Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
1994-01-06
2002-10-15
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
C514S643000, C514S358000, C514S635000, C424S052000, C424S054000
Reexamination Certificate
active
06465521
ABSTRACT:
The present invention relates to novel compositions which desorb bacteria and other microorganisms from solid surfaces and from living tissue.
The main use contemplated for the compositions of the present invention is in oral hygiene. Compositions of the invention can also be used in entirely different applications, where microorganisms are to be removed from surfaces to which they are attached, or where enhanced microbial adhesion to oil droplets is desired.
According to the present invention there is now provided a composition for desorbing bacteria from solid surfaces and from living tissues, which is in the form of a two-phase preparation, and which upon shaking forms a temporary oil-in-water emulsion of limited lifetime said composition comprising:
a) about 50 to about 97% w/w of an aqueous phase;
b) about 3 to about 50% w/w of a water immiscible oily phase, comprising a vegetable oil, a mineral oil, a pharmacologically acceptable aliphatic hydrocarbon or a mixture thereof; and
c) about 0.003 to about 2.0% w/w of an amphipathic cationic moiety in an effective amount to enable the formation of said temporary oil-in-water emulsion which emulsion breaks down and separates within a period of about 10 seconds to thirty minutes of the formation thereof.
Amongst edible oils, which can be used to form said water immiscible oily phase there may be mentioned oils such as olive oil, corn oil, coconut oil, soybean oil, safflower oil. There can also be used a wide variety of pharmacologically acceptable hydrocabons such as octane, decane, tetradecane, hexadecane, xylene, white mineral oil, and mixtures thereof etc.
Amongst suitable colors, there may be mentioned colors of triphenylmethane, naphthol, xanthene, monoazo, pyrazol, anthraquinone and cationic colors; examples include Food Blue 2 and its ammonium salt; D&C Yellow No. 7, D&C Yellow No. 10, D&C Yellow Nos. 4, 6, 22, 28, 33 or 40; D&C Green No. 5, D&C Orange No. 11, D&C Red Nos. 19 and 37, Basic Blue Nos. 6, 9, 41, 99, etc.
Preferably said amphipathic cationic moiety is selected from pyridinium core surface-active cationic molecules such as cetylpyridinium chloride, laurylpyridinium chloride, etc.; from chlorhexidines such as chlorhexidine, its diacetate, chlorhexidine digluconate, chlorhexidine dihydrochloride; from monalkyl quaternary ammonium compounds (quats) such as benzalkonium chloride, cetalkonium chloride and bromide, lauralkonium chloride and bromide, soytrimonium chloride, PEG-5 stearyl ammonium lactate; from dialkyl quaternary ammonium compounds (diquats) such as dilauryl dimonium chloride, dicetyl dimonium chloride and bromide, dequalinium chloride, soyamido propyl benzyldimonium chloride, quaterniums such as quaternium 15 and polyquaterniums, etc; amine fluorides, from cationic polysaccharides, such as chitosan and its derivatives; from cationic polypeptides, such as poly L-lysine, poly D-lysine, lysozyme.
In especially preferred embodiments of the present invention said amphipathic cationic moiety is selected from cetylpyridinium chloride, a chlorhexidine compound, chitosan, chitin derivatives, poly L-lysine and lysozyme.
The invention also provides a method for enhancing microbial adhesion at an oil-water interface comprising admixing an aqueous microbial suspension and oil in the presence of an amphipathic cationic moiety.
