Dental Instrument Cleanser

Abstract

The present invention relates to an improved composition for cleaning dental instruments comprising hydrogen peroxide and at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid.

Description

[Technical field]

[0001] The present invention relates to an improved composition for cleaning dental appliances. The composition is both aqueous and storage stable and contains at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid, and low levels of hydrogen peroxide. Specifically, the composition in the form of an aerated foam is applied to the dental appliance outside the wearer's mouth. [Background technology]

[0002] A complete or partial denture is a form of dental appliance intended to be worn in the mouth as a substitute to serve as a replacement for some or all of the teeth normally found in the oral cavity.

[0003] Like teeth, dentures and other dental appliances should be cleaned regularly for cosmetic reasons and to maintain good oral hygiene. It is well known that the attachment and growth of microorganisms on dentures and other dental appliances can cause several problems for patients, such as odor, denture-induced stomatitis, staining, and unpleasant taste in the mouth. However, unlike teeth, dentures and other dental appliances can be removed for cleaning. Generally, dental appliances are cleaned either by immersing them in a cleansing bath or by brushing them with toothpaste or specially formulated cleansers.

[0004] Although soaking offers the advantage of reaching all parts of the dental appliance, typically the cleansers used are sold in solid form as denture cleanser powders or tablets or in concentrated liquid form. These solid forms must be dissolved in water to form a cleansing bath, followed by a soaking time (e.g., overnight) that allows time for the cleanser solution to work. Such a regime can be very inconvenient and leave the patient without a prosthesis for a long period of time. In contrast, mechanical brushing or scrubbing with creams and dentifrices is not always effective in removing bacteria and can scratch or damage the surface of the dental appliance. Summary of the Invention [Problem to be solved by the invention]

[0005] Thus, there remains a need for additional dental instrument cleansers that not only have an excellent safety and compatibility profile, but are also convenient to use, fast acting, and compatible with denture materials. [Means for solving the problem]

[0006] The present inventors have developed a composition having desirable cleaning properties, particularly for use with dental appliances, such as dentures.

[0007] In a first aspect, there is provided an aqueous dental instrument cleanser composition comprising: (a) hydrogen peroxide; (b) at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid; and (c) an anionic surfactant.

[0008] More specifically, the aqueous composition of the present invention comprises: (a) about 0.05% to about 4% by weight of hydrogen peroxide; (b) about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid; and (c) about 0.05% to about 2.00% by weight of an anionic surfactant.

[0009] In some embodiments, the compositions of the present invention consist essentially of: (a) from about 0.05% to about 4% by weight of hydrogen peroxide; (b) from about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid; and (c) from about 0.05% to about 2.00% by weight of an anionic surfactant.

[0010] The balance or remainder of the aqueous dental instrument cleanser composition is water. More specifically, the composition comprises at least 80% by weight water, such as at least 85% or 90% by weight water. More specifically, the composition may comprise at least 91% by weight, at least 92% by weight, at least 93% by weight, at least 94% by weight, at least 95% by weight, at least 96% by weight, or at least 97% by weight water.

[0011] A test suspension (1–5 × 10 per ml) of either Candida albicans or Klebsiella pneumoniae 8 cfu) to the compositions of the present invention results in at least a log 2.5 reduction in the number of colony forming units, preferably at least a log 3 reduction, more preferably at least a log 4 reduction, and most preferably at least a log 5 reduction within 60 seconds.

[0012] The composition of the present invention is storage stable for a commercially reasonable period of time.More specifically, the composition of the present invention is stable during storage and can reduce the number of colony forming units as described above when measured 3 months after preparation.More preferably, the composition can reduce the number of colony forming units by at least log 2.5, preferably at least log 3, more preferably at least log 4, and most preferably at least log 5 within 60 seconds when measured 6 months after preparation, even more preferably when measured 12 months after preparation, and even more preferably when measured up to 24 months after preparation.

[0013] The composition of the present invention preferably has a pH within the range of 2.8 to 3.5.

[0014] In some embodiments, the compositions of the present invention consist essentially of: (a) from about 0.05% to about 4% by weight of hydrogen peroxide; (b) from about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid; and (c) from about 0.05% to about 2.00% by weight of an anionic surfactant, wherein the composition has a pH in the range of 2.8 to 3.5.

[0015] The compositions of the present invention may further comprise (d) a means for adjusting or maintaining the pH of the composition, in certain embodiments, the compositions of the present invention comprise a means for adjusting or maintaining the pH of the composition within the range of 2.8 to 3.5.

[0016] In some embodiments, the compositions of the present invention consist essentially of: (a) from about 0.05% to about 4% by weight of hydrogen peroxide; (b) from about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid; (c) from about 0.05% to about 2.00% by weight of an anionic surfactant; and (d) a means for adjusting or maintaining the pH of the composition, wherein the composition has a pH within the range of 2.8 to 3.5.

[0017] The composition may comprise about 0.01% to about 0.09% by weight of the means for adjusting or maintaining the pH of the composition. The means for adjusting or maintaining the pH of the composition may be an acid or a buffer. The composition may comprise about 0.02% to about 0.08% by weight of the means for adjusting or maintaining the pH of the composition. Specifically, the means for adjusting or maintaining the pH of the composition is a buffer. More specifically, the means for adjusting or maintaining the pH of the composition is a buffer, and the composition comprises about 0.01% to about 0.09% by weight of the buffer. Even more specifically, the means for adjusting or maintaining the pH of the composition is a buffer, and the composition comprises about 0.02% to about 0.08% by weight of the buffer. In some embodiments, the means for adjusting or maintaining the pH of the composition is a buffer comprising sodium citrate, more specifically, a sodium citrate buffer.

[0018] Thus, in another embodiment, there is provided a storage stable, aqueous dental instrument cleanser composition consisting essentially of about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid, about 0.05% to about 2.00% by weight of an anionic surfactant, and about 0.01% to about 0.08% by weight of a buffer solution, specifically a sodium citrate buffer solution, wherein the composition has a pH in the range of 2.8 to 3.5.

[0019] The compositions of the present invention may further comprise a sensory ingredient. In a particular embodiment, the sensory ingredient is a flavoring agent and / or a coloring agent and / or an aroma agent.

[0020] In a further embodiment, there is provided a storage stable, aqueous dental instrument cleanser composition consisting essentially of about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid, about 0.05% to about 2.00% by weight of an anionic surfactant, about 0.01% to about 0.08% by weight of a buffer solution, specifically a sodium citrate buffer solution, the composition having a pH in the range of 2.8 to 3.5, and further comprising about 0.01% to about 0.5% by weight of a sensory ingredient.

[0021] In some embodiments, the anionic surfactant is a sodium alkyl sulfate, hi certain embodiments, the anionic surfactant is a sodium alkyl sulfate selected from the group consisting of sodium lauryl sulfate, sodium lauryl sulfonate, and sodium laureth sulfate.

