Study on Formulation development and shelf life indicating stability of Artesunate loaded Self-nanoemulsifying Drug Delivery System

Abstract

Solubility plays an important role in the formulation. When a drug is poorly soluble, their bioavailability will be affected. However, the solubility of the drug can be enhanced by using various methods like pharmaceutical approach, pharmacokinetic approach and biological approach. It can also be improved by formulating a lipid based drug delivery system. In the present study, nanoemulsion has been developed by using oil, surfactant and a co-surfactant in order to increase the solubility of poorly soluble BCS Class II and Class IV drugs. Nanoemulsions can be prepared by different techniques. In the current study, nanoemulsion has been formulated by using simple spontaneous emulsification approach. Artesunate was used as a choice of drug and capryol 90 was used as oil in the present study. Pseudo-ternary phase diagrams were used in order to determine the oil and Smix ratio. After the formulation, the product was subjected to various evaluation studies like droplet size, zeta potential, PDI and viscosity etc. Further, the in-vitro dissolution test was carried out for the formulated product, marketed formulation and the pure drug. And it was observed that the formulated product showed an improved drug release. In addition to these evaluation tests, accelerated stability studies according to the ICH guidelines were also carried in order to determine the shelf life as well as the effect of added ingredients on the stability of the product. The shelf life of the product was observed to be 2.38 years at room temperature.