Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
1999-12-30
2003-08-19
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
C424S054000, C514S836000, C514S901000
Reexamination Certificate
active
06607711
ABSTRACT:
FIELD OF INVENTION
This invention relates to a mouth hygienic composition, which is useful in preventing or reducing bad breath, in particular for the treatment of halitosis, in the prevention of plaque formation, gingivitis and calculus and thus suitably facilitate the development of a healthy mouth hygiene. It also relates to the use of a particular metal chelate in the composition and a method for using the composition.
BACKGROUND OF THE INVENTION
It is widely accepted that for many people the affliction of halitosis (bad breath) may constitute a serious problem, particularly in social encounters. The breath malodour may be very severe and it may occur e.g. occasionally, regularly, or chronically and at specific times of the day or month. For the purposes of this application, the terms “bad breath”, “halitosis” and “breath malodour” all mean an unpleasant breath odour that is objectionable to others.
Public awareness and concern for this phenomenon are evidenced e.g. by the support of an estimated $850 million mouth wash industry in the United States of America, despite reports that commercially available products have no significant effect on breath malodour. Recent public opinion polls (taken between 1994 and 1995) have for example revealed that about 55 to 75 million Americans consider bad breath a principle concern in social encounters (J. L. Richter: Diagnosis and Treatment of Halitosis; Compendium 17 (1996); p. 370-386, and references quoted therein).
Studies on the etiologies of breath malodour agree that hydrogen sulphide (H
2
S), methyl mercaptan (CH
3
SH), and dimethyl sulphide (CH
3
SCH
3
), collectively referred to as volatile sulphur compounds (VSC) are the principal odourants in bad breath. Volatile sulphur compounds (VSC) originate from the anaerobic bacterial degradation of sulphur-containing amino acids within the oral cavity. It is now generally accepted that volatile sulphur compounds (VSC) constitute the major component of halitosis or bad breath originating from the oral cavity. It has also been shown that anaerobic, Gram negative bacteria are responsible for this odour production.
Consequently, all conditions which favour the retention of such a microbial flora predispose for the formation of VSC and thereby contribute to the development of halitosis. As substrates for odour production, the bacteria mainly utilize the amino acids methionine and cysteine present in e.g. proteins from a dietary intake. These amino acids contain sulphur and are metabolized by the bacteria to yield volatile sulphur compounds. These substances have an unpleasant odour, even in extremely low concentrations.
DESCRIPTION OF THE PRIOR ART
It is known that aqueous solutions of zinc salts used as mouth rinses reduce and inhibit VSC formation in the oral cavity. It is assumed that zinc ions form stable mercaptides with the substrate, with precursors of VSC or with the VSC directly, since zinc has an affinity for sulphur and oxidizes sulphhydryl groups. It has for example been established that zinc-containing chewing gum has an affect on VSCs in the oral cavity (S. M. W{dot over (a)}ler: The effect of zinc-containing chewing gum on volatile sulfur-containing compounds in the oral cavity; Acta Odontol. Scand. 55 (1997); p. 198-200).
Several examples of compounds suggested to be effective as halitosis inhibitors are described in the prior art. As an example, Canadian patent application no. 2,154,860 relates to an oral care product which contains alkali metal pyrophosphate and a water-soluble zinc polyamine complex capable of releasing zinc ions in an environment such as the oral cavity. The zinc polyamine complex is formed from a polyamine and a normally water-in-soluble zinc compound such as zinc oxide or zinc citrate. The aim is to provide a high-molecular weight water-soluble polyamine complex of a normally water-insoluble zinc compound which has utility as an ingredient of improved palatability and reduced astringency in oral care products. The water-soluble zinc polyamine complex is present in an aqueous solution which has a clear transparency and is without any visible evidence of a second phase which is distinct from the aqueous phase. Reference is made to the fact that the polyamines cited in the above-mentioned Canadian patent application have an average molecular weight of about 1,500 to 70,000. The invention described in Canadian patent application no. 2,154,860 is significantly different from the present invention, both in terms of the solubility of the zinc compound and in terms of the molecular weight of the composition used.
European patent application no. 0 522 965 A1 discloses a composition for use in the treatment of e.g. halitosis. The composition does not comprise a chelate of an amino acid with a metal ion.
U.S. Pat. No. 4,814,163 relates to a solid antitartar and mouth deodorant composition comprising a physiologically acceptable zinc compound, an ionone ketone terpene derivative, a mint flavour and a sodium or potassium gluconate, and having an acidic pH, in a sugar-free carrier. U.S. Pat. No. 4,814,163 does not disclose a mouth hygienic composition comprising a chelate of a metal ion with an amino acid.
In general, when metals such as zinc, manganese, magnesium, copper, iron, cobalt and others become surrounded by and bonded to amino acids, in a stable form, this is referred to as chelation or chelate formation. Such chelates are referred to in the art as e.g. metal amino acid chelates, mineral amino acid chelates and chelates comprising a metal ion and one or more amino acids. Furthermore, chelates are also often referred to in the art as socalled coordination compounds. The coordination compounds are very often slightly soluble, non-ionic complexes. In the present description, the term “metal amino acid chelate” is used in this meaning.
Chelation is the natural means for the body to transport minerals across the intestinal wall as part of digestion. The body is very efficient at absorbing amino acids in this way. In a priority list of nutritional substances crossing the intestinal wall after digestion, amino acids rank highly. In fact, 95% of all amino acids are absorbed. Chelating minerals such as metal ions to these amino acids facilitates the transport of the mineral across the intestinal wall. In this respect it is very important for the mineral to have a stable bond to the amino acid.
U.S. Pat. No. 5,516,925 relates to mineral amino acid-chelates specifically as supplementary mineral sources for use in human or animal nutrition. It does not relate to a mouth hygienic composition, but is concerned with facilitating the absorption in the gut and mucosal cells of the amino acid chelate.
Water-soluble as well as water-insoluble zinc compounds have also been utilized as physiologically active ingredients in oral care preparations. Water-soluble and highly ionized zinc compounds, such as zinc chloride, would appear to provide a valuable source of bioavailable zinc ions. However, zinc chloride in aqueous solution tends to form oxychloride and zinc hydroxides of low solubility, which results in a two-phase, cloudy solution. The pH of a conventional zinc chloride solution can be lowered to less than 4.5 through the use of mineral or organic acid buffers to provide a stable and clear solution. However, this method is not acceptable since the resultant oral care product exhibits severe astringency and an undesirable sour taste.
Other zinc salts, such as e.g. zinc acetate and zinc citrate, have been used for the prevention of halitosis. However, zinc acetate and zinc citrate also have a high degree of astringency and an undesirable metallic taste. As a consequence of these undesirable characteristics, there has been a long felt need for a zinc-containing compound which is capable of reducing and/or eliminating halitosis. It would be desirable to provide the zinc-containing compound as part of a mouth hygienic composition which dissolves slowly and under controlled conditions in the environment of the oral cavity so as to provide an effective contact between the zi
Jacobson & Holman PLLC
Jagoe Donna
Krass Frederick
LandOfFree
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