Abstract

FORMULATION, EVALUATION AND IN –VITRO CHARACTERISATION OF SELF NANO EMULSIFYING DRUG DELIVERY SYSTEM OF LERCANIDIPINE

Dr. M. Sunitha Reddy*, Navya Sai.K, S. Muhammad Fazal Ul Haq

ABSTRACT

A selfnano emulsying drug delivery system (SNEDDS) was developed to improve the solubility and disssolution profile of LERCANIDIPINE which has poor solubility (0.000156mg/ml) and low bioavailability (10%). SNEDDS concentrate was prepared by screening various oils, surfactants and co surfactants. Pseudo ternary phase diagrams were constructed for the selected systems to identify nano emulsification regions. The mixtures consisting of peppermint oil as oily phase, Cremophore EL, as surfactant, Labrasol as co-surfactant were found to have good nano emulsification property. Liquid SNEDDS were prepared with selected mixtures and evaluated for self emulsification time, Phase separation and precipitation of the drug, Robustness to dilution, Percentage Transmittance, drug loading efficiency, FT-IR Studies, Thermodynamic stability studies, Droplet size, PDI and Zeta potential. From the evaluation studies it was found that formulation consisting of peppermint oil (28.71%w/w), Cremophore EL (16.745%w/w), Labrasol (50.235%w/w) and Drug (4.306%w/w) was stable and optimum and selected for preparation of s-SNEDDS. With selected optimum formulation s-SNEDDS are prepared using Neusilin US2 (22.2 % w/w) as carrier in 1:2 ratio by adsorption technique. Prepared s-SNEDDS was evaluated for Flow properties, Drug Content, Effect of dilution, Droplet size Determination, FT – IR Studies, In–Vitro drug release study and Accelerated Stability Studies. Prepared s-SNEDDS showed “Good” flow properties and 96.452 ± 1.57 %drug content. Reconstitution properties showed spontaneous nano emulsification with globule size 108.1nm with PDI 0.554. Results of In-Vitro dissolution revealed that there is enhancement of dissolution rate of Lercanidipine. Results of Accelerated stability studies showed that formulation was stable and does not alter the dissolution rate of Lercanidipine.From the results of present study it was concluded that, Neusilin US2 (22.2 % w/w) can be used to develop solid SNEDDS by adsorption technique to enhance dissolution rate of poorly water soluble drug Lercanidipine.

Keywords: Lercanidipine, solubility, dissolution, neusilin US2 (22.2 % w/w), nano emulsification region.