TeraView has used its expertise in terahertz light to successfully apply its proprietary terahertz imaging and spectroscopy technology to the quality by design initiative and increase pharmaceutical product and process understanding.
This new technology is called 3D Terahertz Pulsed Imaging ( TPI™), and is used in TeraViews systems to non-destructively estimate critical quality attributes in pharmaceutical products such as crystalline structure, thickness and chemical composition.
The Pharma Innovations team at Teraview has demonstrated how terahertz instruments can assemble 3D coating thickness maps for multiple coating layers and structural feature models, enhancing understanding and increasing control of product scale up and manufacture. The measurements made by the 3D TPI™ are equivalent or better than traditional techniques in terms of analytical performance.
Terahertz Pharma Applications
Solid Dosage Analysis of Tablets – Terahetz imaging can be used to determine heterogeneity and integrity of pharmaceutical cores and coatings.
Tablet Coating Thickness In-line Control - Monitor and guide in-line pharmaceutical products to enhance understanding of product and process design.
Crystalline Structure Analysis of Drugs - Analyze polymorphs of drugs with terahertz spectroscopy and understand the dynamics of polymorphic interconversion.
Once in manufacture, TeraView can offer its innovative 21CFR part 11 compliant terahertz instruments to monitor and ensure compliant product. TeraView technology is continuously advancing and has recently demonstrated its capability to collect information at speed from tablets in random motion without destruction of the sample, with the ultimate goal of use for in-line control.
In working with the TeraView Pharma Innovations team, predictive models can be developed that allow you to speed your product through R&D and successful product transfer.
The US Food and Drug Administration (FDA) has recently shown support for the active use of terahertz technology, saying, "the speed and ease of terahertz imaging may make it an attractive potential replacement for wet dissolution testing both in product development and eventually for process analysis" (Spencer, J.A., J Pharm Sci 2007).
This information has been sourced, reviewed and adapted from materials provided by TeraView Ltd.
For more information on this source, please visit TeraView Ltd.