Design, Optimization and Evaluation of Snedds Based System for Orlistat: A Quality by Design Approach with 2^3 Factorial

Abstract

Obesity, as defined by WHO is an abnormal or excessive fat accumulation that may impair health. Bodyweight is directly proportional to the resultant impact of genetic, metabolic, environment, behaviour and culture issues. The leading cause of obesity is an energy imbalance between calories consumed and calories exhausted. To design and optimize Orlistat SNEDDS formulation by the development of SNEDDS with an appropriate quantity of oil, surfactant and co-surfactant with the factorial approach. A series of SNEDDS formulations for Orlistat was prepared based on solubility studies, pseudo ternary phase diagram and visual observation. Orlistat was added inaccurately weighed amount of oil into a screw-capped glass vial and heated in a water bath at 40ºC. The surfactant and co-surfactant were added to the oily mixture and stirred with a magnetic bar. The formulation was further sonicated for 15 minutes and stored at room temperature. From the result of evaluation parameters such as emulsification time 6±1s, % transmittance 94.01±1.5%, drug Loading 99.89%±0.56%, Polydispersity Index 0.47±0.01 and 0.211±0.02, Globulesize 99±6 nm, Zeta potential -28.12 mV and -24.5 mV, the centrifugation, Freeze-thaw cycle, Heating-cooling cycle showed no signs of phase separation, Viscosity 132.4±0m Pa.s, drug release 99.25% within 90 minutes, drug release follows Korsmeyer-Peppas model mechanism, n value was found to be 1.083 hence it can be postulated formulation F-6 followed the non-Fickian or anomalous release and P-value for factors emulsification time, % transmittance and % drug release was found less than 0.0500 and hence it was concluded formulation F-6 an optimized formulation.