Formulation, Characterization, In-vitro Evaluation and Ex-Vivo Studies of Doxepin Loaded Self Micro Emulsifying Drug Delivery system
Abstract
The objective of the present study was to develop a novel Self Micro emulsifying drug delivery system (SMEDDS) of Doxepin to increase the oral bioavailability by escaping metabolism from the effect of the CYP450 enzyme, and evaluate its stability, drug release by In-vitro and Ex-vivo drug permeation studies. The solubility of Doxepin in oils, surfactants and co-surfactants was determined. Pseudo ternary phase diagrams were constructed for oil, Smix and water to identify the microemulsion forming region. The optimized SMEDDS formulation was composed of Oleicacid, Tween, PEG, Drug in ratios of 25:60:15:5.The SMEDDS were evaluated for self-micro emulsification time, PDI, Zeta potential, globule size, drug content. Optimized formulation (F6) was showed globule size of 37.1nm, PDI 0.21, zeta potential-22.3mv and drug content of 98.21%. Invitro drug release studies were carried out in 0.1N HCL for 2hrs followed by pH 6.8 phosphate buffer for 10 hrs using dialysis bag method. Optimized formulation F6 converted to solid SMEDDS by physical adsorption technique Neusilin US2 as carrier. Ex-vivo permeation studies were performed for the optimized solid formulation (F6-S) and drug suspension using normal sac method.The percentage drug release of optimized formulation was significantly high when compared to drug suspension. Through this we can conclude that bioavailability of formulation of doxepin could be enhanced significantly by formulating into solid SMEDDS or liquid SMEDDS.
Keywords: Self Micro emulsifying drug delivery system, Pseudo ternary phase diagram, Doxepin, Ex-vivo permeation.
Keywords:
Self Micro emulsifying drug delivery system, Pseudo ternary phase diagram, Doxepin, Ex-vivo permeationDOI
https://doi.org/10.22270/jddt.v11i6-S.5150References
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