GB2436463A

GB2436463A - Breath deodoriser

Info

Publication number: GB2436463A
Application number: GB0705395A
Authority: GB
Inventors: Derek Samual David Norwood; Alan Stewart Gibson
Original assignee: Biofilm Ltd
Current assignee: Biofilm Ltd
Priority date: 2006-03-21
Filing date: 2007-03-21
Publication date: 2007-09-26
Also published as: GB0705395D0; GB0605634D0

Abstract

The present invention relates to a breath deodoriser. In particular, the present invention relates to a breath deodoriser capable of providing a low dose of zinc and/or a cetyl pyridinium salt to an oral cavity which has the effect of preventing and/or reducing breath malodour. In a preferred embodiment the deodorizer is in the form of a breath deodorizing strip. The deodoriser acts by delivering zinc and/or cetyl pyridinium chloride in an amount that can reduce or prevent the formation of volatile sulphur compounds in an oral cavity.

Description

BREATH DEODORISER

FIELD OF THE INVENTION

The present invention relates to a breath deodoriser. In particular, the present invention relates to a breath deodoriser capable of providing a low dose of zinc and/or a cetyl pyridinium salt to an oral cavity which has the effect of preventing and/or reducing breath malodour.

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BACKGROUND OF THE INVENTION * S *S*.

Bad breath, sometimes referred to as halitosis, is a * .* common and socially embarrassing condition and is found S..

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in both humans and animals. It is common for bad breath * *5 : 15 to be found in domestic pets such as cats and dogs.

*SS**S * * It is thought that bacteria located on the upper rear surface of the tongue (dorsum) towards the rear are C.' mainly responsible for the production of malodorous compounds resulting in bad breath. Tongue scrapers are commonly used in an attempt to remove such bacteria.

Various forms of bacteria found in the oral cavity are known to be responsible for the production of volatile sulphur compounds. it is the volatile sulphur compounds that cause mouth malodour and the resulting bad breath. These types of bacteria possess enzymes that transform sulphur amino acids into volatile sulphur compounds. One important enzyme is called cysteine desulfhydrase and catalyses the transformation of cysteine (or other thiol compounds) into hydrogen suiphide.

There have been many previous attempts to deodorise oral cavities using mouth rinses, lozenges, chewing gum, chewable tablets and mouth sprays. However, many problems exist with previous deodorising products such as relatively short term reduction in bad breath and high C, levels of active materials required.

US 2001/0022964 and US 2003/0206941, which are S...

: ..*. incorporated herein by reference, relate to fast S...

* dissolving orally consumable films which use essential S..

I

oils such as thyrnol, eucalyptol and methyl salicylate to provide antimicrobial efficacy and reduce the existence S. * S of bad breath. However, high oil films are difficult to manufacture and provide a rather short-term reduction in (.. bad breath.

GB-A-2173701, which is incorporated herein by reference, relates to compositions that prevent and control breath odour by containing as an essential ingredient, a salt which provides zinc ions and an ionone ketone terpene derivative. However, the compositions disclosed rely on higher than necessary levels of zinc ions to attack volatile sulphur containing compounds.

US-A-4,138,477, which is incorporated herein by reference, relates to compositions which prevent and control mouth odour by providing high levels of a zinc compound.

US-A-6,723,305, which is incorporated herein by reference, relates to a mouth rinse comprising cetylpyridinium chloride (CPC) and zinc ions. However, once again high levels of zinc are required with the intention of attacking volatile sulphur containing compounds residing in an oral cavity.

:..::: It is an object of at least one aspect of the * S..

: present invention to provide a breath deodoriser which S...

obviates or mitigates at least one or more of the S..

S

aforementioned disadvantages.

It is a further object of at least one aspect of the *....* * * present invention to provide a breath deodoriser capable of delivering a low dose of zinc to an oral cavity which C has the effect of preventing and/or reducing breath malodour.

SUMMARY OF THE INVENTION

According to a first aspect of the present invention there is provided a breath deodoriser comprising zinc and/or cetyl pyridinium salt, wherein said breath deodoriser is capable of delivering zinc and/or a cetyl pyridinium salt in an amount to reduce and/or prevent the formation of volatile sulphur compounds in an oral cavity.

The present invention may therefore relate to a synergistic effect occurring between zinc ions and a cetyl pyridinium salt which has a prolonged effect in reducing breath malodour.

The present invention relates to the surprising finding that by providing, for example, a low dose of zinc ions in combination with a low dose of cetyl

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pyridinium salt to an oral cavity in an efficacious amount, breath malodour may be prevented and/or reduced. *.

: The present invention is therefore intended to provide a S...

user with fresh breath. Although not wishing to be bound S..

S

by theory, the low level of zinc ions are thought to have an effect on enzymes such as desulfhydrase enzymes *SSSS* * S resulting in the formation of volatile sulphur compounds.

