Process Parameters Optimization, In Vitro Characterization and Stability Evaluation of Human Serum Albumin Nanoparticle Based Paclitaxel Delivery for Anticancerous Activity.

Efficient delivery of low water soluble paclitaxel (PTX) through the use of human serum albumin (HSA) as suitable carriers to targeted site with reduced toxicities and improved pharmaceutical attributes remains challengeable and still required deep investigation. Herein, PTX-HSA NPs were synthesized by emulsion solvent evaporation method using high-pressure homogenization technique. The impact of drug and HSA concentration, homogenization pressure, and number of cycles onto to the particle size, zeta potential, drug loading, and in vitro drug release profile of developed nanoparticles was optimized. Herein, optimized NPs (F5 formulation) possessing the particle size of 165 ± 8.53 nm, PDI of 0.126, and zeta potential of − 22.4 ± 3.5 mV were obtained as spherical shaped. Additionally, in vitro release profile of F5 formulation demonstrated the biphasic pattern initiated with burst release (12% after 2 h) followed by sustained release (45% after 48 h) at pH 7.4. Furthermore, in vitro cytotoxicity study of optimized formulation revealed potential cytotoxicity at dose-dependent manner in which IC₅₀ of PTX-HSA NPs displayed 12.23 ± 2.4 µg/ml and 11.31 ± 2.2 µg/ml against MCF-7 and MDA-MB-231 human breast cancer cell lines, respectively, irrespective to free drug. Stability study of F5 lyophilized powder further showed well-maintained integrity, potentivity, and stability. Conclusively, process parameter optimization and in vitro characterization of developed PTX-HSA NPs further provide suitable platform for industrial or scale-up production. [ABSTRACT FROM AUTHOR]