FORMULATION AND QBD-BASED OPTIMIZATION OF CHITOSAN-COATED NANOSTRUCTURED LIPID CARRIERS FOR ENHANCED DRUG DELIVERY OF AZILSARTAN MEDOXOMIL

Abstract

Objective: Azilsartan medoxomil (AZM) is a Class II antihypertensive drug with poor aqueous solubility that limit its dissolution and oral performance. The aim of present investigation was to improve its dissolution properties by formulating chitosan-coated AZM NLCs (CH-NLCs) and optimizing using QbD approach. Methods: Oleic acid, Compritol® 888 ATO, Kolliphor® RH 40, Chitosan as a liquid lipid, solid lipid, coating polymer and surfactant respectively. Chitosan coated AZM- NLCs were prepared by hot homogenization-ultrasonication method and optimized using BBD. Particle size, entrapment efficiency, zeta potential, DSC, FTIR, SEM and X-RD and release studies were evaluated. Results: Optimized CH-NLCs displayed particle size (172.25 ± 5.09 nm), entrapment efficiency (85.04 ± 2.61%), and zeta potential (+36.2 ± 1.2 mV). Solid-state analysis indicated reduced crystallinity and amorphous dispersion of AZM within the lipid–polymer matrix. The in vitro drug release (~92% over 24 h) showed diffusion-controlled release kinetics. Conclusion: The results of chitosan coated NLCs showed better drug loading and controlled release behaviour. The study suggests the potential of CH-NLCs for improved oral delivery.