Comparative in-vitro dissolution study of five brands of Diclofenac sodium delayed release tablets in QbD environment
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 6
Abstract
Diclofenac sodium tablets are available as delayed release tablets in the market. Delayed release tablets are typically produced by coating the tablet with enteric coating polymers. These polymers provide the resistance of drug release in acidic environment of stomach and allow the drug to be released in alkaline environment of the intestine. A large number of enteric polymers are available which provide excellent protection to drug release in acidic environment. However, each polymer dissolves at different alkaline pH. For e.g. Eudragit L-100 dissolves at pH 6 and above while Eudragit S-100 dissolves at pH 6.5 and above. HPMC Phthalate P5.5 dissolves at pH 5.5 and above while HPMC Phthalate P dissolves at pH 6 and above. Hence, for the same drug the bioavailability can subtly but significantly change based on which enteric polymer is used to provide the delayed release. The aim of the current work was to comparatively evaluate five brands of Diclofenac sodium enteric coated tablets and determine which brands may be equivalent to each other based on in vitro testing. Comparative dissolution profile testing was carried out in pH 5.5, pH 6 and pH 6.8 buffers. It was determined that brand 1 and 5 are equivalent to each other while brands 2, 3 and 4 are equivalent to each other. Similarity factor f2 was used for comparing the dissolution profiles. Alcohol dumping studies indicated that only brand 1 was able to withstand the enteric effect at 40% level of alcohol. All other marketed brands fail the alcohol dumping test. This indicates that patients may have to counsel not to concomitantly consume alcohol while on Diclofenac sodium delayed release tablets.
Authors and Affiliations
V Malleswari Bai, M Prasada Rao, M Chandana, K Naga Harini, B Naga Deepthi, K Thirumala Devi, P Lakashmana Rao, Vinay U rao, J Naga raja
Keywords
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