FORMULATION AND EVALUATION OF SITAGLIPTIN ORO DISPERSIBLE FILMS FOR THE MANAGEMENT OF DIABETES MELLITUS

Diabetes mellitus is a chronic metabolic disorder characterized by persistent hyperglycemia, requiring effective and patient-friendly drug delivery systems to ensure optimal glycemic control. Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is widely used in the management of type 2 diabetes mellitus due to its glucose-dependent mechanism of action and low risk of hypoglycemia. However, conventional tablet dosage forms may present limitations such as swallowing difficulty, delayed onset of action, and reduced patient compliance. The present study aims to formulate and evaluate sitagliptin orodispersible films (ODFs) as an alternative oral drug delivery system to overcome these limitations. Sitagliptin orodispersible films were prepared by the solvent casting method using suitable film-forming polymers such as hydroxypropyl methylcellulose (HPMC), along with plasticizers and other excipients to enhance flexibility, palatability, and rapid disintegration. The prepared films were evaluated for physicochemical parameters including thickness, weight uniformity, folding endurance, surface pH, drug content uniformity, disintegration time, and in vitro drug release. Compatibility studies were carried out to ensure the stability of sitagliptin with selected excipients.