Dissolvable oral films, process of manufacture thereof

Abstract

There is herein described a dissolvable oral strip or film. In particular, the present invention relates to a dissolvable or substantially dissolvable oral strip or film comprising at least one whitening agent and at least one oral hygiene agent. There is also described a process for the manufacture of a dissolvable or substantially dissolvable oral strip or film. There is further described a method of using a dissolvable oral strip or film comprising at least one whitening agent to whiten teeth and at least one oral hygiene agent that is effective against oral health conditions.

Description

[0001] DISSOLVABLE ORAL FILMS, PROCESS OF MANUFACTURE THEREOF

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to dissolvable oral films having compositions useful for the delivery of active agents. More particularly, to compositions suitable for formation of orally soluble, mucoadhesive films that provide delivery of whitening and oral hygiene active agents, such as antibacterial agents. Also provided is a process of manufacturing the films and a method of using the films.

[0004] BACKGROUND

[0005] Human teeth naturally exhibit a variety of colours, which can be influenced by a number of factors, such as diet and / or medication. For instance, a number of foods, such as berries, and drinks, such as tea and red wine, contain chromogens which can stain teeth. Tobacco may also darken teeth. Other substances, such as acidic fruits can promote staining by eroding dental enamel, softening teeth and making it easier for chromogens to attach. There is a desire to whiten teeth to remove such staining.

[0006] Similarly, consumption of such products can lead to an individual having bad breath, or prolonged breath related issues, such as halitosis, as well as other oral hygiene conditions. An example of an oral hygiene condition in the present field is Oral Malodour. Oral Malodour can be classified as Transient or Chronic. Transient Oral Malodour is widespread and is caused by things like early morning dry mouth, eating foods like onion or garlic. Transient Oral Malodour can be successfully treated (1) by morning tooth cleaning etc for dry mouth and (2) by use of odour eliminating products, that is, until eating the offending item again. Chronic Oral Malodour affects about 25% of the population and is usually caused by having too many of certain types of bacteria in the mouth, mainly on the back of the tongue, which may produce Volatile Sulphur Compounds (VSCs) and other unpleasant odours. Hydrogen sulphide is believed to be the main VSC in Oral Malodour. Chronic Oral Malodour cannot be cured permanently, it can however be successfully treated, giving relief for considerable periods of time by taking products known to be effective in controlling the output of VSCs.

[0007] Therefore, there is also a need to freshen breath and treat oral health or hygiene conditions, such as oral malodour / halitosis.

[0008] Current solutions for the treatment of stained teeth are mainly delivered in the form of liquids, pastes, gels, patches, disks and pressed tablets. These forms often spread easily, or get dislocated and cause their effects throughout the oral mucosa. Other oral compositions may be provided in the solid state in the form of a strip or film with a backing layer, which adheres to teeth or mucosal surfaces upon contact with saliva. These solid strips are simple to use and may be applied by a practitioner or the individual desiring treatment. However, it can be difficult to incorporate an active agent into such strips or films. For instance, active agents may lack the requisite solubility to form a solid solution in the oral composition. Instead, the active agent precipitates as solid particulates in the composition, which may be unevenly distributed throughout the solid composition. Further, the backing strips must be peeled from the treated teeth and discarded after use.

[0009] Current solutions for the treatment of bad breath, are mainly delivered in the form of soluble strips, designed to be placed on an individual's tongue and to dissolve rapidly, imparting a breath freshening effect. An example breath freshening strip is Listerine Pocketpacks®. These strips are intended to be placed on the tongue, dissolve rapidly and provide a breath freshening effect exclusively. Traditional breath freshening products such as strips are intended to be placed on the tongue and therefore do not have the ability to impart dental whitening properties.

[0010] Alternative solutions include the delivery of breath freshening solutions as a spray to the back of the throat. A yet further alternative solution for treatment of oral conditions, such as bad breath, include chewable gums. However, gums are not always socially acceptable (such as at schools), and are not dissolvable, thereby requiring the user to discard the item after a set period.

[0011] A common active agent for inclusion in oral compositions to be used in strips, films or gels, that is particularly effective at whitening teeth is hydrogen peroxide (H2O2). However, prolonged use of hydrogen peroxide has been linked to dental hypersensitivity (DH) issues. As an alternative, nonhydrogen peroxide bleaching whitening agents, such as phthalimido peroxy caproic acid (PAP) can be used. However, these agents typically do not exhibit comparable whitening efficacy to hydrogen peroxide based whitening agents. Further, there is a limit as to the total amount of PAP that can be reasonably added to a formulation due to stability issues.

[0012] It is an object of at least one aspect of the present invention to provide a dissolvable oral strip or film that comprises at least one whitening agent and at least one oral hygiene agent, that exhibits comparable or improved whitening to traditional bleaching agent containing strips, whilst simultaneously providing effective treatment of other oral hygiene conditions, such as bad breath. It is a further object of the present invention to provide a dissolvable oral strip or film that comprises at least one whitening agent that is compatible with simultaneous delivery of at least one oral hygiene agent for the simultaneous whitening of teeth and treatment of oral malodour.

[0013] It is a further object to provide a dissolvable oral strip or film that provides a long-lasting activity compared to existing products.

[0014] It is also an object of at least one aspect of the present invention to mitigate at least one or more of the aforementioned problems.

[0015] It is a further object of the present invention to provide a process for manufacturing the dissolvable oral strip or film.

[0016] A yet further object of the present invention is to provide a cosmetic treatment for teeth whitening and / or teeth bleaching using a dissolvable oral strip or film.

[0017] SUMMARY OF INVENTION

[0018] According to a first aspect of the present invention there is provided a dissolvable oral strip or film adapted to adhere to a user's teeth, comprising: at least one whitening agent; and at least one oral hygiene agent.

[0019] Advantageously, when such a strip is placed on the teeth of a user, the strip begins to dissolve in the mouth, delivering the whitening agent directly to the teeth (for topical teeth whitening) and the oral hygiene agent to the oral mucosa, saliva and entire mouth. This provides for gradual release of oral hygiene agents as the strip dissolves, allowing for extended exposure time in comparison to rapid dissolution strips that are placed directly on the tongue. This also provides greater delivery of the oral hygiene agent than would be possible through a non-dissolvable strip with a backing layer (which is occlusive), which are designed to swell in the oral cavity, thereby delivering actives by diffusion as opposed to dissolution. Therefore, where the dissolvable strip of the present invention comprises an oral hygiene agent that has anti-bacterial capabilities, the strip has significantly improved efficacy in the treatment of oral malodour.

[0020] In a preferred embodiment, the or each at least one oral hygiene agent comprises a zinc compound, for the treatment of bad breath (such as oral malodour or halitosis). More preferably, the or each at least one oral hygiene agent comprises one or any combination of: zinc acetate; zinc oxide; zinc sulfate; zinc chloride; zinc citrate; zinc lactate; zinc gluconate; zinc malate; zinc tartrate; zinc carbonate; and / or zinc phosphate.

[0021] The wt.% for all amounts recited herein is based on the wt.% of the film or strip. The dissolvable oral film or strip is defined in terms of the dry weight of the film e.g. the weight of components dried to exclude water, expressed as percentages (i.e. wt.%) by total dry weight of the film alone i.e. without any backing sheet or support.

[0022] The dissolvable oral strip or film may comprise: 0.1 to 10.0 wt.%; 0.5 to 9.0 wt.%; 0.5 to 8.0 wt.%; 1.0 to 7.0 wt.%; 1.0 to 6.0 wt.%; 1.0 to 5.0 wt.%; 1.0 to 4.0 wt.%; 1.0 to 3.0 wt.%; or 1.0 to 2.0 wt.% of the or each at least one oral hygiene agent.

[0023] More preferably, the dissolvable oral strip or film may comprise one or any combination of: zinc acetate; zinc citrate; and / or zinc gluconate as the or each at least one oral hygiene agent. The zinc acetate; zinc citrate; and / or zinc gluconate may each be present in a total amount; 0.1 to 10.0 wt.%; 0.5 to 9.0 wt.%; 0.5 to 8.0 wt.%; 1.0 to 7.0 wt.%; 1.0 to 6.0 wt.%; 1.0 to 5.0 wt.%; 1.0 to 4.0 wt.%; 1.0 to 3.0 wt.%; or 1.0 to 2.0 wt.% of the dissolvable oral strip or film.

[0024] The at least one oral hygiene agent may comprise Cetylpyridinium chloride (CPC). CPC may be present in the strips of the present invention, having a concentration of: about 0.1 to about 5 wt.%; about 0.1 to about 3.0 wt.%; about 0.1 to about 2.0 wt.%; about 0.1 to about 1.0 wt.%; about 0.1 to about 0.8 wt.%; about 0.1 to about 0.6 wt.%; about 0.1 to about 0.4 wt.%; about 0.1 to about 0.3 wt.%; or about 0.2 to about 0.3 wt.% of the dissolvable oral strip or film.

[0025] The dissolvable oral strip or film may comprise: 1.0 wt.% to 5.0 wt.% or 1.0 wt.% to 2.0 wt.% zinc acetate as the or each at least one oral hygiene agent. The dissolvable oral strip or film may further comprise 0.1 to 10.0 wt.% CPC.

[0026] The dissolvable oral strip or film may comprise: 1.0 wt.% to 5.0 wt.% or 1.0 wt.% to 2.0 wt.% zinc gluconate as the or each at least one oral hygiene agent. The dissolvable oral strip or film may further comprise 0.1 to 10.0 wt.% CPC. The dissolvable oral strip or film may comprise: 1.0 wt.% to 5.0 wt.% or 1.0 wt.% to 2.0 wt.% zinc citrate as the or each at least one oral hygiene agent. The dissolvable oral strip or film may further comprise 0.1 to 10.0 wt.% CPC.

[0027] For enhanced anti-bacterial efficacy, the dissolvable oral strip or film may comprise the combination of a zinc containing anti-bacterial agent and CPC. More preferably, a combination of: zinc acetate; and / or zinc citrate; and / or zinc gluconate; with CPC. The combination of these agents together provides significantly enhanced oral malodour suppression.

[0028] The dissolvable oral strip or film may therefore comprise: 0.1 to 10.0 wt.%; 0.5 to 9.0 wt.%; 0.5 to 8.0 wt.%; 1.0 to 7.0 wt.%; 1.0 to 6.0 wt.%; 1.0 to 5.0 wt.%; 1.0 to 4.0 wt.%; 1.0 to 3.0 wt.%; or 1.0 to 2.0 wt.% of a zinc compound (such as zinc acetate; and / or zinc citrate; and / or zinc gluconate); in combination with 0.1 to about 5 wt.%; about 0.1 to about 3.0 wt.%; about 0.1 to about 2.0 wt.%; about 0.1 to about 1.0 wt.%; about 0.1 to about 0.8 wt.%; about 0.1 to about 0.6 wt.%; about 0.1 to about 0.4 wt.%; about 0.1 to about 0.3 wt.%; or about 0.2 to about 0.3 wt.% CPC.

[0029] The whitening agent of the dissolvable oral strip or film preferably comprises: hydrogen peroxide; and / or a hydrogen peroxide-polyvinyl pyrrolidone complex; and / or 6-phthalimido peroxy caproic acid (PAP).

[0030] Preferably, the strip or film comprises: 0.1 wt.% to 20.0 wt.%; 1.0 wt.% to 15 wt.%; 5 wt.% to 15 wt.%; or 5 to 11 wt.% of the or each at least one whitening agent.

[0031] The dissolvable oral strip or film may further comprise a dental hypersensitivity agent. Advantageously, inclusion of such an agent allows for greater quantities of peroxide to be used in the strip for enhanced tooth whitening, whilst preventing dental hypersensitivity issues for the user.

[0032] The dental hypersensitivity agent comprises Hydroxyapatite, optionally at 1 to 15 wt.% or 3 to 7 wt.% of the strip or film.

[0033] The dissolvable oral strip or film may further comprise a dissolution profile modulating agent. Advantageously, this allows the strip to be tailored to provide a specific dissolution profile. This can be selected to give a longer dissolution time for the whitening agent to act and for more gradual delivery of the oral hygiene active, or reduced to avoid dental hypersensitivity and to increase the dose time of the oral hygiene active. The dissolution profile modulating agent may comprise polycarbophils, optionally at 1 to 5 wt.% or 1.5 to 3 wt.% of the strip or film.

[0034] The dissolvable oral strip or film may comprise one or more polyphosphates. The polyphosphates may comprise one or more cyclic and / or one or more linear polyphosphates. Advantageously, polyphosphates increase the miscibility and compatibility of the active agents in the solution. Surprisingly, inclusion can also provide a smoother more aesthetic finish to the resulting strip. Increased smoothness of the strip can also lead to more effective whitening, due to an improved interface with the teeth of a user when the strip is applied.

[0035] Preferably, the one or more cyclic polyphosphates comprise sodium hexametaphosphate and / or the one or more linear polyphosphates comprise sodium tripolyphosphate.

[0036] More preferably, the cyclic and / or linear polyphosphates are present in a total amount of from: 0.1% to 9% by weight of the strip or film; 3% to 8% by weight of the strip or film; or 3% to 4% by weight of the strip or film.

[0037] Most preferably, the strip or film comprises 3.5 wt.% of sodium hexametaphosphate and 3.5 wt.% sodium tripolyphosphate, which has been found to be particularly effective at improving the miscibility and compatibility of the active agents and providing a smooth strip.

[0038] The dissolvable oral strip or film may further comprise: an oil, such as Wintergreen oil and / or coconut oil; and / or a flavour agent, such as peppermint and / or Menthol and / or Spearmint and / or Novamint.

