Abstract

STATISTICAL DESIGN AND EVALUATION OF A SIMVASTATIN GASTRIC FLOATING TABLET

Shyam S. Kumar* and Sivakumar R.

ABSTRACT

The study is to design and statistical optimization of Simvastatin floating tablets using 32factorial design for the identification of best formula composition to overcome the first-pass effect and reduce the frequency of administration. The tablets were prepared by wet granulation method using HPMC, NaHCO3, PVP K-30, Citric acid Talc and Magnesium stearate. Totally 4 batches were prepared using different drug to polymer ratio for preliminary trial. The prepared floating matrix tablets were evaluated for FT-IR, hardness, thickness, friability, weight variation, floating property and In vitro release study etc. the results of the study indicates all the prepared formulations had desired floating lag time and constantly floated on dissolution medium maintaining the matrix integrity. Best preliminary trial batch (B3) selected for optimization using 32factorial design. Independent variables were HPMC (X1) and PVP K-30 (X2). Hardness, Buoyancy, Total floating time and in-vitro release study for 12 h were considered for dependent variables. Batch f3 selected from the optimization batch through in-vitro characterization techniques. This means relaxation of polymer chains, water diffusion which influences the drug release mechanism. This dosage form reduces the frequency of administration, improved bioavailability and patient compliance. The optimized batch could useful for further large scale production.

Keywords: Floating drug delivery system, Simvastatin, optimization, 32 factorial design