Formulation and Evaluation of Microspheres Containing Fluvastatin Sodium

Fluvastatin sodium is a cholesterol lowering agent. It has shorter half life (1.2).It undergoes extensive first pass metabolism. Frequent dosing is required in case of conventional dosage form. The purpose of the study is to formulate microcapsules containing Fluvastatin sodium by complexing with anionic exchange cholestyramine resin Indion-454 by coating with ethyl cellulose, eudragit-RS100 polymers for achieving controlled release in the small intestine. Complexation of drug on the resins by batch method. Compatibility studies were carried out using FTIR, DSC and Xray diffraction studies. Microencapsulation was carried out by w/o/w double emulsion solvent evaporation technique. Characterization of various physicochemical properties like % Yield, % DEE, % Polymer coating and particle size were evaluated. In vitro drug release studies were carried out in USP type I dissolution test apparatus. The accelerated stability studies were carried out on the most satisfactory formulations. FTIR, X-Ray diffraction and DSC spectra of drug, ion-exchange resin and drug-polymers revealed that no chemical interaction. Drug loading was observed in 4 hrs 1:4 ratio. Percentage yield for the formulations observed that for F1 to F8 is varied from 93.4±5.84 to 98.7±6.30. Percentage drug entrapment efficiency was observed for the formulations of F1 to F8 are varied from 96±0% to 98.3±0.1%. Microcapsules of F4 and F5 prepared with EudragitRS100 and Ethyl cellulose using ion-exchange resins provide a convenient dosage forms for achieving best performance regarding release study, there is no changes in % DEE and %CDR was observed after stability studies.

Author(s): Venkatesh D. P, Roopa Karki,Sajal Kumar Jha, Geetha Lakshmi A, Santha Kumar G.S, Divakar Goli

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