Iohexol powder and method of using the same

Abstract

Iohexol particles, contrast agent compositions comprising iohexol particles, methods of preparing iohexol particles, and methods of administering iohexol particles are provided herein. The iohexol particles of the present invention substantially dissolve in water within about 60 seconds when tested using Modified United States Pharmacopeia Method 641.

1 .- 86 . (canceled) 
     
     
         87 . A contrast agent composition comprising particles of iohexol with a particle size distribution having two or more of the following characteristics:
 D90 of no more than about 40 μm;   D50 of no more than about 20 μm; and   D10 of no more than about 11 μm,   wherein said particles of iohexol substantially dissolve in water within about 60 seconds when tested using Modified United States Pharmacopeia Method 641.   
     
     
         88 . The contrast agent composition of  claim 87 , wherein the particle size distribution has the following characteristics:
 D90 of no more than about 40 μm;   D50 of no more than about 20 μm; and   D10 of no more than about 11 μm.   
     
     
         89 . The contrast agent composition of  claim 87 , wherein said particles of iohexol are substantially dissolved within about 40 seconds. 
     
     
         90 . The contrast agent composition of  claim 87 , wherein the amount of iohexol ranges from about 0.2 g to about 75 g. 
     
     
         91 . The contrast agent composition of  claim 87 , substantially free of pharmaceutically acceptable functional excipients. 
     
     
         92 . The contrast agent composition of  claim 87 , further comprising at least one pharmaceutically acceptable non-functional excipient selected from the group consisting of dispersants, disintegrants, coatings, fillers, flavors, sorbents, preservatives, sweeteners, coloring agents, wetting agents, binders, anti-caking agents, and combinations thereof. 
     
     
         93 . The contrast agent composition of  claim 87 , wherein the iohexol is substantially the exo isomer. 
     
     
         94 . The contrast agent composition of  claim 87 , prepared by spray drying a solution of iohexol. 
     
     
         95 . The contrast agent composition of  claim 94 , wherein the inlet temperature of the spray drier falls within the range of about 220-255° C., and the outlet temperature falls within the range of about 95-115° C. 
     
     
         96 . The contrast agent composition of  claim 95 , wherein the atomizer rpm is about 25,000. 
     
     
         97 . The contrast agent composition of  claim 95 , wherein the iohexol solution has a concentration of about 20-45% (w/w). 
     
     
         98 . The contrast agent composition of  claim 94 , wherein said iohexol is substantially amorphous. 
     
     
         99 . The contrast agent composition of  claim 94 , wherein the particles of iohexol have a bulk density of about 0.90 g/cm 3 . 
     
     
         100 . The contrast agent composition of  claim 94 , wherein the particles of iohexol have an interparticle spacing of about 60% of bulk volume. 
     
     
         101 . A contrast agent composition prepared by spray drying a 20-45% (w/w) solution of iohexol, wherein the inlet temperature of the spray drier falls within the range of about 220-255° C., and the outlet temperature falls within the range of about 95-115° C., whereby said particles of iohexol substantially dissolve in water within about 60 seconds when tested using Modified United States Pharmacopeia Method 641. 
     
     
         102 . A method of forming an iohexol contrast solution, comprising:
 (a) adding a pharmaceutically acceptable aqueous diluent to a container containing the contrast agent composition of claim  1 ; and   (b) agitating the container for no more than 90 seconds, whereby substantially all of the iohexol contrast agent is dissolved.   
     
     
         103 . The method of  claim 102 , wherein step (b) is manual agitation. 
     
     
         104 . The method of  claim 102 , wherein the container is manually agitated for no more than 60 seconds. 
     
     
         105 . The method of  claim 102 , wherein the container is manually agitated for no more than 40 seconds. 
     
     
         106 . Administering an iohexol contrast solution to a patient in need thereof, comprising:
 (a) adding a pharmaceutically acceptable aqueous diluent to a container containing the contrast agent composition of  claim 87 ;   (b) agitating the container for no more than 90 seconds, whereby substantially all of the iohexol contrast agent is dissolved; and   (c) administering said contrast solution to the patient.