Nanodispersion

Abstract

The present invention provides a nanodispersion comprising nanoparticles having a mean size less than 300 nm dispersed in a vehicle comprising a water miscible solvent and water, said nanoparticles comprising one or more taxane derivative, a polymer and a surfactant comprising a mixture of fatty acids or its salts and sterol or its derivatives or its salts.

We claim: 
     
         1 . A nanodispersion comprising nanoparticles having a mean size less than 300 nm dispersed in a vehicle comprising a water miscible solvent and water, said nanoparticles comprising one or more taxane derivatives, a polymer and a surfactant comprising a mixture of fatty acids or its salts and sterol or its derivatives or its salts. 
     
     
         2 . A nanodispersion as claimed in  claim 1 , wherein the taxane derivative is selected from paclitaxel, docetaxel or pharmaceutically acceptable salts thereof. 
     
     
         3 . A nanodispersion as claimed in  claim 1  wherein the ratio of surfactant to taxane derivative is about 1:5 to 1:10 and wherein the said nanodispersion is stable for at least 4 hours. 
     
     
         4 . A nanodispersion as claimed in  claim 2  wherein the ratio of surfactant to paclitaxel is about 1:5 to about 1:10 and wherein the said nanodispersion is stable for 24 hours. 
     
     
         5 . A nanodispersion as claimed in  claim 2  wherein the ratio of surfactant to docetaxel is about 1:10 and the wherein the said nanodispersion is stable for 8 hours. 
     
     
         6 . A nanodispersion as claimed in  claim 1 , wherein the mean size of the nanoparticles is in the range of about 10 nm to about 200 nm. 
     
     
         7 . A nanodispersion as claimed in  claim 1 , wherein the water miscible solvent is selected from alcohols, glycols and its derivatives, poly alkylene glycols and its derivatives, glycerol, glycofurol and combinations thereof. 
     
     
         8 . A nanodispersion as claimed in  claim 7 , wherein the water miscible solvent is selected from the group consisting of alcohol and polyethylene glycol (PEG). 
     
     
         9 . A nanodispersion as claimed in  claim 1 , wherein the polymer is a water soluble polymer. 
     
     
         10 . A nanodispersion as claimed in  claim 9 , wherein the water soluble polymer is selected from the group consisting of polyvinylpyrrolidone and polyethylene glycol. 
     
     
         11 . A nanodispersion as claimed in  claim 10 , wherein polyvinylpyrrolidone used has a molecular weight in the range of 1000 to about 50,000 and is used in the amount ranging from 0.001% w/v to 10% w/v. 
     
     
         12 . A nanodispersion as claimed in  claim 1 , wherein the fatty acid or its salt is selected from the group consisting of caprylic acid, oleic acid, stearic acid and mixture thereof. 
     
     
         13 . A nanodispersion as claimed in  claim 1 , wherein the sterol or its derivatives or its salts is selected from the group consisting of cholesterol, cholesteryl esters of polar acids, phytosterols, bile acids their derivative, salts and mixtures thereof. 
     
     
         14 . Nanoparticles as claimed in  claim 13  wherein the polar acid is selected from the group consisting of succinic acid, hemisuccinic acid, sulfuric acid, phosphoric acid, glutamic acid, aspartic acid, boric acid. 
     
     
         15 . A nanodispersion as claimed in  claim 1 , wherein the surfactant is used in an amount ranging from about 0.001% w/v to about 5.0% w/v. 
     
     
         16 . A solution comprising one or more taxane derivatives, a polymer and a surfactant comprising a mixture of fatty acids or its salts and sterol or its derivatives or salts thereof in a water miscible solvent, which on dilution with an aqueous liquid vehicle gives a nanodispersion. 
     
     
         17 . Nanoparticles having a mean particle size less than 300 nms comprising one or more taxane derivatives, a polymer and a surfactant comprising a mixture of and fatty acid or it salts and sterol or its derivatives or its salts.