quality-by-design guided development, optimization and characterization of irbesartan-loaded chitosan nanoparticles: a novel antihypertensive drug delivery system

This study aimed to formulate, optimize, and characterize irbesartan-loaded chitosan nanoparticles (irbnps) as a novel antihypertensive formulation using the quality-by-design (qbd) methodology. the formulation was designed to enhance the bioavailability and therapeutic efficacy of irbesartan by improving its solubility and achieving a controlled release profile. irbnps were synthesized using the ionic-gelation method, and a box-behnken design was employed to evaluate the effects of tripolyphosphate concentration, chitosan concentration, stirring speed on particle size (ps), and percentage entrapment efficiency (% ee). the optimized irbnps showed a ps of 387.21 ± 1.42 nm and % ee of 72.25 ± 1.71%. ftir analysis confirmed the drug-excipient compatibility of irbesartan within the nanoparticles, with no evidence of drug-excipient incompatibility. xrd analysis demonstrated irbesartan transition to an amorphous state, while sem and tem revealed spherical nanoparticles ranging from 200 to 400 nm. in vitro release studies indicated a sustained release profile, with a cumulative drug release of 86.01% over 42 hours. stability studies over three months confirmed the integrity of the formulation, maintaining % cumulative drug release (% cdr) and % ee across different temperature conditions. this study highlights the successful application of qbd principles in developing irbnps, which demonstrate potential for effective and sustained delivery of irbesartan. the formulation offers significant promise for improved management of hypertension through enhanced bioavailability and controlled drug release.