DoE-guided Development of Hydroxypropyl-β-cyclodextrin Complex-loaded Curcuminoid Orodispersible Tablets for Geriatric Use

Abstract

This study aimed to enhance the physicochemical properties of curcuminoids by preparing an inclusion complex and formulate an orodispersible tablet (ODT) suitable for elderly patients. A purified curcuminoid was complexed with hydroxypropyl-β-cyclodextrin (HP-β-CD). A design of experiments was employed to optimize the formulation by investigating the effects of a binder and a superdisintegrant on critical tablet attributes. The final optimized ODT was evaluated for compliance with pharmacopeial standards. The 1:1 molar ratio curcuminoid:HP-β-CD complex was identified as optimal, providing a substantial (214-fold) increase in solubility. The complex demonstrated superior photostability, thermal resistance, and ambient storage stability compared to the uncomplexed curcuminoid. The optimized ODT formulation, exhibited excellent mechanical robustness and achieved a rapid disintegration time of 22.21 ± 1.94 s. In vitro dissolution studies showed enhanced drug release, achieving 97.79 ± 0.66% release at 60 min and demonstrating a distinct dissolution profile compared to a commercial non-complexed formulation. This work presented a rational, dual-strategy formulation approach that combines molecular-level solubility enhancement with dosage form optimization to improve the in vitro performance of curcuminoids. The findings highlight the potential of cyclodextrin-based ODT systems as a scalable platform for delivering poorly soluble phytochemicals, particularly for geriatric and dysphagic populations.