It is thought that the desulfhydrase enzymes which ( produce volatile sulphur compounds may be inhibited, at least partly inhibited and/or reduced in efficiency by the presence of a low dose of zinc ions. A low dose of zinc ions may therefore have an impact on volatile sulphur generating mechanisms present in an oral cavity.

Examples of microbial species thought to possess desulfhydrase enzymes capable of producing volatile sulphur compounds in an oral cavity are as follows: Actinobacillus sp; Cainpylobacter recta; Capnocytophaga sp.; Eikenella corrodens; Fusobacterium nucleatum; Porphyrornonas gingivalis; Prevotella intermedia; Viellonella sp.; Actinomyces naeslundii; Actinornyces visocosus; :..::: Streptococcus mutans; and 11.

Streptococcus sanguis.

A low level of zinc ions in combination with cetyl S..

: pyridinium salt in an oral cavity may therefore disable, *.. S at least partly disable and/or reduce the efficiency of * S the enzymes (possessed by above and other. oral species) to produce volatile sulphur containing compounds. The low level of zinc ions may therefore perform a blocking action on the enzyme.

The concentration and amount of zinc therefore provided in the present invention is not chosen to react with the volatile sulphur compounds themselves but rather, although not wishing to be bound by theory, chosen to disable enzymes producing volatile sulphur compounds such as the desulfhydrase enzymes. As the enzymes forming the volatile sulphur compounds are thought to have been at least partly disabled or reduced in efficiency, the production of volatile sulphur compounds may be minimised or prevented. Therefore, in the event that existing volatile sulphur compounds in an oral cavity are neutralised or deodorised, then an oral cavity may remain free of malodorous compounds for the period in which the desulfhydrase enzymes may be disabled and/or prevented from producing further volatile sulphur compounds.

The present invention may include any suitable form : . or mixture of zinc compounds that may have the effect of * S *S*.

* disabling and/or reducing the efficiency of enzymes producing volatile sulphur compounds such as the S..

S

desulfhydrase enzymes. * *S

:.: : 15 The zinc compound may be selected from any suitable * S combination of water soluble and/or water insoluble zinc compounds.

The zinc compound may also be provided in combination with another metal based compound other than zinc.

The zinc compound may be selected from any one of or combination of the following: organic or inorganic zinc salts; organic or inorganic zinc based polymers or copolymers; zinc based esters; zinc based ketones or aldehydes; zinc alkali or acid based derivatives; zinc based amides; zinc halides; zinc organo-halide derivatives; zinc based fatty acid derivatives; zinc based sugar derivatives; and zinc based amino acid derivatives.

A non-limiting list of suitable zinc compounds that may be employed either singly or in any combination are as follows: zinc acetate; zinc acetate (dihydrate); zinc acetylacetonate;

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zinc acrylate; S. * . :..::: zinc arnmonium sulphate; **S.

zinc benzoate; * S. * . . **..

zinc bromide; 0*S * : zinc beryllium orthosilicate; S.. * * 15 zinc borate; *..... * .

zinc butylphthalate; zinc butyixanthate; ( zinc caprylate; zinc carbonate; zinc chioroanilate; zinc chlorate; zinc chromate; zinc citrate; zinc chloride; zinc cyclohexanebutyrate; zinc dithionate; zinc gallate; zinc formate; zinc fluoride; zinc fluorosilicate; zinc aipha-glucoheptonate; zinc gluconate; zinc glycerophosphate; zinc hexafluorosilicate; zinc hydroxide; C 10 zinc 8-hydroxyquinoline; : .. zinc 12-hydroxystearate; * 0 zinc iodide; * 0. * . * **.*

zinc isovalerate; *0*

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zinc D-lactate; * ** * * S zinc DL-lactate; *..** * . zinc laurate; zinc methacrylate; ( zinc molybdate; zinc naphthenate; zinc nitrate; zinc octanoate; zinc oleate; zinc orthosphosphate; zinc oxide; zinc phenolsulfonate; zinc propionate; zinc pyridine-2-thiol-1-oxide; zinc pyrophosphate; zinc resinate; zinc ricinoleate; zinc salicylate zinc selenide; zinc stearate; zinc succinate; zinc sulfanilate; C: zinc sulfate; : zinc tartrate; q.. * S

zinc tellurate; * *5 zinc tribromosalicylanilide S. J

S

zinc tungstate; * S. : 15 zinc valerate; and S..... * a

zinc vanadate.

Therefore, any suitable zinc containing compound may be used in the breath deodoriser to provide a low level dose of zinc in an oral cavity to disable, at least partly disable and/or reduce the ability of enzymes to produce volatile sulphur containing compounds. In contrast to previous breath deodorising products, the present invention allows a much lower level of zinc to be used which therefore provides a safer product to be ingested by a consumer.

