Inclusion of prednicarbate in the SBA-15 silica: Protective effect and analytical profile when incorporated in a semisolid pharmaceutical formulation

Abstract

The present work describes the development and characterization of a nanostructured mesoporous SBA-15 silica loaded with prednicarbate, a corticosteroid widely used in the treatment for atopic dermatitis, and the assessment of its in vitro release profile in comparison with a conventional cream formulation. The inclusion of prednicarbate in the SBA-15 pores was confirmed by the respective 24 and 16 % decrease in the surface area (S BET) and mesopores volume (V), in combination with supporting data obtained by thermal analysis (TG and DSC), FTIR spectroscopy, X-ray diffraction, and elemental analysis. Additionally, it has been shown through X-ray diffraction and DSC that the encapsulated molecules remain in an amorphous state, and the protective function of the loading was demonstrated through thermogravimetry by the decrease in the rate of the thermal decomposition reaction of the drug-loaded material (Δm 600–850 °C). Finally, the HPLC–MS/MS method developed was proven to be precise and accurate for the determination of prednicarbate in the receiving fluid samples collected during the in vitro release test using Franz diffusion cells.