[0022] Accordingly, there is also provided a storage stable, aqueous dental instrument cleanser composition consisting essentially of about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid, about 0.05% to about 2.00% by weight of an anionic surfactant selected from the group consisting of sodium lauryl sulfate, sodium lauryl sulfonate, and sodium laureth sulfate, about 0.01% to about 0.08% by weight of a buffer solution, specifically a sodium citrate buffer solution, the composition having a pH in the range of 2.8 to 3.5, and further comprising about 0.01% to about 0.5% by weight of a sensory component.

[0023] A further embodiment provides a storage stable, aqueous dental instrument cleanser composition consisting essentially of about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid, about 0.05% to about 2.00% by weight of an anionic surfactant, specifically selected from the group consisting of sodium lauryl sulfate, sodium lauryl sulfonate, and sodium laureth sulfate, about 0.01% to about 0.08% by weight of a buffer, specifically a sodium citrate buffer, the dental instrument cleanser composition having a pH in the range of 2.8 to 3.5, and further comprising about 0.01% to about 0.5% by weight of a sensory ingredient.

[0024] In some embodiments, the compositions of the present invention comprise from about 0.1% to about 2% hydrogen peroxide by weight, specifically from about 0.25% to 1% hydrogen peroxide by weight.

[0025] Preferably, the at least one acid is an acid. Preferably, the acid is salicylic acid. In some embodiments, the composition of the present invention comprises about 0.01% to 0.25% by weight of salicylic acid, specifically about 0.1% to 0.2% by weight of salicylic acid.

[0026] In some embodiments, the compositions of the present invention comprise from about 0.25% to about 1% by weight of an anionic surfactant, in some embodiments, the compositions of the present invention comprise from about 0.25% to about 1.00% by weight of an anionic surfactant selected from the group consisting of sodium lauryl sulfate, sodium lauryl sulfonate, and sodium laureth sulfate.

[0027] The compositions of the present invention are ready to use and do not require dilution or reconstitution. The compositions are foamable and may be applied to surfaces in the form of an aerated foam. The compositions of the present invention are substantially alcohol-free or alcohol-free. The compositions of the present invention are free of ethylenediaminetetraacetic acid (EDTA).

[0028] In a second aspect of the present invention, a container is provided that contains the composition of the first aspect. Specifically, the container is a dispenser. Specifically, the dispenser comprises or essentially consists of a container that defines a reservoir and an applicator head in fluid communication with the reservoir, where the reservoir contains the composition of the present invention, and the applicator head is configured to dispense the composition from the reservoir, specifically in the form of a spray and / or foam.

[0029] In certain embodiments, the dispenser comprises or consists essentially of a container defining a reservoir and a foaming applicator head in fluid communication with the reservoir, where the reservoir comprises a composition according to the first aspect, and the foaming applicator head is configured to dispense the composition from the reservoir in the form of a foam. As non-limiting examples, the container comprises high density polyethylene (HDPE) and / or polyethylene terephthalate (PET). In some embodiments, the container comprises high density polyethylene (HDPE) and polyethylene terephthalate (PET). In some embodiments, the container is a high density polyethylene (HDPE) container. In some embodiments, the container is a polyethylene terephthalate (PET) container.

[0030] In the third aspect of the present invention, the composition according to the first aspect is provided for use in a method for cleaning dentures.Also provided is a method for cleaning dental instruments outside the oral cavity, comprising maintaining the dental instruments in contact with the composition according to the first aspect for a period of time.Also provided is an aqueous dental instrument cleanser according to the first aspect for use in a method for killing microorganisms, such as Candida albicans, on the surface of dental instruments.Specifically, the method comprises contacting the microorganisms on the surface of dental instruments with the dental instrument cleanser for a period of time sufficient to kill the microorganisms.

[0031] In particular, the microorganism is a bacterium, a fungus, or a virus. In some embodiments, the microorganism is a Bacterium, in particular a Gram-negative bacterium, such as Klebsiella pneumoniae. In some embodiments, the microorganism is a fungus, in particular a yeast, such as Candida albicans. In some embodiments, the microorganism is a virus, for example an enveloped or non-enveloped virus, such as an influenza virus or a coronavirus. In certain embodiments, the virus is an influenza virus H1N1. In certain embodiments, the virus is a coronavirus, such as SARS-CoV, SARS-CoV-1, or SARS-CoV-2. [Brief description of the drawings]

[0032] [Figure 1] FIG. 1 shows two tea-stained ceramic tiles comparing an untreated area (UT) with an area (T) treated with either (a) a composition of the present invention or (b) a commercial toothpaste. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] The present invention is directed to a dental instrument cleansing composition comprising at least one acid selected from the group consisting of salicylic acid, furoic acid, or formic acid in combination with hydrogen peroxide and an anionic surfactant.

[0034] Surprisingly, the inventors have found that such compositions not only exhibit rapid action, but also excellent antimicrobial efficacy.Without wishing to be bound by theory, there appears to be a synergistic antimicrobial effect when microorganisms are exposed to a combination of hydrogen peroxide and an acid component (selected from salicylic acid, formic acid, and furoic acid), and even low levels of hydrogen peroxide achieve a reduction in the number of colony-forming units of log 2.5 or even greater within 60 seconds (in a killing assay).It is noted that other acids, such as phosphoric acid or citric acid, do not exhibit such synergistic antimicrobial efficacy, and the effect is not related to, for example, pKa.

[0035] Advantageously, such compositions have improved skin tolerability (compared to existing formulations on the market), making them particularly suitable for use in cleaning dental prostheses that are washed outside the mouth, where the product is likely to come into contact with the skin of the hands and fingers.The compositions are also effective in removing stains and are highly compatible with surfaces, so they do not corrode or discolor plastics, such as acrylics, nylons, porcelains, resins, metals, or other materials that are often found in full or partial dentures and other dental appliances.Furthermore, the formulations have a low impact on the environment, decomposing mainly into oxygen and water.

[0036] As used herein, the term "dental appliance" refers to dentures or partial dentures, artificial teeth, removable orthodontic bridges and denture bases (both upper and lower types), orthodontic retainers and appliances, protective mouth guards, night guards to prevent teeth grinding and / or temporomandibular joint (TMJ) disorders, etc. The term "dental appliance cleanser" refers to a composition for use outside the mouth to clean dental appliances, for example, to clean the surfaces and inside the pores of dental appliances, to kill bacteria and remove food particles, stains and other oral debris.

[0037] For the avoidance of doubt, references to "wt %" mean that the amount of each component is by weight of the total composition, selected so that all components in the composition add up to 100 weight percent. Although not always explicitly listed as a component, it is understood that in the case of aqueous solutions of the present invention, the balance or remainder of the composition is water.