Typically, the breath deodoriser may provide a dose of zinc of less than about 1.0 mg, less than about 0.8 mg, less than about 0.6 mg, less than about 0.5 mg, less than about 0.4 mg, less than about 0.2 mg, less than about 0.1 mg, less than about 0.05 mg, less than about 0.01 mg, less than about 0.005 mg, less than about 0.002 mg or less than about 0.001 mg.

The stoichiometric ratio of zinc ions to sulphur ions in the present invention may be in excess of 1:1, or substantially in excess of 1:1. For example, the stoichiometric ratio of zinc ions to sulphur ions may be **** in the region of about 200:1 or about 80:1. * ..

Typically, the breath deodoriser may provide a dose I..

S

* of cetyl pyridinium salt in an amount of about 0.01 -10 :,, : 15 mg, about 0.05 -5 mg, about 0.05 -1 mg, about 0.05 -***..I * S 0.5 mg, about 0.1 -0.2 mg or about 0.125 -0.156 mg.

The cetyl pyridinium salt may be any suitable salt C (e.g. any inorganic salt) such as a halide salt based on chloride, bromide, iodine or fluoride. Alternatively, the salt may be a sulphate, a phosphate, an acetate, a carbonate, a citrate, a hydroxide, a nitrate or a nitrite. Preferably, the cetyl pyridiniuin salt may be cetyl pyridinium chloride.

It is found that the combination of the zinc and the cetyl pyridinium chloride exhibits a synergistic and surprising effect towards the control of breath malodour.

The breath deodoriser may be in any suitable form such as any of the following: a, film; a strip; a mouthwash; a spray; chewing gum; a lozenge; a chewable tablet; toothpaste; or dental cream. Therefore, any suitable method of supplying a low dose of zinc to an oral cavity may be used.

Typically, the breath deodoriser may be in the form of a strip (i.e. a breath deodorising strip) which may be suitable for contact and adhere with a surface in an oral cavity of a human or animal. The breath deodorising strip may comprise a single layer, may be in the form of a bi-layer or may comprise multi-layers. * ***

The breath deodorising strip may comprise a layer * ** having a water-dispersible edible material such as a *** water-soluble polymeric edible material in the form of a matrix which is intended to dissolve in an oral cavity.

* ..S..

* The layer containing the water-dispersible edible ( material in the form of a matrix may also comprise the zinc containing compound. The zinc and/or cetyl pyridinium salt in the breath deodorising strip may be provided in a single layer of the strip or may be impregnated substantially throughout multiple layers in the breath deodorising strip. Alternatively, the zinc and/or cetyl pyridinium salt containing compound may simply be deposited onto a strip of water-dispersible edible material.

The breath deodorising strip may dissolve rapidly in the oral cavity and thereby deliver the required dose of zinc and cetyl pyridinium salt. Typically, a user may place the breath deodorising strip on the upper surface of a tongue, thereby allowing the zinc to be provided to the oral cavity where the majority of the desulfydrase enzymes and volatile sulphur compounds may be located. By placing the breath deodorising strip on the tongue facilitates the zinc and/or cetyl pyridinium salt being delivered to enzymes on the tongue thereby allowing the strip to provide relatively fast alleviation from bad I. * * * breath. * * S...

The breath deodorising strip has a thickness of at * ** ***. least an order of magnitude less than the width and S..

length thereof. Typically, the strip may be substantially * ** rectangular in shape, but any shape of strip (e.g. S.....

* substantially rounded rectangle, substantially oval, (. substantially square, substantially circular) may be used. The strip may have a minimum thickness of about 10 urn to prevent the strip from being damaged in handling.

The strip may have a preferred maximum thickness of about 500 pm, or more preferably about 200 pm, so that the physical dimensions of the strip do not prevent the body from dissolving in a desired period of time in an oral cavity e.g. by the action of saliva. Typically, the thickness of the strip may be in the range of about 20 to pm, and more usually about 30 to 70 pm.

The strip may have a width and length sufficient to cover at least a part or a substantial part of an area of the top of the back of a tongue of a user. Therefore, in the case of a strip for use on a human tongue, the width of the strip may be approximately about 0.1 to 5 cm or preferably about 1 to 4 cm and the length may be about 0.1 to 6 cm or preferably about 1 to 3 cm. In the case of a strip for use with a domestic dog, the maximum width may be about 5 cm, and the maximum length may be about 8 cm. A larger strip may therefore be required to cover a S...

substantial portion of a tongue of a dog.

S..: The minimum width of the breath deodorising strip S..

may be about 0.1 cm and the minimum length of the strip * *S :.: * may be about 0.5 cm also. This means that the breath S.....

* deodorising strip remains easy to handle and is ( applicable to both the oral cavities of humans and small animals such as cats and dogs.