[0039] A preferred flavour agent for use in the dissolvable oral strip or film is peppermint.

[0040] The dissolvable oral strip or film may further comprise any one of or combination of the following: one or more water soluble film-forming polymers; one or more plasticizers; and / or one or more emulsifiers. Preferably, the one or more soluble film-forming polymer is one or more of the group comprising: polyvinylpyrrolidone (PVP); pullulan; pectin; starch; dextrin; chitosan; alginic acid; salts of alginic acid and / or cellulose derivatives.

[0041] Preferably, the one or more plasticizers are selected from the group comprising a polyol such as glycerol.

[0042] Preferably, the one or more emulsifiers are selected from the group comprising a fatty acid derivative, a lecithin and / or a polysorbate.

[0043] The dissolvable oral strip or film may further comprise one or more further components selected from the group comprising colourant, flavouring and / or sweetener.

[0044] Most advantageously the strip or film is fully dissolvable, such that it dissolves completely within the oral cavity of a user, thereby avoiding the need for anything to be removed from the mouth and discarded.

[0045] Advantageously, the dissolvable oral strip or film is flexible to facilitate uniform adhesion of the strip to the users teeth.

[0046] The dissolvable oral strip or film is preferably adapted to dissolve completely or substantially completely in an oral cavity of a user over a period of: 5 to 30 minutes; 5 to 20 minutes; 5 to 15 minutes; or 10 to 15 minutes. Most preferably, 5 to 15 minutes or 10 to 15 minutes.

[0047] In a second aspect, there is provided a process for the manufacture of a dissolvable oral strip or film, the process comprising at least the steps of: mixing an oral hygiene agent in a total amount of about 0.1% to about 10% by weight, a whitening agent in a total amount of 1% to 20% by weight, one or more water soluble film-forming polymers in a total amount of 30% to 90% by weight, one or more plasticizers in a total amount of 0.1% to 15% by weight and one or more emulsifiers in a total amount of 0.1% to 10% by weight; with water to provide an aqueous liquid; applying the aqueous liquid to a substrate to provide a substrate carrying the aqueous liquid; and drying the aqueous liquid to provide a dissolvable oral strip or film on the substrate. The mixing step may further comprise mixing one or more further components selected from the group comprising: colourant, flavouring, sweetener.

[0048] In a third aspect, there is provided a purely cosmetic method of whitening teeth, said method comprising at least the step of: applying a dissolvable tooth whitening strip or film as described above to one or more teeth of a subject.

[0049] Advantageously, the strip dissolves completely in the users mouth, simultaneously whitening the teeth and delivering the oral hygiene agent to the oral mucosa, saliva and throat, for treatment of conditions such as bad breath (halitosis).

[0050] According to a fourth aspect, there is provided an oral composition, in the form of at least one dissolvable film or strip, comprising about 50 wt% to about 70 wt% of a water-soluble or water- dispersible polymer that is polyvinylpyrrolidone, about 0.1 wt% to about 10 wt% of a whitening agent that is at least one of hydrogen peroxide and phthalimidoperoxycaproic acid, about 0.1 wt% to about 2.0 wt% of a disinfecting agent that is zinc acetate, about 0.1 wt% to about 10 wt% menthol, and about 0.1 wt% to about 10 wt% water.

[0051] The oral composition may further comprise a thickening agent, a sugar alcohol, a water softening agent, a sequestrant, a dental hypersensitivity agent, a dissolution extender, a natural gum, an abrasive substance, an emulsifier, an artificial sweetener, and / or an additional aromatic component. The oral composition may comprise between about 52 wt% to about 62 wt% polyvinylpyrrolidone. The oral composition may comprise about 7 wt% to about 9 wt% at least one of hydrogen peroxide and phthalimidoperoxycaproic acid. The oral composition may comprise about 0.8 wt% to about 1.8 wt% zinc acetate. The aromatic component may comprise menthol, limonene, peppermint oil, Wintergreen oil, or a combination thereof. The oral composition may comprise about 1.8 wt% to about 2.8 wt% menthol. The oral composition may comprise about 4.5 wt% to about 5.5 wt% water. The thickening agent may comprises pectin. The oral composition may comprise about 3.5 wt% to about 4.5 wt% thickening agent. The sugar alcohol may comprise glycerin. The oral composition may comprise about 3.3 wt% to about 4.3 wt% sugar alcohol. The water softening agent may comprise pentasodium triphosphate. The oral composition may comprise about 2.8 wt% to about 3.8 wt% water softening agent. The sequestrant may comprise sodium hexametaphosphate. The oral composition may comprise about 2.8 wt% to about 3.8 wt% sequestrant. The dental hypersensitivity agent may comprise hydroxyapatite. The oral composition may comprise about 2.3 wt% to about 3.3 wt% dental hypersensitivity agent. The dissolution extender may comprise polycarbophil calcium. The oral composition may comprise about 1.0 wt% to about 2.0 wt% dissolution extender. The natural gum may comprise gum arabic. The oral composition may comprise about 0.1 wt% to about 1.0 wt% natural gum. The abrasive substance may comprise silicon dioxide. The oral composition may comprise about 0.1 wt% to about 1.0 wt% silicon dioxide. The emulsifier may comprise polysorbate 80. The oral composition may comprise about 0.1 wt% to about 1.0 wt% emulsifier. The artificial sweetener may comprise sucralose. The oral composition may comprise about 0.1 wt% to about 1.0 wt% artificial sweetener. The oral composition may comprise about 0.1 wt% to about 10 wt% of an additional aromatic component. The oral composition may comprise: about 57 wt% polyvinylpyrrolidone; about 8 wt% hydrogen peroxide; about 2.3 wt% menthol; about 1.3 wt% zinc acetate; and about 5 wt% water.

[0052] The oral composition may include a water-soluble or water-dispersible polymer (e.g., PVP) in an amount of 50-70 wt% (w / w), e.g., e.g., about 50, 55, 60, 65, or 70 wt%, greater than 50 wt%, greater than 55 wt%, greater than 60 wt%, greater than 65 wt%, less than 70 wt%, less than 65 wt%, less than 60 wt%, less than 55 wt%, 50-55 wt%, 55-60 wt%, 60-65 wt%, 65-70 wt%, 50-60 wt%, 55-65 wt%, 60-70 wt%, 50-65 wt%, 55-70 wt%, or 50-70 wt%, a whitening agent (e.g., at least one of hydrogen peroxide and PAP) in an amount of 0.1-10 wt% (w / w), e.g., about 0.1, 0.2, 0.5, 1, 2, 5, or 10 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, greater than 2 wt%, greater than 5 wt%, less than 10 wt%, less than 5 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5-1 wt%, 1-2 wt%, 2-5 wt%, 5-10 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 1-5 wt%, 2-10 wt%, 0.1-1 wt%, 0.2-2 wt%, 0.5-5 wt%, or 1-10 wt%, a disinfecting agent (e.g., cetylpyridinium chloride (CPC) or zinc acetate) in an amount of 0.1-2 wt% (w / w), e.g., about 0.1, 0.2, 0.5, 1, or 2 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5-1 wt%, 1-2 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 0.1-1 wt%, or 0.2-2 wt%, an aromatic component (e.g., menthol) in an amount of 0.1-2 wt% (w / w), e.g., about 0.1, 0.2, 0.5, 1, or 2 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5-1 wt%, 1-2 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 0.1-1 wt%, or 0.2- 2 wt%, and water in an amount of about 0.1 wt% and about 10 wt% water, e.g., about 0.1, 0.2, 0.5, 1, 2, 5, or 10 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, greater than 2 wt%, greater than 5 wt%, less than 10 wt%, less than 5 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5-1 wt%, 1-2 wt%, 2-5 wt%, 5-10 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 1-5 wt%, 2-10 wt%, 0.1-1 wt%, 0.2-2 wt%, 0.5-5 wt%, or 1-10 wt%.

[0053] The oral composition may include thickening agent (e.g., pectin) in an amount of about 3-5 wt% (e.g., 2-4%, 4-5%, or 3.5-4.5%; e.g., about 3%, about 3.5%, about 4%, about 4.5%, or about 5%), a sugar alcohol (e.g., glycerin (i.e., glycerol)) in an amount of about 3-5 wt% (e.g., 2-4%, 4-5%, or 3.5- 4.5%; e.g., about 3%, about 3.5%, about 3.8%, about 4%, about 4.5%, or about 5%), a water softening agent (e.g., pentasodium triphosphate) in an amount of about 2-5 wt% (e.g., 2-4%, 2-3%,

[0054] 3-5%, 4-5%, or 3.5-4.5%; e.g., about 2%, about 2.5%, about 3%, about 3.3%, about 3.5%, about 4%, about 4.5%, or about 5%), a sequestrant (e.g., sodium hexametaphosphate) in an amount of about 2-5 wt% (e.g., 2-4%, 2-3%, 3-5%, 4-5%, or 3.5-4.5%; e.g., about 2%, about 2.5%, about 3%, about 3.3%, about 3.5%, about 4%, about 4.5%, or about 5%), a dental hypersensitivity agent (e.g., hydroxyapatite) in an amount of about 2-5 wt% (e.g., 2-4%, 2-3%, 3-5%, 4-5%, or 3.5-4.5%; e.g., about 2%, about 2.5%, about 2.9%, about 3%, about 3.5%, about 4%, about 4.5%, or about 5%), a dissolution extender (e.g., polycarbophil calcium) in an amount of about 1-3 wt% (e.g., about 1%, about 1.5%, about 1.6%, about 2%, about 2.5%, or about 3%), a natural gum (e.g., gum Arabic or acacia Senegal gum abstract) in an amount of about 0.1-0.4 wt% (e.g., about 0.1%, about 0.15%, about 0.2%, about 0.25%, about 0.29%, about 0.3%, about 0.35%, or about 0.4%), an abrasive substance (e.g., silicon dioxide or hydrated silica) in an amount of about 0.1-0.4 wt% (e.g., about 0.1%, about 0.15%, about 0.2%, about 0.25%, about 0.29%, about 0.3%, about 0.35%, or about 0.4%), an emulsifier (e.g., polysorbate 80) in an amount of about 0.1-0.5 wt% (e.g., about 0.1%, about 0.15%, about 0.2%, about 0.25%, about 0.3%, about 0.35%, about 0.39%, about 0.4%, about 0.45%, or about 0.5%), an artificial sweetener (e.g., sucralose) in an amount of about 0.1-0.5 wt% (e.g., about 0.1%, about 0.15%, about 0.2%, about 0.25%, about 0.3%, about 0.35%, about 0.38%, about 0.4%, about 0.45%, or about 0.5%), and / or an additional aromatic component (e.g., peppermint oil, Wintergreen oil, or a combination thereof) in an amount of about 0.1-10 wt% (e.g., about 0.1, 0.2, 0.5, 1, 2, 5, or 10 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, greater than 2 wt%, greater than 5 wt%, less than 10 wt%, less than 5 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5- 1 wt%, 1-2 wt%, 2-5 wt%, 5-10 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 1-5 wt%, 2-10 wt%, 0.1-1 wt%, 0.2-2 wt%, 0.5-5 wt%, or 1-10 wt%, a disinfecting agent (e.g., cetylpyridinium chloride (CPC) or zinc acetate) in an amount of 0.1-2 wt% (w / w), e.g., about 0.1, 0.2, 0.5, 1, or 2 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5-1 wt%, 1-2 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 0.1-1 wt%, or 0.2-2 wt%, an aromatic component (e.g., menthol) in an amount of 0.1-2 wt% (w / w), e.g., about 0.1, 0.2, 0.5, 1, or 2 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5-1 wt%, 1-2 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 0.1-1 wt%, or 0.2-2 wt%, and water in an amount of about 0.1 wt% and about 10 wt% water, e.g., about 0.1, 0.2, 0.5, 1, 2, 5, or 10 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, greater than 2 wt%, greater than 5 wt%, less than 10 wt%, less than 5 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5-1 wt%, 1-2 wt%, 2-5 wt%, 5-10 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 1-5 wt%, 2-10 wt%, 0.1-1 wt%, 0.2-2 wt%, 0.5-5 wt%, or 1-10 wt%.

