Abstract:
The primary objective of the research effort is to establish efficient solid self-nanoemulsifying drug
delivery systems (S-SNEDDS) for benidipine (BD) through the systematic application of a quality-bydesign
(QbD)-based paradigm. Utilizing Labrafil M 2125 CS, Kolliphor EL, and Transcutol P, the BD-SSNEDDS
were created. The central composite design was adopted to optimize numerous components.
Zeta potential, drug concentration, resistance to dilution, pH, refractive index, viscosity, thermodynamic
stability, and cloud point were further investigated in the most efficient formulation, BD14, which had
a globule size of 156.20 ± 2.40 nm, PDI of 0.25, zeta potential of −17.36 ± 0.18 mV, self-emulsification time
of 65.21 ± 1.95 s, % transmittance of 99.80 ± 0.70%, and drug release of 92.65 ± 1.70% at 15 min. S-SNEDDS
were formulated using the adsorption process and investigated via Fourier transform infrared
spectroscopy, Differential scanning calorimeter, Scanning electron microscopy, and powder X-ray
diffraction. Optimized S-SNEDDS batch BD14 dramatically decreased blood pressure in rats in contrast
to the pure drug and the commercial product, according to a pharmacodynamics investigation.
Accelerated stability tests validated the product’s stability. Therefore, the development of oral S-SNEDDS
of BD may be advantageous for raising BD's water solubility and expanding their releasing capabilities,
thereby boosting oral absorption.