In alternative embodiments, the strip may be chopped-up or Comrninuted into small pieces of about 1 mm X 1mm and used in, for example, toothpaste.

The breath deodorising strip may be dry, by which is meant that the strip is dry to the touch. However, the strip may contain approximately about 1 to 20% by weight or about 1 to 10% by weight of residual water which remains after a manufacturing process.

The breath deodorising strip may rapidly dissolve in water/saliva in an oral cavity. By rapid dissolution is meant that the water-soluble components (e.g. the water-dispersible material) of the strip preferably dissolves, or substantially dissolves, in a maximum time of about 5 minutes to provide effective breath deodorising action.

The released zinc and/or cetyl pyridinium salt or at * 10 least part of the released zinc and/or pyridinium salt may become attached to a surface of an oral cavity e.g. a top surface of the tongue or the side of the mouth. Zn a... attached to a surface of an oral cavity may then disable or at least partly disable volatile sulphur generating a.

mechanisms.

A suitable test procedure for dissolution time is * *....

* a given in British Pharmacopoeia 2003 Appendix XII, Tablet ( and Capsule Disintegration.

The breath deodorising strip may therefore dissolve quickly when it is applied to a surface of an oral cavity, thereby preventing the recipient such as a person or animal from changing the location of the strip, or even expelling the strip from an oral cavity completely, by swallowing it, or otherwise.

Typically, the maximum time for the dissolution of the breath deodorising strip in an oral cavity may be about 60 seconds and the minimum time would be about 1 second. Conveniently, the breath deodorising strip substantially dissolves in about 3 to 30 seconds or in the region of about 20 seconds.

The breath deodorising strip may also provide sustained release over the time of dissolution.

By "edible material" is meant a material that is acceptable for consumption by a user. Normally, this is a material approved for use by the appropriate regulatory authorities.

The breath deodorising strip may be formed from any suitable film-forming material or combination thereof. S...

For example, any suitable hydrocolloid may be used.

:.:::. In particular, the breath deodorising strip may be formed from any suitable edible water-soluble polymeric * ** :.: * materials such as any of the following: * *.. . . * * carrageenan; cellulose derivatives or modified celluloses, such as methyl celluloses, (e.g. sodium carboxymethyl cellulose), hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose; alginates (e.g. sodium alginate); gums (e.g. xanthan gum, tragacanth gum, guar gum, acacia gum, Arabic gum); starches and modified starches; gelatin; copolymers of methyl vinyl ether and maleic anhydride, e.g. Gantrez (Trademark); carbopols (i.e. carbomers); polyvinyl acetate; polyvinyl alcohol; acrylic based polymers, such as methylmethacrylate polyacrylates and polymethacrylates and esters and salts and copolymers thereof; C, polycarbophils; proteins; pullulan; S...

polyacrylic acid; :.:::. carboxyvinyl polymer;

S *. S

* 15 amylase; high arnylase starch; *SSS..

* hydroxypropylated high arnylase starch; ( dextrin; pectin; chitjn; chitosan; levan; elsinan; collagen; gelatine; zein; gluten soy protein isolate; whey protein isolate; sorbitol; glycerol; and casein.

Any suitable combination of the above compounds such as a mixture of two, three, or four of the materials may be employed. Additionally, different layers in a multi-layer breath deodorising strip may comprise different combinations of water-dispersible materials.

The breath deodorising product may also comprise antimicrobial agents (i.e. bactericides) in any suitable S...

form. The antimicrobial agents may be present in an amount of about 0 to 20 wt.% or about 0 to 5 wt.% of the S..

* 15 breath deodoriser. For example, any of the following antimicrobial agents may be used: *.

* triclosan; cetyi. pyridinium chloride (CPC); domiphen bromide; quaternary ammonium salts; sanguinarine;

suitable fluorides;

alexidine; octonidine; and EDTA.

In embodiments where the breath deodoriser comprises both zinc, cetyl pyridinium salt and an antimicrobial agent, the breath deodoriser performs the dual function of preventing bad breath and acting as a bactericide.

Flavourings may also be included in the breath deodoriser. Suitable flavourings may exhibit fragrant properties to provide an additional odour masking effect.

However, the flavourings may simply present a pleasant flavour for an intended user. Suitable flavourings may be

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added during a manufacturing process in the form of flavoured oils. The flavourings may form amounts of about 0 to 30 wt.% or about 0 to 10 wt.% of the breath *... * S

deodoriser.

The flavourings may be chosen from natural oils, * S..

* 15 synthetic flavour oils, flavouring aromatics, oleo resins and extracts derived from plants, leaves, flowers, fruits S.....

* and so forth, and combinations thereof.

Flavour oils which may be used include any of the following: spearmint oil; cinnamon oil; peppermint oil; clove oil; bay oil; thyme oil; cedar leaf oil; oil of nutmeg; oil of sage; and oil of bitter almonds.

