US2019083448A1PendingUtilityA1

Compositions and formulations including cabazitaxel and human serum albumin

Assignee: ZHUHAI BEIHAI BIOTECH CO LTDPriority: Jan 15, 2016Filed: Jan 12, 2017Published: Mar 21, 2019
Est. expiryJan 15, 2036(~9.4 yrs left)· nominal 20-yr term from priority
Inventors:Qun Sun
A61K 38/385A61K 31/337A61K 9/0019A61P 35/00A61K 9/19A61K 9/08C07D 305/14A61K 47/42
61
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Claims

Abstract

This document relates to non-covalently bound complexes comprising cabazitaxel and human serum albumin. This document also relates to compositions comprising non-covalently bound complexes comprising cabazitaxel and human serum albumin. This document also relates to compositions comprising cabazitaxel and human serum albumin. This document also relates to compositions consisting essentially of cabazitaxel and human serum albumin.

Claims

exact text as granted — not AI-modified
1 - 63 . (canceled) 
     
     
         64 . A composition comprising cabazitaxel and human serum albumin, wherein the cabazitaxel and the human serum albumin in the composition have a ratio by weight from about 1:150 to about 1:1000. 
     
     
         65 . The composition of  claim 64 , wherein the cabazitaxel and the human serum albumin in the composition have a ratio by weight from about 1:200 to about 1:600. 
     
     
         66 . The composition of  claim 64 , wherein the cabazitaxel and the human serum albumin in the composition have a ratio by weight from about 1:250 to about 1:500. 
     
     
         67 . The composition of  claim 64 , wherein the cabazitaxel and the human serum albumin in the composition have a ratio by weight from about 1:300 to about 1:400. 
     
     
         68 . The composition of  claim 64 , wherein the cabazitaxel and the human serum albumin in the composition are in a ratio by weight of about 1:340, or about 1:350. 
     
     
         69 . The composition of  claim 64 , wherein the composition is a clear aqueous solution when the composition is dissolved in an aqueous solvent, and wherein the aqueous solution is substantially free of solvent other than water. 
     
     
         70 . The composition of  claim 64 , wherein the composition is a clear aqueous solution when the composition is dissolved in an aqueous solvent, and wherein after the clear aqueous solution is filtered by a 0.22 micron filter, the amount of cabazitaxel in the filtered aqueous solution is at least 96% of the total amount of cabazitaxel in the aqueous solution before the filtration. 
     
     
         71 . The composition of  claim 64 , wherein the composition is a clear aqueous solution when the composition is dissolved in an aqueous solvent, and wherein after the clear aqueous solution is filtered by a 0.22 micron filter, the amount of cabazitaxel in the filtered aqueous solution is at least 98% of the total amount of cabazitaxel in the aqueous solution before the filtration. 
     
     
         72 . The composition of  claim 64 , wherein the composition is a clear aqueous solution for at least 3 hours when the composition is dissolved in an aqueous solvent. 
     
     
         73 . The composition of  claim 64 , wherein the composition is a solid formulation. 
     
     
         74 . The composition of  claim 64 , wherein the composition is an aqueous formulation. 
     
     
         75 . The composition of  claim 74 , wherein the aqueous formulation is a clear aqueous solution for at least 3 hours, and wherein the aqueous formulation is substantially free of solvent other than water. 
     
     
         76 . The composition of  claim 74 , wherein the aqueous formulation is a clear aqueous solution for at least 6 hours, and wherein the aqueous formulation is substantially free of solvent other than water. 
     
     
         77 . A composition comprising cabazitaxel and human serum albumin, wherein the cabazitaxel and the human serum albumin in the composition have a ratio by weight from about 1:100 to about 1:2000, wherein the composition forms a clear aqueous solution when the composition is dissolved in an aqueous solution, and wherein the solubility of the composition in the aqueous solution is at least 10 mg/ml. 
     
     
         78 . The composition of  claim 77 , wherein the cabazitaxel and the human serum albumin in the composition have a ratio by weight from about 1:250 to about 1:800. 
     
     
         79 . The composition of  claim 77 , wherein the composition has a solubility in an aqueous solution of about 20 mg/ml, about 30 mg/ml, about 40 mg/ml, about 50 mg/ml, 60 mg/ml, about 70 mg/ml, about 80 mg/ml, about 90 mg/ml, or about 100 mg/ml. 
     
     
         80 . The composition of  claim 64 , wherein the human serum albumin in the composition is a native human serum albumin. 
     
     
         81 . A pharmaceutical composition comprising the composition of  claim 64 , and a pharmaceutically acceptable carrier. 
     
     
         82 . A method of treating a cancer, the method comprising the step of administering to a subject in need thereof a therapeutically effective amount of the pharmaceutical composition of  claim 81 . 
     
     
         83 . The method of  claim 82 , wherein the cancer is a prostate cancer.

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