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AssigneeCspc Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd.
InventorsChunlei Li, Yanhui Li, Min Liang, Caixia Wang, Yajuan Wang, Shixia Wang, Dongjian Chen, Yongfeng Li
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Purified therapeutic nanoparticles are provided herein. Such nanoparticles comprise an active pharmaceutical ingredient and human serum albumin, wherein the weight ratio of human serum albumin to the active ingredient in the therapeutic nanoparticles is from 0.01:1 to 1:1, and wherein the nanoparticles are substantially free of free human serum albumin that is not incorporated in the nanoparticles. The present disclosure also provides pharmaceutical compositions that comprise the purified therapeutic nanoparticles and are also substantially free of free human serum albumin. Methods for preparing and using the purified therapeutic nanoparticles and compositions thereof are also provided.
Purified therapeutic nanoparticles, consisting essentially of paclitaxel and human serum albumin (HSA), wherein the weight ratio of HSA to paclitaxel in the therapeutic nanoparticles is from 0.03:1 to 0.95:1, wherein less than 10% HSA in the therapeutic nanoparticles is free HSA that is not incorporated into the nanoparticles, wherein the therapeutic nanoparticles contain less than 0.05 mg/ml organic solvent(s), and wherein when suspended in 0.9% sodium chloride or 5% mannitol, the resulting suspension is stable for 48 hours at room temperature.
Dependencies are inferred from the claim text.