In vitro, ex vivo, and in vivo appraisal of clobetasol propionate microparticles embedded topical bigel for psoriasis management

Abstract

The current work aims to develop a bigel-containing clobetasol propionate-loaded PLGA microparticles and further assess its in vitro, ex vivo, and in vivo behavior for psoriasis management. PLGA microparticles (2%w/w) containing clobetasol propionate were developed by solvent evaporation technique. For the developed particles, size, drug loading, entrapment efficiency, and surface morphology were determined. Further, the particles were suspended into bigel developed from oleogel and hydrogel (40:60) and assessed for stability, in vitro drug release, ex vivo skin permeation, retention, and in vivo study in BALB c mice for antipsoriatic potential. PLGA microparticles developed by solvent evaporation were found to have a mean particle size of 19.45 ± 1.74 μm. Drug loading and entrapment efficiency for clobetasol were found to be 43.5 ± 4.94% and 94.5 ± 3.68%, respectively. For the developed bigel, sustained in vitro drug release was observed till 7 h. Ex vivo skin permeation with the developed formulation was found to be higher than the marketed formulation and drug suspended in bigel. A retention study performed on pig skin suggested the topical skin retention of the drug. Further, the psoriatic model was developed in BALB c mice with IMQ cream, and it was observed that the developed formulation helped considerably reduce the irritation score and PASI scoring in mice as compared to the standard treatment. The same is corroborated with the help of histopathological studies performed by Hematoxylin and Eosin (H&E) staining in the same animals. The study findings suggest that clobetasol microparticle-loaded bigel formulation appeared to be a promising therapy option for psoriasis.