Injectable nanosuspension of docetaxel-loaded biodegradable periodic mesoporous Organosilica: A stable formulation with enhanced anticancer efficacy

Current intravenous docetaxel (DTX) formulations often contain excipients like polysorbate 80 and high-dose ethanol, which are associated with severe adverse effects and compound DTX's inherent systemic toxicity. This study addresses these limitations by developing a novel injectable nanosuspension of docetaxel-loaded biodegradable periodic mesoporous organosilica (BPMO), termed B@D, aiming for an excipient-free and less toxic alternative. We successfully formulated a highly stable B@D nanosuspension using polyethylene glycol 400 and povidone K12 polymers, optimized pH conditions, and ultrasonic homogenization. This formulation demonstrated excellent stability for up to two months and exhibited superior in vitro drug release efficiency compared to free DTX. Cytotoxicity assays confirmed that the B@D nanosuspension achieved anticancer efficacy comparable to the commercial product Docetaxel Ebewe (10 mg/mL), while maintaining minimal toxicity on normal fibroblast L929 cells. This research provides a promising new direction for developing stable, effective, and less toxic nanosuspension-based injectable formulations for docetaxel, with significant implications for pharmaceutical development. • Novel docetaxel nanosuspension developed without toxic excipients. • Biodegradable mesoporous organosilica enhances DTX delivery. • Stable formulation achieved using polymer coating and pH optimization. • Superior in vitro drug release and improved DTX solubility. • Comparable anticancer efficacy with reduced normal cell toxicity.