Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
2001-11-30
2003-07-01
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Dentifrices
C424S058000, C424S725000, C424S055000, C424S742000
Reexamination Certificate
active
06585961
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to compositions comprising essential oils having antimicrobial activity with one or more cationic, anionic, or amphoteric surfactants having a hydrophilic-lipophilic balance (HLB) or about
16
or greater. In particular, this invention relates to the employment of the combined essential oils and surfactants as an effective antimicrobial and plaque removal oral rinse. Other uses are also contemplated such as a topical solution to kill microbes and remove biofilm from medical and dental equipment and tubing.
Essential oils have long been known to have some degree of antimicrobial properties and some degree of antiplaque activity. However, sufficient activity is lacking, until the present invention.
A wide variety of microorganisms are found in the oral cavity, and among these are gram-positive anaerobic rods associated with the development of plaque such as Corynebacterium, Nocardia, Neisseria, and Streptococci, such as S. mutens, S. bovis, S. salivarius, and gram-positive streptococci of the genus Peptostreptooccus.
In addition, there is also present in plaque relatively small amounts of other substances such as salivary proteins, carbohydrates, epithelial cells and leukocytes. These organisms play a key role in the etiology of plaque. The bacterial organisms associated with plaque formation produce a capsular material, which apparently causes the cells of the organism to adhere to each other, holding the plaque together and allowing for further growth. For example, one of the capsule forming bacteria, which occurs in large numbers in early plaque is Neisseria sicca.
Removal of plaque and/or calculus by a dentist is currently the only safeguard against serious gingival inflammation caused by the accumulation of significant amounts of plaque.
Conventional mouthwashes serve primarily to sweeten the breath, are formulated for that purpose, and are believed not to function in any in any significant way to loosen or remove plaque from the dental surfaces.
There is a definite need in the art for an oral hygiene composition which, when used alone, or in conjunction with a regular tooth brushing regime, renders the plaque present on the dental surface more susceptible to removal.
ESSENTIAL OILS
Essential oils which have the characteristic or flavor of the plant (or synthetically derived) from which they are obtained having long been used as antimicrobial agents. Most essential oils are composed of terpenes, oxygenated constituents, sesquiterpenes, and a small amount of a nonvolatile residue. The principal essential oil constituents can therefore be divided into two broad classes of organic compounds: those, which contain only carbon and hydrogen, and those, which contain carbon, hydrogen and oxygen.
The carbon-hydrogen essential oils include paraffins, olefins, aromatic hydrocarbons, terpenes (olefinic as well as mono and tricyclic) a few lower terpene homologs, sesquiterpenes (aliphatic as well as mono, bi, and tricyclic), diterpones, and azulenes. Of these the terpenes and sesquiterpenes are most characteristic of essential oils. The fundamental building block of the terpene series is the isoprene unit, sometimes called a hemiterpene. Two such units give rise to the terpenes; three to the sesquiterpenes, four, to the diterpenes.
The carbon hydrogen - oxygen essential oils usually represent the more soluble portion of the oil. In this very broad class are included alcohols, aldehydes, ketones, and esters. As in the case of the carbon-hydrogen essential oils, many types are to be found saturated and unsaturated aliphatic as well as aromatic compounds, and also terpenic and sesquiterpenic compounds (aliphatic, monocyclic, bicyclic, and in the case of the sesquiterpene compounds, even tricyclic). Other important constituents are phenols and phenolic ethers, acids (usually esterified), lactones, oxides, and coumarins. Of lesser importance are the furan derivatives, the coumarones, and the quinones.
As in the pharmaceutical industry where the chirality of the bioactivity drug can play an important part in the enhance activity, the same can be true with essential oils and their antimicrobial efficacy. When stereoisomerism occurs, the molecule can have enantiomers, which differ in structure only in the left - and right handedness of their orientations. Optical activity in essential oils exists primarily by having one or more chiral carbon atoms. Thus it is theoretically possible that one of the enantiomers has greater antimicrobial activity, then the racemic mixture. Of course, the separation of an optically active substance would require additional expense, and unless there was a dramatic improvement at relative low costs, this methodology would not be cost-effective. Nevertheless, the preparation or optically active separation resulting in a significant enhancement of antimicrobial and/or biofilm removal capability is incorporated into the body of this invention.
The following list illustrates the voluminous numbers of essential oils having varying degrees of antimicrobial activity (not all inclusive): anethol, anise oil, anol, bay oil, bergamot oil, camphor, carvacrol, carvone, cedar leaf oil, citronel, eucalyptol, eugenol, guaiacol, hinokitiol, Isoeugenol, lavender oil, lemon oil, d-limonene, linalool, menthol, methyl salicylate, mustard oil, oil of cajeput, oil of cubeb, oil of santal, osimen, peppermint oil, phenolics, phenyl salicylate, pimento, pine oil, rosemary oil, safrale sage oil, saligenin, sassafras oil, spearmint oil, storax, vanillin, wintergreen oil, and other similar constituents.
This invention is not limited by the above specific essential oils. Many of the above components can be further chemically modified to enhance antimicrobial activity and are therefore part of the specifications of this invention concerning essential oils.
Furthermore, the specification includes stereoisomers and/or geometrical isomers of essential oils having chirality, because it is known that there can be significant difference in antimicrobial activity between the isomers.
For the purpose of carrying out the experimental portion of this invention, the following well-known essential oils were utilized; thymol, menthol, eucalyptol, and methyl salicylate were used.
SURFACTANTS
Surfactants are often an important constituent of disinfectants. They are employed to achieve both uniform wetting of the surface to be treated and frequently an additional cleaning effect. This is why particular attention should be given to this group of substances when formulating a disinfectant, as there are many ways in which the two groups of compounds can interact. It is generally known that, for instance, anionic surfactants promote the inactivation of quaternary ammonium compounds. The same most likely applies to other positively charged biocides, e.g., betaines, guanidines, biguanides, etc. The inactivating effects are generally obtained with surfactant concentrations well above critical micelle concentration of about 0.75 to about 2.5 weight %.
In contrast at lower concentrations improvements of the biocide often occur. The cause of the improved action by additional of low quantities of surfactants is considered to be an accumulation of the agent within micelles of the surfactant which adsorb at the microorganism cell wall. The active substance thus becomes enriched at the cell wall which means that a lower does is required for the desired effect. The property of surfactant at a higher concentration to inhibit the action of antimicrobial agents is attributed both to complexing and solubilizing in surfactant micelles. In both cases, the availability of full antimicrobial active substance is reduced.
ALCOHOL
Several mouthwashes that have been marketed for the reduction of bacteria and the prevention of plaque build-up generally rely on a combination of biocides and ethanol.
Commercial products contain up to 26.9% ethanol. However, the use of alcohol containing formulations tends to produce unpleasant side effects including pain and stinging of the oral mucous, foul
Tate Christopher R.
Winston Randall
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