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L.Sambath 1, 3*, A.Kottai Muthu2, M Ashis Kumar1

1Matrix Laboratories Limited, R&D Center, Bollaram Village, Medak Dist, India.
2Department of Pharmacy, Annamalai University, India.
3PRIST University, Centre for Research & Development, Thanjavur, India.


Lovastatin is a myocardial infraction agents belonging to MG-CoA reductase enzyme inhibitors. It is administered as immediate release solid oral dosage form, a short elimination half life with significant fluctuation in plasma concentration necessitate it to be formulated into modified release dosage forms. A system that can deliver drug at a prolonged rate is very important for the treatment of various chronic diseases such as diabetes, asthma and heart disease. The objective of the present study was to enhance the solubility, bioavailability, dissolution rate and reduce fluctuation of plasma concentration of a poorly water-soluble drug Lovastatin. The aqueous solubility of lovastatin, in present formulation was improved by the presence of both the polymers. Dispersions with soluplus and PEG 1500 were prepared by hot melt extrusion technique. These formulations were characterized for solid state properties by X-ray powder diffraction studies; Controlled porosity osmotic pump tablet (CPOP) system was designed to deliver Lovastatin solid dispersion in a controlled manner up to 16 hr. It was prepared by incorporating drug solid dispersion in the core and coated with cellulose acetate ,Polyethylene glycol -400 levels (30, 50 % w/w of polymer) of pore former at a weight gain of 5, 7 & 10%. Formulation variables like level of pore former and percent weight gain of membrane was found to affect the drug release from the developed formulations. Drug release was inversely proportional to the membrane weight but directly related to the level of pore former. Drug release from the optimized tablet formulation was found to be independent of pH and hydrodynamic conditions of the body. Dissolution models were applied to drug release data in order to establish the mechanism of drug release kinetics.

Keywords: Lovastatin, soluplus, solid dispersion, cellulose acetate, pore former.

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