[0038] The term "aqueous solution" refers to a solution in which the solvent is water and the other components of the composition are dispersed, mixed, and / or dissolved in the composition. Specifically, the composition comprises at least 80% by weight of water, such as at least 85% or 90% by weight of water. More specifically, the composition may comprise at least 91% by weight, at least 92% by weight, at least 93% by weight, at least 94% by weight, at least 95% by weight, at least 96% by weight, at least 97% by weight, at least 98% by weight, or at least 99% by weight of water. Thus, the composition may comprise 80% to 99% by weight of water, such as 85% to 99% by weight, 90% to 99% by weight, or 95% to 99% by weight of water. Specifically, water is the only solvent and no additional organic solvent, such as alcohol, is used.

[0039] The composition of the present invention comprises hydrogen peroxide, also referred to as H2O2, having CAS number: 7722-84-1. Specifically, the composition of the present invention comprises about 0.05% to about 4% by weight of hydrogen peroxide, for example, about 0.05% to about 4% by weight, about 0.1% to about 4% by weight, or about 0.25% to about 4% by weight of hydrogen peroxide. More specifically, the composition of the present invention comprises about 0.05% to about 2% by weight, about 0.1% to about 2% by weight, or about 0.25% to about 2% by weight of hydrogen peroxide. Even more specifically, the composition of the present invention comprises about 0.05% to about 1% by weight, about 0.1% to about 1% by weight, or about 0.25% to about 1% by weight of hydrogen peroxide. Even more specifically, the composition contains from about 0.1% to about 0.75% by weight, or from about 0.25% to about 0.75% by weight, for example, about 0.25% by weight, about 0.3% by weight, about 0.4% by weight, about 0.5% by weight, about 0.6% by weight, about 0.7% by weight, or about 0.75% by weight of hydrogen peroxide.

[0040] The composition of the present invention comprises at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid. Salicylic acid (CAS number: 69-72-7) may also be referred to as 2-hydroxybenzoic acid. Formic acid (CAS number: 64-18-6) may also be referred to as methanoic acid. Furoic acid refers to either 2-furoic acid (CAS number: 88-14-2), also known as furan-2-carboxylic acid, and 3-furoic acid (CAS number: 488-93-7), also known as furan-3-carboxylic acid. The composition may comprise 2-furoic acid and / or 3-furoic acid. In some embodiments, the acid is 2-furoic acid. In other embodiments, the acid is 3-furoic acid.

[0041] Although it is preferred to use one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid, those skilled in the art will understand that combinations of these acids may also be used. For example, the composition of the present invention further comprises at least two acids selected from the group consisting of salicylic acid, furoic acid, and formic acid, such as two of these acids, or three of these acids. Thus, in certain embodiments, the composition may comprise a combination of salicylic acid, furoic acid, and formic acid, for example, in any suitable molar ratio, for example, 1:1:1 to 2:1:1, 1:2:1, or 1:1:2. In other embodiments, the composition may comprise a combination of salicylic acid and furoic acid, a combination of salicylic acid and formic acid, or a combination of furoic acid and formic acid, for example, in any suitable molar ratio, for example, 1:1 to 3:1, 1:1 to 1:1, for example, 1:1, 1:2, 1:3, 3:1, or 2:1.

[0042] In particular, the compositions of the present invention comprise an acid selected from the group consisting of salicylic acid, furoic acid, and formic acid. In a preferred embodiment of the present invention, the acid is salicylic acid.

[0043] The compositions of the present invention may comprise from about 0.01% to about 0.25% by weight of at least one acid, from about 0.1% to about 0.25% by weight of at least one acid, or from about 0.15% to about 0.2% by weight of at least one acid, such as about 0.15%, 0.16%, 0.17%, 0.18%, 0.19%, or about 0.2% by weight of at least one acid.

[0044] The composition of the present invention comprises a surfactant, more specifically an anionic surfactant. Suitable anionic surfactants are known in the art. Specifically, the anionic surfactant is a sodium alkyl sulfate, such as a sodium sulfate having an alkyl group having 8 to 20 carbon atoms. Non-limiting examples of these include sodium decyl sulfate, sodium lauryl sulfate (also referred to as SLS or sodium dodecyl sulfate (SDS)), sodium tetradecyl sulfate, sodium hexadecyl sulfate, and sodium octadecyl sulfate. In a particular embodiment, the anionic surfactant is a sodium alkyl sulfate selected from the group consisting of sodium lauryl sulfate, sodium lauryl sulfonate, and sodium laureth sulfate. Specifically, the anionic surfactant is sodium lauryl sulfate.

[0045] The composition may comprise from about 0.05% to about 2.00% by weight of anionic surfactant, specifically from about 0.1% to about 2% by weight, more specifically from about 0.25% to about 1% by weight, or even more specifically from about 0.3% to about 0.8% by weight of anionic surfactant, such as about 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, or about 0.8% by weight of anionic surfactant.

[0046] The compositions of the present invention preferably have a pH in the range of 2.8 to 3.5, for example a pH in the range of 2.8 to 3.2, for example a pH of about 3.0 or about 3.1. To achieve this, the compositions of the present invention may comprise a means for adjusting or maintaining the pH of the composition within this range. The compositions may comprise from about 0.01% to about 0.09% by weight, for example from about 0.02% to 0.08% by weight of the means for adjusting or maintaining the pH of the composition. The compositions may comprise from about 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07% or about 0.08% by weight of the means for adjusting or maintaining the pH of the composition.

[0047] The means for adjusting or maintaining the pH of the composition may be an acid or a pH buffer (also referred to as a buffer). Specifically, the means for adjusting or maintaining the pH of the composition is a pH buffer. More specifically, the means for adjusting or maintaining the pH of the composition is a pH buffer containing sodium citrate. Even more specifically, the means for adjusting or maintaining the pH of the composition is a sodium citrate buffer. Sodium citrate buffers are known in the art and can be prepared and adjusted to a desired pH by, for example, mixing citric acid (monohydrate) and trisodium citrate (dehydrate) in a ratio of 82:18 to 73:27, respectively, as a non-limiting example.

[0048] Specifically, the compositions of the present invention exhibit a skin tolerability score of at least 10% mean cell viability, at least 11%, at least 12%, at least 13%, at least 14%, or at least 15% mean cell viability as measured by an in vitro skin tolerability assay, more specifically, as measured by the in vitro EPIDERM skin irritation test (EPI-200-SIT, MatTek Corporation). Specifically, the compositions of the present invention exhibit improved skin tolerability scores (e.g., at least 10% or greater mean cell viability) when compared to FRESHDENT denture foam (EverSmile).

[0049] Preferably, the composition of the present invention is alcohol-free. The term "alcohol-free" refers to the absence of alcohol (0% by weight). For the avoidance of doubt, this term may include the presence of alcohol, but in amounts below the detection limit of the analytical method and in amounts that are too low to be detected or accurately measured.

