ABSTRACT:
The present investigation was aimed at developing a stable self micro emulsifying drug delivery system (SMEDDS) of herbal extract and evaluating its in vitro potential. SMEDDS PROVIDES liquids filled a hard gelatin capsule which has been an option for this herbal extract developing stable and safe dosage forms. The solubility of herbal extract was determined in various vehicles. Pseudoternary phase diagrams were used to evaluate the micro emulsification existence area. Release rate of herbal extract was investigated using a dissolution method. SMEDDS were characterized for clarity, precipitation and particle size distribution. Formulation development and screening was done based on results of solubility and from phase diagram. The optimized formulation used for in vitro dissolution was composed of herbal extract (30 %), Cremophor RH 40 (40 %), Plurol Oleique (30%). The SMEDDS formulation showed complete release in 10 min. as compared with the plain extract and conventional marketed formulation with limited dissolution rate. SMEDDS were subjected to various conditions of storage as per ICH guidelines for 3 months. SMEDDS successfully withstood the stability testing. It has been found that dissolution profile of herbal extract from SMEDDS was much improved. SMEDDS appeared to be an interesting approach to improve solubility, and ultimately bioavailability.