Preparations for measuring gastric emptying ability

Abstract

Preparations whereby reduction or acceleration of the gastric emptying rate can be noninvasively evaluated: and a method of evaluating the gastric emptying rate by using these preparations. Thus, reduction or acceleration of the gastric emptying rate can be safely and conveniently examined. Namely, theses preparations are useful in objectively diagnosing the gastric motor function, as well as in evaluating and judging the drug effect or therapeutic effect of a drug concerning the gastric motor function on individual patients.

1 - 24 . (canceled)  
   
   
       25 . A preparation for measuring the gastric emptying rate comprising a compound that is labeled with at least one of the isotopes of C and O, and that is converted into labeled CO 2  in the body and excreted in the exhalation, the preparation being a disintegrate-released type sustained-release preparation, 
 wherein the labeled compound is chosen from alkali metal salts, alkaline earth metal salts, ammonium salt of carbonic acid, alkali metal hydrogencarbonate salts, alkaline earth metal hydrogencarbonate salts, and ammonium hydrogencarbonate.    
   
   
       26 . A preparation for measuring the gastric emptying rate comprising a compound that is labeled with at least one of the isotopes of C and O, and that is converted into labeled CO 2  in the body and excreted in the exhalation, the preparation being a disintegrate-released type sustained-release preparation, 
 wherein the labeled compound is chosen from acetic acid, glycine, octanoic acid, and alkali metal salts thereof.    
   
   
       27 . The preparation according to  claim 25  or  26 , wherein the preparation is soluble in the stomach.  
   
   
       28 . The preparation according to  claim 25  or  26 , wherein the behavior of the preparation following oral administration to a subject is such that: 
 (1) the preparation remains inside the stomach after entering the stomach, without being immediately discharged from the stomach,    (2) the surface of the preparation is gradually eroded by the gastric contraction so that the preparation is disintegrated, and as this erosion and disintegrate occurs, the labeled compound is gradually eluted into the stomach, and    (3) the eluted labeled compound is converted into labeled carbon dioxide gas inside the stomach and excreted in the exhalation, or is absorbed, metabolized and excreted in the exhalation as labeled carbon dioxide gas.    
   
   
       29 . The preparation according to  claim 25  or  26 , wherein the preparation expands to a size sufficient to remain inside the stomach prior to passing through the pylorus following oral administration.  
   
   
       30 . The preparation according to  claim 25  or  26 , further comprising an anti-disintegrator.  
   
   
       31 . The preparation according to  claim 30 , wherein the anti-disintegrator is chosen from water-soluble high-molecular weight compounds, fats, oils, and sugars.  
   
   
       32 . The preparation according to  claim 31 , wherein the anti-disintegrator is chosen from hydroxypropylcellulose, hydroxypropylmethylcellulose, ethylcellulose, cellulose acetate phthalate, hardened oil, carnauba wax, sugars, and sugar alcohol.  
   
   
       33 . The preparation according to  claim 25  or  26 , wherein the isotope is at least one member chosen from  13 C,  14 C and  18 O.  
   
   
       34 . A method for measuring the gastric emptying rate, comprising: 
 orally administering to a subject the preparation according to  claim 25  or  26 , and    measuring the behavior of the labeled compound inside the body or the amount or rate of a labeled compound excreted from the body.    
   
   
       35 . A method for measuring the gastric emptying rate, comprising: 
 orally administering to a subject the preparation according to  claim 25  or  26 , and    measuring the amount or rate of labeled CO 2  excreted in the exhalation.    
   
   
       36 . A method for evaluating the gastric emptying rate, comprising: 
 orally administering to a subject suspected of having a reduction or acceleration of gastric emptying, the preparation according to  claim 25  or  26 , and    comparing the behavior of the labeled compound inside the body or the amount or rate of a labeled compound excreted from the body with the behavior of the labeled compound inside the body or the amount or rate of a labeled compound excreted from the body obtained from a healthy subject using the same preparation for measuring the gastric emptying rate.    
   
   
       37 . A method for evaluating the gastric emptying rate, comprising: 
 orally administering to a subject suspected of having a reduction or acceleration of gastric emptying, the preparation according to  claim 25  or  26 , and    comparing the amount or rate of labeled CO 2  excreted in the exhalation with the amount or rate of labeled CO 2  excreted in the exhalation obtained from a healthy subject using the same preparation for measuring the gastric emptying rate.    
   
   
       38 . A method for evaluating the pharmacological effect of a drug relating to gastric motor function, or the therapeutic effect of the drug, comprising: 
 orally administering to a subject the preparation according to  claim 25  or  26  before and after administering a drug relating to gastric motor function, and    comparing the behavior of the labeled compound inside the body or the amount or rate of a labeled compound excreted from the body following the administration of said drug with the behavior of the labeled compound inside the body or the amount or rate of a labeled compound excreted from the body prior to the administration of said drug.    
   
   
       39 . A method for evaluating the pharmacological effect of a drug relating to gastric motor function, or the therapeutic effect of the drug, comprising: 
 orally administering to a subject the preparation according to  claim 25  or  26  before and after the administration of a drug relating to gastric motor function, and    comparing the amount or rate of labeled CO 2  excreted in the exhalation following the administration of said drug with the amount or rate of labeled CO 2  excreted in the exhalation prior to the administration of said drug.