JOURNAL OF THE CZECH PHARMACEUTICAL SOCIETY AND THE SLOVAK PHARMACEUTICAL SOCIETY

Čes. slov. farm. 2009, 58(4):155-159

Determination of the coating thickness of HPMC hard capsules by near-infrared reflectance spectroscopy

J. Muselík1,*, K. Dvořáčková1, M. Rabišková1, A. Bartošíková1, M. Rosendorfová1, M. Dračková2, L. Vorlová2
1 University of Veterinary and Pharmaceutical Sciences Brno, Faculty of Pharmacy, Department of Pharmaceutics, Czech Republic
2 University of Veterinary and Pharmaceutical Sciences Brno, Faculty of Veterinary Hygiene and Ecology, Institute of Milk Hygiene and Technology, Czech Republic

The aim of this study was to develop the method for off-line determination of hard capsules coating thickness. The polymer films studied were Eudragit® L 12.5 and Eudragit® S 12.5 applied on hypromellose capsules surface in a bottom-spray fluid-bed coater equipped with a Wurster column. The coating thickness reference values for calibration were obtained from microscopic analysis. Calibration model was created using partial least squares regression with six factors for Eudragit® L film and five factors for Eudragit® S film. The calibration and validation results led to following parameters: determination coefficients R2 were more than 0.98 and standard error of cross validation was 6.6 μm (coat thickness range was 15-235 μm) for Eudragit® L film and 8.3 μm (coat thickness range was 30-230 μm) for Eudragit® S film, respectively. Obtained results confirmed suitability of near infrared spectroscopy for coating process quality control in pharmaceutical industry.

Keywords: film-coating; Eudragit® L and S; hard capsules; coating thickness; near-infrared spectroscopy
Grants and funding:

This work was supported by IGA VFU 136/2008/ FaF and IGA Ministry of Healthcare of Czech Republic NS 10222-2/2009.

Received: June 23, 2024; Accepted: July 14, 2009; Published: April 1, 2009  Show citation

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Muselík J, Dvořáčková K, Rabišková M, Bartošíková A, Rosendorfová M, Dračková M, Vorlová L. Determination of the coating thickness of HPMC hard capsules by near-infrared reflectance spectroscopy. Čes. slov. farm. 2009;58(4):155-159.
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