Volume 9

April-June 2017

Optimization and characterization of stavudine from controlled porosity osmotic pump tablets using osmotic agent and porogen

Chinmaya Keshari Sahoo, Surepalli Ram Mohan Rao, Muvvala Sudhakar

Abstract:
The present work was aimed to develop controlled porosity osmotic pump tablets of stavudine. Wet granulation technique was adopted for the preparation of all these formulations. Conventional spray coating pan was used to develop coating upon core tablets by using cellulose acetate as wall forming material and sorbitol as pore former. The developed tablets were evaluated for pre compression parameters, post compression parameters, in vitro drug release study, Fourier Transform Infrared Spectroscopy (FTIR) study, Differential Scanning Calorimetry (DSC) study and scanning electron microscopy (SEM) study. The formulation variables such as effect of osmogen concentration, effect of pore former concentration, effect of membrane thickness of semi permeable membrane were evaluated for drug release characteristics. For the optimized formulation effect of osmotic pressure, effect of pH and effect of agitation intensity was evaluated. The in vitro release kinetics were analyzed for different batches by different pharmacokinetic models such as zero order, first order, Higuchi, Korsmeyer Peppas and Hixson Crowell model. The optimized formulation was found to be stable up to 3 months when tested for stability study at 40±2°C/ 75±5% RH.

Keywords: CPOP, Wet Granulation, In Vitro Drug Release, Stability Study.