Real time analysis of tablet and capsule dosage during pharmaceutical manufacturing

Projektinformationen

ATRS Instrument

ID Finanzhilfevereinbarung: 674107

DOI

10.3030/674107

Projekt abgeschlossen

EK-Unterschriftsdatum 17 April 2015

Startdatum 1 April 2015

Enddatum 30 September 2015

Finanziert unter

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

Gesamtkosten

€ 71 429,00

EU-Beitrag

€ 50 000,00

Koordiniert durch

COBALT LIGHT SYSTEMS LIMITED
United Kingdom

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

Berichtszeitraum: 2015-04-01 bis 2015-09-30

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

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.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

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.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

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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