FABRICATION AND CHARACTERIZATION OF ROSUVASTATIN TABLETS BY EFFERVESCENT GASTRO-RETENTIVE DRUG DELIVERY TECHNIQ

Abstract

The purpose of present study was to develop, optimize a gastro retentive drug delivery formulation for oral drug delivery system of Rosuvastatin calcium in order to ensure maximum controlled drug release. Oral solid dosage forms are the preferred administration route for many drugs, especially for modified release products. However, for optimal therapeutics effect the drug must be well absorbed throughout the GIT. Challenges arise when drugs have a narrow absorption window GIT or when they are unstable in GI fluids. Developing oral controlled release dosage forms crucial not only to prolong drug delivery but also to enhance retention within stomach or intestine. Successful formulation of gastro retentive drug delivery system for Rosuvastatin calcium was achieved using Direct Compression technique, Employing the HPMC K 100M, PVPK 30 as binder, karaya-gum and Carbopol 940 as Polymers, micro crystalline cellulose as Diluent, sodium bicarbonate, citric acid as gas generating agents, Talc and magnesium stearate as lubricant for effervescent system. We have Effervescent system from F1 to F6. These formulations are demonstrated over 12 hrs. All the prepared formulations were evaluated for pre- compressional studies as angle of repose, bulk density, tapped density, Hausner’s ratio, Carr’s index and for post- compressional studies as thickness, weight variation, hardness, friability, in-vitro buoyancy studies, swelling index and in-vitro dissolution studies are found satisfactory