The development of ternary and quaternary solid dispersion based hydrotropic blends of atorvastatin calcium

Abstract

Background and objective: Atorvastatin calcium (ATV) has a solubility in aqueous solutions of greater than 0.1 mg/ml to less than 1 mg/ml, which is very slightly soluble. When developing dosage forms for these medications, formulation scientists still face challenges. This study's goal was to use various hydrotropic agents in the formation of solid dispersion-based hydrotropic blends to improve the solubility properties of atorvastatin calcium. Methods: In this study, twenty-two distinct binary, ternary, and quaternary formulations of ATV were prepared by employing five different hydrotropic agents and combining at least two hydrotropic agents in concentrations of 10% and 20% (w/v). Moreover, solid dispersion by the solvent evaporation method and physical mixture-based hydrotropic blends in the ratio of (1:2) have been formulated. The produced formulations were characterized using an FTIR analysis. Results: According to the findings, binary formulations containing 20% (w/v) concentrations of sodium benzoate (SB), sodium salicylate (SS), and resorcinol (R) enhanced the solubility ratio of ATV by 439.31, 689.57, and 106.21 folds, respectively. Furthermore, ternary formulations (FT14) and quaternary formulations (FQ18) resulted in the enhancement of ATV solubility by 938.45 and 995.12 folds, respectively. Ternary solid dispersion demonstrated the highest enhancement in solubility ratio by 87.68 folds and resulted in a higher dissolution rate of ATV than pure samples of the drug. Finally, FTIR analyses excluded any interactions between medications and excipients by showing no noticeable shift in the peaks. Conclusion: Solid dispersion based hydrotropic blends can provide the production of the dosage forms of practically insoluble drugs with a favorable enhancement ratio in solubility.