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Alternative method for enteric coating of HPMC capsules resulting in ready-to-use enteric-coated capsules.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences (2004-04-07)
Nathalie Huyghebaert, An Vermeire, Jean Paul Remon
ABSTRACT

The aim of this study was to develop an alternative method for enteric coating of HPMC capsules that avoids the sealing step before coating, resulting in ready-to-use enteric-coated capsules for the use in retail or hospital pharmacy or R&D sections of pharmaceutical industry and for the production of enteric-coated heat and moisture sensitive biomaterials. HPMC caps and bodies 00 (Vcaps, Capsugel) were coated separately in a fluid bed apparatus prior to filling (GPCG-1, Glatt) with Eudragit L30D-55 or Eudragit FS 30 D (Röhm), Aqoat AS-HF (Shin-Etsu) and Sureteric (Colorcon), using an optimised coating process. The coated bodies were filled and closed with the coated caps without encountering problems of coating damage. The release in 0.1N HCl after 2h from capsules coated with Eudragit L30D-55, Eudragit FS 30 D, Aqoat AS-HF and Sureteric was 0.6+/-.03, 0.6+/-0.3, 1.2+/-0.2 and 7.3+/-1.9%, respectively. The alternative method was reproducible and offered a way to overcome the time-consuming and expensive sealing step required using the conventional coating procedure. The obtained enteric-coated HPMC capsules can be stored (un)-filled for at least 6 months without loosing enteric properties.