Research on: “Formulation, Development and Evaluation of Oro-dispersible film of Sitagliptin Phosphate Monohydrate”

The oral route is considered one of the most convenient routes for the administration of various pharmaceutical dosage forms like tablets, capsules, syrup, suspension and emulsion. Fast Dissolving Drug Delivery systems have developed various fast-disintegrating preparations like mouth dissolving film, and MDT. Oral thin films are new dosage forms that are prepared from hydrophilic polymers which when placed in the mouth, the buccal cavity disintegrates rapidly. Mouth dissolving film is superior as compared to mouth dissolving tablet as the cost of production is low. Geriatric and pediatric patients are facing difficulty in swallowing tablets and capsules, the oral film can bypass it, along with that it has other advantages self-administrable, fast dissolving, and rapid absorption that make it a versatile dosage form. The present study aims to enlighten specifically different polymers along with their concentrations and applications. This study also focuses on the use of, polymers e.g. HPMC E15 HPMC E15, PEG 400, sweeteners e.g. Saccharine, sucralose, different methods which are used for the preparation of oral films and various evaluation parameters of the film. The selected solid dispersions were then utilized for the preparation of film by solvent casting method utilizing HPMC E15 as a film-forming agent and PEG-400 as a plasticizer. Five formulae were prepared and evaluated for their in vitro dissolution characteristics, vitro disintegration time, and physicomechanical properties. The promising film (F3) showed the greatest drug dissolution. (More than 99% within 3 min), satisfactory in vitro disintegration time (20 sec) and physicomechanical properties that are suitable for mouth-dissolving films. The objective of this study was to design and evaluate Sitagliptin Phosphate Monohydrate mouth dissolving film using solvent casting method for the management of Type-II diabetes mellitus.