Pharmaceutical Compositions of Near IR Closed Chain, Sulfo-Cyanine Dyes

Abstract

Sterile and non-toxic pharmaceutical compositions of near IR, closed chain, sulfo-cyanine dyes and methods for visualizing tissue under illumination with near-infrared radiation are provided.

What is claimed is: 
     
         1 . A sterile pharmaceutical composition comprising a unit dosage form of a compound having the formula: 
       
         
           
           
               
               
           
         
         wherein,
 R 1 , R 2 , R 3 , and R 4  are each independently hydrogen, C 1-3  alkyl, or —CO 2 T; 
 X is a single bond, —O—, or —S—; 
 subscripts a, b, c, and d are each independently an integer from 1 to 6, and 
 T is a metal ion, H, or a negative charge; 
 
         wherein, the composition is sterile, non-toxic, and adapted for administration to a patient for visualization of tissue under illumination with near-infrared radiation; and 
         wherein, the unit dosage form of the compound is between 0.05 and 8 mg/kg. 
       
     
     
         2 . The composition of  claim 1  having the formula: 
       
         
           
           
               
               
           
         
         wherein,
 R 1 , R 2 , R 3 , and R 4  are each independently hydrogen, —CH 3 , or —CO 2 T. 
 
       
     
     
         3 . The composition of  claim 1  having the formula: 
       
         
           
           
               
               
           
         
       
     
     
         4 . The composition of  claim 1 , wherein the composition unit dosage form is 0.05, 0.10, 0.20, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, 0.65, 0.70, 0.75, 0.80, 0.90, 1, 2, 4, 6, or 8 mg/kg. 
     
     
         5 . The composition of  claim 1  where the composition is adapted for administration to a human patient to obtain visualization of human tissue under illumination with near-infrared radiation wherein the unit dosage form is between 0.05 and 8 mg/kg. 
     
     
         6 . The composition of  claim 1  where the composition is dry and a single dose form. 
     
     
         7 . The composition of  claim 1  where the composition is lyophilized in a sterile container. 
     
     
         8 . The composition of  claim 1  where the composition is contained within a sterile container, where the container has a machine detectable identifier which is readable by a medical device. 
     
     
         9 . The composition of  claim 1  further comprising combination with pharmaceutically acceptable excipients in an oral dosage form. 
     
     
         10 . The composition of  claim 1  further comprising combination with pharmaceutically acceptable carriers in an injectable dosage form. 
     
     
         11 . The composition of  claim 1  further comprising combination with pharmaceutically acceptable excipients in a dosage form for direct application to a surgical site.