Preclinical evaluation of albumin-bound docetaxel nanoparticles as potential anti-cancer products

[Display omitted] •The clinical application of docetaxel has been limited due to the serious adverse effects caused by its solvent systems (e.g. ethanol and Tween 80).•Albumin-bound docetaxel nanoparticles were successfully prepared.•Systematic pre-clinical studies of the prepared albumin-bound docetaxel nanoparticles were performed.•Albumin-bound docetaxel nanoparticles have equivalent pharmacokinetic profiles, similars safety profile and better anti-tumor efficacy compared with Docetaxel Injection. Docetaxel is a highly potent anti-tumor agent which is clinically effective for the treatment of various cancers. However, the clinical application of docetaxel is limited due to its poor solubility. The solvent and cosolvent existing in the complex solvent systems can lead to serious adverse effects in clinical application. This paper aimed to develop a novel formulation of docetaxel with improved aqueous solubility and enhanced anti-tumor efficacy. Novel albumin-bound docetaxel nanoparticles were successfully developed based on the nanoparticle albumin-bound (nabTM) technology platform, showing a perfect particle size of 115.6 nm and high encapsulation efficiency (95.43%). Then the in vivo anti-tumor efficacy, plasma pharmacokinetics, tissue distribution and toxicity profiles of albumin-bound docetaxel nanoparticles were evaluated in comparison with those of Docetaxel Injection. The preclinical study demonstrated that albumin-bound docetaxel nanoparticles exhibited equivalent pharmacokinetic profiles, similar safety profiles and better anti-tumor efficacy on NCI-N87 human gastric carcinoma and BxPC-3 human pancreatic carcinoma compared with those of Docetaxel Injection. These results indicated that such albumin-bound docetaxel nanoparticles are promising in reducing toxicity and enhancing efficacy in clinical applications, showing great potential for developing an advanced drug delivery system for cancer therapy.