Author:

Keywords:

hpmc capsules, enteric coating, sealing, Science & Technology, Life Sciences & Biomedicine, Pharmacology & Pharmacy, HPMC capsules, Capsules, Lactose, Methylcellulose, Oxazines, Polymethacrylic Acids, Tablets, Enteric-Coated, Technology, Pharmaceutical, 1115 Pharmacology and Pharmaceutical Sciences, 3214 Pharmacology and pharmaceutical sciences

Abstract:

The aim of this study was to develop an alternative method for enteric coating of HPMC capsules that avoids the scaling 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(R) L30D-55 or Eudragit(R) FS 30 D (Rohm), Aqoat(R) AS-HF (Shin-Etsu) and Sureteric(R) (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 2 It from capsules coated with Eudragit(R) L30D-55, Eudragit(R) FS 30 D, Aqoat(R) AS-HF and Sureteric(R) was 0.6 +/- 0.3, 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. (C) 2004 Elsevier B.V. All rights reserved.