[0050] Alternatively, if sensory ingredients are included, the compositions of the present invention may be substantially alcohol-free, as some sensory ingredients (described below) include alcohol. As used herein, "substantially alcohol-free" means that the composition contains less than 0.5% alcohol, such as 0.4% or less, 0.3% or less, 0.25% or less, 0.2% or less, 0.1% or less, 0.05% or less, or less than 0.01% alcohol.

[0051] The composition of the present invention is a foaming formulation. "Foaming formulation" refers to a composition that can form a foam, specifically a foam with small bubble size that gives the appearance of a thick and rich foam. The foam can be easily brushed over the entire device.

[0052] The compositions of the present invention form stable foams with desirable physicochemical properties, such as volume, density, and spreadability, that do not change significantly over a period of time, and thus the foam does not break down immediately during use. More specifically, the foams formed by the compositions of the present invention do not "break down quickly" and are stable when dispensed from a container and do not break down immediately on contact with a surface, such as the surface of a dental appliance. The foams formed by the compositions of the present invention do not break down quickly, but are "fragile", in other words, can be easily spread across a surface by applying a weak shear force. The foam characteristics can be measured using tests known in the art, such as by performing foam formation (foam height vs. time) and foam collapse experiments. Preferably, the foam maintains its structure and thus remains in contact with the surface for a time sufficient to clean and / or kill microorganisms. Specifically, the use time is 3 minutes or less, more specifically 2 minutes or less, and even more specifically 60 seconds or less, such as about 30 to 60 seconds.

[0053] The composition of the present invention can be foamed in the absence of a propellant. Specifically, the composition of the present invention is dispensed from a container without the use of a propellant. Specifically, the composition can be foamed by manual aeration (e.g., passing atmospheric air through the formulation, such as by manually actuating a dispensing head, to generate foam). Specifically, the composition of the present invention can be dispensed from a container with a suitable dispensing head, such as a foaming applicator head. The foam can be applied directly to the surface of the dental appliance, and optionally brushed. After cleaning, the dental appliance can be rinsed with water to remove the formulation before being placed in the wearer's mouth.

[0054] For dental instrument cleansing compositions used to clean instruments before being placed in the mouth, it may be desirable to include at least one sensory ingredient. "Sensory ingredient" refers to an ingredient that can be used to impart flavor, fragrance, color, and / or sensation (e.g., cool, warm, or tingly) to the composition. Other than imparting to the composition sensory properties that are desirable for consumers, sensory ingredients are generally not active ingredients, in other words, they do not play an active role in cleaning or killing bacteria. Specifically, sensory ingredients are at least one flavor, fragrance, and / or colorant. Sensory ingredients are known in the art and may be natural or artificial (synthetic).

[0055] The compositions of the present invention may comprise from about 0.01% to about 0.5% by weight of the sensory ingredient, specifically from about 0.1% to about 0.3% by weight of the sensory ingredient, more specifically from about 0.2% to about 0.3% by weight of the sensory ingredient, for example about 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4%, 0.45%, or about 0.5% by weight of the sensory ingredient.

[0056] The sensory ingredient must be compatible with the components of the composition and must not be altered or decomposed, for example, upon contact with hydrogen peroxide or acid. Thus, in a particular embodiment, the composition of the present invention comprises at least one flavor ingredient selected from the group consisting of (+)-menthol, (-)-menthol, (+)-isomenthol, (+)-neomenthol, (-)-neomenthol, and (-)-neoisomenthol. Suitable sensory ingredients are commercially available, for example, under the name OPTAMINT from Symrise AG, e.g. OPTAMINT 999529 GlacierFresh. In a particular embodiment, the composition of the present invention does not comprise (-)-isomenthol or (+)-neoisomenthol.

[0057] Typically, the compositions of the present invention are stable at room temperature of 20° C. for at least 3 months, particularly at least 6 months at room temperature of 20° C., more particularly at least 12 months at room temperature of 20° C., and even more particularly at least 24 months at room temperature of 20° C.

[0058] As used herein, the term "stability" refers to the ability of a composition to maintain particular physical or chemical properties, such as antimicrobial efficacy, at a particular storage temperature for a period of time after manufacture.

[0059] The stability of the compositions of the present invention can be evaluated using antimicrobial efficacy as a proxy, for example any decrease over time indicates deterioration. Thus, stability can be evaluated by comparing the antimicrobial efficacy of the composition before and after storage using a suitable killing assay that measures the decrease in the number of viable microorganisms present in a sample after exposure to the composition.

[0060] As used herein, the term "microorganism" refers to bacteria, fungi, such as yeast or mold, and viruses. The compositions of the present invention kill and / or inhibit the growth of bacteria, fungi, and viruses and may be referred to as "antimicrobial agents" or "microbicides." Thus, the compositions of the present invention may be "biocidal" compositions that kill bacteria and / or inhibit the growth of bacteria, and / or "fungicidal" compositions that kill fungi and / or inhibit the growth of fungi, and / or "viricidal" compositions that inactivate viral particles so that they cannot infect host cells.

[0061] As used herein, the term "kill" refers to causing the death of a microorganism. In the context of a population of microorganisms, the term "kill" or "killing" refers to reducing the total amount or level of the microorganisms by causing the death of some or all of the microorganisms in the population. In the context of viruses, killing or killing refers to rendering the virus unable to infect and / or replicate in host cells, for example by inactivation or destruction.

[0062] For the avoidance of doubt, use of the terms "a" or "an" in relation to microorganisms, e.g. bacteria, fungi, and viruses, is to be read to refer to one or more of that entity, e.g. a population of bacteria growing on a surface, e.g. in the form of a biofilm.

[0063] The killing assay may be a bactericidal assay, a fungicidal assay, or a virucidal or virus inactivation assay.

[0064] In some embodiments, the composition is a virucidal composition capable of killing influenza viruses or coronaviruses. In certain embodiments, the virus is influenza virus H1N1. In certain embodiments, the virus is a coronavirus, such as SARS-CoV, SARS-CoV-1, or SARS-CoV-2.

[0065] Oropharyngeal candidiasis (OPC) can be caused by opportunistic yeasts, such as Candida albicans. It is often associated with wearing oral prosthetic appliances, such as dentures, leading to denture-induced stomatitis, inflammation of the oral mucosa. C. albicans has been implicated as the main causative organism of denture-induced stomatitis. Thus, the stability of the compositions of the present invention can be determined by measuring and comparing the antimicrobial efficacy of the compositions against Candida albicans before and after storage using a suitable killing assay, such as the assay described in the Examples.

