Formulation, Evaluation and Optimization of Osmotic Drug Delivery System for a Highly Insoluble Drug

Author(s)

Sharma, A.R., Shaikh, R.G., Patel, K.N., Patel, B.A., Patel, P.A.

Author's Affiliation

Abstract

The present study focuses on the preparation of push pull osmotic drug delivery system for a highly insoluble drug, an antipsychotic category. The main aim is to improve the site specification and to provide the controlled release of drug for once-a-day drug delivery system with zero order drug release profile with applying drug release kinetic modelling. The push pull osmotic tablets were prepared by wet granulation method; the drug layer consists of the drug, osmotic agent, suspension agent and in push layer extender, osmotic agent and pigment to distinguish push layer form drug layer. The coating was carried out by cellulose acetate (CA) and plasticizer was used as propylene glycol. This study evaluates that regardless of the drug properties which do not significantly affect the drug delivery, the release kinetics is mainly controlled by some factors as, the plasticizer proportion in the membrane, the osmotic agent proportion and the drug layer polymer grade. The influence of each factor was investigated defining their acceptability range. Results shows that tablet made by PEO200K and diluents used in drug layer and PEO7000K and sodium chloride in push layer with 10% of CA coating, the plasticizer content was upto 20% to 30%  and 0.8mm of orifice diameter. Results, shows that the use of suspension agent in drug layer affects the drug release. The formulation batch F13 was taken as ideal optimized batch and it follows the zero order drug release. On the basis of results the effect of orifice diameter, polymer concentration in drug layer, coating composition and plasticizer amount was tested and promising results were found. The drug release was independent of pH but dependent on the osmotic pressure of the dissolution medium. The release kinetics followed the Zero order model.

Keywords

Push Pull Osmotic Drug Delivery System, Highly insoluble drug Osmotic pump, Antipsychotic agent, PEO and Cellulose acetate

Cite This Article

Sharma, A.R., Shaikh, R.G., Patel, K.N., Patel, B.A., Patel, P.A. (2012). Formulation, Evaluation and Optimization of Osmotic Drug Delivery System for a Highly Insoluble Drug, International Journal for Pharmaceutical Research Scholars (IJPRS), 1(2), 296-305.