Also useful are artificial, natural or synthetic fruit flavours such as vanilla, chocolate, coffee, cocoa and citrus oil, including lemon, orange, grape, lime and grapefruit and fruit essences including apple, pear, peach, strawberry, raspberry, cherry, plum, pineapple, apricot and so forth. These flavourings can be used individually or in a mixture. Commonly used flavours include mints such as peppermint, artificial vanilla, cinnamon derivatives, and various fruit flavours, whether employed individually or in admixture. Flavourings such as aldehydes and esters including cinnamyl acetate, cinnamaldehyde, citral, diethylacetal, dihydrocarvyl acetate, eugenyl formate, p-methylanisole, and so forth may also be used.

Further examples of aldehyde flavourings include, but are not limited to any of the following: acetaldehyde (apple); benzaldehyde (cherry, almond); cinnamic aldehyde (cinnamon); citral, i.e. alpha citral (lemon, lime); * I. neral, i.e. beta citral (lemon, lime); decanal (orange, * **.

* 15 lemon); ethyl vanillin (vanilla, cream); helliotropine, i.e., piperonal (vanilla, cream); variillin (vanilla, * ** **.

* cream) ; aipha-amyl cinnamaldehyde (spicy fruity ( flavours); butyraldehyde (butter, cheese); valeraldehyde (butter, cheese); citronellal; decanal (citrus fruits); aldehyde C-8 (citrus fruits); aldehyde C-9 (citrus fruits); aldehyde C-12 (citrus fruits); 2-ethyl butyraldehyde (berry fruits); hexenal, i.e. trans-2 (berry fruits); tolyl aldehyde (cherry, almond); veratraldehyde (vanilla); 2, 6-dimethyloctanal (green fruit); and 2-dodecenal (citrus, mandarin); cherry; grape; mixtures thereof; and the like.

As required, the breath deodoriser may comprise a sweetening agent or a combination of sweetening agents.

The sweetening agents may be present in an amount of about 0 to 20 wt.% or about 0 to 5 wt.% of the breath deodoriser. Typical sweeteners include monosaccharides, disaccharides and polysaccharides such as any of the following: xylose; ribose; glucose (dextrose); manriose; galactose; * * fructose (i.e. levulose); sucrose (i.e. sugar) ; and *.

* 15 maltose; an invert sugar (i.e. a mixture of fructose and S.....

* glucose derived from sucrose); partially hydrolysed starch; corn syrup solids; dihydrochalcones; monellin; steviosides; and glycyrrhizin.

Additionally, water-soluble artificial sweeteners such as soluble saccharin salts may be used. For example, any of the following artificial sweeteners may be used: sodium or calcium saccharin salts; cyclamate salts; sodium, ammonium or calcium salts of 3,4-dihydro-6-methyl-i, 2, 3-oxathiazine-4-one-2, 2-dioxide; potassium salts of 3,4-dihydro-6-methyl-1,2,3-oxathiazine-4-one-2,2-diOxide (acesulfane-K); and the free acid form of saccharin.

Moreover, dipeptide based sweeteners such as any of the following may be used: L-aspartic acid derived sweeteners, such as L-aspartyl-L-phenylalaflifle methyl ester (aspartame); L-alpha-aspartyl--N-(2,2,4, 4-tetrarnethyl-3-thietanyl) -D-alaninamide hydrate; methyl esters of L-aspartyl-L-pheflylglYCerifl and L- * 15 aspartyi-L-2, 5-dihydrophenyl-glycine; L-aspartyl-2, 5-dihydro-L-phenylalafline; and ****** * L-aspartyl-L-(1-cyclohexyen) -alanine.

( Water-soluble sweeteners derived from naturally occurring water-soluble sweeteners, such as a chlorinated derivative of ordinary sugar (i.e. sucrose) may also be used.

Furthermore, protein based sweeteners such as thaumatoccous danielli (i.e. Thaumatin I and II) may be used.

Plasticising agents may also be added to the breath deodoriser. The plasticising agents may be present in an amount of about 0 to 20 wt.% or about 0 to 10 wt.% of the breath deodoriser. For example, plasticising agents such as triacetin, monoacetin, diacetin and polyols e.g. glycerol, sorbitol and mannitol may be used.

The breath deodoriser may also comprise colouring agents, sulphur precipitating agents, saliva stimulating agents, cooling agents, surfactants, stabilising agents, emulsifying agents and thickening agents.

Preferably, the breath deodoriser according to the present invention may be ionene terpene free.

The breath deodorising strip may be formed using standard techniques known in the art. In particular embodiments, the zinc and/or cetyl pyridinium salt containing compound may be deposited onto a strip.

Alternatively, the zinc and/or cetyl pyridinium salt containing compound may be impregnated into a body of a S.....

* strip using, for example, a soaking process.

