Compositions and methods for delivery of poorly water soluble drugs and methods of treatment

Abstract

The present embodiment of the invention is generally directed to compositions comprising suspensions of poorly water soluble compounds recrystallized in nanoparticulate sizes ranging from 0.1 to 5 μm. In addition, the embodiment of the invention is directed to methods for preparation and administration of these compositions to a patient for prevention and treatment of disease states. In particular, the embodiment of the invention is directed to compositions comprising suspensions of poorly water-soluble compounds, such as antimitotics and antibiotics, in nanoparticulates and methods of prevention and treatment of chronic disease states, such as cancer, by intraperitoneal and intravenous administration of such compositions.

What is claimed is:  
     
         1 . A composition comprising: 
 nanoparticulates of at least one antimitotic drug, wherein the nanoparticulates have a particle size from 0.1 micrometer to 5 micrometers.    
     
     
         2 . The composition of  claim 1 , wherein the antimitotic drug is selected from the group consisting of: paclitaxel, paclitaxel derivatives, taxanes, epithilones, Vinca alkaloids, camptothecin analogs, epipodophyllotoxins and combinations thereof.  
     
     
         3 . The composition of  claim 1 , wherein the nanoparticulates have a particle size from 0.4 to 2 micrometers.  
     
     
         4 . The composition of  claim 2 , wherein the antimitotic drug is a Vinca alkaloid.  
     
     
         5 . The composition of  claim 4  wherein the antimitotic drug is selected from the group consisting of: vinblastine, vincristine, vindesine and vinorelbine.  
     
     
         6 . The composition of  claim 2 , wherein the amitotic drug is a camptothecin analog.  
     
     
         7 . The composition of  claim 2 , wherein the antimitotic drug is an epipodophyllotoxin.  
     
     
         8 . The composition of  claim 2 , wherein the antimitotic drug is a paclitaxel derivative.  
     
     
         9 . The composition of  claim 2 , wherein the antimitotic drug is a taxane.  
     
     
         10 . The composition of  claim 7 , wherein the antimitotic drug is selected from the group consisting of: etoposide and teniposide.  
     
     
         11 . The composition of  claim 1 , further comprising: 
 a suspension medium.    
     
     
         12 . A method of administering the composition of  claim 11 .  
     
     
         13 . The method of  claim 12 , wherein the composition is administered intravenously.  
     
     
         14 . The method of  claim 12 , wherein the composition is administered intraperitoneally.  
     
     
         15 . The composition of  claim 11 , wherein the suspension is phosphate buffered saline.  
     
     
         16 . The composition of  claim 11 , further comprising anticlotting agents.  
     
     
         17 . The composition of  claim 11 , further comprising surfactants.  
     
     
         18 . A composition comprising: 
 nanoparticulates of paclitaxel, wherein the nanoparticulates have a particle size from 0.1 micrometer to 5 micrometers.    
     
     
         19 . The composition of  claim 18 , wherein the nanoparticulates have a particle size from 0.4 to 2 micrometers.  
     
     
         20 . The composition of  claim 18 , further comprising: 
 a suspension medium.    
     
     
         21 . A method of administering the composition of  claim 20 .  
     
     
         22 . The method of  claim 21 , wherein the composition is administered intravenously.  
     
     
         23 . The method of  claim 21 , wherein the composition is administered intraperitoneally.  
     
     
         24 . A composition comprising: 
 nanoparticulates of an antibiotic drug, wherein the nanoparticulates have a particle size from 0.1 micrometer to 5 micrometers.    
     
     
         25 . The composition of  claim 24 , wherein the nanoparticulates have a particle size from 0.4 to 2 micrometers  
     
     
         26 . The composition of  claim 24 , wherein the antibiotic is selected from the group consisting of: actinomycin D, mitomycin, daunorubicin, doxorubicin and idarubicin.  
     
     
         27 . The composition of  claim 24 , further comprising: 
 a suspension medium.    
     
     
         28 . A method of administering the composition of  claim 27 .  
     
     
         29 . The method of  claim 28 , wherein the composition is administered intravenously.  
     
     
         30 . The method of  claim 28 , wherein the composition is administered intraperitoneally.