Formulation and characteristic evaluation of tacrolimus cubosomal gel for vitiligo

Abstract

The present study investigates and highlights the potency of tacrolimus (TAC) for effective vitiligo management using cubosome gel formulation. TAC-loaded cubosome formulations were prepared by using the ultrasonication technique. The central composite design (CCD) statistical design was employed for optimization of TAC-loaded cubosome based on responsible variables like particle size and entrapment efficiency. The optimized (F-14) TAC-loaded cubosome was subjected to physicochemical characterizations, including, particle size and zeta potential analysis, SEM, drug loading and drug release profiling assessment. SEM imaging confirmed spherical morphology of TAC loaded cubosome. Drug release percentage from cubosome was found to be with controlled drug release of 73% for 12 hour and release kinetics follows zero-order and Fickian diffusion mechanism. The optimized TAC-loaded cubosome formulation was incorporated in Carbopol 934 for the topical application of TAC-loaded cubosome gel (TAC-CG) for vitiligo. Therapeutic efficacy of TAC-CG for effective control of inflammation in vitiligo condition was assessed using monobenzene (60%) induced model of vitiligo using C57BL/6 mice. TAC-CG treatment exhibited a significant reduction in the depigmentation as a response when compared to that of the monobenzene-sensitized normal control mice.