European Journal of Biomedical and Pharmaceutical Sciences

QUALITY BY DESIGN APPROACH FOR DEVELOPMENT AND EVALUATION OF SELF EMULSIFYING DRUG DELIVERY SYSTEM OF NITROFURANTOIN

Sujitkumar K. Devkar, Vinit R. Sulakhe*, Sagar L. Pol, Kiran S. Patil, Sachin S. Mali

ABSTRACT

The Objective of present work is to develop a Solid Self Emulsifying Drug Delivery System (S-SMEDS) of poorly water soluble drug Nitrofurantoin (NFT). Nitrofurantoin is antibiotic or antimicrobial drug belongs to BCS Class II drug, having half-life 20 minutes. For formulation; solubility of NFT was determined in oil, surfactant and co-surfactant. The final components of micro-emulsion were found to be Cinnamon oil, Tween 20 as surfactant and PEG400 as a co-surfactant. Pseudoternary phase diagram NFT loaded micro-emulsion were prepared and optimized by using design of Experiments (DOE). By considering 2 factor globule size and emulsification time the 9 formulations were prepared. Batch No. 5 was selected on the basis of optimization of globule size 0.492 and emulsification time 75sec. According to the design of experiments, probability plots, pounter plots, pormal probability, Response surface plot 3D response curve it was observed that with increase in ratio of surfactant to co-surfactant and emulsification time leads to decrease in particle size. Formulated NFT SMEDDS was characterized for the various tests followed by formulated liquid microemulsions was converted into solid by Adsorption technique by using Neusilin US2. Solid SMEDDS formulation was tested for various test including FTIR DSC study and XRD study. Results showed that drug releases from S-SMEDDS formulation were found to be significantly higher compared to pure Nitrofurantoin. Stability study results showed that S-SMEDDS was found to stable. Thus study concluded that S-SMEDDS provides good solubility, dissolution rate and stability than Nitrofurantoin.

Keywords: Nitrofurantoin, Solubility, DoE, S-SMEDDS, Dissolution rate.