Abstract

SOLUBILITY ENHANCEMENT OF POORY SOLUBLE DRUG CINACALCET HYDROCHLORIDE BY FORMULATING INTO SELF EMULSIFYING DRUG DELIVERY SYSTEM

Dr. Devi Thamizhanban, Dr. P. Prem Kumar*, Dr. S. Hemalatha, N. Ramya and G. Lakshmi Priya

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Abstract

The present study is aimed to formulate and develop self emulsifying drug delivery system (SEDDS) of Cinacalcet for enhancement of bioavailability. Drug substance having poor water solubility are observed with low absorption and permeation through the GI tract which leads to the lower bioavailability. The self emulsifying drug delivery system (SEDDS) enhances the solubility of drug, The SEDDS formulation of Cinacalcet was optimized with combination of oil, surfactant, co-surfactant taken in different proportion having different HLB value to prepare a stable and effective formulation of nano sized globule. Glyceryl Caprylate Oil (Capmul MCM), surfactant (gelucire 44/14) and co surfactant (PEG 400) were selected, pseudo ternary phase diagram was plotted in titration method by taking in different combination of Smix with oil, surfactant and cosurfactant. The efficiency of emulsification was good when the surfactant/co-surfactant concentration was more than 50% of SEDDS formulation. The combination was evaluated with cinacalcet, the optimized formulation with the ratio of drug: oil: surfactant: co-surfactant at 3:20:15:15 respectively showed better performance with respect to emulsification time, dissolution study, assay of drug, Diffusion study revealed a significant improvement in dissolution rate.

Keywords: SEDDS (Self emulsifying drug delivery system), Cinacalcet HCl, Surfactant, Co-surfactant, Phase diagram.