepaper from Malvern Panalytical 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 Panalytical 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.
For more information on how Malvern Panalytical’s instruments can help with all aspects of OSD formulation download the paper at: http://www.malvern.com/osdtoolkit
About Malvern Panalytical
Malvern Panalytical provides the materials and biophysical characterization technology and expertise that enables scientists and engineers to understand and control the properties of dispersed systems. These systems range from proteins and polymers in solution, particle and nanoparticle suspensions and emulsions, through to sprays and aerosols, industrial bulk powders and high concentration slurries. Used at all stages of research, development and manufacturing, Malvern Panalytical’s materials characterization instruments provide critical information that helps accelerate research and product development, enhance and maintain product quality and optimize process efficiency.
Our products reflect Malvern Panalytical’s drive to exploit the latest technological innovations and our commitment to maximizing the potential of established techniques. They are used by both industry and academia, in sectors ranging from pharmaceuticals and biopharmaceuticals to bulk chemicals, cement, plastics and polymers, energy and the environment.
Malvern Panalytical systems are used to measure particle size, particle shape, zeta potential, protein charge, molecular weight, mass, size and conformation, rheological properties and for chemical identification, advancing the understanding of dispersed systems across many different industries and applications.
Headquartered in Malvern Panalytical, UK, Malvern Panalytical has subsidiary organizations in all major European markets, North America, China, Japan and Korea, a joint venture in India, a global distributor network and applications laboratories around the world.