Design and Evaluation of Extended Release Capsules of Acetazolamide Using Eudragit RS100 And Eudragit RL100
Journal Title: Indo American Journal of Pharmaceutical Research - Year 2011, Vol 1, Issue 5
Abstract
Utilizing the concept of incorporating drug in to the polymer matrices and extend the drug release for prolong period of time, an attempt was made to design and evaluate extended release capsules of acetazolamide using extended release polymers. The initial three formulations of Acetazolamide ER capsules were formulated with Ethyl cellulose N-7, Benecel (HPMC 15M) and Natrosol (HHX Pharm) with concentrations of 11%, 13% and 15% respectively. However satisfactory results were not obtained these polymers and it was decided to proceed further with high viscosity polymers which would effectively sustain the release of drug. The F1 - F16 batches were taken with different concentrations of Eudragit RS100 and Eudragit RL100. The combinations of these polymers in different proportions provide varied sustained release profiles. The optimized formulation (F12) was developed by using Eudragit RS100 (6%) and Eudragit RL100 (4%). The dissolution profiles of formulation F12 and innovator product were compared by calculating differential factor (f1) and similarity factor (f2). The f1 and f2 were found to be 2.97 and 69.70 respectively for the comparison of dissolution profiles of formulation F12 and innovator product. Infrared Spectroscopy studies were showed sharp characteristic peaks for Acetazolamide at different wave numbers. All the above peaks appeared in optimised formulation at same wave numbers, indicating no interaction between the drug and the polymer. The stability studies on Acetazolamide ER capsules 500 mg in HDPE container at 400C / 75 % RH were conducted as per ICH protocol and no significant change was observed in the assay value after a storage period of 1 month at 400C / 75 % RH and 2 months at 400C / 75 % RH.
Authors and Affiliations
B. Srinivas, Nansri Saha Ghosh, Soumik Ghosh, Subal Debnath, Santhosh kumar C. , Abhishek Datta, Niraj Kumar
Keywords
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- EP ID EP221923
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