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Development and stability evaluation of enteric coated Diclofenac sodium tablets using Sureteric
1College of Pharmacy, An Najah National University, Nablus, Palestine. anzaid@najah.edu
Pakistan Journal of Pharmaceutical Sciences
|December 22, 2011
Summary
This study developed stable enteric-coated diclofenac sodium tablets using Sureteric, an aqueous coating system. The formulation effectively prevents stomach release and ensures drug release in the duodenum.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
Background:
- Diclofenac sodium requires enteric coating to prevent gastric irritation and ensure effective delivery.
- Traditional enteric coating methods often involve subcoating layers, adding complexity and cost.
Purpose of the Study:
- To develop stable enteric-coated diclofenac sodium tablets using Sureteric without a subcoating layer.
- To evaluate the performance of Sureteric as an aqueous enteric coating system.
Main Methods:
- Diclofenac sodium tablets were manufactured via non-direct compression.
- Tablets were coated with Sureteric, an aqueous dispersion containing Polyvinyl Acetate Phthalate (PVAP).
- Coated tablets underwent disintegration and dissolution testing at pH 1.2 and pH 6.8.
Main Results:
- Enteric-coated tablets showed no cracking at pH 1.2.
- Complete disintegration occurred within 10 minutes at pH 6.8.
- Drug release was <0.9% in acid (pH 1.2) and ~97% in buffer (pH 6.8).
Conclusions:
- Sureteric is effective for creating stable diclofenac sodium enteric-coated tablets without a subcoating.
- This aqueous coating system provides controlled drug release, preventing gastric release and enabling duodenal absorption.
- The Sureteric system offers an economical and straightforward approach for enteric coating applications.
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