Abstract
The objective of the present study was to develop a novel self micro emulsifying drug delivery system of a poorly water soluble drug Atorvastatin calcium trihydrate. The oral delivery of such drugs is frequently associated with implications of low bio availability, high intra and inter subject variability and lack of dose proportionality. Phase solubility studies were conducted for the maximum solubility of Atorvastatin. Highest solubility was found in Transcutol (surfactants), Cremophor RH40 (co surfactant) and Sunflower oil (oil). Ternary phase diagrams were constructed to evaluate micro emulsion regions. FTIR analysis was done for investigating the drug-excipient interactions. The mean globule size of both micro emulsion and SMEDDS was observed to be below 200 nm for the optimized formulations and the zeta potential was negative. The dissolution of emulsion formulations was compared with commercial tablets, the results indicated that the rate of dissolution of developed formulations containing Atorvastatin was increased compared with that of commercial tablets. SEM studies were done for the shape and morphology of the globules. Thus, SMEDDS can be regarded as novel and commercially feasible alternative to the current Atorvastatin formulations.
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