SELF NANO EMULSIFYING DRUG DELIVERY SYSTEM OF RAMIPRIL: FORMULATION AND IN VITRO EVALUATION

摘要

Objective: The primary goal of the present work was to formulate and evaluate self-nano emulsifying drug delivery systems (SNEDDS) of ramipril in order to improve the solubility of this highly lipophilic antihypertensive drug. Methods: SNEDDS are generally liquid form preparations obtained by homogeneously mixing drug substance with oils, surfactants and co-surfactants using cyclomixer. Based on solubility studies Capmul PG8 NF, Gelucire 44/14 and Transcutol P were selected as oil, surfactant and co-surfactant respectively in order to prepare SNEDDS. Nine different SNEDDS formulations were prepared and subjected to various evaluation tests in order to obtain optimized SNEDDS formulation. Results: The SNEDDS formulations with 16.5-24.75 % of oil, 24.75-68.75 % of surfactant and 12.375-41.25 % of co-surfactant formed thermodynamically stable emulsion with droplet size ranging from 22.6-188.8 nm. Finally, out of 9 different SNEDDS formulations, SN9 formulation was optimized containing 16.5 % of oil, 68.75 % of surfactant and 13.75 % of co-surfactant as it formed a thermodynamically stable emulsion with least globule size (22.6 nm) and without any drug precipitation or phase separation. Conclusion: Finally, stable, optimized SNEDDS formulation of ramipril was successfully prepared that showed significant improvement in the rate of dissolution of ramipril. Keywords : Self nano emulsifying drug delivery system (SNEDDS), Ramipril, Emulsification time, Ternary phase diagram, Simulated Gastric Fluid (SGF).