[0055] Alternatively, the oral composition may include a water-soluble or water-dispersible polymer (e.g., PVP or a combination of PVP and pullulan) in an amount of 30-70 wt% (w / w) (30, 35, 40, 45, 50, 55, 60, 65, or 70 wt%, greater than 30 wt%, greater than 35 wt%, greater than 40 wt%, greater than 45 wt%, greater than 50 wt%, greater than 55 wt%, greater than 60 wt%, greater than 65 wt%, less than 70 wt%, less than 65 wt%, less than 60 wt%, less than 55 wt%, less than 50 wt%, less than 45 wt%, less than 40 wt%, less than 35 wt%, 30-60 wt%, 30-50 wt%, 30-40 wt%, 40-50 wt%, 40-60 wt%, 40-70 wt%, 45-55 wt%, 50-55 wt%, 55-60 wt%, 60-65 wt%, 65-70 wt%, 50-60 wt%, 55-65 wt%, 60-70 wt%, 50-65 wt%, 55-70 wt%, or 50-70 wt%), a whitening agent (e.g., at least one of hydrogen peroxide and PAP) in an amount of 0.1-10 wt% (w / w) (e.g., about 0.1, 0.2, 0.5, 1, 2, 5, or 10 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, greater than 2 wt%, greater than 5 wt%, less than 10 wt%, less than 5 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5-1 wt%, 1-1.5 wt%, 1-2 wt%, 2-5 wt%, 5-10 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 1-5 wt%, 2-10 wt%, 0.1-1 wt%, 0.2-2 wt%, 0.5-5 wt%, or 1- 10 wt%), a disinfecting agent (e.g., cetylpyridinium chloride (CPC) or zinc acetate) in an amount of 0.1-2 wt% (w / w) (e.g., about 0.1, 0.2, 0.5, 1, or 2 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5-1 wt%, 1-2 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 0.1- 1 wt%, or 0.2-2 wt%), an aromatic component (e.g., menthol) in an amount of 0.1-5 wt% (w / w) (e.g., about 0.1, 0.2, 0.5, 1, 2, 3, 4, or 5 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, greater than 2 wt%, greater than 3 wt%, less than 5 wt%, less than 4 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 1-3 wt%, 2-4 wt%, 3-5 wt%, 3- 4 wt%, 3.5-4 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5-1 wt%, 1-2 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 0.1-1 wt%, or 0.2-2 wt%), and water in an amount of about 0.1 wt% and about 10 wt% water (e.g., about 0.1, 0.2, 0.5, 1, 2, 5, or 10 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, greater than 2 wt%, greater than 5 wt%, less than 10 wt%, less than 5 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5- 1 wt%, 1-2 wt%, 2-5 wt%, 5-10 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 1-5 wt%, 2-10 wt%, 0.1-1 wt%, 0.2-2 wt%, 0.5-5 wt%, or 1-10 wt%). These alternative oral compositions may also include thickening agent (e.g., pectin) in an amount of about 3-5 wt% (e.g., 2-4 wt%, 4-5 wt%, or 3.5-4.5 wt%; e.g., about 3 wt%, about 3.5 wt%, about 4 wt%, about 4.5 wt%, or about 5 wt%), a sugar alcohol (e.g., glycerin (i.e., glycerol)) in an amount of about 3-7 wt% (e.g., 2-4 wt%, 4-5 wt%, 3.5-4.5 wt%, 4-7 wt%, 5-6 wt%, 5.5-6.5 wt%, or 2-6 wt%; e.g., about 3 wt%, about 3.5 wt%, about 3.8 wt%, about 4 wt%, about 4.5 wt%, about 5 wt%, about 5.5%, about 6%, about 6.5%, or about 7 wt%), a water softening agent (e.g., pentasodium triphosphate) in an amount of about 2-5 wt% (e.g., 2-4 wt%, 2-3 wt%, 3-5 wt%, 4-5 wt%, or 3.5-4.5 wt%; e.g., about 2 wt%, about 2.5 wt%, about 3 wt%, about 3.3 wt%, about 3.5 wt%, about 4 wt%, about 4.5 wt%, or about 5 wt%), a sequestrant (e.g., sodium hexametaphosphate) in an amount of about 2-5 wt% (e.g., 2-4 wt%, 2-3 wt%, 3-5 wt%, 4-5 wt%, or 3.5-4.5 wt%; e.g., about 2 wt%, about 2.5 wt%, about 3 wt%, about 3.3 wt%, about 3.5 wt%, about 4 wt%, about 4.5 wt%, or about 5 wt%), a dental hypersensitivity agent (e.g., hydroxyapatite) in an amount of about 2-7 wt% (e.g., 2-4 wt%, 2-3 wt%, 3-5 wt%, 4-5 wt%, 3.5-4.5 wt%, 4-7 wt%, 5-6 wt%, 5.5-6.5 wt%, or 2-6 wt%; e.g., about 2 wt%, about 2.5 wt%, about 2.9 wt%, about 3 wt%, about 3.5 wt%, about 4 wt%, about 4.5 wt%, about 5 wt%, about 5.5%, about 6%, about 6.5%, or about 7 wt%), a dissolution extender (e.g., polycarbophil calcium) in an amount of about 1-3 wt% (e.g., about 1 wt%, about 1.5 wt%, about 1.6 wt%, about 2 wt%, about 2.5 wt%, or about 3 wt%), a natural gum (e.g., gum Arabic or acacia Senegal gum abstract) in an amount of about 0.1-0.6 wt% (e.g., about 0.1 wt%, about 0.15 wt%, about 0.2 wt%, about 0.25 wt%, about 0.29 wt%, about 0.3 wt%, about 0.35 wt%, about 0.4 wt%, about 0.45%, about 0.48 wt%, about 0.5 wt%, about 0.55 wt%, or about 0.6 wt%), an abrasive substance (e.g., silicon dioxide or hydrated silica) in an amount of about 0.1-0.6 wt% (e.g., about 0.1 wt%, about 0.15 wt%, about 0.2 wt%, about 0.25 wt%, about 0.29 wt%, about 0.3 wt%, about 0.35 wt%, about 0.4 wt%, about 0.45%, about 0.48 wt%, about 0.5 wt%, about 0.55 wt%, or about 0.6 wt%), an emulsifier (e.g., polysorbate 80) in an amount of about 0.1-1.5 wt% (e.g., about 0.1%, about 0.15%, about 0.2%, about 0.25%, about 0.3%, about 0.35%, about 0.39%, about 0.4%, about 0.45%, about 0.5%, about 0.6 wt%, about 0.7 wt%, about 0.8 wt%, about 0.9 wt%, about 1.0 wt%, about 1.1 wt%, about 1.2 wt%, about 1.3 wt%, about 1.4 wt%, or about 1.5 wt%), an artificial sweetener (e.g., sucralose) in an amount of about 0.1-0.5 wt% (e.g., about 0.1%, about 0.15%, about 0.2%, about 0.25%, about 0.3%, about 0.35%, about 0.38%, about 0.4%, about 0.45%, or about 0.5%), and / or an additional aromatic component (e.g., peppermint oil, Wintergreen oil, or a combination thereof) in an amount of about 0.1-10 wt% (e.g., about 0.1, 0.2, 0.5, 1, 2, 5, or 10 wt%, greater than 0.1 wt%, greater than 0.2 wt%, greater than 0.5 wt%, greater than 1 wt%, greater than 2 wt%, greater than 5 wt%, less than 10 wt%, less than 5 wt%, less than 2 wt%, less than 1 wt%, less than 0.5 wt%, less than 0.2 wt%, 0.1-0.2 wt%, 0.2-0.5 wt%, 0.5-1 wt%, 1-2 wt%, 2-5 wt%, 5-10 wt%, 0.1-0.5 wt%, 0.2-1 wt%, 0.5-2 wt%, 1-5 wt%, 2-10 wt%, 0.1-1 wt%, 0.2-2 wt%, 0.5-5 wt%, or 1-10 wt%). The oral composition may further include about 5% to about 10 wt% (e.g., about 5, 6, 7, 8, 9, or 10 wt%; e.g., about 5-9 wt%, 5-8 wt%,5-7 wt%, 5-6 wt%, 6-10 wt%, 7-10 wt%, 8-10 wt%, 9-10 wt%, 7-9 wt%, or 8-9 wt%) cyclodextrin.

[0056] The oral composition may comprise about 57 wt% polyvinylpyrrolidone, about 8 wt% hydrogen peroxide, about 1.3 wt% zinc acetate, about 2.3 wt% menthol, and about 5 wt% water; wherein, optionally, the oral composition further comprises one or more of the following: i) about 4 wt% thickening agent, wherein, optionally, the thickening agent is pectin; ii) about 3.9 wt% sugar alcohol, wherein, optionally, the sugar alcohol is glycerin; iii) about 3.3 wt% water softening agent, wherein, optionally, the water softening agent is pentasodium triphosphate; iv) about 3.3 wt% sequestrant, wherein, optionally, the sequestrant is sodium hexametaphosphate; v) about 2.9 wt% dental hypersensitivity agent, wherein, optionally, the dental hypersensitivity agent is hydroxyapatite; vi) about 1.6 wt% dissolution extender, wherein, optionally, the dissolution extender is polycarbophil calcium; vii) about 0.29 wt% natural gum, wherein, optionally, the natural gum is gum arabic; about 0.29 wt% abrasive substance, wherein, optionally, the abrasive substance is silicon dioxide viii) about 0.39 wt% emulsifier, wherein, optionally, the emulsifier is polysorbate 80; ix) about 0.38 wt% artificial sweetener, wherein, optionally, the artificial sweetener is sucralose; and x) about 6 wt% additional aromatic component, wherein, optionally, the additional aromatic xi) component is limonene, peppermint oil, Wintergreen oil, or a combination thereof.

[0057] In an alternative example, the oral composition may include about 25.5 wt% polyvinylpyrrolidone, about 23.3 wt% pullulan, about 1.1 wt% phthalimidoperoxycaproic acid (PAP), about 8.5 wt% cyclodextrin, about 6.0 wt% glycerin, about 5.2 wt% hydroxyapatide, about 4.4 wt% pectin, about 3.3 wt% sodium hexametaphosphate, about 3.3 wt% pentasodium triphosphate, about 1.3 wt% zinc acetate, about 1.2 wt% polysorbate 80, about 0.5 wt% gum arabic, about 0.5 wt% hydrated silica, about 0.3 wt% sucralose, about 3.8% menthol, about 6.7 wt% peppermint oil, about 0.2 wt% Wintergreen oil, and about 5 wt% water.

[0058] The oral composition may be configured to dissolve upon contact with oral or buccal mucosa within about 10 minutes. The oral composition may have a thickness between about 50 um and about 500 um. The oral composition may have a width between about 10 mm to about 20 mm and a length between about 10 mm to about 85 mm. The oral composition may have a weight between about 10 mg to about 1 g.

[0059] According to a fifth aspect, there is provided a method of making the oral composition of the fourth aspect, comprising the steps of: a} combining a whitening agent that is at least one of hydrogen peroxide and phthalimidoperoxycaproic acid, a water-soluble or water-dispersible polymer that is polyvinylpyrrolidone, a volatile solvent that is water, a disinfecting agent that is zinc acetate, and an aromatic component that is menthol to form a mixture; b) optionally, further combining one or more other components to the mixture; c) mixing or stirring the mixture to form a uniform mixture; d) spreading the uniform mixture onto a surface using a brush or applicator until a thin film is formed; e) drying the thin film until the volatile solvent fully evaporates to form a dry film; and f} peeling away the dry film from the surface to form the oral composition.

[0060] The whitening agent may comprise about 8 wt% hydrogen peroxide. The water-soluble or water- dispersible polymer may comprise about 57 wt% polyvinylpyrrolidone. The volatile solvent may comprise about 5 wt% water. The disinfecting agent may comprise about 1.3 wt% zinc acetate. The aromatic component may comprise about 2.3 wt% menthol. The one or more other components may include a thickening agent, a sugar alcohol, a water softening agent, a sequestrant, a dental hypersensitivity agent, a dissolution extender, a natural gum, an abrasive substance, an emulsifier, an artificial sweetener, and / or an additional aromatic component. The thickening agent may comprise about 4 wt% pectin. The sugar alcohol may comprise about 3.9 wt% glycerin. The water softening agent may comprise about 3.3 wt% pentasodium triphosphate. The sequestrant may comprise about 3.3 wt% sodium hexametaphosphate. The dental hypersensitivity agent may comprise about 2.9 wt% hydroxyapatite. The dissolution extender may comprise about 1.6 wt% polycarbophil calcium. The natural gum may comprise about 0.29 wt% gum arabic. The abrasive substance may comprise about 0.29 wt% silicon dioxide. The emulsifier may comprise about 0.39 wt% polysorbate 80. The artificial sweetener may comprise about 0.38 wt% sucralose. The additional aromatic component may comprise about 6 wt% limonene, peppermint oil, Wintergreen oil, or a combination thereof.

[0061] According to a sixth aspect, there is provided a method of using the oral composition of the fourth aspect, comprising applying the oral composition to one or more teeth of a subject. The method may further comprise, prior to applying the oral composition to the teeth of the subject, the steps of: a) removing the oral composition from a sachet; and / or b) moistening one or more teeth of the subject. The oral composition may dissolve within 10 minutes. The oral composition may be packaged within foil sachets that preserve the oral composition for at least two months. The method may further comprise applying the oral composition to cover the one or more teeth of the subject. The oral composition whitens the teeth of the subject. The oral composition reduces halitosis in the subject. The oral composition reduces the number of, or kills, oral bacteria in the subject.

[0062] According to a seventh aspect, there is provided a kit comprising the oral composition of the fourth aspect, wherein the oral composition is present within a foil sachet.

[0063] DETAILED DESCRIPTION

[0064] The present invention relates to dissolvable oral strips or films. In particular, the present invention relates to dissolvable oral strips or films having compositions useful for the simultaneous delivery of whitening active agents and oral hygiene active agents. More particularly, to compositions suitable for formation of orally soluble, mucoadhesive films that are adapted to adhere to a user's teeth. Also provided is a process of manufacturing the films and a method of using the films.

[0065] The dissolvable oral strip or film comprises at least one oral hygiene agent. Preferably, the dissolvable oral strip or film comprises about 0.1 wt.% to about 10 wt.% of the or each at least one oral hygiene agent.

[0066] The or each at least one oral hygiene agent is capable of imparting its specific effect by gradual release into the oral mucosa upon dissolution of the strip. The or each at least one oral hygiene agent may comprise a zinc compound.

[0067] Where the or each at least one oral hygiene agent comprises a zinc compound, it may be selected from one or any combination of: zinc acetate; zinc oxide; zinc sulfate; zinc chloride; zinc citrate; zinc lactate; zinc gluconate; zinc malate; zinc tartrate; zinc carbonate; and / or zinc phosphate. Where any such zinc compound is selected as the or each at least one oral hygiene agent, it is capable of freshening a user's breath. Without wishing to be bound by theory, it is believed that the zinc compound achieves this by two mechanisms of action. The first mechanism involves the ability of the zinc compound to bind with gaseous hydrogen sulfide (H2S) which may be generated by Volatile sulfur compound (VSC) generating bacteria. The second mechanism is related to the anti-bacterial nature of the zinc compound that impacts growth of VSC generating bacteria, thereby killing bacteria which lead to the cause of oral malodour.

