Acidic solid oral compositons without erosive potential in saliva and method for determining erosive potential in saliva

Abstract

Acidic oral compositions having calcium contents and effective pH-values in the area indicated by grey tone in FIG. 2 are non-erosive in saliva and capable of stimulating saliva production, even in “dry mouth” patients. A new multi-step test method for determining erosive potential in saliva has been used for identifying the compositions.

1 - 25 . (canceled) 
   
   
       26 . An acidic solid oral composition, which is a boiled sweet, a candy, a lollipop, a jelly, a chewing gum, a drop, a pastille, a lozenge, an ice cream, a sorbet or a tablet, with reduced erosive potential in saliva, comprising a calcium component and an acid component, wherein the amounts of calcium component and acid component in the solid oral composition are adjusted so as to provide
 (i) a pH in the range of 2.2 to 3.2, when the solid oral composition is dissolved in an equal amount by weight of highly purified water, and   (ii) a calcium content in the acidic solid oral composition within the following limits:
   175−(50·pH)≦calcium content (mmol/kg)≦660−(200·pH), 
   the pH being as indicated above, with the proviso that the composition does not include a polyphosphate being a phosphate polymer wherein the number of phosphate groups (n) is at least 3.   
   
   
       27 . A solid composition according to  claim 26 , wherein the mole ratio of calcium component to acid component is in the range of 0.3 to 0.8. 
   
   
       28 . A solid composition according to  claim 27 , wherein the mole ratio of calcium component to acid component is in the range of 0.4 to 0.7. 
   
   
       29 . A solid composition according to  claim 26 , wherein the pH, determined as indicated in claim  1 , is between 2.5 and 3.2. 
   
   
       30 . A solid composition according to  claim 29 , wherein the pH, determined as indicated in claim  1 , is between 2.6 and 3.1. 
   
   
       31 . A solid composition according to  claim 26 , wherein the calcium component is selected among calcium carbonate, calcium hydroxide, calcium citrate, calcium malate, calcium lactate, calcium chloride, calcium glycerophosphate, calcium acetate, calcium sulphate, and calcium formate, or hydrates or combinations thereof. 
   
   
       32 . A solid composition according to  claim 31 , wherein the calcium component is calcium lactate. 
   
   
       33 . A solid composition according to  claim 26 , wherein the acid component is selected from the group consisting of citric acid, malic acid, ascorbic acid, tartaric acid, acetic acid, fumaric acid and lactic acid. 
   
   
       34 . A solid composition according to  claim 26 , which is intended for being sucked or chewed. 
   
   
       35 . A method for stimulating the saliva production in an individual comprising orally administering a solid composition according to  claim 26  to the individual. 
   
   
       36 . A method according to  claim 35 , which is not for treatment of the human or animal body by therapy. 
   
   
       37 . A method according to  claim 35 , for alleviating the sufferings of an individual having impaired saliva production. 
   
   
       38 . A method according to  claim 37 , wherein the impaired saliva production is caused by a disease such as Sjögren's syndrome, cystic fibrosis, diabetes or an eating disorder. 
   
   
       39 . A method according to  claim 37 , wherein the impaired saliva production is caused by a therapeutic treatment, such as a medical treatment or radiotherapy. 
   
   
       40 . A method for determining the erosive potential in saliva of an oral composition, comprising the steps of:
 bringing the oral composition to be tested into contact with saliva in the mouth,   collecting a sample of the saliva under conditions so as to prevent CO 2  from escaping from the sample,   measuring the pH of the sample collected under b),   removing CO 2  from the sample, optionally assisted by vacuum and/or addition of a non-volatile acid,   adjusting the pH of the sample to the value measured under c) using a non-volatile acid or, if necessary, a non-volatile base,   adding tooth substance to the sample obtained from step e), and observing any rise in the pH,   if a rise in pH is observed in step f), titrating the sample to the pH value measured in c) using an acid, and   calculating the amount of tooth substance eroded based on the amount of acid consumed in step g).   
   
   
       41 . The method according to  claim 40 , wherein the non-volatile acid optionally used in step d) is a strong acid. 
   
   
       42 . The method according to  claim 40 , wherein the non-volatile acid is HCl or HNO 3 . 
   
   
       43 . The method according to  claim 40 , wherein the tooth substance is hydroxyapatite. 
   
   
       44 . The method according to  43 , wherein the hydroxyapatite is of non-dental origin. 
   
   
       45 . The method according to  claim 40 , wherein the acid used for titration is HCl. 
   
   
       46 . A solid composition according to  claim 26 , which, when tested in randomly selected healthy test persons by a method comprising the steps of:
 bringing the oral composition to be tested into contact with saliva in the mouth,   collecting a sample of the saliva under conditions so as to prevent CO 2  from escaping from the sample,   measuring the pH of the sample collected under b),   removing CO 2  from the sample, optionally assisted by vacuum and/or addition of a non-volatile strong acid,   adjusting the pH of the sample to the value measured under c) using a non-volatile acid or, if necessary, a non-volatile base,   adding tooth substance to the sample obtained from step e), and observing any rise in the pH,   if a rise in pH is observed in step f), titrating the sample to the pH value measured in c) using an acid, and   calculating the amount of tooth substance eroded based on the amount of acid consumed in step g),   no rise in pH in step f) is observed, within a period of 5 minutes for at least 90% of the test persons.