Study the Effect of Surfactant Concentration and Ultrasonication Time on Aqueous Solubility, Particle Size and In-vitro Drug Diffusion of Ezogabine Nanosuspension by 32 Factorial Designs

Objectives: The objective of the existing study was to prepare ezogabine nanosuspension for intranasal administration and study the effect of surfactant concentration (0.1, 0.2, 0.3 ml), ultrasonication time (10, 20, 30 min) on aqueous solubility, particle size and in-vitro drug diffusion of drug. Methods: All the nanosuspensions of ezogabine were prepared using the nanoprecipitation–ultrasonication technique at different surfactant conc. and ultrasonication time. There have been still few of published researches on formulation of ezogabine using co-crystal, solid dispersion. The formulation was studied using design of experiments by employing a 2-factor, 3-level factorial design. The nanosuspensions were studied for saturation solubility, particle size, in-vitro drug diffusion, pH, drug content, viscosity, FT-IR study and nasal cilio toxicity studies. Results: The average saturation solubility, particle size and in-vitro drug diffusion of nanosuspensions was found in the range of 0.2931-0.8121mg/ml, 155.2-454.4nm and 88.14-97.91% at 2.5hrs.respectively.The pH, drug content and viscosity of nanosuspensions was found in the range of 5.48-6.16, 96.43-99.12%, 110.7138.5 cps respectively. The statistical analysis of data revealed that surfactant conc.(X1) and ultrasonication time (X2) has a significant effect on saturation solubility (p=0.0001), whereas a surfactant conc. (X1) has no effect and ultrasonication time has significant effect on particle size (p=0.0042). The surfactant conc. (X1) has no significant effect and ultrasonication time has significant effect on in-vitro drug diffusion (p=0.0020).FT-IR study revealed that there was no significant change in principle peak of the drug in physical mixture (Ezogabine, Tween 80 and Poloxamer 188).Nasal Cilio toxicity study showed no nasociliary damage, indicates safety of formulation. Conclusion: This examination verified the prospective of the experimental design in understanding the effect of formulation variables on the development of nanosuspensions. The results reassures, nanosuspension are encouraging for solubility enhancement.

Author(s): Pawar Anil R, Choudhari Pravin D, Ghule Prashant J, Pawar Amol R and Bankar Prakash V

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