Alternatively, the breath deodorising strip may comprise a plurality of layers. For example, a number of zinc and/or cetyl pyridinium salt containing layers may be sandwiched between non-zinc containing strips. In further alternatives, there may be another layer(s) included which contains no zinc containing compounds, but is present to release a fragrance into an oral cavity on dissolution of the strip so as to provide a further malodour masking effect. For example, the additional layer(s) may contain a fragrant flavouring, such as peppermint, mint, citrus or other fragrant flavourings.

In further alternatives, any form of gel formation or extrusion steps may be used to form the required product.

According to a second aspect of the present invention there is provided a method of controlling breath odour of a human or animal, said method comprising placing a breath deodoriser comprising zinc and/or cetyl pyridinium salt in an oral cavity, wherein said breath deodoriser is capable of delivering zinc and/or cetyl pyridinium salt in an amount to reduce and/or prevent the formation of volatile sulphur compounds.

According to an third aspect of the present invention there is provided a dispenser containing at I..

least one or a plurality of breath deodorising strips comprising zinc and/or cetyl pyridinium salt, wherein S.....

* said breath deodorising strip is capable of delivering (. zinc in an amount to reduce and/or prevent the formation of volatile sulphur compounds in an oral cavity.

According to an fourth aspect of the present invention there is provided use of a breath deodoriser comprising zinc and/or cetyl pyridinium salt for reducing and/or preventing breath malodour, wherein said breath deodoriser is. capable of delivering zinc in an amount to reduce and/or prevent the formation of volatile sulphur compounds in an oral cavity.

According to a fifth aspect of the present invention there is provided a method of manufacturing a breath deodoriser comprising: (i) combining water with a zinc and/or cetyl pyridinium salt containing compound and a water-dispersible material to form a solution, mixtures or emulsified mixture containing zinc and/or cetyl pyridinium salt, water and the water-dispersible material; wherein said breath deodoriser comprises an amount of zinc and/or cetyl pyridinium salt to reduce and/or prevent the formation of volatile sulphur compounds in an *.S. * *

oral cavity. S.

The breath deodoriser may be formed into any of the

S *5* * 15 following using standard techniques known in the art: a S 55 :.: *

film; a strip; a mouthwash; a spray; chewing gum; a **.

* lozenge; a chewable tablet; toothpaste; a gel; or dental cream.

In embodiments where the breath deodoriser is manufactured into the form of a strip, the emulsified mixture containing zinc, cetyl pyridinium salt, water and the water-soluble edible polymeric material may be dried to form a laminar body and thereafter formed into a strip using standard techniques.

According to a sixth aspect of the present invention there is provided a breath deodoriser comprising zinc, wherein said breath deodoriser is capable of delivering zinc in an amount to reduce and/or prevent the formation of volatile sulphur compounds in an oral cavity.

The stoichiometrjc ratio of zinc ions to sulphur ions in the present invention may be in excess of 1:1, or S...

substantially in excess of 1:1. For example, the :5 stoichiometric ratio of zinc ions to sulphur ions may be *55 in the region of about 200:1 or about 80:1.

According to a seventh aspect of the present *5*:: * invention there is provided a breath deodoriser comprising cetyl pyridinium chloride, wherein said breath deodoriser is capable of delivering cetyl pyridinium chloride in an amount to reduce and/or prevent the formation of volatile sulphur compounds in an oral cavity.

Typically, the breath deodoriser may provide a dose of cetyl pyridinium salt in an amount of about 0.01 -10 mg, about 0.05 -5 mg, about 0.05 -1 mg, about 0.05 - 0.5 mg, about 0.1 -0.2 mg or about 0.125 -0.156 mg.

The cetyl pyridinium salt may be any suitable salt (e.g. any inorganic salt) such as a halide salt based on chloride, bromide, iodine or fluoride. Alternatively, the salt may be a sulphate, a phosphate, an acetate, a carbonate, a citrate, a hydroxide, a nitrate or a nitrite. Preferably, the cetyl pyridinium salt may be cetyl pyridinium chloride.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings in which: S...

S." Figure 1 is a representation of organoleptic scores versus time for a range of different samples; S..

* 15 Figure 2 is a representation of changes in log halimeter readings versus time for the samples * * represented in Figure 1; Figures 3a -3c represent strip-diffusion inhibition tests; Figure 4 represents ion selective electrode measurements of HS ions versus the concentration of the HS ions; and Figure 5 is a representation of recovery of volatile sulphur compound generation following pre-treating with Zn2.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIINTS

The present invention relates to the provision of a low dose of zinc and/or cetyl pyridinium salt (e.g. cetyl pyridinium chloride) in an oral cavity of a human or animal. In contrast to many products in the prior art which provide higher levels of zinc specifically directed to reacting with volatile sulphur compounds, the present invention provides a low level of zinc which has the effect of inhibiting or substantially reducing the efficiency of enzymes which produce volatile sulphur compounds.