[0068] The present invention may provide a dissolvable or substantially dissolvable oral strip or film comprising at least one oral hygiene agent with the concentration of: about 0.1 to about 10.0 wt.%; about 0.5 to about 9.0 wt.%; about 0.5 to about 8.0 wt.%; about 1.0 to about 7.0 wt.%; about 1.0 to about 6.0 wt.%; about 1.0 to about 5.0 wt.%; about 1.0 to about 4.0 wt.%; about 1.0 to about 3.0 wt.%; or about 1.0 to about 2.0 wt.% of the strip or film.

[0069] Particularly preferred oral hygiene agents that may be used in the dissolvable teeth whitening strip or film include any one of or combination of the following: zinc acetate; and / or zinc citrate and / or zinc gluconate.

[0070] The present invention may provide a dissolvable or substantially dissolvable oral strip or film comprising zinc acetate and / or zinc citrate and / or zinc gluconate, with the concentration of each said compound being: about 0.1 to about 10.0 wt.%; about 0.5 to about 9.0 wt.%; about 0.5 to about 8.0 wt.%; about 1.0 to about 7.0 wt.%; about 1.0 to about 6.0 wt.%; about 1.0 to about 5.0 wt.%; about 1.0 to about 4.0 wt.%; about 1.0 to about 3.0 wt.%; or about 1.0 to about 2.0 wt.% of the strip or film.

[0071] A particular preferred composition of zinc acetate and / or zinc citrate and / or zinc gluconate in the dissolvable or substantially dissolvable oral strip or film of the present invention is: 1.4 wt.%; 2.5 wt.%; or 5.0 wt.%.

[0072] Optionally, the dissolvable oral strip or film may comprise two or more different oral hygiene agents that have different treatment modalities, for treatment of multiple oral health conditions or for combined treatment of a single oral health condition. The different oral hygiene agents can be used in varying compositions of the strip or film to provide tailored benefits. Another oral hygiene agent of preference in the present invention is Cetylpyridinium chloride (CPC). CPC may optionally be added to the dissolvable oral strip as the sole oral hygiene agent, or in combination with one or more of any of the above referenced agents. CPC may be present in the strips of the present invention, having a concentration of: about 0.1 to about 5 wt.%; about 0.1 to about 3.0 wt.%; about 0.1 to about 2.0 wt.%; about 0.1 to about 1.0 wt.%; about 0.1 to about 0.8 wt.%; about 0.1 to about 0.6 wt.%; about 0.1 to about 0.4 wt.%; about 0.1 to about 0.3 wt.%; or about 0.2 to about 0.3 wt.% of the strip or film. CPC has been shown to have anti-bacterial properties, killing bacteria which lead to the cause of oral malodour.

[0073] The present invention provides a dissolvable oral strip or film that comprises at least one oral hygiene agent in combination with at least one whitening agent. The at least one whitening agent may include: hydrogen peroxide; a hydrogen peroxide-polyvinyl pyrrolidone complex; and 6-phthalimido peroxy caproic acid (PAP), or any combination thereof.

[0074] The dissolvable or substantially dissolvable oral strip or film may therefore comprise at least one oral hygiene agent (such as zinc acetate and / or zinc citrate and / or zinc gluconate) in combination with: hydrogen peroxide and / or a hydrogen peroxide-polyvinyl pyrrolidone complex (such as Peroxydone®) and / or PAP (such as Eureco HCP11®). Advantageously, this provides a dissolvable oral strip or film that delivers whitening agents for stain removal and tooth whitening efficacy, at the same time as oral hygiene agents for treatment of specific oral hygiene conditions. The dissolvable oral strip or film that comprises at least one oral hygiene agent in combination with at least one whitening agent is therefore advantageously a multi-treatment modality strip or film.

[0075] Where the present invention provides a dissolvable or substantially dissolvable oral strip or film comprising at least one oral hygiene agent (such as zinc acetate and / or zinc citrate and / or zinc gluconate) and hydrogen peroxide (optionally as a hydrogen peroxide-polyvinyl pyrrolidone complex), the concentration of hydrogen peroxide in the strip or film may be: about 1 wt.% to 20 wt.% of the strip or film; about 1 wt.% to 15 wt.% of the strip or film; about 1.0 wt.% to 10.0 wt.% of the strip or film; about 2.0 wt.% to 10.0 wt.% of the strip or film; about 4.0 wt.% to 10.0 wt.% of the strip or film; about 4.0 wt.% to 9.0 wt.% of the strip or film; or about 5.0 wt.% to 9.0 wt.% of the strip or film. A preferred range for the concentration of hydrogen peroxide in the strip or film may be: about 1.0 wt.% to about 6.0 wt.% of the strip or film. As an example, Peroxydone K-30® is a dental bleaching agent formed from a complex of 17.0 to 20.0 wt.% hydrogen peroxide and polyvinyl pyrrolidone having a molecular weight of 58,000 supplied by Ashland Inc. Therefore, where 70.6 wt.% Peroxydone K-30® is used as a source of hydrogen peroxide in a strip or film of the present invention, the strip or film is provided with approximately 12.00 wt.% to 14.12 wt.% content hydrogen peroxide. Such a dissolvable or substantially dissolvable oral strip or film provides the benefit of combined tooth whitening and oral malodour suppression (anti-bacterial properties).

[0076] Where the present invention provides a dissolvable or substantially dissolvable oral strip or film comprising at least one oral hygiene agent (such as zinc acetate and / or zinc citrate and / or zinc gluconate) and PAP, the concentration of PAP in the strip or film may be: about 0.1 wt.% to 10.0 wt.% of the strip or film; about 0.1 wt.% to 5.0 wt.% of the strip or film; about 0.1 wt.% to 2.0 wt.% of the strip or film; or about 1.0 wt.% to 2.0 wt.% of the strip or film. As an example, Eureco HC-P11® is an 11 wt.% PAP non-hydrogen peroxide bleaching agent complex with p-cyclodextrin supplied by Solvay. Therefore, where 10.1% Eureco HC-P11® is used as the source of PAP in a strip or film of the present invention, the strip or film is provided with approximately 1.11 wt.% content PAP. A peroxy carboxylic acid bleaching agent may be provided as a complex, such as a complex of peroxy carboxylic acid and a carbohydrate, for instance dextrin. Complexes of a peroxy carboxylic acid, such as PAP, with a carbohydrate, such as dextrin, provide the bleaching agent with improved stability, particularly improved thermal and chemical stability. The bleaching agent is less reactive because it is intermolecularly bonded with the carbohydrate, such as within a dextrin ring, thereby providing a thermal energy barrier to degradation. Energy is required to dissociate the peroxy carboxylic acid from the complex before it can be degraded. Such a dissolvable or substantially dissolvable oral strip or film provides the benefit of combined tooth whitening and oral malodour suppression (antibacterial properties).

[0077] The dissolvable oral strip or film of the present invention may include a combination of hydrogen peroxide and PAP, provided at the above disclosed wt.% ranges. Advantageously, this affords use of less hydrogen peroxide to achieve a comparable overall tooth whitening effect, whilst reducing the likelihood of dental hypersensitivity to the user.

[0078] The invention therefore provides a dissolvable or substantially dissolvable oral strip or film comprising whitening agents that act to reduce staining and whiten a user's teeth when said strip or film is applied to said user's teeth. The whitening agents are therefore advantageously delivered topically directly onto the teeth, imparting direct activity of the whitening agent to the surface of the teeth. The dissolvable oral strip is provided with no backing layer or liner. Therefore, when the strip is applied to the user's teeth, it dissolves and leaves behind little to no residue. Advantageously therefore, a user has nothing to discard besides the packaging, when the dissolvable oral strip is utilised. This reduces environmental impact of the product and improves usability. Further advantageously, providing a dissolvable strip with no backing layer means there is no occlusive layer to reduce the dissolution of the agents into the oral mucosa. This therefore enables the whitening agents and oral hygiene agents to be more efficacious in imparting their benefits. More specifically, when the strips of the present invention comprise an anti-microbial agent (such as zinc acetate and / or zinc citrate and / or zinc gluconate and / or CPC), together with a tooth whitening agent (such as hydrogen peroxide and / or a hydrogen peroxide-PVP complex and / or PAP), the strips are able to be placed on the users teeth and fully dissolve in use, to impart the maximum efficacy of those agents. This therefore leads to enhanced teeth whitening and reduction in the bacteria present in a user's mouth simultaneously.

[0079] It has been found that the combination of Zn2+(in the form of zinc salts) with CPC lead to a significant reduction in the perceived oral malodour of a user. Particularly enhanced anti-bacterial properties were found for the specific combination of Zinc Acetate with CPC in the dissolvable oral strip or film of the present invention. An example formulation for such a strip or film of the present invention may comprise: 1.0 to 3.0 wt.% Zinc salt (such as zinc acetate, zinc gluconate or zinc citrate); and 0.1 to 1.0 wt.% CPC. An exemplary composition may comprise: 50.0 to 60.0 wt.% PVP; 5.0 to 7.0 wt.% Pectin; 1.0 to 2.0 wt.% polycarbophil(s); 1.0 to 1.5 wt.% glycerol; 0.1 to 1.0 wt.% polysorbate 80; 1.0 to 3.0 wt.% zinc acetate; 0.1 to 1.0 wt.% CPC; 2.0 to 4.0 wt.% hydroxyapatite; 3.0 to 10.0 wt.% combined cyclic and linear polyphosphates (such as 3.5 wt.% SHMP and 3.5 wt.% STPP); 1.0 to 3.0 wt.% menthol; 6.0 to 8.0 wt.% flavour; and 0.2 to 0.5 wt.% sucralose.

[0080] Further advantageously, the strip can be in the oral cavity for a period of time that exceeds what would be possible from a breath freshening strip, that is placed directly on the tongue and is designed to dissolve rapidly. Therefore, the oral hygiene agents in the dissolvable strip or film of the present invention that is placed on the teeth provide extended exposure of the oral mucosa to said oral hygiene agents. Advantageously, this increases the treatment efficacy of the oral hygiene agents. This also allows for delivery of a total amount of oral hygiene agents that may have otherwise not been possible with a rapid dissolving strip.

[0081] Advantageously, where a zinc compound (such as zinc acetate and / or zinc citrate and / or zinc gluconate) is combined with hydrogen peroxide or PAP in the present dissolvable oral strip or film, it provides combined treatment of: whitening and stain removal of teeth (by the whitening agent) and freshening of a user's breath (through anti-bacterial properties). This therefore saves money for manufacturing costs as a single product is produced that serves as a combined whitening strip and breath freshening strip. It also provides the user with savings (only having to buy a single product as opposed to at least two) and provides efficiency of treatment (single application, as opposed to two or more). Further, where the dissolvable oral strip or film of the present invention is applied by a user to the teeth (i.e. when in use), the strip gradually dissolves, leaving behind no trace.

[0082] The dissolvable oral strip or film also allows for the inclusion of further agents to further increase the benefits provided in a single use.

[0083] The placement of the dissolvable oral strip directly on the teeth, coupled with the ability to control the dissolution time (either by including an optional dissolution modulating agent, such as polycarbophils, or adjusting film thickness) presents additional benefits. The strip can be in the oral cavity for a period of time that exceeds what would be possible from a breath freshening strip, that is placed directly on the tongue and is designed to dissolve rapidly. The dissolving nature of the present dissolvable oral strip or film also provides benefits over a non-dissolving strip, even if a non-dissolving strip were formulated to include a breath freshening agent and placed on the teeth. A non-dissolving strip with a breath freshening agent, which would have a barrier layer, would only permit diffusion release of any active(s) upon swelling of the strip. Whereas, the dissolvable oral strip of the present invention provides it's actives via dissolution release, therefore, there is greater opportunity for the saliva to come into contact with the breath freshening agent (such as zinc acetate and / or zinc citrate and / or zinc gluconate) for enhanced treatment of bad breath. The same holds true for any oral hygiene agent that is incorporated into the present dissolvable oral strip, that would otherwise have been introduced via a rapid dissolution strip directly onto the tongue of a user.

[0084] The present invention may also provide a dissolvable oral strip or film that further comprises dental hypersensitivity (DH) agents, such as hydroxyapatite (HAP). The dissolvable or substantially dissolvable oral strip or film may therefore comprise: at least one oral hygiene agent (such as zinc acetate); at least one whitening agent (such as hydrogen peroxide and / or PAP); and optionally HAP. Where the strip optionally includes HAP, it may be included at: 1 to 15 wt.% or 3 to 7 wt.% of the strip or film. Other possible dental hypersensitivity agents that may optionally be added to the dissolvable oral strip or film include: potassium nitrate, strontium, Arginine, calcium carbonate, Stannous Fluoride, Biomimetic glass (novamin®), and / or osteopontin (a heavily phosphorylated, acidic glycoprotein).

[0085] Careful consideration must be given to the specific formulation of the present invention, as a balance must be struck between the active agents provided and the physical properties of the resulting strip. In this regard, the formulation must be balanced so at to provide: a casting liquid (aqueous solution of the components) that is stable; has appropriate viscosity for casting onto a backing layer for drying; dries evenly; and provides a finished strip that is smooth and free of unsightly finishes (such as streaks, blotches or a grainy texture).