[0066] Kill levels can also be defined as a proportion, e.g., a percentage, or by reference to the log reduction in the total amount or level of microorganisms. Log reduction is used in the art to refer to the number of viable microorganisms killed, for example, after the microorganisms are contacted with the aqueous dental appliance composition of the present invention. The terms "log X reduction" and "x log reduction" are used interchangeably and refer to a reduction of 10 xA log 4 reduction refers to a reduction in the number of viable microorganisms. For example, a log 4 reduction means that after contacting a population of microorganisms with an aqueous dental instrument cleanser, the number of microorganisms remaining in the population is 10,000 times less than the population before contact with the aqueous dental instrument cleanser, or 1 / 10 4 This means that:

[0067] Specifically, a suspension of Candida albicans (10 per ml) 8 Exposure of Candida albicans suspensions (10 cfu per ml) to the compositions of the invention results in at least a log 2.5 reduction, specifically at least a log 3 reduction, more specifically at least a log 4 reduction, and even more specifically at least a log 5 reduction in the number of Candida albicans colony forming units within 60 seconds of exposure when measured at least 3 months after preparation of the composition. 8 Exposure of Candida albicans suspensions (10 cfu per ml) to the compositions of the invention results in at least a log 2.5 reduction, specifically at least a log 3 reduction, more specifically at least a log 4 reduction, and even more specifically at least a log 5 reduction in the number of Candida albicans colony forming units within 60 seconds of exposure when measured at least 6 months after preparation of the composition. 8 Exposure of Candida albicans suspensions (10 per ml) to the compositions of the invention results in at least a log 2.5 reduction, specifically at least a log 3 reduction, more specifically at least a log 4 reduction, and even more specifically at least a log 5 reduction in the number of Candida albicans colony forming units, within 60 seconds of exposure, when measured at least 12 months after preparation of the composition. 8 cfu) to a composition of the invention results in at least a log 2.5 reduction, specifically at least a log 3 reduction, more specifically at least a log 4 reduction, and even more specifically at least a log 5 reduction in the number of Candida albicans colony forming units within 60 seconds of exposure when measured at least 24 months after preparation of the composition.

[0068] Klebsiella pneumoniae is a Gram-negative bacterium that causes multiple healthcare associated infections. Thus, the stability of the compositions of the invention can also be determined by measuring their antimicrobial efficacy against Klebsiella pneumoniae using a suitable bactericidal assay, such as the assay described in the Examples.

[0069] Specifically, a suspension of Klebsiella pneumoniae (10 per ml) 8 Exposure of a suspension of K. pneumoniae (10 cfu per ml) to a composition of the invention results in at least a log 2.5 reduction, specifically at least a log 3 reduction, more specifically at least a log 4 reduction, and even more specifically at least a log 5 reduction in the number of K. pneumoniae colony forming units within 60 seconds of exposure when measured at least 3 months after preparation of the composition. 8 Exposure of a suspension of K. pneumoniae (10 cfu per ml) to a composition of the invention results in at least a log 2.5 reduction, specifically at least a log 3 reduction, more specifically at least a log 4 reduction, and even more specifically at least a log 5 reduction in the number of K. pneumoniae colony forming units within 60 seconds of exposure when measured at least 6 months after preparation of the composition. 8 Exposure of a suspension of K. pneumoniae (10 per ml) to a composition of the invention results in at least a log 2.5 reduction, specifically at least a log 3 reduction, more specifically at least a log 4 reduction, and even more specifically at least a log 5 reduction in the number of K. pneumoniae colony forming units, within 60 seconds of exposure, when measured at least 12 months after preparation of the composition. 8 cfu) to a composition of the invention results in at least a log 2.5 reduction, specifically at least a log 3 reduction, more specifically at least a log 4 reduction, and even more specifically at least a log 5 reduction in the number of K. pneumoniae colony forming units, within 60 seconds of exposure, when measured at least 24 months after preparation of the composition.

[0070] The compositions of the present invention retain at least 80%, at least 85%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of their active ingredient content after at least 3 months, at least 6 months, at least 12 months, or at least 24 months at room temperature (20° C.).

[0071] Also provided is a container comprising the aqueous dental instrument cleanser composition of the present invention. Also provided is a dispenser comprising (i) a container comprising the aqueous dental instrument cleanser composition of the present invention and (ii) a foaming applicator head. More specifically, provided is a dispenser consisting essentially of (i) a container comprising the aqueous dental instrument cleanser composition of the present invention and (ii) a foaming applicator head configured to dispense the aqueous dental instrument cleanser composition in the form of a foam. Even more specifically, provided is a dispenser comprising or consisting essentially of a container defining a reservoir and a foaming applicator head in fluid communication with the reservoir, the reservoir comprising the cleanser composition of the present invention and the foaming applicator head configured to dispense the aqueous dental instrument cleanser composition from the reservoir in the form of a foam.

[0072] The container can be made of any suitable material. Suitable materials are those that do not decompose, interact with, or react with the components of the dental instrument cleanser composition. Specifically, suitable materials do not interact with, react with, or decompose on contact with hydrogen peroxide, more specifically, 0.05% to 4% by weight hydrogen peroxide, e.g., on prolonged contact. Specifically, suitable materials do not interact with, react with, or decompose on contact, e.g., on prolonged contact with salicylic acid, furoic acid, or formic acid, more specifically, 0.01% to about 0.25% by weight salicylic acid, furoic acid, or formic acid. Specifically, suitable materials do not interact with, react with, or decompose on contact, e.g., on prolonged contact with anionic surfactants, more specifically, 0.05% to about 2.00% by weight anionic surfactants.

[0073] As non-limiting examples, the container may comprise high density polyethylene (HDPE) and / or polyethylene terephthalate (PET). In some embodiments, the container comprises high density polyethylene (HDPE) and polyethylene terephthalate (PET). In some embodiments, the container is a high density polyethylene (HDPE) container. In some embodiments, the container is a polyethylene terephthalate (PET) container.

[0074] After accelerated stability testing of the compositions of the present invention stored in containers made from high density polyethylene (HDPE) or polyethylene terephthalate (PET) and other plastic and metal components, no evidence of corrosion or other damage to the container was observed.Therefore, a container containing the aqueous dental instrument cleanser composition of the present invention, the container being made from polyethylene terephthalate (PET) or high density polyethylene (HDPE), is also provided.Also provided is a dispenser comprising (i) a container containing the aqueous dental instrument cleanser composition of the present invention and (ii) a foaming applicator head, the container being made from polypropylene (PP), more specifically, a dispenser consisting essentially of (i) a polyethylene terephthalate (PET) or high density polyethylene (HDPE) container containing the aqueous dental instrument cleanser composition of the present invention and (ii) a foaming applicator head configured to dispense the aqueous dental instrument cleanser composition in the form of a foam. Even more specifically, a dispenser is provided that includes or consists essentially of a polyethylene terephthalate (PET) or high density polyethylene (HDPE) container defining a reservoir and a foaming applicator head in fluid communication with the reservoir, the reservoir containing the cleanser composition of the present invention, and the foaming applicator head configured to dispense the aqueous dental instrument cleanser composition from the reservoir in the form of a foam.

