A non-destructive analysis technology for coated tablets - which was highlighted by a recent FDA study as a potential alternative to current wet dissolution - is to be made available as a service by Melbourn Scientific, a leading provider of contract analytical, formulation and drug development services. This follows an agreement with TeraView Ltd, pioneers in the development of terahertz solutions for the pharmaceutical industry.
Terahertz Pulsed Imaging (TPI) is a quick non-destructive technology developed by TeraView that can generate precise 3D images of solid dosage systems. These images can be used to identify and quantify key quality attributes such as coating uniformity, thickness and porosity.
Melbourn Scientific is always at the forefront of new technology making advances available to its pharmaceutical clients where there is a sufficient evidence-base available for supporting its introduction. By combining TeraView TPI with the wider analytical capabilities and experience of Melbourn, this agreement will enable for the first time the full power of TPI to be available to pharmaceutical companies.
TPI, when used with other established tools, enables the creation of chemometric models which accurately relate the product’s performance to its physical characteristics. This is particularly relevant for modified release and control release products, which today account for about 25% of all launched products.
The FDA said of this technology, “The speed and ease of TPI mapping may make it an attractive replacement for wet dissolution testing both in product development and eventually for process analysis.”
Mark Hammond, CEO of Melbourn Scientific, believes that the new service will provide benefits both within product development and scale-up.
“The TPI system developed by TeraView enables, for example, the analysis of the tablet coating prior to its dissolution. This provides new insights and will enable us to quickly correlate the release of the active ingredient with the density or thickness of the coating. This increased understanding then allows trouble free scale up and product optimisation. Clearly it also fits well with the FDA’s directives on QbD and PAT.”
Dr Don Arnone, Chief Executive Officer of TeraView, agrees. “Modified release coatings can be difficult to scale-up as there is a need to change process parameters as well as batch size. With the development of TPI it is now possible to directly and non-destructively assess the impact of changing process conditions on the critical quality attributes of the coating.”
Don Arnone added, “By offering TPI as a service alongside their existing capabilities Melbourn Scientific will enable its customers to achieve significant business benefits, accelerating the development of new products as well as helping to ensure that these products remain in-spec and compliant during development and once they are on the market.”
For many products on the market today, weight gain is largely used to infer coating thickness uniformity and density. Various studies, including the FDA study (published J Pharm Sci 2007) have shown this assumption can be flawed.
Mark Hammond sees the technology opening up new opportunities. “Pharma companies are getting more creative. Drugs are getting more engineered, with bi-layers, tri-layers, tablets within tablets, patches, multiple APIs etc. However increased complexity necessitates a better understanding of the critical quality attributes. These are complex products. The mapping offered by TPI, alongside the more established technologies, will allow us to generate this understanding quickly for our customers.”
About Melbourn Scientific www.melbournscientific.com
Melbourn Scientific provides high quality analytical and formulation services to the pharmaceutical and healthcare industry. Clients include major pharmaceutical companies, drug delivery innovators, consultants and virtual companies.
Melbourn Scientific has invested continually in the latest equipment and provides a range of services: pharmaceutical analysis, physical testing; stability trials; HPLC and inhaled product analysis.
About TeraView www.teraview.com
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.
