Compositions and formulations including cabazitaxel and human serum albumin

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.

1 - 63 . (canceled) 
     
     
         64 . A method for the preparation of 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, said method comprising:
 (i) obtaining an organic solution of cabazitaxel in a polar water-miscible organic solvent, wherein the concentration of cabazitaxel in the organic solution is from about 0.02 mg/ml to about 20 mg/ml;   (ii) obtaining a first aqueous solution of human serum albumin, wherein the concentration of human serum albumin in the first aqueous solution is from about 0.1 mg/ml to about 100 mg/ml; and   (iii) adding the organic solution of cabazitaxel to the first aqueous solution of human serum albumin to obtain a second aqueous solution comprising the composition comprising cabazitaxel and human serum albumin, wherein the addition is done at ambient temperature.   
     
     
         65 . The method of  claim 64 , wherein the polar water-miscible organic solvent is an alcohol. 
     
     
         66 . The method of  claim 64 , wherein the polar water-miscible organic solvent is ethanol. 
     
     
         67 . The method of  claim 64 , wherein the range of pH in the second aqueous solution is from about 4 to about 8. 
     
     
         68 . The method of  claim 64 , wherein the human serum albumin is a native human serum albumin. 
     
     
         69 . The method of  claim 64 , wherein the human serum albumin is a recombinant human serum albumin.