ROLE OF QUALITY BY DESIGN FOR THE OPTIMIZATION OF PUSH PULL OSMOTIC PUMP OF S-METOPROLOL SUCCINATE

Abstract

The present research was focus on the preparation and evaluation of push pull osmotic pump of S-metoprolol succinate based on Quality by Design (QbD) approaches. For preparation of push pull osmotic pump, pull layer of S-metoprolol succinate was prepared using low molecular weight Polyox by wet granulation. Push layer containing higher molecular weight polyox and sodium chloride as osmotic agents were prepared by wet granulation. Both layers were compressed to get bilayer tablets and these bilayer tablets were coated with cellulose acetate, which act as a semipermeable membrane, and polyethylene glycol, which act as pore former. Extended release coated tablets were laser drilled on drug layer side to allow delivery of drug. The formulation was optimized using a center composite design (CCD). The effect of different drilled diameter on drug release was also evaluated. Extended release coating (%), concentration of sodium chloride (%w/w) and cellulose acetate : PEG 3350 ratio impact on drug release was optimized using center composite design (CCD). 20% Extended release coating. 20% w/w concentration of sodium chloride, and 90:10 cellulose acetate : PEG 3350 ratio gave zero order release (R2 value greater than 0.9) up to 20 h. Push pull osmotic pump of S-metoprolol succinate was successfully developed using low molecular weight polyox in pull layer and higher molecular weight of polyox in push layer.