[0086] The present invention may also provide a dissolvable oral strip or film that further comprises one or more polyphosphates. Surprisingly, it has been found that by including polyphosphates into a dissolvable oral strip or film according to the present invention, the miscibility and compatibility of the active components during formulation is improved. As a specific example, when a dissolvable oral strip or film of the present invention includes 1.4 wt.% zinc acetate in combination with 13 wt.% to 16 wt.% hydrogen peroxide (supplied as Peroxydone K30® or K90®) the resulting strip was found to have a grainy appearance, which is undesirable to an end user. However, when said strip was supplemented with 3.5 wt.% to 7 wt.% total content of one or more cyclic polyphosphates and / or one or more linear polyphosphates, the resulting strip was smooth (i.e. no longer grainy and therefore more appealing to a user).

[0087] The dissolvable oral strip or film preferably comprises one or more cyclic and / or one or more linear polyphosphates. The Applicant has found that use of one or more cyclic and / or one or more linear polyphosphates in the dissolvable oral strip or film also improves the whitening efficacy of the at least one whitening agent (or agents) within the strip. Therefore, such a dissolvable oral strip or film provides enhanced whitening (or bleaching) and improved stain removal when the strip is applied to the teeth of a user.

[0088] In addition, enhanced whitening efficacy may be achieved at lower concentrations of the whitening agent, due to the presence of the polyphosphates.

[0089] In one embodiment, the one or more cyclic polyphosphates are defined by formula (II):

[0090]

[0091] In which "a" is a whole number from 3 to 10. Preferably "a" is a whole number from 4 to 8. More preferably "a" is 6. "M" is selected from one or more of the group comprising hydrogen and an alkali metal. Preferred alkali metals comprise one or both of Na and K, more preferably Na.

[0092] For the avoidance of doubt, the one or more cyclic polyphosphates of formula (II) are defined by the repeat unit [-P(=O)(OM)-O-], with the term 'a' representing the number of repeat units present. The arc joining the two free bonds of the repeat unit of formula (II) is intended to represent the cyclic nature of the polyphosphate. The cyclic polyphosphate may thus be represented by the formula Ma(P03)a. Thus, when "a" = 6, a hexametaphosphate is provided.

[0093] Preferably, the one or more cyclic polyphosphates comprise sodium hexametaphosphate.

[0094] The one or more cyclic polyphosphates may be present in the dissolvable oral strip or film in a total amount of from about 0.1% to about 9% by weight of the dissolvable oral strip or film. Preferably the one or more cyclic polyphosphates may be present in a total amount of from about 3% to about 8% by weight of the dissolvable oral strip or film. More preferably 3% to 4% by weight of the dissolvable oral strip or film. Still more preferably, the one or more cyclic polyphosphates may be present in a total amount of about 3.5% by weight of the dissolvable oral strip or film.

[0095] In one embodiment, the one or more polyphosphates may further comprise one or more linear polyphosphates. The one or more linear polyphosphates may comprise a compound of formula (III): in which "b" is a whole number from 2 to 5. Preferably "b" is 3 or 4. Still more preferably, "b" is 3. "M" is selected from one or more of the group comprising hydrogen and an alkali metal. Preferred alkali metals comprise one or both of Na and K, more preferably Na.

[0096] For the avoidance of doubt, substituent "M" of formulae (II) and (III) may be selected independently, although in a preferred embodiment they may be the same, such as Na.

[0097] For the avoidance of doubt, the one or more linear polyphosphates of formula (III) are defined by the repeat unit [-P(=O)(OM)-O-], with the term 'b' representing the number of repeat units present. The linear polyphosphate may thus be represented by the formula Mb+2O(PO3)b. Thus, when "b" = 3, a tripolyphosphate is provided.

[0098] Preferably, the one or more linear polyphosphates are selected from the group comprising sodium dipolyphosphate, sodium tripolyphosphate and sodium tertrapolyphosphate. More preferably, the one or more linear polyphosphates comprises sodium tripolyphosphate.

[0099] The one or more linear polyphosphates may be present in the dissolvable oral strip or film in a total amount of from 0.1% to 9% by weight of the dissolvable oral strip or film. Preferably the one or more linear polyphosphates may be present in a total amount of from 3% to 8% by weight of the dissolvable oral strip or film. More preferably the one or more linear polyphosphates may be present in a total amount of from 3% to 4% by weight of the dissolvable oral strip or film. Still more preferably, the one or more linear polyphosphates may be present in a total amount of about 3.5% by weight of the dissolvable oral strip or film.

[0100] In a preferred embodiment, the one or more polyphosphates comprise sodium hexametaphosphate and sodium tripolyphosphate. Preferably sodium hexametaphosphate is present in the dissolvable oral strip or film in an amount of from 0.1% to 9% by weight of the dissolvable strip or film and sodium tripolyphosphate is present in an amount of from 0.1% to 9% by weight of the dissolvable strip or film. More preferably sodium hexametaphosphate is present in an amount of from 3% to 8% by weight of the dissolvable strip or film and sodium tripolyphosphate is present in an amount of from 3% to 8% by weight of the dissolvable strip or film. Still more preferably sodium hexametaphosphate is present in an amount of from 3% to 6% by weight of the dissolvable strip or film and sodium tripolyphosphate is present in an amount of from 3% to 6% by weight of the dissolvable strip or film. Still more preferably, the one or more cyclic polyphosphates and the one or more linear polyphosphates may each be present in a total amount of about 3.5% by weight of the dissolvable strip or film to provide a total polyphosphate content of 7% by weight of the dissolvable strip or film.

[0101] Where the dissolvable oral strip or film of the present invention comprises a complex of hydrogen peroxide with polyvinylpyrrolidone (PVP) as a whitening agent, a preferred source is Peroxydone K- 30®. The hydrogen peroxide is complexed with the polymer (e.g. PVP), so an increase in the content of hydrogen peroxide (H2O2) in the formulation is accompanied by an increase in PVP / Polymer component of the strip or film. Utilisation of hydrogen peroxide in a complexed form with PVP has the advantage that it may act as a whitening agent and a film forming agent at the same time, reducing the need to add a separate film forming polymer, or in other embodiments, removing the need for further film forming polymers entirely.

[0102] An advantage of using the hydrogen peroxide / PVP complex is that a higher percentage of hydrogen peroxide (H2O2) remains in the strip or film post-manufacture than would be the case if the strip or film were comprised of a formulation consisting of PVP and hydrogen peroxide added separately. This appears to be due to a greater stability of the complexed composition versus the non-complexed composition when exposed to the drying process required to make thin films.

[0103] Alternatively, the dissolvable strip or film of the present invention may comprise hydrogen peroxide and PVP that have not been complexed together and are therefore present in the strip or film as separate chemical components.

[0104] Plasticiser may be used to ensure acceptable physical properties of the strip or film of the present invention. Other ingredients such as colouring and flavouring agents may be chosen to ensure acceptable appearance and taste respectively.

[0105] The present invention may also provide a dissolvable oral strip or film with selective dissolution time, such that the formulation may be adapted to extend or shorten the amount of time it takes for said strip or film to dissolve in the oral cavity of the user. The dissolution time may be adjusted through adjusting the thickness of the strip or film and / or by adding dissolution modulating agents.

[0106] Advantageously, the dissolution time can be tailored to provide optimal treatment times of the whitening agents, relative to the concentrations of those agents within the strip or film. The dissolution time can also be selected to provide a balance between the optimum exposure time of the teeth to the whitening agent vs gradual release of the oral hygiene agent to the oral cavity. This therefore optimises the treatment efficacy of the active agents on the teeth and the oral mucosa of the user when the strip or film is in use within the oral cavity.

[0107] The dissolvable or substantially dissolvable oral strip or film may be adapted to dissolve completely or substantially completely when used in an oral cavity of a user over a period of: 5 to 30 minutes; 5 to 20 minutes; 5 to 15 minutes; or 10 to 15 minutes. Most preferably, the dissolvable or substantially dissolvable oral strip or film may be adapted to dissolve completely or substantially completely when used in an oral cavity of a user over a period of 5 to 15 minutes.

[0108] It has also been found that the addition of additional components such as polycarbophils (such as Noveon®) may be used to adjust a dissolution time for the strip or film. Noveon® is a synthetic polymer of polyacrylic acid cross-linked with divinyl glycol. Preferred concentrations of the polycarbophils in a dissolvable oral strip ort film of the present invention include: about 1 to 5 wt.% or about 1.5 to 3 wt.%.

[0109] The dissolvable or substantially dissolvable oral strip or film may have a thickness ranging from: about 50 pm to about 500 pm; about 50 pm to about 250 pm; about 50 pm to about 100 pm; or about 100 pm to about 200 pm. By selecting a thinner strip or film, the dissolution time will be shortened, whilst selecting a thicker strip or film will extend the dissolution time. These parameters can be selected and the strip optionally supplemented with polycarbophils to provide a tailored dissolution profile, relative to the required delivery of specific active agents.

[0110] The dissolvable or substantially dissolvable oral strip or film may have a length of: from 10 to 100mm; or 40 to 70 mm; or more preferably from 50 to 60 mm.

[0111] The dissolvable or substantially dissolvable oral strip or film may have a width of: from 8 to 20 mm; or more preferably from 10 to 15 mm. The dissolvable or substantially dissolvable oral strip or film may further comprise water. The water may be present in the film in an amount of less than about 15 wt.%, particularly from about 0.1 wt.% to 15 wt.%. Typically, the tooth whitening film may further comprise water in an amount of from about 3 wt.% to 12 wt.%, preferably from about 5 wt.% to 10 wt.% by weight of the strip or film.

[0112] The dissolvable or substantially dissolvable oral strip or film may further comprise one or more further components selected from any one of or combination of the group comprising: colourant; flavouring; and / or sweetener.

[0113] The dissolvable or substantially dissolvable oral strip or film is defined in terms of the dry weight of the film i.e. the weight of components dried to exclude water, expressed as percentages (i.e. wt.%) by total dry weight of the film alone i.e. without any backing sheet or support.

[0114] The dissolvable or substantially dissolvable oral strip or film is flexible such that it is mouldable to, and can adopt the surface shape of the teeth.

[0115] The strip or film is dissolvable, such that it dissolves completely or substantially completely within the oral cavity of a user.

[0116] The dissolvable or substantially dissolvable oral strip or film comprises one or more water soluble film-forming polymers.

[0117] The water soluble film-forming polymer provides structure to the film and may control the release of the whitening agent(s) and oral hygiene agent(s) during dissolution of the film. As used herein, a "water soluble" polymer is one in which one gram of polymer is soluble in 30 g or less of water. For instance, a polymer may be water soluble if 1 g of polymer is soluble in 25 g water.

[0118] The one or more water soluble film-forming polymers may be one or more selected from the group comprising: a polyvinyl pyrrolidone (such as Peroxydone® or Luviskol®); polyacrylic acid or a salt thereof; pullulan; pectin; starch; dextrin; chitosan; alginic acid; salts of alginic acid and / or cellulose derivatives.

[0119] Preferably the water soluble film-forming polymer may be selected from the group comprising any one of or combination of the following: polyvinyl pyrrolidone; pullulan; pectin; starch; carboxyalkyl cellulose or a salt thereof; hydroxyalkyl cellulose or a salt thereof, in which the alkyl group is independently selected from C1-5 alkyl, alginic acid, salt of alginic acid, polyalkylene glycol in which the alkylene group has 2 or 3 carbon atoms and copolymers thereof, polyacrylic acid or a salt thereof and combinations thereof.

[0120] More preferably, the water soluble film-forming polymer comprises a water soluble film-forming polymer selected from any one of or combination of the following: polyvinyl pyrrolidone; pullulan; or pectin.

[0121] The polyvinyl pyrrolidone may be selected from any one of or combination of the following: uncrosslinked polyvinyl pyrrolidone; crosslinked polyvinyl pyrrolidone; a copolymer of vinyl pyrrolidone and acrylic acid; a copolymer of vinyl pyrrolidone and vinyl acrylate or alkylated polyvinyl pyrrolidone.

[0122] The polyvinyl pyrrolidone may preferably have a weight average molecular weight in the range of from: 10,000 to 200,000; 10,000 to 100,000; 20,000 to 80,000; or 30,000 to 70,000. Still more preferably, the polyvinyl pyrrolidone may preferably have a weight average molecular weight of 58,000.

[0123] Alternatively, the polyvinyl pyrrolidone may have a weight average molecular weight in the range of 1,100,000 to 1,300,00 g / mol.

[0124] Certain water soluble film-forming polymers may also function as adhesives, aiding attachment of the tooth whitening film to one or more teeth. Such adhesive water soluble film-forming polymers may be one or more selected from the group comprising: polyvinyl pyrrolidone, a carboxyalkyl cellulose, a salt of carboxyalkyl cellulose, carbomer, dextrin, chitosan and polyethylene glycol. Polyethylene glycol, also known as polyethylene oxide, is a preferred adhesive water soluble film-forming polymer.

[0125] The one or more film forming polymers may be present in the film in a total amount of from about 40 wt.% to about 95 wt.% of the dissolvable strip or film. Preferably, the one or more film forming polymers may be present in a total amount of from about 60 wt.% to about 90 wt.% of the dissolvable strip or film. More preferably, the one or more film forming polymers may be present in a total amount of from about 70 wt.% to about 85 wt.% of the dissolvable strip or film. Still more preferably, the one or more film forming polymers may be present in a total amount of from about 75 wt.% to about 80 wt.% of the dissolvable strip or film.

