Method and means for detecting inflammatory processes

Abstract

A method of detecting inflammatory processes comprises (a) administering per-orally or per-rectally a composition comprising a diagnostically effective amount of L-[guanido- 15 N 2 ]-arginine, L-[guanido- 15 N]-arginine, their mixtures and pharmaceutically acceptable salts thereof, and a pharmaceutically acceptable carrier; (b) collecting a sample of exhaled air, saliva or urine; (c) determining 15 NO in the air sample or its transformation products 15 N-nitrite and/or 15 N-nitrate in the saliva sample or urine. Also disclosed is a corresponding diagnostic composition for use in diagnosing inflammatory processes and a method for its manufacture.

1 . A method of detecting the existence of an inflammatory process comprising: 
 administering per-orally or per-rectally to a person a composition comprising a diagnostically effective amount of L-[guanido- 15 N 2 ]-arginine, L-[guanido 15 N]-arginine, their mixtures and pharmaceutically acceptable salts thereof, and a pharmaceutically acceptable carrier,    collecting a sample of exhaled air, saliva or urine,    determining  15 NO in the air sample or its transformation products  15 N-nitrite and/or  15 N-nitrate in the saliva sample or urine.    
   
   
       2 . The method of  claim 1 , wherein administration is per-oral is for release in the small intestine or in the upper part of the large intestine or both.  
   
   
       3 . The method of  claim 1 , wherein the administration is per-rectal for release in the lower part of the large intestine.  
   
   
       4 . (canceled)  
   
   
       5 . The method of  claim 2 , wherein the composition is in form of a tablet, a capsule, or granules.  
   
   
       6 . The method of  claim 2 , wherein the inflammatory process is selected from the group consisting of ulcerative colitis, Crohn's disease and celiac disease.  
   
   
       7 . The method of  claim 3 , wherein the composition is in form of an enema, a suppository or a foam.  
   
   
       8 . The method of  claim 3 , wherein the inflammatory process is ulcerative colitis.  
   
   
       9 - 10 . (canceled)  
   
   
       11 . The method of  claim 1 , wherein determination is by IR-spectrometry, laser spectrometry, mass spectrometry, gas chromatography, and their combinations.  
   
   
       12 . (canceled)  
   
   
       13 . A diagnostic composition for per-oral administration, including pulmonary administration, and per-rectal administration, for use in diagnosing inflammatory processes, comprising a diagnostically effective amount of L-[guanido- 15 N 2 ]-arginine, L-[guanido- 15 N]-arginine, their mixtures, and pharmaceutically acceptable salts thereof, and a pharmaceutically acceptable per-oral or per-rectal carrier, in a form selected from the group consisting of tablet, capsule, granules, enema, suppository and foam.  
   
   
       14 . The composition of  claim 13 , wherein said amount is from 1 mg to 2,000 mg.  
   
   
       15 . A method of manufacture of a diagnostic composition for per-oral administration, including pulmonary administration, and per-rectal administration, for use in diagnosing the existence of an inflammatory process, comprising combining a diagnostically effective amount of L-[guanido- 15 N 2 ]-arginine, L-[guanido- 15 N]-arginine, their mixtures, and pharmaceutically acceptable salts thereof, and a suitable pharmaceutically acceptable per-oral or per-rectal carrier into a form selected from the group consisting of tablet, capsule, granules, enema, suppository and foam.  
   
   
       16 . The method of  claim 15 , wherein said amount is from 1 mg to 2,000 mg.  
   
   
       17 . The composition of  claim 13 , wherein the carrier is a peroral carrier and the composition is in form of a tablet, a capsule, or granules.  
   
   
       18 . The composition of  claim 13 , wherein the carrier is a per-rectal carrier and composition is in form of an enema, a suppository or a foam.  
   
   
       19 . The method of  claim 1 , wherein the sample collected is exhaled air or saliva.  
   
   
       20 . The method of  claim 2 , wherein said amount is from 1 mg to 2,000 mg and the sample collected is exhaled air or saliva.  
   
   
       21 . The method of  claim 20 , wherein the composition is in form of a tablet, a capsule, or granules.  
   
   
       22 . The method of  claim 3 , wherein said amount is from 1 mg to 2,000 mg and the sample collected is exhaled air or saliva.  
   
   
       23 . The method of  claim 22 , wherein the composition is in form of an enema, a suppository or a foam.