Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2001-08-06
2003-01-28
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S048000, C424S465000, C426S003000, C426S660000
Reexamination Certificate
active
06511679
ABSTRACT:
BACKGROUND OF THE DISCLOSURE
1. Field of the Invention
The present invention is directed to a comestible product which effectively controls breath malodor. More particularly, the present invention is directed to a breath malodor-controlling comestible product which includes inulin.
2. Background of the Prior Art
Bad breath, medically referred to as breath malodor, is primarily caused by volatile sulfur compounds (VSC), which are mainly hydrogen sulfide (H
2
S) and methyl methyl mercaptan (CH
3
SH). Although the identification of VSC as the cause of bad breath is well established in the art, recent research has rebutted a common misconception regarding the basis of generation of VSC. Many health professionals previously believed that breath malodor, caused by VSC, was the result of intestinal malfunction. However, recent medical and dental research has established that VSC-causing breath malodor is generated in the human oral cavity, i.e. the mouth, rather than in the intestine.
Specifically, Gram-negative bacteria in the oral cavity, which are anaerobic, e.g.
Porphyromonas denticola, Treponema gingivalis, Prevotella intermedia,
Fusobacterium and Bacteroides, metabolize protein to produce VSC. It is theorized that it is protein, present in saliva, that is the subject of anaerobic metabolism, which primarily occurs in the tongue dorsum.
This identification of the cause of breath malodor suggests methods of its control. Those skilled in the microbiological arts are aware that Gram-negative bacteria thrive under alkaline conditions but are inactive under acidic conditions. Thus, the generation of an acid environment in the mouth cavity, it is believed, would go a long way towards controlling this condition.
This theory has not been pursued in the past due to the well established association between the generation of acid in the oral cavity and the formation of tooth caries. Thus, the suggestion that sucrose-rich foods, such as candies, gums and the like, could be used to fundamentally control breath malodor has not, in the past, been considered a viable solution to breath malodor since the Gram-positive bacteria in the oral cavity that metabolize sucrose cause caries.
However, it is not the generation of acid which causes caries. Acid in and of itself is quickly removed from the enamel of teeth by saliva in the oral cavity since the acid generated by Gram-positive bacteria is soluble in saliva. The fundamental problem associated with acid production in the oral cavity, caused by metabolism of sucrose, lies in the production, by Gram-positive bacteria, of plaque which is deposited on the enamel of teeth. That plaque protects the acid from dissolution by saliva, since plaque is not soluble in saliva. Thus, the acid is fixed to the enamel of teeth with the resultant formation of acid-induced caries.
The above discussion presents a solution to this seeming dilemma. If a foodstuff could be found which is metabolized by Gram-positive bacteria, which generate acid and thus prevents Gram-negative bacteria from actively metabolizing protein, but which acid so generated is not insoluble in saliva, the problem of breath malodor could be solved without introducing the associated problem of enhancing the formation of caries.
Of course, if the formation of caries is not deemed critical, i.e., in cases where only small amounts of a comestible is to be ingested or where the comestible is ingested infrequently, then the problem of breath malodor can be even more effectively addressed by the inclusion of a sugar component.
Whether a sugar ingredient is present or not, inulin, a naturally-occurring class of fructooligosaccharide molecules, has long been known for its ability to resist human enzymes and reach the colon largely undigested where the inulin is broken down to short chain fatty acids by intestinal microflora.
It is understood that most intestinal microflora cannot metabolize inulin. However, the presence of inulin stimulates the growth of bacteria that do metabolize inulin, i.e. bifdobacteria and lactobacilli. It is for this reason that inulin is deemed a beneficial agent in the treatment of intestinal disorders.
There has been no suggestion in the medical or dental literature that inulin could have an impact in the prevention or alleviation of breath malodor. However, it is known that many streptococci, which are Gram-positive bacteria, present in the oral cavity, can metabolize inulin to produce acid. It is speculated that inulin can thus reduce breath malodor in the same manner as does sucrose. However, while inulin reduces pH in the oral cavity, as does sucrose, it is questioned whether inulin would stimulate the development of tooth caries.
Prior art pertinent to the above discussion includes U.S. Pat. No. 4,311,722. The '722 patent discloses a hard candy having excellent color and long shelf-life which contains 50% or more fructose. The hard candy may optionally include dextrin and inulin or cellulose gums. The dextrin and inulin of the fructose-containing hard candy glass during manufacture. The inulin constituent represents between 0 to about 20% of the hard candy. When included in the hard candy, the inulin is preferably present in an amount of about 1% to about 10% by weight, based on the total weight of the candy.
U.S. Pat. No. 5,286,501 is directed to a petroleum wax-free chewing gum having enhanced flavor release and breath freshening. The chewing gum of the '501 patent includes a petroleum wax-free gum base which contains at least 1 wt. % of at least one elastomer plasticizer and at least 0.01 wt. % of a flowing agent. An especially important requirement of the chewing gum of the '501 patent is that the gum base have an average weighted Solubility Parameter of from about 16 to 21 S.P.U.s and that at least 5 wt. % of the flavoring agent has a Solubility Parameter of from about 0.5 S.P.U. greater than, or less than, the weight Solubility Parameter of the gum base. The chewing gum of the '501 patent preferably includes binders and bulking agents. When present these agents may be corn syrups, inert sugar syrups, hydrogenated starch hydrolysates, sucrose syrups and oligosaccharides.
U.S. Pat. No. 5,342,631 relates to another petroleum wax-free chewing gum. This gum contains a binder containing at least 35 weight percent of at least one poorly metabolized oligosaccharide having noncariogenic characteristics. The average degree of polymerization ranges from at least 3 to about 50 although the degree of polymerization may be as high as 100.
BRIEF SUMMARY OF THE INVENTION
It has now been discovered that an inulin-containing comestible significantly controls breath malodor with or without the inclusion of a sugar ingredient.
In accordance with the present invention a comestible product selected from the group consisting of a tablet, a pressed tablet, a lozenge, a hard candy and a chewy candy is provided which comprises between about 40% and about 95% inulin, between about 5% and about 60% formentable carbohydrate and between about 0.02% and about 0.3% divalent zinc or copper compound, said percentages being by weight, based on the total weight of the comestible product.
In further accordance with the present invention a chewing gum is presented which includes between about 40% and about 95% inulin, between about 5% and about 60% of a second component selected from the group consisting of a polyol, a formentable carbohydrate and mixtures thereof, between about 0.02% and about 0.3% divalent zinc or copper compound and between about 5% and about 50% gum base, said percentages being by weight, based on the total weight of the chewing gum.
In further accordance with the present invention, a method of controlling breath malodor is set forth. This method comprises ingesting or chewing a breath malodor controlling effective amount of a comestible product which includes between about 40% and about 95% inulin, between about 5% and about 60% polyol and/or formentable carbohydrate and between about 0.02% and about 0.3% divalent zinc or copper compound, said percentages bein
Bell Joseph
Carroll Thomas J.
Cole Martin
Cooley Judith K.
D'Amelia Ronald
Hershey Chocolate and Confectionary Corporation
Scully Scott Murphy & Presser
Tran S.
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