Development and Evaluation of Niosomal Gel for TransdermalApplication of steroidal API

Abstract

Niosomal drug delivery system serves as drug depots within the body that release the drug in a controlled manner through its bilayer, providing the enclosed drug to be released with sustainedaction.Transdermal drug delivery system for steroidal drug molecules through the development of a niosomal gel is needed for an optimized drug delivery system due to various problems associated with conventional treatment of steroidal molecule. The objective of this study was to develop a niosomalgel-based formulation system for testosterone steroidal molecule dissolved in a mixture of non-ionic surfactant and cholesterol in nanoparticulate form and evaluation of niosomal gel by different optimization parameters. The niosomal gel dispersion was prepared by heating system technique.The drug loaded niosomes showed much less vesicle size [10 - 500 nm] and good PDI, which means that the drug loaded can easily permeate the skin. Niosomal based gel was formulated by using the xanthan gum as gelling agent by optimizing different concentration of different gelling agents to get the best consistency of final niosomal gel. Various measurement parameters such as product quality, pH, purity, homogeneity, spread ability, viscosity, In vitro drug release, particle size determination, zeta potential, FTIR studies and TEM analysis were done to optimize the best batch.Entrapment efficiency was very good with value of 92.17 ± 0.02 percent. Niosomal gel has been found to exhibit strong consistency, good homogeneity, spread ability, and viscosity parameters.Studies of FTIR showed no excipient interaction with the API molecule. TEM images showed that all the particles were in uniform range in niosomal dispersion.Data on the release of in vitro drugs also showed that the release pattern was comparable to the industry formula. The niosomalbased gel formulation developed can be a promising alternative to delivering steroidalbased molecule to minimize the side effects due to skin problems as well as to increase the permeation rate of steroids by using transdermal drug delivery.