Formulation, Evaluation and Optimization using Full Factorial Design of Guar Gum based Diclofenac potassium Sustained Release Micropellets
A. Mittal, A. Maiti, K. K. Jha
Background: The study was undertaken with an aim to develop sustained release guar gum micropellet dosage form for Diclofenac potassium which is an anti-inflammatory agent and is one of the broadly used for treating mild and severe pains. Purpose: The approach of this study was to make a comparative evaluation among polymers and excipients and to assess the effect of physicochemical nature of the active ingredients on the drug release profile. Method: The prototype formulations of micropellets were prepared using drum pelletizer at 300 rpm. Percentage of water in binding liquid, i.e. IPA, is varied from 95 to 99% and the effect on various parameters, such as particle size, entrapment, bulk density and particle shape, were observed. Concerning the results of prototype preparation of Diclofenac micropellets were prepared using Guar gum, as release retardant, in three different concentrations i.e. 16.7%, 33.3% & 50%. Results: Formulated micropellets showed particle size in the range of 178-202 µm, bulk density (0.74-0.81 g/ml), % yield (25.8-54.4%) & % entrapment (32.0-34.4%). Formulation FDH3 showed the maximum desirability 0.874. Dry suspension formulation parameters such as pH (5.04), Viscosity (536 cps), Redispersibility (5) & Sedimentation volume (0.44 ml), was found in range. Formulation FDG3 were selected as the best optimized formulation and evaluated for In-vivo parameters, results inferred good sustainability with p>0.0001. Conclusion: Formulated micropellet showed sustained in-vitro dissolution rate, due to optimized polymer concentration. The micropellets were stable at 40±2 °C/ 75±5% RH as per ICH guidelines, after 3 months.
How to cite this article:
A. Mittal, A. Maiti, K. K. Jha. Formulation, Evaluation and Optimization using Full Factorial Design of Guar Gum based Diclofenac potassium Sustained Release Micropellets. Pharma Innovation 2013;2(9):01-09.