Anti-microbial breath freshening mouthrinse

Details Anti-microbial breath freshening mouthrinse Anti-microbial breath freshening mouthrinse

2003-02-05

2004-04-20

Rose, Shep K. (Department: 1614)

Drug, bio-affecting and body treating compositions

Dentifrices

Ammonia, amine, or derivative thereof

C424S049000

Reexamination Certificate

active

06723305

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to an anti-microbial breath freshening mouthrinse that contains cetylpyridinium chloride (abbreviated herein to “CPC”) and zinc ion. More particularly the invention relates to a mouthrinse that contains CPC and zinc ion and an ionone terpene ketone.
BACKGROUND OF THE INVENTION
It has been known that a mouthrinse composition that contains zinc ions and alpha or beta ionone terpene is effective to reduce mouth odor in humans. This is discussed in U.S. Pat. No. 4,689,214. The zinc ion is provided by a non-toxic organic zinc or inorganic zinc compound. These compositions are effective in counteracting breath odors. However, it has been found that mouthrinse compositions that contain CPC and zinc ions, and in particular zinc acetate have an improved affect in providing fresher breath. This composition can also contain alpha or beta ionone terpenes for additional counteracting of breath odors. However, it is a synergistic anti-microbial effect of CPC and zinc ions that is most effective in providing fresher breath.
BRIEF SUMMARY OF THE INVENTION
A new mouthrinse containing cetylpridinium and zinc salt (CPC/Zn) significantly reduced mouthodor scores caused by volatile sulfur compounds in clinical studies versus a control rinse. It also can contain an ionone terpene. This investigation examined the antimicrobial effects of these rinses in laboratory and clinical studies. Laboratory tests were performed with oral bacteria with alamar blue, a redox dye that rapidly detects bacterial viability. A Treatment of
A. viscosus, S. sanguis
, and
S. mutans
by CPC/Zn resulted in a 25, 35 and 16% decrease in bacterial viability respectively versus a control In one study a randomized, double blind clinical study with volunteer subjects was conducted to confirm these laboratory results. After a washout phase, the subjects abstained from oral hygiene and provided a saliva sample for determining the total and oral odorigenic producing bacteria on enriched and indicator plates. Mouthrinses were used once and the subjects sampled at 90 and 180 minutes post treatment for total and oral odorigenic bacteria. In a comparison to a control, the decrease of total bacteria following CPC/Zn use at 90 and 180 minutes were 59.9% and 32.1% respectively. The use of CPC/Zn resulted in 61.7% and 72.5% decrease of odorigenic bacteria at 90 and 180 minutes respectively versus a control rinse. The decrease in bacteria with a CPC/Zn rinse was significantly higher than the control rinse at all post-use time points.
DETAILED DESCRIPTION OF THE INVENTION
There are various strains of bacteria that are present in the mouth. Many of these aid in the production of volatile sulfur compounds that cause mouth odor. These include the following bacteria:
Actinobacillus
Actinomycetemitans
Campylobacter recta
Capnocytophaga sp.
Eikenella corrodens
Fusobacterium nucleatum
Porphyromonas gingivalis
Prevotella intermedia
Actinomyces naeslundii
Actinomyces viscous
Actinomyces mutans
Streptococcus mutans
Streptococcus sanguis
For a mouthrinse the CPC will be in the mouthrinse composition in an amount of about 0.0005 percent to about 3 percent by weight, and preferably about 0.01 percent to about 1 percent by weight, The primary component of such a mouthwash usually will be water.
In accordance with a preferred embodiment, this invention relates to an oral composition consisting essentially of a non-toxic zinc compound, usually with salt, in an amount which provides at least about 0.01 mg of zinc ions in 1 ml of water. The ratio of zinc ions to the CPC being about 100:1 to 2:1 by weight, and preferably about 50:1 to about 4:1 by weight.
The zinc compounds that provide zinc ions for use in combination with the CPC may be any physiologically acceptable zinc compound including water soluble (inclusive of sparingly water soluble) organic and inorganic zinc compounds. The water-soluble zinc compounds (at least 1% soluble) are preferred. Examples of suitable zinc compounds that may be employed include:
