Thursday, 20 September 2012

A comparison of quality control methods for active coating processes

International Journal of Pharmaceutics

Available online 16 September 2012


  • a Institute of Pharmaceutics and Biopharmaceutics, University of Düsseldorf, Universitätsstrasse 1, 40225 Düsseldorf, Germany
  • b Department of Chemical Engineering and Biotechnology, University of Cambridge, Pembroke Street, Cambridge, CB2 3RA, United Kingdom
  • c Global Chemical & Pharmaceutical Development, Bayer Pharma AG, Müllerstrasse 178, 13353 Berlin, Germany


Abstract

Terahertz pulsed imaging (TPI) is a recent and nondestructive technique to quantify coating thickness of pharmaceutical tablet film coatings. In this study, TPI is used for the first time to quantify the progress of an active coating process. The dosage form consisted of a push-pull osmotic system comprising a two-layer tablet core with a functional film coating and a laser drilled hole. On top of this system an active coating was applied. The coating thickness data acquired by TPI and optical microscopy was compared to the quantification of the active pharmaceutical ingredient (API) via HPLC. Good correlation of TPI and HPLC data was shown for coating thicknesses up to 500 μm. Due to the special structure of the dosage form, the TPI detection limit of 38 μm layer thickness was circumvented by analysing the coating thickness of active coating and functional subcoat in one. Therefore it was possible to monitor the active coating process from the very beginning of the process. Optical microscopy was no suitable reference technique for TPI thickness measurements. The active coating showed deformation artefacts during sample preparation, which biased the subsequent thickness measurements.


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