QBD APPROACH FOR THE DEVELOPMENT OF CAPSAICIN-LOADED STEARIC ACID-GRAFTED CHITOSAN POLYMERIC MICELLES

Objective: Capsaicin (CAP) is a naturally occurring alkaloid forecasted in the treatment of Alcoholic Hepatitis (AH), but least studied due to its hydrophobicity and low bioavailability. Hence, present study aimed optimize parameters for synthesis stearic acid grafted chitosan (CS-g-SA) copolymer preparation CAP-loaded CS-g-SA micelles. Methods: Quality by design (QbD) approach coordination with “Central composite designs (CCD) Box–Behnken (BBD)” was used process parameters. Results: synthesized at 80 °C, 480 min, 946 rpm, these optimized conditions, average particle size practical yield were found be 134.70 nm 85.69%, respectively. Proton Nuclear Magnetic Resonance (1H NMR) spectra depicted sharp signal d=1.0 ppm endorsing -CH2 group SA confirming formation copolymer. Critical micellar concentration (CMC) amino groups substitute degree (SD %) 30.3±1.51µg/ml 21.3±0.58%, The distinguished peaks CAP (0.9 1.31 ppm) 1H NMR disappeared, indicating drug loading core. Micelles had an 163.15 encapsulation efficiency 68.45%. CAP-CS-g-SA biocompatible accordance hemolysis test. vitro release pattern showed 86.78 % 24 h, slower from micelle, whereas 99.48% released non-micellar formulations 6 h. Conclusion: micelle promising improve bioavailability controlled extremely hydrophobic further vivo studies would evident AH using CAP-CS-g-SA.