Drug – bio-affecting and body treating compositions – Dentifrices – Oxygen or chlorine releasing compound containing
Reexamination Certificate
1998-08-03
2002-02-19
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Oxygen or chlorine releasing compound containing
C424S049000, C424S058000, C424S616000
Reexamination Certificate
active
06348187
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates generally to mouthwashes for the prevention and elimination of bad breath as well as for the reduction of oral microorganisms resonsile for the development of dental plaque and tooth decay. Dental plaque can lead to the formation of calculus, gingivitis and other related gum diseases. In particular, the present invention relates to a mouthwash which is effective in preventing these problems and which contains both hydrogen peroxide and one or more essential oils (hereinaer referred to as “a hydrogen peroxide/essential oils containing mouthwash”. The mouthwash may be a high alcohol mouthwash (e.g., containing up to about 25-30% by volume of alcohol), a reduced alcohol mouthwash or an alcohol-free mouthwash with the reduced alcohol mouthwash being particularly preferred. The invention also relates to a two-part mouthwash system for delivering and preparing the mouthwashes of this invention.
2. Description of Related Art
Oral rinse and mouthwash compositions have been used by people for many years for the prevention of bad breath and for the elimination of bacteria and other oral microorganisms that are responsible not only for bad breath but also tooth decay, plaque and gum diseases such as gingivitis and periodontitis. To this end, antiseptic mouthwashes in the past have been designed to clean the oral cavity, provide fresh breath and kill these pathogenic microbes.
Thymol, a well known antiseptic compound also known as an essential oil, is utilized for its antimicrobial activity in a variety of mouthwash preparations. In particular, thymol can be utilized in oral hygiene compositions such as mouth rinses in sufficient quantities to provide desired beneficial therapeutic effects. Listerine®-brand mouthwash is a well-known antiseptic mouthwash that has been used by millions of people for over one hundred years and has been proven effective in killing microbes in the oral cavity that are responsible for plaque, gingivitis and bad breath. Thymol, together with other essential oils such as methyl salicylate, menthol and eucalyptol, are active ingredients in antiseptic mouth rinses such as Listerine®. These oils achieve their efficacy although present in small amounts. Without being restricted to any specific theory, it is now believed that the efficacy and taste of antiseptic mouthwashes such as Listerine® may be due to the dissolution of these four active ingredients. Dissolution is also important from an aesthetic point of view since a clear mouthwash solution is certainly preferred by consumers to one that is cloudy, turbid or heterogeneous.
The leading antiseptic mouthwashes have always contained alcohol (i.e., ethanol) at fairly high levels, ranging from approximately 25 up to about 30% by volume, based on the total mouthwash volume (hereinafter referred to as “% v/v”). Alcohol is used both as a vehicle and as a solvent in which the active ingredients, and additives such as astringents, fluorides, color additives, flavor oils, and the like, can be dissolved and then dispersed into solution. Alcohol also provides a preservative role for the mouthwash during storage and use, and enhances the flavor oil organoleptic cues.
However, the use of high levels of alcohol has been recently challenged from an overall health standpoint, even though clinical data have not proven adverse health risk effects.
Merely reducing the levels of alcohol in these mouthwash compositions, however, has significant disadvantages. It has been found that lower alcohol levels result not only in a loss in the solubility of the actives and other ingredients in the composition, but there is also a noticeable decrease in the ability of the composition to kill the oral microorganisms responsible for bad breath, plaque and gum disease.
Hydrogen peroxide has been employed in alcohol and alcohol-free mouthwash compositions. While hydrogen peroxide is a known bactericide, it is not universally antiseptic and therefore its anti-plaque efficacy is suspect. Thus, a mouthwash composition containing anti-plaque effective essential oils and hydrogen peroxide which results in improved anti-plaque efficacy over compositions containing essential oils alone would be unexpectedly advantageous. Moreover, there is a substantial need for the development of a reduced alcohol mouthwash in which the essential oils are completely dissolved and that continues to be effective in the prevention of bad breath the killing of oral microbes and the resultant reduction or elimination of plaque.
