FORMULATION AND CHARACTERIZATION OF SACITUZUMAB-LOADED CHITOSAN NANOPARTICLES VIA IONOTROPIC GELATION FOR ENHANCED DRUG DELIVERY

Abstract

Sacituzumab loaded chitosan nanoparticles were produced by the ionotropic gelation method. This method exploits the electrostatic interaction between the negatively charged tripolyphosphate (TPP) and the positively charged chitosan polymer. The chitosan/TPP ratio significantly affects the size and efficiency of nanoparticle formation, aiming for a size below 250 nm. The highest levels of chitosan and TPP were found at a concentration of 8 mg/ml. Several formulations were assessed, and the chitosan/TPP ratio of 0.8% yielded the formation of the smallest particles (229±7 nm). The duration of sonication was also a crucial element, since the lowest particle size was obtained after 90 seconds. The zeta potential exhibited a range of +3 to +6 mV, indicating the stability of the colloidal system. The particle size was estimated to be about 100 nm, and the spherical shape was confirmed using FESEM and TEM investigations. The AFM investigation confirmed these results by revealing the presence of compact, almost spherical nanoparticles. The formulation labelled as F3 had the greatest level of entrapment efficiency (EE), ranging from 53.2±1.5% to 68.5±0.3%. An initial rapid and forceful release was detected in drug release studies conducted outside of a living organism, which was thereafter followed by a continuous and prolonged release. F3 attained a discharge rate of 98.2±1.4% during a 24-hour period. The stability and effectiveness of the nanoparticles for possible therapeutic uses were verified using stability experiments done over three-month duration. These investigations demonstrated negligible changes in particle size and constant drug loading.