It has surprisingly been found that a low dose of zinc and/or etyl pyridirtium salt (e.g. cetyl pyridinium chloride) inhibits or substantially reduces the S..

* 15 desulfhydrase enzymes ability to produce volatile sulphur compounds. This effect is further enhanced by the S.... S * presence of a cetyl pyridinium salt (e.g. cetyl pyridinium chloride) . Therefore, by placing the breath deodorisers according to the present invention in an oral cavity, the desulfhydrase enzymes ability to produce volatile sulphur compounds is substantially reduced or completely blocked, thereby enabling other agents such as antimicrobial agents, flavouring agents etc. existing in the breath deodoriser to eliminate or sul7stantially eliminate bad breath resulting from volatile sulphur compounds in an oral cavity.

It has been found that the breath deodorising strips according to the present invention have the ability to eliminate or substantially eliminate bad breath in an oral cavity for up to 4 hours.

Examples according to the present invention are provided below. However, the Examples are non-limiting and the scope of the invention is intended to encompass modifications to the Examples provided. C.

EXAMPLES

EXAMPLE 1

A breath deodorising strip comprising the following was manufactured with the following components: * S. * . . *

S

* 15 Gelatin 63.56 Peppermint flavour 11.77 * *.....

* Cellulose 10.59 Rapeseed oil 7.06 Zinc acetate (dihydrate) 3.06 Glycerol 1.32 Sorbitol 1.32 Aspartame 0.53 Sodium saccharin 0.29 Cetyl pyridinium chloride 0.26 Acesulfame-K 0.21 Brilliant blue FCF 0.01 Total solids 99.98 The breath deodorising strip comprises a weight of 0. 41 mg of zinc ions which equates to 6.2 X 10-6 moles of zinc ions. 6.2 X 106 moles of Zn ions corresponds to 3.73 X 1016 ions.

EXNPLE 2

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Fast dissolving strips according to Example 1 were given to a group of eight human volunteers. Breath parameters were measured using two well-tried standard *...

procedures, called organoleptic score (using a trained : .. odour judge to score bad breath) and an instrument that 15 measures suiphide gases (portable suiphide monitor) : The volunteers breath parameter measurements are taken prior to each volunteer being given a dose (2 dissolving strips) of either one type of the test strips (the batch labelled Sl, S2, S3) or the placebo control (batch labelled S4) . We then continued to monitor the breath parameters at various times up to 4 hours following the dose.

The human volunteers returned to the laboratory a week after their first visit and repeated the whole procedure (monitoring-dose-monitoring) but this time they would use a different product or control and repeat the weekly trial procedure until they had used all 4 types of strips (Si, S2, S3 or S4) . The sequence of strips (Si, S2, S3 or S4) is randomised in such a way that all volunteers complete the cycle after 4-weeks but not in the same order. Neither the volunteers nor the trial operator or breath judge know anything about what components are present nor which strips are tests or control and the strips themselves are not labelled or identified when presented.

An independent volunteer was used (independent of the trial workers or trial volunteers) to distribute the unlabelled strips from the labelled batches to each of the trial volunteers. Only when all the data is : .. collected over the full 4-week trial is the cipher code S...

15 applied that reveals the identity of each strip and the sequence of its use in each volunteer. e call this type of trial a double blind crossover design.

Figure 1 shows changes in organoleptic scores following treatment with different formulations of fast dissolving thin film strips using a randomised, double-blind, crossover design trial.

Si relates to a thin film strip comprising only cetyl pyridiniurn chloride (CPC) S2 relates to a thin film strip comprising 0. 12 mg CPC + 0.41 my Zn.

S3 relates to Listerine (Registered Trademark) S4 relates to a blind control.

S5 relates to Zn alone where the thin film Strip comprises 0.41 mg of Zn.

Figure 1 shows that S2 and S5 provide the best organoleptic scores and therefore are the most effective in reducing malodour.

EXAMPLE 3

Figure 2 relates to the changes in log halimeter readings following treatment with different formulations of fast dissolving thin film strips. This corresponds to the organoleptic results shown in Example 2. Figure 2 S...

shows that the S2 strip comprising CPC + Zn and the S5 strip relating to zinc alone provides the best halimeter 15 scores. The thin film strip comprising S2 and S5 is therefore best in reducing malodour.

The magnitude of reduction (on a log scale) when translated into percentage suggests that the S2 test strip with CPC and Zn can reduce malodour production by more than 80% even at 4 hours.

EXAMPLE 4

Figure 3a represents bacteria inhibition tests for two control strips. The first strip is a control strip which shows no inhibition in preventing bacteria formation. The Si strip which comprises Only cpc provides a slight zone of inhibition.