In U.S. Pat. No. 4,525,342, Weiss et al. have described an essentially detergent free mouthwash based on a combination of an oily phase and an aqueous one. This composition must be marketed in a two-compartment squirt bottle, and the user swishes the two phases in his mouth in order to attain the desired effect. The composition is based on the attachment of amphipathic substances to the oil droplets during the swishing action, thus coating the oil droplets. The presence of detergents is reported to be deleterious in said patent. Various deleterious physiological effects have been reported regarding the use of detergents in the oral cavity. It has been reported that the presence of detergents prevents, or at least decreases adhesion of microorganisms to oil droplets as is taught, e.g. by the statement: “The aqueous bacterial suspension must be free of surfactants, which inhibit the assay” (M. Rosenberg, 1984. Bacterial Adherence to Hydrocarbons: A Useful Technique for Studying Cell Surface Hydrophobicity. FEMS Microbiology Letters 22, 289-295). In a recent review on hydrophobic interactions and adhesion, the authors write: “Our appreciation of the extent to which hydrophobic interactions mediate various bacterial adhesion phenomena could be greatly augmented by including agents that interfere with hydrophobic interactions (e.g., surfactants, chaotrophic agents) in adhesion assays (M. Rosenberg and S. Kjellerberg, 1986, Hydrophobic Interactions: Role in Bacterial Adhesion. Advances in Microbial Ecology 9, 353-393). Moreover, in a previous study which did examine the effect of some cationic amphipathic antibacterial agents on adhesion of relatively non-hydrophobic
Escherichia coli
strains to xylene, the cells were exposed to the cationic agents, but the cationic agents were subsequently removed by washing the cell pellet prior to addition of the xylene, presumably to avoid inhibition of the adhesion in the presence of the cationic agents (B. M. A. El-Falana, D. T. Rogers, A. D. Russell and J. R. Furr. 1985 Effect of Some Antibacterial Agents on the Hydrophobicity of Wild-Type and Envelope Mutant of
Escherichia coli
. Current Microbiology 12, 187-190). Similarly, chlorhexidine, an amphipathic, surface-active cationic agent commonly incorporated into mouthwashes has been shown in many studies to inhibit microbial adhesion to surfaces. For example, J. McCourtie, T. W. MacFarlane and L. P. Samaranayake (Effect of saliva and serum on the adherence of Candida species to chlorhexidine-treated denture acrylic, J. Med. Microbiology, 21:209-213, 1986) showed that treatment of saliva- or serum-coated acrylic with chlorhexidine gluconate reduced adherence by between 19 and 86%.
Moreover, whereas salts such as sodium chloride have been generally considered to enhance microbial adhesion to surfaces, it has now been found that the presence of inorganic cations, such. as sodium and magnesium cations, inhibit the stimulation of adhesion brought about by cationic moieties such as cetylpyridinium, chlorhexidine, chitosan, poly L-lysine, poly D-lysine and lysozyme.
The main use of the compositions is in the form of mouthwashes, which effectively remove a large percentage of microorganisms, debris and other odor-causing materials from the surface of teeth and from the oral cavity. Thus especially preferred embodiments of the present invention relate to a mouthwash as defined above comprising about 0.003 to about 0.5 w/w of an amphipathic cationic moiety in an effective amount to enable the formation of said temporary oil-in-water emulsion which emulsion breaks down and separates within a period of about 10 seconds to thirty minutes of the formation thereof.
The novel compositions comprise, in combination, an organic water-immiscible phase and an aqueous phase, and a small quantity of an amphipatic cationic moiety, which is adequate to form upon vigorous mixing an emulsion of brief life-time. In addition, the composition may comprise additional cationic agent or agents which enhance adhesion to oil droplets, as shall be illustrated later. Optimally, the composition should be relatively free from interfering cations, such as sodium, potassium and magnesium and therefore preferably contain only up to 0.3% of inorganic salts.
In use, the two phases are mixed by shaking, and an emulsion is formed which is used for swishing in the mouth, and which has a limited life time, of the duration of about 10 seconds to about 30 minutes. A small amount of amine fluoride which tends to stabilize the emulsion for a brief period of time and has other beneficial (e.g. anticaries, antibacterial) effects may also be added.
There may also be incorporated certain additives such as fragrances, colors and the like.
While the invention wi
Hoffman Wasson & Gitler PC
Ramot University Authority for Applied Research & Industrial Dev
Travers Russell
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