The prior art reflects a number of attempts at formulating hydrogen peroxide-containing reduced alcohol and alcohol-free mouthwash compositions. For example, U.S. Pat. Nos. 5,310,546 and 5,174,990 disclose a mouthrinse formulation having between about 0.25% and about 0.65% by weight, based on the total volume of the composition (hereinafter referred to as “% w/v”), of hydrogen peroxide, between about 0.005% and about 0.1% w/v zinc chloride, at least about 0.03% w/v sodium lauryl sulfate, at least about 0.006% w/v citric acid, at least about 0.012% w/v sodium citrate and less than about 5% ethanol. The ethanol may be denatured with denaturing agents, generally in an amount less than 0.1% of the mouth rinse. The disclosed denaturing agents include anethole, anise oil, bay oil, bergamot oil, bitter almond oil, cedar leaf oil, cinnamon oil, clove oil, eucalyptol, eucalyptus oil, eugenol, lavender oil, menthol, peppermint oil, sassafras oil, spearmint oil, terpeneless spearmint oil, thyme oil, thymol and wintergreen oil, alone or in combination.
U.S. Pat. No. 4,900,721 discloses an aqueous disinfectant for disinfecting the skin and mucous membranes. The disinfectant may comprise 8 to 25% by weight ethanol, based on the total weight of the composition (hereinafter referred to as “% w/w”), 0.2 to 0.7% w/w hydrogen peroxide, 0.1 to 0.5% w/w of at least one carboxylic acid, such as lactic acid or benzoic acid, 0.05 to 1.0% w/w of at least one microbicidally active nitrogen-containing organic compound, such as chlorhexidine gluconate, 0.01 to 0.2% w/w of a microbicidally active compound, such as an ethereal oil containing 91.4% peppermint oil (90% menthol, 4.0% salicylic acid phenylester, 3.5% anethole, 0.6% eugenol and 0.5% thymol) and the balance water. This reference alleges that antimicrobial phenolic compounds produce a synergistic antimicrobial effect when combined with the other compounds. The reference also discloses adding an emulsifier at a ratio of 2:1 to 1:2 of the phenolic compound. The microbicidally active, nitrogen-containing organic compound is an essential component of the composition.
U.S. Pat. No. 4,431,631 discloses an oral aqueous solution containing 1 to 3% w/v hydrogen peroxide, 3-15% w/v of a polyhydric alcohol, such as glycerin or sorbitol, 3-10% w/v ethanol, 0.3 to 2% w/v of a nonionic water soluble polyoxyethylenated polyoxypropylene polyol surfactant, 0.3 to 2% w/v of a nonionic surface active water soluble polyoxyethylenated monester of sorbitol with C
10-18
fatty acid, a sweetener compound and a flavor selected from either (i) a wintergreen flavor containing methyl salicylate and menthol in a weight ratio of about 3:1 to 5:1 and (ii) a cinnamon flavor that is a propylene glycol solution containing about 6-9% menthol, 32-38% cinnamic aldehyde and 6-9% clove oil. This reference alleges that the specifically disclosed flavorants are not adversely affected by the hydrogen peroxide. In U.S. Pat. No. 4,537,778, an aqueous oral composition containing only 1 to 3% w/v hydrogen peroxide and the particular above-described flavorant is disclosed, but not exemplified. This patent describes the other components listed in U.S. Pat. No. 4,431,631 as preferred adjuvants.
U.S. Pat. No. 5,104,644 discloses a mouthrinse preparation having about 0.5 to about 3% w/v of hydrogen peroxide, at least 0.02% w/v zinc chloride, at least about 0.04% w/v sodium lauryl sulfate, at least about 0.08% w/v sodium citrate and about 2 to 3.5% w/v ethanol. Peppermint oil and menthol are used
Leung Sau-Hung S.
Pan Pauline
Rubin Michael
Federman Evan J.
Little Darryl C.
Rose Shep K.
Warner-Lambert & Company
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