Development and characterisation of Tolvaptan loaded self-micro emulsifying drug delivery system
DOI:
https://doi.org/10.48047/zdeaxk31Keywords:
Bioavailability, self-micro emulsifying drug delivery systems, solubility, TolvaptanAbstract
Tolvaptan, a selective vasopressin receptor antagonist, is a drug with poor solubility used to treat
hyponatremia. To address the solubility issue and enhance its bioavailability, a novel self-micro
emulsifying drug delivery system (SMEDDS) was employed. SMEDDS are isotropic mixtures of oil,
surfactants, and cosurfactants that, upon contact with gastrointestinal fluid, spontaneously form fine oilin-water emulsions. These emulsions are then absorbed into lymphatic pathways, bypassing the first-pass
hepatic effect. In this formulation, oleic acid, Labrafil M 2125 CS, PEG-400, and Labrasol ALF were
selected as the mixed oil, surfactant, and cosurfactant, respectively. The resulting droplet sizes ranged
from 37.8 to 176 μm with a polydispersity index (PDI) value of 0.271. The zeta potential was measured
at -1.6 mV, and an 81.50% drug release was observed in the formulation. This study concludes that the
self-micro emulsifying drug delivery system is effective in improving the drug release and bioavailability
of Tolvaptan.
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