Formulation and Development of Temperature Sensitive In Situ Gelling System of Desmopressin Acetate for Nasal Drug Delivery

摘要

The present work was aimed for the formulation development of stable temperature sensitive thermoreversible in situ gel of desmopressin acetate by cold method using different ratio of Pluronic F127 and Pluronic F68 as thermoreversible polymer. The 3 2 factorial design was employed using concentration of Pluronic F127 and concentration of Pluronic F68 as independent variables and Viscosity and Mucoadhesive strength were selected as dependent variables. The optimized batch was selected using Design Expert software employing overlay plot with desirability approach. The temperature sensitive thermoreversible in situ gel formulation was evaluated for inflection point, gelation temperature, pH, viscosity, % drug content, gel strength, mucoadhessive strength, nasal toxicity study, ex vivo drug diffusion study, stability study and in-vivo study. The composition of optimized formulation consisted of 1 mg of Desmopressin acetate, 1988.67 mg of Pluronic F127, 305.33 mg of Pluronic F68, 1 mg of Benzylkonium chloride and 10 ml of Purified water showing inflection point (32.5 ° C), gelation temperature (33 ° C), viscosity (789.7 cps), mucoadhesive strength (2759.14 dynes/cm 2 ) and % drug content (99.8 %). Temperature sensitive thermoreversible in situ gel increase the nasal residence time and the drug get released in a sustained and controlled manner thus increased the bioavailability of desmopressin acetate.