Using Raman to Track API and Solid Dosage Forms During Drug Development

By David Strachan, Mark Kemper, Maryann Ehly, Ian Lewis and Bryan Bowie, Kaiser Optical Systems, Inc.
PharmaManufacturing.com
Raman spectroscopy offers benefits for processes as diverse as crystallization and tableting.Many pharmaceutical quality programs fail to account for the fact that API forms can change during drug development. They may be the same compound, chemically, but have different particle sizes or morphologies. In tableting or encapsulation, this fact can lead to processing problems — for example, when an API particle that was spherical early on in the development process becomes rod-shaped later on, then causes agglomeration problems during blending.Worse yet, differences in form can also result in quality problems or adverse reactions in patients. This is especially important in crystallization, since different forms or polymorphs of the same compound may have vastly different properties — different solubilities, dissolution rates, stabilities or bioavailabilities. As G. McGeorge has written, “FDA expects that [any] crystallization process is in control and that the polymorph generated will provide predictable properties in-vivo.” [1].Both NIR and Raman spectroscopy are being used to study and monitor API forms during development to understand, correct and improve processes, facilitate continuous processing and improve quality. This brief article will focus on Raman and its use in detecting crystal polymorphs during API development, as well as its use in tableting. It will summarize how the technology is being used, describe the benefits it offers and briefly compare its performance with NIR

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