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Accelerating Solid Dosage Development and Ensuring In-spec Product With Terahertz Imaging – FDA Case Studies

 

FDA logoTeraView’s proprietary technology and expertise have now been successfully applied to define product and process specifications that affect the performance of solid dosage forms.  A series of successful case studies with the pharmaceutical industry and Food and Drug Administration (FDA) were used to illustrate the benefits to the industry in terms of reducing development time, ensuring rapid scale up into manufacture and maintaining in-spec product with reduced risk of regulatory non compliance.

A number of pharmaceutical companies are now actively using terahertz to address issues in solid dosage form development, scale up and QA in manufacture. Applications include a recently published article by the FDA which shows how the measurement of coating thickness and uniformity can be used to understand and potentially predict wet dissolution, an indicator of drug release and performance.

In another published study with pharmaceutical collaborators at the Universities of Dusseldorf and Otaga, scientists have demonstrated how terahertz can be used to gain process understanding and streamline the scale up process from small to large batches of tablets.  In particular, these studies have also demonstrated the ability of terahertz to measure the density of a coating and how this changes across a tablet surface as the process parameters are altered during scale-up. Density is a key factor in determining product performance, and terahertz is a unique and non-destructive means of rapidly measuring this parameter.

At recent conferences including the Heidelberg PAT Conference ‘07 in October, both the FDA and customers such as GlaxoSmithKline and Pfizer have discussed how they have deployed Terahertz solutions to evaluate and establish the correct process parameters for defining the integrity of tablet cores during scale up, as well as address coating integrity issues.

Other case studies with industry leaders looked at the effect of changing spray rate on film coating performance, formulation effects on the adhesion between the layer of a bi- layer tablet and the very early stages of the gel layer in a modified release, hypromellose, matrix tablet.

TeraView uses its proprietary platform and know-how to provide customers in the pharmaceutical industry with solutions to their needs in product development, scale up and quality assurance of solid dosage forms.

About TeraView

TeraView is the world’s first company devoted to the application of terahertz light for spectroscopy and imaging in pharmaceutical drug development and manufacture. TeraView’s technology can improve the quality of pharmaceutical products and decrease the risk of regulatory non-compliance, leading to potentially safer tablets and savings arising from faster times to market and volume production of higher quality, stable products. Other markets for the technology exist in early stage cancer detection, defence and industrial inspection which are explored via commercial partners. Headquartered in Cambridge, UK, TeraView was spun-out of the Toshiba Cambridge Research Laboratory in April 2001. Sales and support are available throughout Europe, North America and the Far East either directly or through a network of distributors.

In previous studies with its pharmaceutical customers, TeraView has demonstrated that its terahertz products and solutions can help to accelerate drug development and design of new formulations, improve product quality and maintain in-specification product to minimise the risk of regulatory non-compliance. Published studies with the Food & Drug Administration (FDA) have also illustrated how terahertz might be used to replace wet dissolution testing which serve as an indicator of drug release.