[0126] The dissolvable or substantially dissolvable oral strip or film comprises one or more plasticizers. Preferably the plasticizer should be a physiologically acceptable plasticizer.

[0127] The one or more plasticizers may be selected from the group comprising any one of or combination of the following: a polyol such as glycerol; polyalkylene glycol in which the alkylene groups are independently selected from from C1-5 alkylene, polyalkylene glycol monomethyl ether in which the alkylene groups are independently selected from from C1-5 alkylene, monosaccharide, oligosaccharide, sorbital and sorbitan, preferably ethylene or propylene. Preferred polyalkylene glycols are one or both of polyethylene glycol and polypropylene glycol. A preferred polyalkylene glycol monomethyl ether is polyethylene glycol monomethyl ether.

[0128] The plasticizer may be a hydrophilic plasticizer, such as one or more of the group comprising a polyol such as glycerol, polyethylene glycol, polyethylene glycol monomethyl ether, propylene glycol, sorbital and sorbitan.

[0129] The preferred plasticizer is glycerol.

[0130] The one or more plasticizers may be present in the film in a total amount of from about 0.1 wt.% to about 15 wt.% by weight. Preferably the one or plasticizers may be present in a total amount of from about 1 wt.% to about 15 wt.% by weight. More preferably, the one or plasticizers may be present in the film in a total amount of from about 3 wt.% to about 12 wt.% by weight. Most preferably, the one or plasticizers may be present in the film in a total amount of from about 8 wt.% to about 12 wt.% by weight of the dissolvable strip or film.

[0131] The dissolvable or substantially dissolvable oral strip or film comprises one or more emulsifiers. The one or more emulsifiers may be selected from ionic emulsifiers and non-ionic emulsifiers.

[0132] Preferably the non-ionic emulsifier is selected from the group comprising a saturated fatty acid derivative, a lecithin (such as soy lecithin) or a polysorbate (such as Polysorbate 80). The fatty acids may be saturated or unsaturated. More preferably the non-ionic emulsifier comprises one or both of at least one unsaturated fatty acid such as oleic acid and / or linoleic acid and optionally at least one saturated fatty acid such as palmitic acid and / or stearic acid or a polysorbate.

[0133] Polysorbates are polyethoxylated esters of sorbital, sorbitans and isosorbide. Preferred saturated fatty acid derivatives include sucrose esters of saturated fatty acids; mono-, di- or tri-glycerides of saturated fatty acids; or sorbitan esters of saturated fatty acids. A preferred emulsifier is Sorbital, such as T80® supplied by Azelis.

[0134] The one or more emulsifiers may be present in the dissolvable or substantially oral whitening strip or film in a total amount of from: about 0.1 wt.% to about 10.0% wt.%; preferably in the range of from about 1.0 wt.% to about 6.0 wt.%; or more preferably 1.5 wt.% to 4.5 wt.% of the dissolvable or substantially dissolvable teeth whitening strip or film.

[0135] The dissolvable oral strip or film may further comprise one or more optional components selected from the group comprising any one of or combination of following: colourant, flavouring, and / or sweetener.

[0136] The flavouring may be an artificial flavouring or a natural flavouring. The flavouring may be selected from the group comprising menthol, peppermint and an alkyl alkanoate, in which the alkyl group may be straight chained or branched and may comprise from 1 to 8 carbon atoms, and the alkanoate group may comprise from 1 to 5 carbon atoms. Preferably the alkyl group of the alkyl alkanoate has 1, 2, 5 or 8 carbon atoms and the alkanoate group of the alkyl alkanoate may comprise from 1 to 5 carbon atoms, preferably 1, 4 or 5 carbon atoms. Preferred alkyl alkanoates are methyl butyrate [apple / pineapple], ethyl butyrate [orange / pineapple], iosamyl acetate [banana / pear], pentyl butyrate [pear / apricot], pentyl pentanoate [apple], octyl acetate [orange].

[0137] Peppermint is preferred in the teeth whitening strip or film. Peppermint flavouring contains menthol as well as other components such as menthone, menthofuran, cineol, pulegone, together with some lesser ingredients.

[0138] Other preferred flavours include: Menthol; Spearmint; Novamint; Bublegum; Cherry; Cotton candy; grape; and Anis. Preferably the flavouring agent is present in a proportion of from about 0.1 wt.% to about 10 wt.% by dry weight of the oral strip or film, more preferably from 1 wt.% to 5 wt.% by dry weight of the oral strip or film.

[0139] The sweetener may be a sugar substitute, such as an artificial sugar substitute or a natural sugar substitute. An artificial sugar substitute may be one or more selected from the group comprising sucralose and cyclamate aspartame, advantame, saccharin, acesulfame potassium. A natural sugar substitute may be selected from the group comprising stevia, erythritol, mannitol, sorbital and xylitol. Preferably the sweetener is sucralose.

[0140] Preferably the sweetener is present in a proportion of from about 0.01 wt.% to about 5 wt.% by dry weight of the teeth whitening strip or film. More preferably the sweetener is present in a proportion of from 0.05 wt.% to 0.5 wt.% by dry weight of the teeth whitening strip or film.

[0141] A preservative may also be present in the dissolvable oral strip or film. Typical preservatives may be one or more compounds selected from the group comprising potassium sorbate, benzoic acid and its salts, propionic acid and its salts, salicylic acid and its salts and triclosan.

[0142] Preferably the preservative is present in a proportion of from about 0.01 wt.% to about 5 wt.% by dry weight of the teeth whitening strip or film. More preferably the preservative is present in a proportion of from 0.05 wt.% to 0.5 wt.% by dry weight of the teeth whitening strip or film.

[0143] Also disclosed herein is a process for the manufacture of a dissolvable or substantially dissolvable oral strip or film. The film does not require the presence of further layers, such as barrier layers or supporting substrates.

[0144] The dissolvable oral strip or film is prepared from an aqueous dissolvable oral liquid. The aqueous dissolvable oral liquid is a mixture of the components of the dissolvable oral strip or film with water.

[0145] The oral hygiene agent (such as zinc acetate and / or zinc citrate and / or zinc gluconate), whitening agents(such as hydrogen peroxide; and / or a complex of hydrogen peroxide and PVP; and / or PAP) and water soluble film-forming polymer components of the dissolvable teeth whitening strip or film can be mixed with water to provide an aqueous dissolvable oral liquid. The water is typically potable water. Distilled or de-ionised water may also be used. Preferably, the components are added to water under shear.

[0146] The mixing step may further comprise the addition of one or more further components of the dissolvable oral strip or film. The one or more further components may be selected from one or more of the group comprising: colourant, gelling agent, flavouring, sweetener, acidifier, antioxidant and chelating agent.

[0147] The mixing step may therefore comprise mixing a oral hygiene agent (such as zinc acetate and / or zinc citrate and / or zinc gluconate) in a total amount of about 0.1% to about 10% by weight; a whitening agent (such as hydrogen peroxide; and / or a complex of hydrogen peroxide and PVP; and / or PAP) in a total amount of 1% to 20% by weight; one or more water soluble film-forming polymers in a total amount of about 30% to about 90% by weight; one or more plasticizers in a total amount of about 0.1% to about 15% by weight; and one or more emulsifiers in a total amount of about 0.1% to about 10% by weight; with water to provide an aqueous dissolvable oral liquid.

[0148] The mixing parameters, such as shear force and duration, will be dependent upon the scale of the process of manufacture, as well as the component of the dissolvable oral strip or film to be mixed. This in turn will affect the choice of equipment to be employed in the mixing step.

[0149] Typically, the mixing step is initiated by adding any water soluble film-forming polymer and plasticizer into the water together with any optional gelling agent, further polymers or gums. Typically, any acidifier and any optional further components such as colourant, sweetener or other low level additives also will be added at this stage. The water soluble film-forming polymer and any other polymeric components or gums will be added in an order which prevents an early excessive viscosity build, i.e. the polymers or gums which produce the lowest viscosity build will be added first. Typically, any flavours will be mixed at the latter stages to prevent any degradation of thermally sensitive components or the loss of volatile components. At the laboratory scale, should a non-hydrogen peroxide bleaching agent, such as a peroxy carboxylic acid, particularly such as a complex of PAP and polysaccharide such as dextrin, be incorporated into the dissolvable teeth whitening strip or film, it can be incorporated near the end of mixing to prevent unnecessary exposure to heat which may result in degradation. At the industrial scale, the build-up of heat during mixing is significantly reduced, and so the non-hydrogen peroxide bleaching agent, can be added at any point in the mixing step. A laboratory scale process may involve a batch size in the range of from 50 g to 10 kg. Suitable mixing apparatus for such laboratory scale batch sizes include bench-top homogenisers such as those by Silverson Machines Ltd. or IKA England LTD and overhead stirrers, such as those by IKA England LTD. An industrial scale process may involve a batch size of greater than 10 kg, such as a batch size in the range of from 15 kg to 40 kg or more. Suitable mixing apparatus for such industrial scale batch sizes include an industrial bowl cutting machine, such as those by Kilia (Fleischerei- und Spezial-Maschinen- Fabrik GmbH).

[0150] For example, the oral hygiene agent (such as zinc acetate and / or zinc citrate and / or zinc gluconate) and whitening agent (such as hydrogen peroxide; and / or a complex of hydrogen peroxide and PVP; and / or PAP), can be mixed at a shear rate in the range of from 1000 to 6000 rpm. For smaller quantities on a laboratory scale, the shear rate may be in a range of from 2000 to 6000 rpm, preferably in a range of from 3000 to 4000 rpm. For larger quantities on an industrial scale, the shear rate may be in a range of from 1500 to 2500 rpm, preferably approximately 2000 rpm. The mixing time for smaller quantities on a laboratory scale can be in a range of from 5 to 20 minutes, preferably from 5 to 10 minutes. For larger quantities on an industrial scale, the mixing time may be in a range of from 10 to 20 minutes, preferably approximately 15 minutes.

[0151] Once the components are mixed with water to provide the aqueous tooth whitening liquid, it may be applied to a substrate. The aqueous tooth whitening liquid may be applied by known film-forming processes, such as dipping, spraying, knife over roller casting, extrusion and injection moulding.

[0152] A casting device may be used to apply the aqueous tooth whitening liquid to the substrate such as a caster, spreader, die or hopper. The aqueous liquid may be pumped into a spreader. If necessary, the temperature of the aqueous liquid may be held constant by heating elements in order to carefully control the viscosity of the liquid.

[0153] The spreader distributes the aqueous tooth whitening liquid homogeneously over a substrate and controls the thickness profile of the film. The spreader typically has a slot through which the aqueous tooth whitening liquid is cast. The slot is preferably designed to ensure that the hydrostatic pressure between the centre and the edges of the cast film is equilibrated. Preferably, the aqueous liquid is maintained at a constant temperature to ensure a constant viscosity and therefore homogenous thickness distribution of the resulting film. Many different materials can be used for the substrate such as copper; silver plated copper; chromium plated steel; stainless steel; metal coated with polyvinyl alcohol or gelatin; paper such as silicone coated paper; or polymer films such as polyethylene, polypropylene, polyester such as polyethylene terephthalate (PET), particularly siliconized PET, polytetrafluoroethylene (PTFE) films. Preferably the substrate comprises paper, paper coated with a release layer such as silicone, polyethylene, polypropylene, polytetrafluoroethylene (PTFE) or a polyester such as polyethylene terephthalate (PET), particularly siliconized PET films.

[0154] The aqueous liquid carried on the substrate can then be dried. Exemplary drying methods include indirect heating, heating by radiation and air stream drying.

[0155] In one embodiment, an air feed stream with no or a low moisture content is directed towards the aqueous liquid on the substrate and an air exhaust stream loaded with water vapour is removed. The air exhaust stream loaded with moisture may be vented or passed to condensers for the condensation and separation of liquid water.

[0156] It is possible to dry both surfaces of the aqueous liquid on the substrate. This can be achieved by looping the drying dissolvable oral film around a series of polished rollers and directing air feed streams to each exposed surface in turn.

[0157] The air feed stream may be at ambient temperature. Alternatively, the air feed stream may be a heated air feed stream. Where a bleaching agent, such as PAP has been incorporated into the invention, said PAP melts above 75°C and the chemical degrades with the evolution of carbon dioxide to a-phthalimido pentanol, such that the heated air stream should have a temperature below 60°C. Preferably, the heated air feed stream may have a temperature in the range of from greater than ambient to 60 °C. More preferably, the heated air stream may have a temperature in the range of from 25 °C to 55 °C, still more preferably in the range of from 45 to 55 °C. The heating may be carried out in a belt heater with a belt speed in the range of from 0.2 to 2.0 m / min, and preferably at a speed in the range of from 0.5 to 1.5 m / min.

[0158] Alternatively, heated rollers or radiative heaters such as infra-red lamps may be used to dry the aqueous liquid to provide the dissolvable teeth whitening strip or film of the present invention. These may heat the aqueous tooth whitening liquid carried on the substrate to a temperature in the range of from greater than ambient to 60 °C, preferably to a temperature in the range of from 25 °C to 55 °C.

[0159] The drying step may comprise first drying of a surface of the aqueous liquid carried on the substrate to provide a dried dissolvable oral strip or film carried on the substrate. The dried dissolvable oral strip or film may then be separated from the substrate.

[0160] In this way, a dissolvable oral strip or film can be provided which comprises less than 15% water by dry weight of the film. The water content is preferably in a range of from 3 to 12% by dry weight of the film, more preferably in a range of from 5 to 10% by dry weight of the film and even more preferably in a range of from 5 to 7% by dry weight of the film.

[0161] The dissolvable oral strip or film may be stored on a support, such as a plastic or paper support, particularly a paper support having a silicone release layer, although this is not required.

