Abstract

FORMULATION AND EVALUATION OF ORAL SUPERSATURABLE SELF MICRO EMULSIFYING DRUG DELIVERY SYSTEM ITRACONAZOLE

Pooja Dave*, Brahmdutta Raval, Naisarg Pujara and Tushar Gohil

ABSTRACT

The present investigation was to formulate and evaluate of oral Supersaturable self-micro emulsifying drug delivery system of itraconazole for the treatment of fungal infection. Supersaturable self-micro emulsifying drug delivery system was prepared by selecting oil, surfactant and cosolvent ratio with HPMC as crystal growth inhibitor. To enhance the dissolution, oral absorption and inhibit the crystal growth of poorly water- soluble itraconazole, Supersaturable self-micro emulsifying drug delivery system (SMEDDS) composed of oil, surfactant and cosurfactant for oral administration of itraconazole was formulated, and various evaluation tests were evaluated. Among the surfactants and oils studies, castor oil, tween 20 and PEG400 were selected that showed the maximal solubility of itraconazole. Phase diagrams were constructed at different ratios of surfactant/co- surfactant (Smix) to determine microemulsion existence region. Supersaturable Self micro emulsifying drug delivery system of Itraconazole may provide a useful dosage form for oral water-insoluble drug without food effect, inhibit crystal growth and reduces GI toxicity. Results of preformulation study were satisfactory as no interaction was observed between itraconazole and various excipients by FTIR and DSC. All the evaluation parameters were tested. In vitro drug release profiles were examined, and compared with marketed product. The drug release of F12 batch is extended up to 95.66% in 120min. The droplet size of F12 is 42.20nm and zeta potential is negative (-28.51). SMEDDS formulation significantly improved oral absorption of itraconazole, improve the solubility and inhibit the crystal growth.

Keywords: Supersaturable SMEDDS, Itraconazole, HPMC.