Formulation of mouth-dissolving tablets containing a spray-dried solid dispersion of poorly water-soluble fenoprofen calcium dihydrate and its characterization

Abstract

The aim and objective of this investigation focus on the formulation of mouth-dissolving tablets of Fenoprofen calcium dihydrate spray dried solid dispersions. Materials and methods. Spray drying is a well-recognized manufacturing technique that can be used to create amorphous solid dispersions, which are an effective delivery method for poorly water-soluble pharmaceuticals such as Fenoprofen calcium dihydrate (FCD). In addition to skimmed milk powder (SMP) and FCD, the carrier β-cyclodextrin was used to produce solid dispersions. Results and discussion. The production of solid dispersions yielded reproducible results. Solid dispersion with β-cyclodextrin and skimmed milk powder is one way to increase disintegration time by increasing the water solubility of inadequately water-soluble FCD. In-vitro dissolution experiments of FCD mouth-dissolving tablets revealed significant differences. Stability studies should evaluate drug product characteristics that are susceptible to change during storage and are anticipated to impact quality, safety, and efficacy to demonstrate that the optimal formulations remain stable over the course of the study. The results of stability experiments were statistically significant at p<0.05 using one-way ANOVA followed by Dunnet's test. During in-vivo anti-inflammatory experiments, the formulation SDC6 demonstrated a greater percentage of inhibition than the purified drug and super disintegrant, and the results were statistically significant using one-way ANOVA followed by the Bonferroni test. Conclusions. The solid dispersions were prepared with β-cyclodextrin, and skimmed milk powder improved the solubility of the poorly water-soluble fenoprofen calcium dihydrate. In vitro dissolution experiments of fenoprofen calcium dihydrate mouth dissolving tablets and controlled tablets revealed significant differences