Formulation and Evaluation of Controlled Porosity Osmotic Pump Tablets for Oral Delivery of Stavudine

Abstract

The current research was designed to develop controlled porosity osmotic pump (CPOP) tablets of stavudine a nucleoside reverse transcriptase inhibitor for the treatment of acquired immune deficiency syndrome (AIDS) Wet granulation method was adopted for the development of tablet of 80 mg dose of stavudine for once daily. The formulated tablets were evaluated for pre compression parameters, post compression parameters, in vitro dissolution study and scanning electron microscopy study. The in vitro release kinetics were analyzed for different batches by different pharmacokinetic models such as zero order, first order, Higuchi, Korsmeyer Peppas and Hixon Crowell model. The results of optimized formulation releases drug up to 18 h in a controlled manner and follow Higuchi kinetics and which is independent of the pH and agitation intensity. Short term stability study at 40±2oC/75±5% RH for three months was carried out and observed that the optimized formulation did not show any significant changes in hardness, friability, weight variation, drug content, in vitro dissolution study etc.