[0162] The dissolvable oral strip or film may be stored in sterile packaging, such as a sealed packet. The sealed packet may be water tight, and more preferably water and air tight. The packet may be made of a metallic foil such as aluminium foil, or a plastic film coated with a metallic layer.

[0163] The dissolvable oral strip or film obtainable by the method disclosed herein may be used in a method of cosmetically bleaching teeth. The method may comprise at least the step of: applying the dissolvable oral strip or film, obtained as described herein, to one or more teeth of a subject.

[0164] The method may be a cosmetic method. Preferably the method is a solely cosmetic method. As used herein, the term a "solely cosmetic method" means a cosmetic method which does not encompass the treatment or prevention of a medical condition or indication.

[0165] In the method, dissolvable oral strip or film may first be released from its sterile packaging. Subsequently, any support is removed, for instance by peeling dissolvable oral strip or film from the support. Once the dissolvable oral strip or film is free from any other layers, it may be applied to one or more teeth. Such an application does not require the action of a dentist, dental hygienist or dental nurse, and can be carried out by any person wishing to whiten their teeth and simultaneously treat an oral hygiene condition, such as bad breath. The dissolvable oral strip or film provides good adhesion to tooth surfaces so that the whitening agent(s) (such as hydrogen peroxide; and / or a complex of hydrogen peroxide and PVP; and / or PAP), can act upon a tooth or teeth, whilst also dissolving in the oral cavity to deliver the oral hygiene agent(s) (such as zinc acetate and / or zinc citrate and / or zinc gluconate) during bleaching, such that subsequent removal of the film by the subject is not required. For instance, the dissolvable oral strip or film may adhere to a tooth or teeth within 10 seconds of contact. Adhesion may occur by the action of saliva on the PVP and / or film forming component of the film, rendering it tacky, or may be as a result of the presence of an adhesive water soluble polymer. The dissolvable oral strip or film can adhere to a tooth or teeth for at least 15 minutes after contact.

[0166] The dissolvable oral strip or film can be applied to one or more teeth of a subject for a period of more than 5 minutes and less than or equal to 30 minutes, preferably for a period of from 5 to 15 minutes, after which the film disintegrates in the oral cavity due to the water solubility of the water soluble film-forming polymer component. Consequently, it is not necessary for the subject to remove the film after use.

[0167] As used herein, the term "film" refers to an article having dimensions defined by three mutually perpendicular axes in which two of the dimensions are larger than the third. Typically, the two larger dimensions are at least an order of magnitude greater than the smallest dimension.

[0168] As used herein, the term "oral hygiene agent", refers to agents that are effective at treating an oral condition, such as bad breath. Example oral hygiene agents therefore may include pharmaceutical actives and compounds.

[0169] Other aspects and embodiments of the invention provide the aspects and embodiments described above with the term "comprising" replaced by the term "consisting of" and the aspects and embodiments described above with the term "comprising" replaced by the term "consisting essentially of".

[0170] It is to be understood that the application discloses all combinations of any of the above aspects and embodiments described above with each other, unless the context demands otherwise. Similarly, the application discloses all combinations of the preferred and / or optional features either singly or together with any of the other aspects, unless the context demands otherwise. The term "and / or" where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example "A and / or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0171] As used herein, the term 'saturated' refers to an organic compound or group which does not contain any carbon-carbon bonds which are double, triple or aromatic bonds. Analogously, the term 'unsaturated' refers to an organic compound or group which contains one or more carbon-carbon bonds which are double, triple or aromatic bonds. In this context, the terms 'saturation' and 'unsaturation' do not refer to bonds between a carbon atom and a heteroatom, such as nitrogen and oxygen, such that for instance an organic compound having a carbonyl group may fall within the definition of an unsaturated organic compound.

[0172] Certain aspects and embodiments of the invention will now be illustrated by way of example and with reference to the following tables and the figures.

[0173] Examples

[0174] The present invention may be exemplified as follows.

[0175] Components

[0176] Eureco HC-P11 is an 11 wt.% PAP non-hydrogen peroxide bleaching agent complex with p-cyclodextrin supplied by Solvay.

[0177] Peroxydone K-30®is a dental bleaching agent formed from a complex of 16-20 wt.% hydrogen peroxide and polyvinyl pyrrolidone having a molecular weight of 58,000 supplied by Ashland Inc.

[0178] Peroxydone K-90® is a dental bleaching agent formed from a complex of 16-20 wt.% hydrogen peroxide and polyvinyl pyrrolidone having a molecular weight of 1,300,000 supplied by Ashland Inc. Pectin is a polysaccharide water soluble film-forming polymer supplied by CP Kelco.

[0179] Glycerol is a plasticiser is supplied by Brenntag.

[0180] Polysorbate 80 is an emulsifier also known as Sorbital T80 and is supplied by Azelis.

[0181] Sucralose is a sweetener supplied by Azelis.

[0182] Sodium tripolyphospate (STPP) is a linear polyphosphate supplied by Brenntag.

[0183] Sodium hexametaphosphate (SHMP) is a cyclic polyphosphate supplied by Brenntag.

[0184] Pullulan is a neutral, simple polysaccharide produced by the growth of Aureobasidium pullulans. It has a chain structure of repeated -1,6-bonds of maltotriose composed of three glucoses in -1,4-bonds. It may contain some maltotetraosyl units. It contains not less than 90 percent of glucan, calculated on the dried basis.

[0185] Hydroxyapatite is a synthetic or natural powder with the chemical formula Caio (PCUMOH . The powder can be either a micro or nano-particle. Kollidon® 90 F is a polyvinyl pyrrolidone water soluble film-forming polymer having a weight average molecular weight in the range of from 1 000000 to 1500000 supplied by BASF.

[0186] Luviskol K-30® is a polyvinyl pyrrolidone water soluble film-forming polymer having a weight average molecular weight in the range of from 20,000 to 60,000 supplied by BASF.

[0187] Soy Lecithin is an emulsifier / surfactant used to stabilise dispersions.

[0188] Table 1: Dissolvable oral strip formulations of the present invention

[0189]

[0190] Worked Examples

[0191] Examples 5856, 5857, 5858, 5859 are all based on a 10% hydrogen peroxide, polyphosphates and zinc acetate formulations, having various flavours. All strips were smooth and showed no graininess.

[0192] Further worked examples of the present invention (not present in Table 1) also investigated the use of chelating agents in the formulations as a prospective replacement of the cyclic and linear polyphosphates. One such example is that of 6236, which comprised: PVP 62.71 wt.%; Pectin 4.77 wt.%; glycerol 4.52 wt.%; Polysorbate 800.45 wt.%; EDTA 0.10 wt.%; menthol 3.00 wt.%; Wintergreen 0.20 wt.%; zinc acetate 1.40 wt.%; Noveon AA-1® 1.67 wt.%; peppermint 6.00 wt.%; sucralose 0.40 wt.%; hydroxyapatite 3.00 wt.%; and hydrogen peroxide solution 11.78 wt.%. This strip formulation therefore sought to replace the use of cyclic and / or linear polyphosphates with EDTA, a chelating agent. Whilst the formulation was able to be cast and dried to form a strip, the resulting strip was grainy and streaked in appearance, indicating issues with stability / miscibility of the agents. This further demonstrates the unexpected capability of the cyclic and linear polyphosphates of the present invention to lead to improved stability and miscibility. Further examples sought to increase the amount of EDTA to: 0.3 wt.% (Example 6237); 0.5 wt.% (Example 6240); 0.7 wt.% (Example 6241); 1.4 wt.% (Example 6308); and 3.5 wt.% (Example 6309) of the strip, with equal reduction in the overall content of PVP in the strips to accommodate the increase in EDTA. In every case, the same issue of graining and streaking was observed.

[0193] It was also found that increased levels of plasticiser as a replacement for the cyclic and linear polyphosphates was also incapable of preventing grainy or streaked strips.

[0194] Breath Freshening Studies

[0195] Dissolvable strips of the present invention were subjected to testing, where a group of eight volunteers had their breath parameters measured using two procedures: a first called organoleptic score (using a trained odour judge to score bad breath); and a second, which utilises an instrument that measures sulphide gases (portable sulphide monitor). The volunteers breath parameter measurements were taken prior to each volunteer being given a dose (2 dissolving strips) of either one type of two test strips (batch labelled SI, S2, S3) or the placebo control (batch labelled S4). The breath parameters were then monitored at various times up to 4 hours following the dose. The human volunteers return to the laboratory a week after their first visit and repeat the whole procedure, but using 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 completed 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 (independent of the trial workers or trial volunteers) was asked to distribute the unlabelled strips from the labelled batches to each of the trial volunteers. Only when all the data was collected over the full 4-week trial was the cipher code applied that revealed the identity of each strip and the sequence of its use in each volunteer. The results of these studies are shown in Figures 1 and 2.

[0196] Strip SI of these studies comprised 0.24 wt.% CPC as the only anti-bacterial agent. Strip S2 comprised the combination of 0.24 wt.% CPC with 0.86 wt.% Zinc Acetate. Strip S3 was a competitor breath freshening strip. Strip S4 was a control, comprising neither CPC or zinc acetate. Strip S5 comprised only 0.86 wt.% Zinc Acetate.

[0197] The trial showed that a dose of two strips in accordance with the present invention (each containing 0.24 wt.% CPC and 0.86 wt.% Zinc Acetate) were shown to significantly (P<0.05) reduce bad breath in human volunteers compared to two strips of placebo control when measured by organoleptic judge (Figure 1) or by sulphide monitor (halimeter, Figure 2) for up to 4 hours following use. The magnitude of reduction (on a log scale) when translated into percent suggests that the test strip with Zinc Acetate and CPC can reduce malodour production by more than 80% even at 4 hours.

[0198] Kill-Time Assay

[0199] Assays can be performed to assess or measure the disinfecting capability of an oral composition of the disclosure. For example, assays can be performed to measure the bactericidal activity of an oral composition.

[0200] An assay is provided for determining the bactericidal activity of the oral composition described herein.

[0201] An in vitro study may be performed where an inoculum of pooled human saliva is exposed to the test product for predetermined time points, 30 seconds and 1 minute. An aliquot is removed, neutralized, and plated on OOPS III diagnostic agar to determine malodor-associated volatile sulfur compound (VSC)-producing dark pigmented Colony Forming Units / mL (CFU / mL). The CFU / mL from the ACB groups (two flavor variants) can be compared to a sterile water negative control for percent and logarithmic reduction. Eighteen replicates for each product can be tested. The experiment can be conducted over three days; within each test day, products can be tested in a random order. The raw data can be captured by automated colony counter, and converted to CFU / mL. The results are expected to show that the adjusted mean CFU / mL of pooled human saliva exposed to ACB rinses is reduced by 2.5 log 10 after 30 seconds, and 3.3 log 10 after 1.0 minute exposure when compared to the negative control. The levels of viable organisms are expected to be significantly lower (p <0.001) for the ACB rinses than for the negative control for both treatments at both time points. In conclusion, the results are expected to indicate that the use of the ACB rinses significantly reduced VSC-producing salivary microbiota.

[0202] A Kill-Time Determination Assay was utilised to identify the percent of bacteria remaining viable after exposure to an antimicrobial agent for stated period of time. The protocol utilised in this study followed the American Society for Testing and Materials (ASTM E2315-16) protocol. The main objective of the study was to evaluate the antimicrobial potential of whitening strips in accordance with the present invention, against oral bacterial species associated with malodour. Specifically, VSC producing bacteria.

[0203] Procedure

[0204] The procedure was conducted utilising fresh human saliva collected from three donors and pooled. Donors were advised to refrain from food, drinks (except water), and any oral hygiene measures overnight. The pooled saliva sample was tested for the presence of VSC-Producing species prior to the initiation of the study. The pooled saliva sample was stored in ice while preparation took place.

[0205] First, to equilibrate the temperature, the positive (0.1% CPC Solution) and negative (DI H2O) controls were prepared by adding 10 mL of each treatment in a sterile 50 mL Eppendorf tubes. All treatments were placed in a water bath and heated to 37°C for 2-10 minutes. Because of the nature of the test product (whitening strips), the preparation step differed for the test products. However, the procedure maintained clinical relevance. For the test product, the strips were cut into small pieces for faster dissolving time, before being placed in the saliva sample.

[0206] Then, the inoculation step began. For the test products, the pooled saliva sample was vortexed, then 5 mL was applied into a sterile cup containing one strip and placed on a stirring plate. The timer immediately started with the application of saliva sample. The total dissolving time needed for 1 strip (~ 0.08 g) in 5 mL of saliva was 2:30 minutes. Two timepoints were tested in this study: 5-minute and 10-minute treatment times. Inoculating the positive and negative controls (liquid form) took place by transferring 100 pL of the pooled human saliva to each treatment tube. The timer was started immediately upon inoculation. After the timer was started, the sample was vortexed for 5 seconds. The total treatment time for both positive and negative controls was 60 seconds.

[0207] After each determined treatment time (60-seconds, 5-minutes, or 10 minutes), 1 mL aliquot of each of the reaction mixture was added to a tube containing 9 mL of neutralizing media (Tryptic Soy Broth) and vortexed. After that, samples were subject to serial dilutions and immediately plated onto Oral Hydrogen Sulfide Organism Carbohydrate Agar (OHO-C). Of each sample, 100 pL was plated on each plate. Plates were incubating anaerobically at 37°C in a GasPak jar for a minimum of 4-5 days. Once the growth of black-pigmented colonies was observed (4 days for negative control and treatment groups, and 5 days for the positive control), the incubation period was terminated. CFU / mL were calculated through manual counting of colonies and factoring the dilution factor; only plates that included 30-300 species were included. Typically, over 300 colonies on a plate can result in the colonies 'running' together making the quantitative counting unreliable.

