The concept relies on fast flowing liquids in a similar manner to High Performance Liquid Chromatography (HPLC) and does not need intrusive mechanical grinding devices.
CambTEK is developing the RES to address the long standing issue of poor productivity of solid dose testing, aimed primarily at the pharmaceutical and food industries. The first system will be ready for beta testing at first client sites in late 2012. CambTEK has licensed the technology from PA Consulting Group, and based the machine on IP developed at PA’s technology centre at Melbourn, UK.
For all drug and food products, testing is a regulatory requirement to demonstrate that products are safe and meet specifications. The sample preparation step is often a labour intensive task, which companies have long wished to automate, to improve productivity and consistency of data, whilst also reducing overall costs. This is particularly pertinent to the pharmaceutical industry, which is under great pressure to deliver better productivity against a back drop of spiralling costs of bringing new products to market. Product testing is viewed as a high cost, low value-add activity, but is often carried out by PhD qualified scientists.
The poor quality, associated with any manual, repetitive task leads to inconsistency and a high repeat cost. Outsourcing the task to lower cost economies is one solution, but doesn’t alter the fact that testing remains a manual activity retaining all the underlying problems.
The product extraction step, turning the solid dose to liquid ready for analysis, remains the major bottleneck in the current process, particularly for slow released products. Many companies still use conventional glassware with simple stirring or shaking methods, which can take many hours to extract the drug from the solid matrix. High powered extraction methods, such as homogenisation, often have other associated problems around reliability and cleaning and can still be the major bottleneck in the test process.
This low productivity in sample extraction has meant that many pharmaceutical companies are unable to realise the full benefits of the new generation of faster analysis systems such as ultra high performance liquid chromatography (UHPLC).
Even though the high volume testing is generally associated with manufacturing companies, the greatest demand for new improved tools has come from pharmaceutical development groups. The test requirements within pharmaceutical development has risen dramatically with the Quality by Design (QbD) initiative launched by the FDA, which drives large Design of Experiments to investigate the variables involved with solid dose products.
The large number of batches needed to understand the design space is overwhelming many test laboratories and new approaches are needed. Equally, RES has been developed to be scalable to provide a route to high volume testing in manufacturing QC and even a solution for at-line testing. Demand has also come from the food industry, where solid food matrices tend to be very complex and difficult to extract.
The view from the pharmaceutical industry is that liquid extraction before analysis is here to stay for the foreseeable future, in spite of fast improving non-destructive techniques (such as near infra-red spectroscopy). Existing systems tend to include complex robotics, whereas what the industry really wants are simpler, robust systems that can be integrated into the laboratory workflow. New low cost tools are needed for ‘business as usual’ that provide a good return on investment.
The RES is built on a scientific understanding of dissolution and liquid flow as opposed to the traditional invasive homogenization and automation of human processes. As part of the proof of concept, PA built a demonstrator system which was tested by a pharmaceutical partner and met all of the performance targets.
The concept relies on fast flowing liquids in a similar manner to High Performance Liquid Chromatography (HPLC) and does not need intrusive mechanical grinding devices. The RES is a user friendly scientific instrument that will substantially ease bottlenecks in sample preparation for food and drugs companies.
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