[0075] Composition for use in cleaning The present invention is also directed to the above compositions for use in methods of cleaning dentures, which methods include applying the composition to a surface of a dental appliance and maintaining the dental appliance in contact with the composition for a period of time.

[0076] Preferably, the composition is applied in the form of a spray and / or foam. Thus, the method may include dispensing the composition from a container in the form of a foam. Specifically, when dispensed, the composition is activated to foam via a foam applicator head. The foam is applied directly to the surface of the dental appliance, and optionally brushed. Alternatively, the composition may be applied in the form of a spray and agitated by manual means, such as by brushing, to form a foam.

[0077] Specifically, the composition is maintained in contact with the surface of the dental appliance for a period of time sufficient to kill at least 80%, e.g., at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or at least 99.9% of the microorganisms present on the surface of the dental appliance.

[0078] Specifically, the microorganisms present on the surface of the dental appliance include Candida albicans and / or Klebsiella pneumoniae, more specifically Candida albicans. Specifically, the composition is maintained in contact with the surface of the dental appliance for a period of time sufficient to achieve at least a log 2.5 reduction, preferably at least a log 3 reduction, more preferably at least a log 4 reduction, and most preferably at least a log 5 reduction in the number of Candida albicans and / or Klebsiella pneumoniae colony forming units on the surface. Preferably, the period of time is not more than 3 minutes, not more than 3 minutes, not more than 2 minutes, not more than 2 minutes, not more than 60 seconds, not more than 60 seconds, specifically 30 seconds to 60 seconds. After this period of time, the dental appliance is rinsed with water to remove residual composition and placed in the wearer's mouth. The compositions of the present invention are particularly suitable for use in cleaning dental prostheses that are washed and then placed in the mouth, since this generally involves some manual handling of the dental appliance. The compositions of the present invention have improved skin tolerability (e.g., compared to certain other cleansers) and are particularly suitable for cleaning dental instruments where the cleansing composition may come into contact with the skin of the hands or fingers either accidentally or during the manual handling process. Specifically, the compositions of the present invention have a skin tolerability score of at least 10% average cell viability, at least 11%, at least 12%, at least 13%, at least 14%, or at least 15% average cell viability as measured by an in vitro skin tolerability assay.

[0079] The cleaning methods of the present invention are carried out outside the oral cavity, and therefore may be referred to as methods of cleaning dental instruments outside the oral cavity.

[0080] In certain embodiments, there is provided a composition of the invention for use in a method of cleaning dentures, the method comprising dispensing the composition in the form of a foam from a container onto a surface of a dental appliance, maintaining the dental appliance in contact with the foam for a period of time, specifically 30 to 60 seconds, optionally brushing the dental appliance and / or rinsing with water to remove the foam, and optionally placing the dental appliance in the subject's mouth.

[0081] In certain embodiments, there is provided a composition of the invention for use in a method of cleaning dentures, the method comprising removing a dental appliance from the mouth of a subject, dispensing a dental appliance cleanser from a container in the form of a foam, applying the foam to a surface of the dental appliance, maintaining the dental appliance in contact with the foam for a period of time, specifically 30 to 60 seconds, optionally brushing and / or rinsing the dental appliance with water to remove the foam, and replacing the dental appliance in the subject's mouth.

[0082] Compositions for use in killing microorganisms - Patents.com Also provided are compositions of the invention for use in a method for killing microorganisms, such as Candida albicans, on the surface of a dental appliance. In some embodiments, compositions of the invention are provided for use in a method for killing bacteria, such as Klebsiella pneumoniae, on the surface of a dental appliance. In some embodiments, compositions of the invention are provided for use in a method for killing fungi, such as yeast, such as Candida albicans, on the surface of a dental appliance. In some embodiments, compositions of the invention are provided for use in a method for inactivating, e.g., killing, viruses on the surface of a dental appliance.

[0083] These methods include applying a composition of the present invention to a surface of a dental appliance containing at least one microorganism and maintaining the dental appliance in contact with the composition for a period of time sufficient to kill the at least one microorganism. One skilled in the art will recognize that when applying a composition to a surface of a dental appliance containing microorganisms, the composition also contacts the microorganisms on the surface of the dental appliance.

[0084] Specifically, the composition is maintained in contact with the surface of the dental appliance for a period of time sufficient to kill at least 80%, e.g., at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or at least 99.9% of the microorganisms present on the surface of the dental appliance.

[0085] Thus, the method may include applying a composition of the present invention to a surface of a dental appliance containing a microbial population and maintaining the dental appliance in contact with the composition for a period of time sufficient to kill at least 80% of the microbial population.

[0086] In particular, the microorganism is Candida albicans and / or Klebsiella pneumoniae, more particularly Candida albicans.

[0087] Specifically, the composition is maintained in contact with the surface of the dental appliance for a period of time sufficient to achieve at least a log 2.5 reduction, preferably at least a log 3 reduction, more preferably at least a log 4 reduction, and most preferably at least a log 5 reduction in the number of Candida albicans and / or Klebsiella pneumoniae colony forming units on the surface.

[0088] Specifically, with regard to viruses, the compositions of the invention are capable of reducing the viral titer (corresponding to the content of infectious virus present per unit volume in a cell culture lysate) of a viral strain by at least log 4. A log 4 reduction is achieved by reducing the viral titer by at least 10% of the tested viral strains. 4 This corresponds to a 1:1 or 99.99% reduction. The virus may be an enveloped or non-enveloped virus. The virus may be an influenza virus, a coronavirus, or a rhinovirus. In certain embodiments, the virus is a respiratory syncytial virus. In certain embodiments, the virus is an influenza virus H1N1. In certain embodiments, the virus is a coronavirus, such as SARS-CoV, SARS-CoV-1, or SARS-CoV-2.

[0089] Thus, the method may include applying a composition of the present invention to a surface of a dental appliance containing a population of bacteria and / or fungi (e.g., including Candida albicans and / or Klebsiella pneumoniae) and maintaining the dental appliance in contact with the composition for a period of time sufficient to achieve at least an 80% or at least the equivalent of a log 2.5 reduction in the number of colony forming units of the bacteria and / or fungi (e.g., Candida albicans and / or Klebsiella pneumoniae).

[0090] Preferably, the period of time is about 30 seconds to no more than 3 minutes, 3 minutes or less, 2 minutes or less, 2 minutes or less, 60 seconds or less, specifically about 30 seconds to about 3 minutes, about 30 seconds to about 2 minutes, preferably about 30 seconds to about 60 seconds. After the period of time, the dental appliance is rinsed with water to remove any residual composition and placed in the wearer's mouth.

[0091] Specifically, the compositions of the present invention have a skin tolerability score of at least 10% mean cell viability, at least 11%, at least 12%, at least 13%, at least 14%, or at least 15% mean cell viability as measured by an in vitro skin tolerability assay.

