ABSTRACT:
The main objective of the current study was to prepare a stable Self Microemulsifying Drug Delivery System (SMEDDS) for the oral delivery of poorly water-soluble drug Darunavir ethanolate (DRE). The liquid SMEDDS was a system that consisted of DRE, Captex 500, Cremophor El, Tween 20 and Labrafil M 1944 CS were optimized with respect to their self-emulsifying properties. The developed SMEDDS were evaluated for phase separation, droplet size, drug content, In vitro dissolution and robustness of dilution study. The SMEDDS formulation showed complete drug release within 30 min or less as compared with API alone which showed limited dissolution rate. DRE loaded SMEDDS were subjected to accelerated storage condition as per ICH guidelines for a period of 3 months. DRE loaded SMEDDS successfully withstood the stability testing. It has been found that dissolution profile of DRE from SMEDDS was much improved than API alone. The results suggest that SMEDDS is a promising drug delivery system to improve dissolution rate and Anti-HIV effect of DRE and may be applied to other lipophilic drugs.