E'igure 3b shows a control strip with no inhibition and S2 which provides a large zone of inhibition. As previously discussed, S2 relates to a strip with 0.12 mg CPCandO.4imgZn.

Figure 3c represents a control strip with no inhibition and S3 which has an intermediate zone of inhibition. S3 relates to Listerine (Registered Trade Mark) The strip-diffusion inhibition test shown in Figure 3a -3c therefore show that the S2 thin film strip *0S comprising 0.12 mg CPC + 0.41 mg Zn is therefore best at inhibiting the formation of bacteria. * 15

EXAMPLE 5 *

****** * * Figure 4 represents ion selective electrode (ISE) measurements of HS ions when a starting volume of 20 ml of water (i.e. control), mild detergent (sodium rjcjrioleate) and a solution of Zn2 ions (ZnAc) is titrated against a standard solution of stabilised HS solution.

Figure 4 shows from the electrode readout (a measure of free HS ions, shown on the y-axis) increases in the voltage raeading with addition of HS solution (x-axis) The increases seen with the addition of HS ions are much more marked when water or detergent is present and much less marked when Zn2 is present. The Zn2 is clearly capable of binding the free HS anions. It would therefore appear that one molecule of zinc ion may bind two molecules of HS.

EXAMPLE 6

Figure 5 represents the partial recovery of volatile sulphur compound (VSC) generating activity from washed cells pre-treated with Zn2 at a final concentration of 1500 tiM.

Figure 5 shows that a cell pre-treated with a wash of ZnAc providing a final concentration of 1500 pM is ::::. effective at reducing the volatile sulphur generation 15 rate to below that of 50%. * I. * * * **. S *

**.... * * (

Claims

CLAIMS

1. A breath deodoriser comprising zinc and/or a cetyl pyridinium salt, wherein said breath deodoriser is capable of delivering zinc and/or cetyl pyridinium salt in an amount to reduce and/or prevent the formation of volatile sulphur compounds in an oral cavity.

2. A breath deodoriser according to claim 1, wherein the zinc disables and/or reduces the efficiency of ( enzymes producing volatile sulphur compounds including that of the desulfhydrase enzymes. S. * S *

* *....CLME: 3. A breath deodoriser according to any of claims 1 or : *se 2, wherein the zinc is selected from a combination of S...

 15 water soluble and/or water insoluble zinc compounds. * .. * . . S.. *

4. The breath deodoriser according to any preceding claim, wherein the zinc is selected from any one of or any combination of the following: organic or inorganic zinc salts; organic or inorganic zinc based polymers or copolymers; zinc based esters; zinc based ketones or aldehydes; zinc alkali or acid based derivatives; zinc based amides; zinc halides; zinc organo-halide derivatives; zinc based fatty acid derivatives; zinc based sugar derivatives; and zinc based amino acid derivatives.

5. A breath deodoriser according to any preceding claim, wherein the zinc is selected from any one of or any combination of the following: zinc acetate; zinc acetate (dihydrate); zinc acetylacetonate; zinc acrylate; zinc ammonium sulphate;

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zinc benzoate; zinc bromide; zinc beryllium orthosilicate; S...

zinc borate; : *** zinc butylphthalate; zinc butyixanthate; zinc caprylate; zinc carbonate; (. zinc chioroanjiate; zinc chlorate; zinc chromate; zinc citrate; zinc chloride; zinc cyclohexanebutyrate; zinc dithionate; zinc gallate; zinc formate; zinc fluoride; zinc fluorosilicate; zinc aipha-glucoheptonate; zinc gluconate; zinc glycerophosphate; zinc hexafluorosilicate; zinc hydroxide; zinc 8-hydroxyquinoline; zinc 12-hydroxystearate; zinc iodide; zinc isovalerate; :*. zinc D-lactate; *::::* zinc DL-lactate; : ** zinc laurate; S...

* 15 zinc methacrylate; zinc molybdate; zinc naphthenate; zinc nitrate; zinc octanoate; zinc oleate; zinc orthosphosphate; zinc oxide; zinc phenolsulfonate; zinc propionate; zinc pyridine-2-thio].-1-oxjde; zinc pyrophosphate; zinc resinate; zinc ricinoleate; zinc salicylate zinc selenide; zinc stearate; zinc succinate; zinc sulfanilate; zinc sulfate; zinc tartrate;

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zinc tellurate; zinc tribromosalicylanilide zinc tungstate; zinc valerate; and S...

* *. zinc vanadate. * S * S...

S

: ** 6. A breath deodoriser according to any preceding *.. S claim, wherein the dose of zinc is less than about 1.0 mg.

7. A breath deodoriser according to any of claims 1 to 5, wherein the dose of zinc is less than about 0.8 mg.

8. A breath deodoriser according to any of claims 1 to 5, wherein the dose of zinc is less than about 0.6 mg.