High-Volume On-Line Spectroscopic Composition Testing of Manufactured Pharmaceutical Dosage Units
Description of Invention:
The invention is a pharmaceutical dosage unit manufacturing process control system that uses continuous spectral imaging to test the actual composition of pharmaceutical dosages even in packaged drugs. The system can screen for errors in coloring of ingredients, for contamination or breakdown that occurs independent of coloring and for other types of errors that might not otherwise be detected. The system can perform composition measurements through the end-user package walls to detect contamination or damage that occurs during packaging. The invention performs composition analysis by comparing spectral information with libraries of known spectral signatures, allowing small concentrations of potentially dangerous contaminants to be detected. Relative quantities of ingredients can be directly measured, such that a change in the ratio of these ingredients can be detected.
Inventors:
E. Neil Lewis (NIDDK) David J. Strachen (NIDDK) Linda H. Kidder (NIDDK)
Devices/Instrumentation-Diagnostics-Imaging-Apparatus-Spectroscopy Devices/Instrumentation-Diagnostics-Imaging-Apparatus Devices/Instrumentation-Environmental Technology -Equipment and Machinery-Methods of Manufacturing Devices/Instrumentation-Diagnostics-Imaging Devices/Instrumentation-Environmental Technology -Equipment and Machinery Devices/Instrumentation-Manufacturing Technologies-Quality Control Testing Devices Devices/Instrumentation-Diagnostics Devices/Instrumentation-Environmental Technology Devices/Instrumentation-Manufacturing Technologies
For Additional Information Please Contact: Michael Shmilovich J.D.
NIH Office of Technology Transfer
6011 Executive Blvd, Suite 325
Rockville, MD 20852-3804
Phone: (301) 435-5019
Email: shmilovm@mail.nih.gov
Fax: (301) 402-0220
