Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Development and Stability Evaluation of Enteric Coated Diclofenac Sodium Tablets Using AquaPolish E.

  • Zaid, A.N. (College of Pharmacy, An- Najah National University) ;
  • Fadda, A.M. (College of Pharmacy University of Cagliari Italy) ;
  • Nator, S. (Pharmacare LTD.) ;
  • Qaddumi, A. (Pharmacare LTD.)
  • Received : 2011.04.22
  • Accepted : 2011.07.05
  • Published : 2011.08.20
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Abstract

The aim of this study was to develop a stable enteric coated diclofenac sodium (DFS) tablets using Aqua-Polish E without using a subcoat. DFS uncoated tablets were manufactured through the non direct compression process. AquaPolish E white aqueous coating dispersion was used as enteric coating material. This film forming polymer is a mixture of selected polymethacrylic/ethylacrylate copolymers. The stability of the obtained enteric coated tablets was evaluated according to ICH guidelines. No signs of disintegration or cracking was observed when they placed in 0.1N HCl solution (pH1.2), but they were completely disintegrated within 10 minutes when they placed in buffered solution at pH6.8. Dissolution test was also conducted by placing tablets in 0.1 N HCl for 2 hours and then 1 hour in phosphate buffer at pH 6.8. Less than 0.9 % of drug was released in the acidic phase and up to 97% in the basic medium. These findings suggest that aqueous enteric coating with AquaPolish E system is an easy and economical approach for preparing stable DFS enteric coat without the use of a subcoating layer.

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