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Near Infrared Spectroscopy Analysis of Intact Pharmaceutical Diclofenac Coated Tablets in Transmission

Max-Werner Scheiwe a , Doris Schilling b , and Patrick Aebi b

Mepha AG, Research and Development Department a , Aesch BL (Switzerland), and Buehler Anatec b , Uzwil (Switzerland)

In general, diffuse reflectance has been used in NIR-spectroscopy of tablets. This paper deals with NIR transmission analysis of tablets, offering new analytical possibilities in pharmaceutical development, production and control. Particularly when the content of the active principle in the final dosage form is detectable by this method, a large number of tablets can quickly and easily be tested with respect to content. This provides possibilities for checking content uniformity, not only from randomised drawn samples but also on-line during tablet production. The analysis is non destructive to the dosage form and measurements as well as calculation of statistics can be fully automated and even GMP conditions are principally maintained while samples are tested. In addition, coated tablets also can be adequately analysed by NIR. Thus both a reduction in time and cost as well as an improved validity of results can be expected.

Key words Chemometric methods · Content uniformity · Near infrared spectroscopy · Tablet inspection · Transmission analysis