FORMULATION DEVELOPMENT AND EVALUATION OF SOLID SELF MICROEMULSIFYING DRUG DELIVERY SYSTEM TO ENHANCE SOLUBILITY OF VORAPAXAR
*Foram Contractor, Kantilal Narkhede, Anuradha Prajapati, Sachin Narkhede and Shailesh Luhar
ABSTRACT
The aim of the study was to formulate and develop Solid Self Microemulsifying Drug Delivery System of Vorapaxar. Vorapaxar is a thrombin receptor antagonist. The formulation consist of Capryol 90 as oil, Tween 80 as surfactant and PEG 400 as co-surfactant. The experiment was subject to factorial design for optimization of the formulation. Based on the design, 2 factors were evaluated, each at 3 level, and experimental trials were performed at all 9 possible combinations. The Concentration of Oil (X1) and the Concentration of Smix (Tween 80: PEG 400) (X2) were chosen as the independent variables. Zeta potential, Self Emulsification time and % Transmittance were taken as the dependent variables. The results are compared with checkpoint batch. Optimized Formulation shows Particle size (90.5nm), % Transmittance 97.5%, Zeta potential (-4.1mV) and polydispersibility index (0.24).The liquid SMEDDS was converted to S-SMEDDS by using Neusilin as adsorbing agent. S- SMEDDS shows drug release (99.55%) in 50 minutes. S-SMEDDS shows better drug release than the marketed formulation. The visual evaluation showed no change in physical appearance during stability study. After stability period, the formulation was found stable with no significant change in IR study and in- vitro drug release of formulation.
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