Formulation and evaluation of enteric coated sustained release matrix tablets of Duloxetine hydrochloride
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2015, Vol 3, Issue 2
Abstract
The present study was aimed at developing enteric coated–sustained release formulation by direct compression for Duloxetine HCl as it lacks the ability to sustain its chemical integrity or stability in acidic gastric environment. Attempts were made to impart the sustained release property by employing HPMC K4M, Sodium Carboxy Methyl Cellulose and Sodium Alginate at drug-polymer ratios 1:1 and 1:0.75. In order to increase the stability at low pH trials were performed by employing 5% CAP as the coating polymer and by the varying the thickness of the coating layer. Initially 5% of the coating polymer was used which resulted in no substantiate increase in stability; the amount of drug release in gastric environment after 2 hrs was found to be greater than 10 %( F1-F3). As a result of this the thickness of the coating polymer was increased by two folds, favourable decrease in the release was observed (F4-F9).Finally it was found in the further trial that the drug release was around 6 -7 % when the coating layer thickness was increased to 20 %( F10-F15).The cumulative release for all the formulations (F1-F15) after 10 hrs in 6.8 phosphate buffer were reported be in compliance with compendial specifications.
Authors and Affiliations
A. Bharathi, P. Rama Chandra rao, V. Aswinipriya, N. Anusha
Keywords
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