[0092] In certain embodiments, there is provided a composition of the invention for use in a method of killing microorganisms, such as Candida albicans, on the surface of a dental appliance, the method comprising dispensing the composition in the form of a foam from a container, applying the foam to the surface of the dental appliance containing the microorganisms, maintaining the dental appliance in contact with the foam for a period of time sufficient to kill the microorganisms, specifically 30-60 seconds, optionally brushing the dental appliance and / or rinsing with water to remove the foam, and optionally placing the dental appliance in the mouth of a subject.

[0093] Specifically, the surface of the dental appliance contains a population of microorganisms, such as Candida albicans. More specifically, the dental appliance is maintained in contact with the foam for a period of time sufficient to kill at least 80%, such as at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or at least 99.9% of the microorganisms present on the surface of the dental appliance. Even more specifically, at least 80%, such as at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or at least 99.9% of the microorganisms present on the surface of the dental appliance are killed within 30 to 60 seconds. Even more specifically, at least 80%, e.g., at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or at least 99.9% of the Candida albicans CFU present on the surface of the dental device are killed within 30 to 60 seconds.

[0094] In certain embodiments, there is provided a composition of the invention for use in a method of killing microorganisms, such as Candida albicans, on the surface of a dental appliance, the method comprising removing the dental appliance from the mouth of a subject, dispensing the composition in the form of a foam from a container onto the surface of the dental appliance containing the microorganisms, maintaining the dental appliance in contact with the foam for a period of time sufficient to kill the microorganisms, specifically 30 to 60 seconds, rinsing the dental appliance with water and optionally brushing to remove the foam, and replacing the dental appliance in the mouth of the subject.

[0095] Use of the composition in a cleaning method The present invention further includes a method of cleaning dental appliances, such as partial or complete dentures, using the above compositions.

[0096] For example, there is provided a method for cleaning dentures, comprising dispensing a composition of the present invention from a container in the form of a spray and / or foam onto the surface of a dental appliance, maintaining the dental appliance in contact with the foam for a period of time, specifically 30 to 60 seconds, rinsing the dental appliance with water and optionally brushing to remove residual composition, and optionally placing the dental appliance in the subject's mouth.

[0097] In some embodiments, a method of cleaning dentures is provided, comprising removing the dental appliance from the subject's mouth, dispensing a composition of the present invention in the form of a foam from a container onto the surface of the dental appliance, maintaining the dental appliance in contact with the foam for a period of time, specifically 30-60 seconds, rinsing the dental appliance with water and optionally brushing to remove residual composition, and replacing the dental appliance in the subject's mouth.

[0098] Use of the composition in a method for killing microorganisms Also provided is a method of killing microorganisms, such as Candida albicans, on the surface of dental appliances using the compositions of the present invention.

[0099] Further provided is a method of killing microorganisms, such as Candida albicans, on the surface of a dental appliance, comprising dispensing a composition according to the present invention in the form of a foam from a container onto the surface of the dental appliance containing the microorganisms, maintaining the dental appliance in contact with the foam for a period of time sufficient to kill the microorganisms, specifically 30 to 60 seconds, rinsing the dental appliance with water and optionally brushing to remove the foam, and optionally placing the dental appliance in the mouth of a subject.

[0100] Further provided is a method of killing microorganisms, such as Candida albicans, on the surface of a dental appliance, comprising removing the dental appliance from the mouth of a subject, dispensing a composition according to the present invention in the form of a foam from a container, applying the foam to the surface of the dental appliance containing the microorganisms, maintaining the dental appliance in contact with the foam for a period of time sufficient to kill the bacteria, specifically 30 to 60 seconds, rinsing the dental appliance with water and optionally brushing to remove the foam, and replacing the dental appliance in the mouth of the subject.

[0101] overview The term "comprising" encompasses "including," e.g., a composition "comprising" X may include additional items (e.g., X+Y). In some implementations, the term "comprising" refers to the inclusion of the indicated active agent, e.g., the compound recited, as well as other active agents known in the consumer health industry and generally recognized as safe (GRAS), as well as carriers, excipients, emollients, stabilizers, and the like. Use of the transitional phrase "consisting essentially of" means that the claims are to be construed to include the specific materials or steps recited in the claims, as well as those that do not materially affect the basic and novel characteristics of the claimed invention. See In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original); see also MPEP §2111.03. Therefore, the term "consisting essentially of" is not intended to be interpreted as equivalent to "comprising" when used in the claims of the present invention. The term "consisting of" and its variants mean including and limited to (e.g., the specific recited components or steps). In certain regions, the term "comprising an active ingredient consisting of" may be used instead of "consisting essentially of". The term "about" in relation to a numerical value x is optional, meaning that, for example, the numerical value may include some variation around the stated number, such as x±10%, x±5%, x±4%, x±3%, x±2%, or x±1%, to allow for routine experimental variation, measurement variance, or to encompass slight deviations that may achieve substantially the same results as the stated number. The word "substantially" does not exclude "completely", for example, a composition "substantially free" of Y may be completely free of Y.Where appropriate, the word "substantially" may be omitted from the definition of the present invention. All percentages and ratios used herein are by weight of the total composition unless otherwise specified.

[0102] All references or patent applications cited within this patent specification are hereby incorporated by reference.

[0103] EMBODIMENTS OF THE PRESENT DISCLOSURE The following clauses describe specific embodiments of the present invention:

[0104] E1) A storage stable, aqueous dental instrument cleanser composition comprising: about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid, and about 0.05% to about 2.00% by weight of an anionic surfactant.

[0105] E2) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid, about 0.05% to about 2.00% by weight of an anionic surfactant, and having a pH in the range of 2.8 to 3.5.

[0106] E3) A storage stable, aqueous dental instrument cleanser composition comprising or consisting essentially of about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid, about 0.05% to about 2.00% by weight of an anionic surfactant, about 0.01% to about 0.08% by weight of a buffer solution, specifically a sodium citrate buffer solution, and having a pH in the range of 2.8 to 3.5.

[0107] E4) A storage stable, aqueous dental instrument cleanser composition comprising or consisting essentially of about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid, about 0.05% to about 2.00% by weight of an anionic surfactant, about 0.01% to about 0.08% by weight of a buffer solution, specifically a sodium citrate buffer solution, having a pH in the range of 2.8 to 3.5, and further comprising about 0.01% to about 0.5% by weight of a sensory component.

[0108] E5) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight 2-furoic acid and / or 3-furoic acid, about 0.05% to about 2.00% by weight anionic surfactant, and having a pH in the range of 2.8 to 3.5.

[0109] E6) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight formic acid, about 0.05% to about 2.00% by weight anionic surfactant, and having a pH in the range of 2.8 to 3.5.

