FORMULATION AND EVALUATION OF OSMOTICALLY CONTROLLED DRUG DELIVERY SYSTEM OF AN ANTI-DIABETIC DRUG

Sagar D. Shinde*, Nilesh A. Nalawade, Swati B. Kavade and Apeksha V. Masal

ABSTRACT

Saxagliptine has a relatively short elimination half-life (2.5 h), thereby requiring twice or thrice daily dosing in patients, which may lead to non-compliance. Extended release formulation of Saxagliptine based on osmotic technology was developed and evaluated. Controlled Porosity osmotic tablets of Saxagliptine were developed using Self Pore forming agent Mannitol. Prepared tablets were evaluated for their Flow property, weight variation, hardness, friability and content uniformity. Tablets were coated with a semi permeable membrane using 6% w/v cellulose acetate Phthalate (CAP) in isopropyl alcohol and Methylene chloride and Polyethylene Glycol-400 as plasticizer. Drug release rate was increased as the increase of Mannitol amount in Core Tablet. Drug release was inversely proportional to weight gain but directly proportional to the Self pore forming agent. The drug release from developed formulations was independent of pH and agitation intensity of release media. The DSC and FTIR studies demonstrated that there was no interaction between polymers and drug. The optimized formulation was stable after one months of accelerated stability studies.

Keywords: “Saxagliptine, “Extended release", Osmotic technology.