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Real time analysis of tablet and capsule dosage during pharmaceutical manufacturing

Objective

The objective of the overall innovation project is to develop a novel instrument to measure and control pharmaceutical drug potency during manufacture at sub-second analysis speeds. This will significantly reduce the cost of quality testing, reduce the dosage variability that a patient receives, reduce production waste and solvent disposal and address challenging new regulatory testing guidelines.

Pharmaceutical companies, in response to regulators (such as the US FDA) setting direction and guidance, need to better understand and control their processes. Real-time release testing (RTRT) and Quality by Design (QbD) are promoted by regulators as their vision of where quality must go; pharmacopeia guidance supports that vision.

Cobalt has developed a successful, patented, high speed quantitative analysis technology called transmission Raman spectroscopy (TRS), which measures drug potency of intact tablets and capsules. When used during production (“on-line”) in combination with an automated physical tablet testing system, TRS will enable immediate release of drug product without “off-line” analysis in a quality control (QC) laboratory.

Field of science

  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug
  • /natural sciences/chemical sciences/analytical chemistry/spectroscopy
  • /natural sciences/chemical sciences/inorganic chemistry/inorganic compounds
  • /natural sciences/chemical sciences/analytical chemistry/quantitative analysis

Call for proposal

H2020-SMEINST-1-2014
See other projects for this call

Funding Scheme

SME-1 - SME instrument phase 1

Coordinator

COBALT LIGHT SYSTEMS LIMITED
Address
Brook Drive 174 Milton Park
OX14 4SD Abingdon Oxfordshire
United Kingdom
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 50 000