[0208] Treatment Groups

[0209] The following treatment groups were tested in this in vitro assessment:

[0210] 1. DI H2O (-) Control

[0211] 2. 0.1% CPC Solution (+) Control

[0212] 3. Whitening Strips (5-minute treatment time)

[0213] 4. Whitening Strips (10-minute treatment time)

[0214] Results and Statistical Analyses

[0215] The results are detailed in Table 2 below. All raw CFU / ml and Log CFU / ml data was provided for each treatment group. The Mean (N=9) CFU / ml and Log CFU / ml for each group were calculated. Log CFU / ml values statistical analysed by a one-way analysis of variance (ANOVA) & Student-Newman-Keuls (SNK) multiple comparison model using Sigma Plot Software (14.5). Statistical significance was determined at p < 0.050 (95% Cl).

[0216] Table 2 - CFU / ml, Log CFU / ml, Log CFU / ml Reduction and % Reduction of VSCs-Producing Microorganisms Following In Vitro Kill-Time Procedure

[0217] Mean (SD), N=9

[0218] Log CFU / ml values with same letter superscript do not differ significantly (p > 0.050, ANOVA / SNK)

[0219] Comparisons for Factor via ANOVA / SNK Procedure (Power = 1.000 with a = 0.050)

[0220] Comparison Diff of Means p q P

[0221] DI H2O vs. 0.1% CPC 7.532 4 74.332 <0.001

[0222] DI H2O vs. 10-Min Tx. 1.258 3 12.415 <0.001

[0223] DI H2O vs. 5-Min. Tx. 1.187 2 11.714 <0.001

[0224] 5-Min. Tx. vs. 0.1% CPC 6.345 3 62.618 <0.001

[0225] 5-Min. Tx. vs. 10-Min. Tx. 0.0710 2 0.701 0.624

[0226] 10-Min. Tx. vs. 0.1% CPC 6.274 2 61.917 <0.001

[0227] Conclusions

[0228] The Whitening Strips of the present invention demonstrated Log CFU / ml Reductions of 1.187 (5-min treatment period) and 1.258 (10-min treatment period) compared to the DI H2O (-) Control, which equates to % Reductions of 93.49% and 94.48% of VSCs-Producing microorganisms, respectively compared to the DI H2O (-) Control.

[0229] The 0.1% CPC Solution (+) Control demonstrated a Log CFU / ml Reduction of 7.532 (99.999997% Reduction) compared to the DI H2O (-) Control, supporting the validity of the testing methodology in this assessment.

[0230] Statistical analyses (ANOVA / SNK) of Log CFU / mL (Mean, N=9) values indicate statistically significant differences (p < 0.001) between the Whitening Strips of the present invention (at both the 5-min. and 10-min treatment periods) and both the DI H2O (-) Control and 0.1% CPC (+) Control. There was not a statistically significant difference (p = 0.159) observed between the 5-min and 10-min treatment times for the Whitening Strips of the present invention, based on observed Log CFU / ml (Mean, N=9) values.

[0231] Performance of Oral Composition Containing 8 wt% Hydrogen Peroxide

[0232] A study was conducted to determine whether a teeth whitening strip in the form of a dissolvable film or strip could be improved by the addition of a breath freshening agent that reduces halitosis.

[0233] A titration of hydrogen peroxide was performed, and a formulation with 8 wt% hydrogen peroxide in combination with 1 wt% zinc acetate was determined to be capable of achieving a desired level of teeth whitening while also being capable of promoting disinfection (e.g., killing of oral bacterial, thereby reducing halitosis).

[0234] A dissolvable strip (e.g., containing 57 wt% PVP, about 8 wt% hydrogen peroxide, about 1.3 wt% zinc acetate, about 5.7 wt% menthol, about 5 wt% water, about 4 wt% pectin, about 3.9 wt% glycerin, about 3.3 wt% pentasodium triphosphate, about 3.3 wt% sodium hexametaphosphate, about 2.9 wt% hydroxyapatite, about 1.6 wt% polycarbophil calcium, about 0.29 wt% gum arabic, about 0.29 wt% silicon dioxide (e.g., hydrated silica), about 0.39 wt% polysorbate 80, about 0.38 wt% sucralose, and about 6 wt% peppermint oil, Wintergreen oil) prepared according to the method described above was shown to kill 93% of bacteria that cause halitosis. The dissolvable strip was shown to whiten teeth by up to 4 shades after a single use.

[0235] In a well-established extrinsic stain / whitening laboratory model, the effect of the dissolvable strip (hydrogen peroxide and hydroxyapatite) was evaluated for stain removal potential. The color parameters (L*, a*, b*) of 6 stained enamel specimens were measured using a calibrated Konica Minolta CM-700d Spectrophotometer and delta E (AE, measure of total change) was calculated. Final "whiter" shade changes were determined by converting AE to R-20 Bleaching Shade guide tabs. One AE unit is equivalent to 1.3 VR-20 Bleaching shade change units. Specimens were cycled in and out of an artificial staining broth to achieve baseline stain levels. Twenty-eight applications of the whitening strip product were applied to the enamel specimen samples with 30 minute immersions in artificial saliva between each treatment. The color (L*, a*, b*) of each block was measured at baseline and after the 1st, 3rd, 7th, 10th 14th and 28th treatment applications. Mean R-20 shades scores were compared to baseline for the treatment applications. Following a single treatment application, the oral composition described herein (e.g., dissolvable strip) showed 4.93 shades reductions from baseline. After 28 treatment applications, the dissolvable strip provided at least 7 shades improvement.

Claims

CLAIMS1. A dissolvable oral strip or film adapted to adhere to a user's teeth, comprising: at least one whitening agent, comprising at least one of: hydrogen peroxide and / or a hydrogen peroxide-polyvinyl pyrrolidone complex and / or 6-phthalimido peroxy caproic acid (PAP); and at least one oral hygiene agent, comprising a zinc compound.

2. The dissolvable oral strip or film of claim 1 , wherein the zinc compound comprises one or any combination of: zinc acetate; zinc oxide; zinc sulfate; zinc chloride; zinc citrate; zinc lactate; zinc gluconate; zinc malate; zinc tartrate; zinc carbonate; and / or zinc phosphate.

3. The dissolvable oral strip or film of any preceding claim, wherein the strip or film comprises: 0.1 to 10.0 wt.%; 0.5 to 9.0 wt.%; 0.5 to 8.0 wt.%; 1.0 to 7.0 wt.%; 1.0 to 6.0 wt.%; 1.0 to 5.0 wt.%; 1.0 to 4.0 wt.%; 1.0 to 3.0 wt.%; or 1.0 to 2.0 wt.% of the or each at least one zinc compound.

4. The dissolvable oral strip or film of any preceding claim, wherein the strip or film comprises: 1.0 wt.% to 5.0 wt.% or 1.0 wt.% to 2.0 wt.% zinc acetate.

5. The dissolvable oral strip or film of any preceding claim, wherein the strip or film further comprises a dental hypersensitivity agent and / or a dissolution profile modulating agent.

6. The dissolvable oral strip or film of claim 5, wherein the dental hypersensitivity agent comprises Hydroxyapatite, optionally at 1 to 15 wt.% or 3 to 7 wt.% of the strip or film.

7. The dissolvable oral strip or film of either claim 5 or claim 6, wherein the dissolution profile modulating agent comprises polycarbophils, optionally at 1 to 5 wt.% or 1.5 to 3 wt.% of the strip or film.

8. The dissolvable oral strip or film of any preceding claim, further comprising cetylpyridinium chloride (CPC); optionally wherein the CPC is present in a total amount of: about 0.1 to about 5 wt.%; about 0.1 to about 3.0 wt.%; about 0.1 to about 2.0 wt.%; about 0.1 to about 1.0 wt.%; about 0.1 to about 0.8 wt.%; about 0.1 to about 0.6 wt.%; about 0.1 to about 0.4 wt.%; about 0.1 to about 0.3 wt.%; or about 0.2 to about 0.3 wt.% of the strip or film.

9. The dissolvable oral strip or film of any preceding claim, wherein the wherein the strip or film comprises: 0.1 wt.% to 20.0 wt.%; 1.0 wt.% to 15 wt.%; 5 wt.% to 15 wt.%; or 5 to 11 wt.% of the or each at least one whitening agent.

10. The dissolvable oral strip or film of any preceding claim, further comprising one or more polyphosphates.

11. The dissolvable oral strip or film of claim 10, wherein the polyphosphates comprise one or more cyclic and / or one or more linear polyphosphates.

12. The dissolvable oral strip or film of claim 11, wherein the one or more cyclic polyphosphates comprise sodium hexametaphosphate and / or the one or more linear polyphosphates comprise sodium tripolyphosphate.

13. The dissolvable oral strip or film of any one of claims 11 or 12, wherein the cyclic and / or linear polyphosphates are present in a total amount of from: 0.1% to 9% by weight of the strip or film; 3% to 8% by weight of the strip or film; or 3% to 4% by weight of the strip or film.

14. The dissolvable oral strip or film of any preceding claim, wherein the strip or film further comprises: an oil, such as Wintergreen oil and / or coconut oil; and / or a flavour agent, such as peppermint, Menthol, Spearmint, and / or Novamint.

15. The dissolvable oral strip or film of any preceding claim, wherein the strip or film further comprise any one of or combination of the following: one or more water soluble film-forming polymers; one or more plasticizers; and / or one or more emulsifiers.

16. The dissolvable oral strip or film of claim 15, wherein the one or more soluble film-forming polymer is one or more of the group comprising: polyvinylpyrrolidone (PVP); pullulan; pectin; starch; dextrin; chitosan; alginic acid; salts of alginic acid and / or cellulose derivatives.

17. The dissolvable oral strip or film of claim 15 or claim 16, wherein the one or more plasticizers are selected from the group comprising a polyol such as glycerol; and / or the one or moreemulsifiers are selected from the group comprising a fatty acid derivative, a lecithin and / or a polysorbate.

18. The dissolvable oral strip or film of any preceding claim, wherein the strip or film further comprises one or more further components selected from the group comprising colourant, flavouring and / or sweetener.

19. The dissolvable oral strip or film of any preceding claim, wherein the strip or film is fully dissolvable, such that it dissolves completely within the oral cavity of a user.

20. The dissolvable oral strip or film of any preceding claim, wherein the strip or film is flexible.

21. The dissolvable oral strip or film of any preceding claim, wherein the strip or film is adapted to dissolve completely or substantially completely in an oral cavity of a user; optionally over a period of: 5 to 30 minutes; 5 to 20 minutes; 5 to 15 minutes; or 10 to 15 minutes.

22. A process for the manufacture of a dissolvable oral strip or film, the process comprising at least the steps of: mixing an oral hygiene agent in a total amount of about 0.1% to about 10% by weight, a whitening agent in a total amount of 1% to 20% by weight, one or more water soluble filmforming polymers in a total amount of 30% to 90% by weight, one or more plasticizers in a total amount of 0.1% to 15% by weight and one or more emulsifiers in a total amount of 0.1% to 10% by weight; with water to provide an aqueous liquid; applying the aqueous liquid to a substrate to provide a substrate carrying the aqueous liquid; and drying the aqueous liquid to provide a dissolvable oral strip or film on the substrate.

23. The process of claim 22, wherein the mixing step further comprises mixing one or more further components selected from the group comprising: colourant, flavouring, sweetener.

24. A cosmetic method of whitening teeth, said method comprising at least the step of: applying a dissolvable tooth whitening strip or film according to any one of claims 1 to 21 to one or more teeth of a subject.

25. An oral composition, in the form of at least one dissolvable film or strip, comprising about 50 wt% to about 70 wt% of a water-soluble or water-dispersible polymer that is polyvinylpyrrolidone, about 0.1 wt% to about 10 wt% of a whitening agent that is at least one of hydrogen peroxide and phthalimidoperoxycaproic acid, about 0.1 wt% to about 2.0 wt% of a disinfecting agent that is zinc acetate, about 0.1 wt% to about 10 wt% menthol, and about 0.1 wt% to about 10 wt% water.

26. The oral composition of claim 25, wherein the oral composition further comprises a thickening agent, a sugar alcohol, a water softening agent, a sequestrant, a dental hypersensitivity agent, a dissolution extender, a natural gum, an abrasive substance, an emulsifier, an artificial sweetener, and / or an additional aromatic component.

27. A method of making the oral composition of claim 25, comprising the steps of: a} combining a whitening agent that is at least one of hydrogen peroxide and phthalimidoperoxycaproic acid, a water-soluble or water-dispersible polymer that is polyvinylpyrrolidone, a volatile solvent that is water, a disinfecting agent that is zinc acetate, and an aromatic component that is menthol to form a mixture; b) optionally, further combining one or more other components to the mixture; c) mixing or stirring the mixture to form a uniform mixture; d) spreading the uniform mixture onto a surface using a brush or applicator until a thin film is formed; e) drying the thin film until the volatile solvent fully evaporates to form a dry film; and f} peeling away the dry film from the surface to form the oral composition.

28. A method of using the oral composition of claim 25, comprising applying the oral composition to one or more teeth of a subject; optionally further comprising, prior to applying the oral composition to the teeth of the subject, the steps of: a) removing the oral composition from a sachet; and / or b) moistening one or more teeth of the subject.

29. A kit comprising the oral composition of claim 25, wherein the oral composition is present within a foil sachet.

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