Abstract
FORMULATION AND EVALUATION OF SELF-MICRO EMULSIFYING DRUG DELIVERY SYSTEM OF ELTROMBOPAG OLAMINE FOR ORAL ADMINISTRATION

Ankitkumar Bhagora*, Tora Shah and Jaini Patel

ABSTRACT

The present work is to formulated and evaluated a self-micro emulsifying drug delivery system (SMEDDS) containing Eltrambopag Olamine (ELT) and also explored the ability of porous Neusilin® US2 capsule as a solid carrier for SMEDDS. SMEDDS formulations of varying proportions of clove oil, tween 80 and PEG 400 were selected and subjected to in-vitro evaluation, including dispersibility studies, droplet size, zeta potential measurement and release studies. The results indicated that the drug release profile of ELT from SMEDDS formulations was statistically significantly higher (p-value < 0.05) than the plain ELT powder. Thermodynamic stability studies also confirmed the stability of the prepared SMEDDS formulations. The optimized formulation, which consists of 12% of clove oil, 44% of tween 80 20% of PEG 400 was loaded into directly filled liquid loadable capsule of Neusilin® US2 by simple adsorption method. The droplet size of the microemulsion formed by the optimized formulation was 245.7 ± 1.6 nm, and the droplets were spherical in shape. The % transmittance, zetapotential and viscosity of optimized formulation is 99.22%, -26.34 mv and 12.33 cps respectively. SMEDDS adsorbed powder also evaluated for DSC, FTIR and XRD and compare with pure drug. In vitro release studies performed in comparison to pure drug and it reveals that the SMEDDS loaded with ELT capsule showed about 3 folds improvement in release of drug. Overall, incorporation of ELT in SMEDDS, either liquid or solid, resulted in improved solubility and dissolution rate compared to pure ELT. This study indicates that a liquid and solid SMEDDS is a strategy for solubility enhancement in the future development of orally delivered dosage forms.

Keywords: SMEDDS, Eltrambopag Olamine (ELT), Neusilin® US2, XRD, FTIR.


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