Solubility Enhancement of Satranidazole Using Self Emulsified Drug Delivery Systems

Abstract:

Background: Satranidazole is an antiprotozoal and antibacterial drug which falls under class II drug as per biopharmaceutical classification systems having poor aqueous solubility. Aim: Therefore, present study was aimed at solubility enhancement of Satranidazole using self emulsified drug delivery system (SEDDS). Methods: SEDDS was prepared using Oleic acid as oil, Tween 20 and PEG400 as Surfactant and Co-surfactant respectively. For preparation of stable SEDDS, micro emulsion region was identified by constructing pseudo ternary phase diagram containing different proportion of surfactant: co-surfactant (1:1, 2:1 and 3:1), oil and water. Physico-Chemical Evaluation: Total nine SEDDS formulations were prepared (F-1 to F-9) and evaluated for self emulsification time & dispersibility, droplet size analysis, stability studies, turbidimetry, zeta potential, drug content and in vitro drug release. Results: Among all the formulations, three formulations (F-1, F-4 & F-7) showed a drug release of greater than 70% in 45 minutes whereas marketed preparation showed more than 70% of drug release in 90 minutes. Based on results of self emulsification time & dispersibility, droplet size analysis, drug content and in vitro drug release, F-7 formulation was selected as an optimized formulation which showed a maximum drug release of 94.89% in 45 minutes. Conclusion: Hence SEDDS formulations can be a potential alternative to traditional oral drug delivery systems of Satranidazole to improve its solubility.

Key words: Satranidazole, Surfactants, Lipid vehicles, Pseudo ternary phase diagrams, SEDDS.