zinc acetate
zinc fluoride
zinc ammonium sulfate
zinc formate
zinc bromide
zinc iodide
zinc chloride
zinc nitrate
zinc chromate
zinc phenol sulfonate
zinc citrate
zinc salicylate
zinc dithionate
zinc sulfate
zinc fluosilicate
zinc gluconate
zinc tartarate
zinc succinate
zinc glycerophosphate
Other zinc compounds disclosed in U.S. Pat. No. 4,138,477 having a solubility of a least about 0.01 mg of zinc ions per ml water are incorporated by reference.
The zinc compounds is present in amounts which provides about 0.01-5% by weight of zinc ions and preferably about 0.02-1% of zinc ions by weight in the oral composition.
The mouthrinse composition preferably also will contain an alpha or beta ionone terpene. Ionone is a ketone terpene derivative containing one ketonic carbonyl group. The basic ionone formula is (CH
3
)
3
(C
6
H
6
)
2
(CH CO CH
3
)
3
. It is available as alpha-ionone (b.p. 120 degree. C.) and beta-ionone (b.p. 135.degree.), both of which are colorless liquids and slightly soluble in water. It is employed in oral compositions in amounts such that the ratio of zinc ions to ionone is about 1,000:1 to 10:1 by weight. Other variants of ionone such as gamma-ionone dihydroionone and alphamethyl ionone may also be employed. These include isomeric forms of ionones, e.g. irone. It is convenient to employ it in oral compositions in amounts of about 0.0005-1% by weight, preferably about 0.001-1%. Alpha-ionone is the preferred mouthrinse ionone variant.
Any suitable flavoring or sweetening materials may be employed in the mouthrinse or other composition. The presence of flavoring oil improves the taste of the zinc-containing product. Examples of suitable supplemental flavoring oils include oils of spearmint, peppermint, wintergreen, sassafras, clove, sage eucalyptus, marjoram, cinnamon, lemon and orange, as well as methylsalicylate. Mint oils such as oil of peppermint is most preferred. Suitable sweetening agents include sucrose, lactose, maltose, sorbitol, sodium cyclamate, saccharine, acetosulfam, N-1 alpha.-asparty1-1-phenylalanine-methyl ester (“aspartame”), xylitol, chalcone materials. Suitably, flavor and sweetening agents may together comprise from about 0.01 to 5% by weight or more of the compositions of the instant invention, each typically being about 0.005-2.5%.
A fluorine-containing compound having a beneficial effect on the care and hygiene of the oral cavity, e.g., diminution of enamel solubility in acid and protection of the teeth against decay may also be incorporated in the composition. Examples thereof include sodium fluoride, potassium fluoride, potassium stannous fluoride (SnF
2
—KF), sodium hexafluorostannous, stannous chloroflouride, sodium fluorozirconate, and sodium monofluorophosphate. These materials, which disassociate or release fluorine-containing ions in water, suitably may be present in an effective but non-toxic amount, usually within the range of about 0.01 to 1% by weight of the water-soluble fluorine content thereof.
When the oral preparation is a liquid such as mouth rinse or mouth spray which typically contains 20-99% by weight of an aqueous vehicle comprising non-toxic lower aliphatic, preferably having about 1-30% by weight alcohol such as ethanol, n-propyl, or isopropyl alcohol with the remainder water. Flavor and/or sweetener and surface active agent are also generally present. Mouth sprays also contain a suitable amount of an orally acceptable propellant materials such as a fluorocarbon, e.g. Freon or isobutane to propel the spray from a pressurized container. The CPC/Zn/ionone can also be delivered in dentifrices, gums, lozenges, breathe strips or any other technique suitable to deliver the material into the mouth.
The oral presentations should have a PH practicable for use. The pH range of about 4-9, preferably about 5-7.5, is considered the most practicable for use.
The following examples further illustrate preferred embodiments of the invention.


REFERENCES:
patent: 4416867 (1983-11-01), Ritchey et al.
patent: 4689214 (1987-08-01), Niles et al.

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