Real time analysis of tablet and capsule dosage during pharmaceutical manufacturing

Project Information

ATRS Instrument

Grant agreement ID: 674107

DOI

10.3030/674107

Project closed

EC signature date 17 April 2015

Start date 1 April 2015

End date 30 September 2015

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

COBALT LIGHT SYSTEMS LIMITED
United Kingdom

Periodic Reporting for period 1 - ATRS Instrument (Real time analysis of tablet and capsule dosage during pharmaceutical manufacturing)

Reporting period: 2015-04-01 to 2015-09-30

Summary of the context and overall objectives of the project

The purpose of the project was to assess potential for an on-line automated tablet tester in manufacturing of pharmaceutical products. Quantitative testing of the active ingredients is not usually done during manufacturing but can be weeks later. There is an opportunity, using Cobalt’s technology, to make that testing happen as soon as possible and dramatically reduce work in progress delays.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

A comprehensive market study was performed, surveying the QC process for oral solid dose products through the production process, exposed areas for exploitation in Pharma QC testing using Cobalt’s technology. This enabled concept development and testing for new instruments and applications and their impact on QC cost savings.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The workhorse tool for quantitative QC testing in Pharma is HPLC (high performance liquid chromatography), which is resource-intensive, relies on expensive sample preparation steps and is difficult to use outside of a QC laboratory. This is virtually the default analysis technique, and is worth >$1.1Bn pa, 60% of which is consumable items. One of the largest costs is in the use and disposal of solvents. Cobalt’s transmission Raman technology (TRS) avoids the use of consumable items and is non-destructive. It can test large numbers of tablets quickly and is easy for non-skilled operators to use, which makes it ideal for production environments.
By avoiding the use of solvents and other consumables TRS can reduce environmental impact of testing. Cost reductions and work in progress reductions have a significant benefit to the cost of manufacture, which impacts the cost of drugs on the market – particularly generic products which have a lower profit margin than those on patent. This is an area that is not well exploited and has the potential to improve the testing process. For Pharma manufacturing on-line or at-line testing, TRS can replace many HPLC instruments, reduce staff resource in QC and streamline manufacturing in high volume production.

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