[0110] E7) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight salicylic acid, about 0.05% to about 2.00% by weight anionic surfactant, and having a pH in the range of 2.8 to 3.5.

[0111] E8) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.1% to about 2% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight salicylic acid, about 0.05% to about 2.00% by weight anionic surfactant, and having a pH in the range of 2.8 to 3.5.

[0112] E9) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.1% to about 2% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, and having a pH in the range of 2.8 to 3.5.

[0113] E10) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.1% to about 2% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, and having a pH in the range of 2.8 to 3.5.

[0114] E11) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.25% to about 1% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight salicylic acid, about 0.05% to about 2.00% by weight anionic surfactant, and having a pH in the range of 2.8 to 3.5.

[0115] E12) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.25% to about 1% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, and having a pH in the range of 2.8 to 3.5.

[0116] E13) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight salicylic acid, about 0.05% to about 2.00% by weight anionic surfactant, about 0.01% to about 0.08% by weight of a buffer solution, specifically a sodium citrate buffer solution, and having a pH in the range of 2.8 to 3.5.

[0117] E14) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.1% to about 2% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.01% to about 0.08% by weight of a buffer solution, specifically a sodium citrate buffer solution, and having a pH in the range of 2.8 to 3.5.

[0118] E15) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.1% to about 2% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.02% to about 0.06% by weight of a buffer solution, specifically a sodium citrate buffer solution, and having a pH in the range of 2.8 to 3.5.

[0119] E16) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.1% to about 2% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.02% to about 0.08% by weight sodium citrate buffer, and having a pH in the range of 2.8 to 3.5.

[0120] E17) A storage stable, aqueous dental instrument cleanser composition comprising or consisting essentially of about 0.25% to about 1% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.01% to about 0.08% by weight buffer, specifically sodium citrate buffer, and having a pH in the range of 2.8 to 3.5.

[0121] E18) A storage stable, aqueous dental instrument cleanser composition comprising or consisting essentially of about 0.25% to about 1% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.02% to about 0.08% by weight of a buffer solution, specifically a sodium citrate buffer solution, and having a pH in the range of 2.8 to 3.5.

[0122] E19) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.25% to about 1% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.02% to about 0.08% by weight sodium citrate buffer, and having a pH in the range of 2.8 to 3.5.

[0123] E20) A storage stable, aqueous dental instrument cleanser composition comprising or consisting essentially of about 0.05% to about 4% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight salicylic acid, about 0.05% to about 2.00% by weight anionic surfactant, about 0.01% to about 0.08% by weight buffer, specifically sodium citrate buffer, having a pH in the range of 2.8 to 3.5, and further comprising about 0.01% to about 0.5% by weight of a sensory ingredient.

[0124] E21) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.1% to about 2% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.02% to about 0.08% by weight sodium citrate buffer, having a pH in the range of 2.8 to 3.5, and further comprising about 0.01% to about 0.5% by weight of a sensory ingredient.

[0125] E22) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.1% to about 2% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.02% to about 0.08% by weight sodium citrate buffer, having a pH in the range of 2.8 to 3.5, and further comprising about 0.1% to about 0.3% by weight of a sensory ingredient.

[0126] E23) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.25% to about 1% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.02% to about 0.08% by weight sodium citrate buffer, having a pH in the range of 2.8 to 3.5, and further comprising about 0.01% to about 0.5% by weight of a sensory ingredient.

[0127] E24) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.25% to about 1% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.02% to about 0.08% by weight sodium citrate buffer, having a pH in the range of 2.8 to 3.5, and further comprising about 0.1% to about 0.3% by weight of a sensory ingredient.

[0128] E25) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.25% to about 1% by weight hydrogen peroxide, about 0.1% to about 0.2% by weight salicylic acid, about 0.25% to about 1.00% by weight sodium lauryl sulfate, about 0.02% to about 0.08% by weight sodium citrate buffer, having a pH in the range of 2.8 to 3.5, and further comprising about 0.1% to about 0.3% by weight of a sensory ingredient.

[0129] E26) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.25% to about 1% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight 2-furoic acid and / or 3-furoic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.02% to about 0.08% by weight sodium citrate buffer, having a pH in the range of 2.8 to 3.5, and further comprising about 0.1% to about 0.3% by weight of a sensory ingredient.

[0130] E27) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.25% to about 1% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight 2-furoic acid and / or 3-furoic acid, about 0.25% to about 1.00% by weight sodium lauryl sulfate, about 0.02% to about 0.08% by weight sodium citrate buffer, having a pH in the range of 2.8 to 3.5, and further comprising about 0.1% to about 0.3% by weight of a sensory ingredient.

[0131] E28) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.25% to about 1% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight formic acid, about 0.25% to about 1.00% by weight anionic surfactant, about 0.02% to about 0.08% by weight sodium citrate buffer, having a pH in the range of 2.8 to 3.5, and further comprising about 0.1% to about 0.3% by weight of a sensory ingredient.

[0132] E29) A storage stable, aqueous dental instrument cleanser composition comprising, or consisting essentially of, about 0.25% to about 1% by weight hydrogen peroxide, about 0.01% to about 0.25% by weight formic acid, about 0.25% to about 1.00% by weight sodium lauryl sulfate, about 0.02% to about 0.08% by weight sodium citrate buffer, having a pH in the range of 2.8 to 3.5, and further comprising about 0.1% to about 0.3% by weight of a sensory ingredient.

[0133] E30) A dispenser comprising, or consisting essentially of, a container defining a reservoir and a dispenser head in fluid communication with the reservoir, wherein the reservoir comprises a composition according to any one of embodiments E1-E29, and wherein the dispenser head is configured to dispense the composition from the reservoir in the form of a spray and / or foam.

[0134] E31) The dispenser of embodiment E30, wherein the dispenser head is a foaming applicator head configured to dispense the composition in the form of a foam.

[0135] In order that this invention may be better understood, the following examples are set forth. These examples are for illustrative purposes only and are not to be construed as limiting the scope of the invention in any way. EXAMPLES

[0136] [Example 1] Aqueous compositions containing 0.5% hydrogen peroxide, 0.5% sodium lauryl sulfate, acid (for amounts see Table 1), and water (balance to 100%) were prepared and tested for in vitro antimicrobial efficacy against the opportunistic pathogenic yeast Candida albicans.

[0137] The test consisted of applying the composition to a planktonic suspension of Candida albicans (1–5 × 10 8 cfu / ml) and then neutralized after a 60 second contact time. The log reduction of Candida albicans was then calculated for each composition, with a performance goal of >log 5 reduction (99.999% kill).

[0138] [Table 1]

[0139] Of these compositions, only those containing salicylic acid, furoic acid, or formic acid were able to achieve a reduction in colony forming units of C. albicans of ≥ 2.50 log. Surprisingly, the composition containing 0.18% salicylic acid resulted in a reduction of > 5 log (equivalent to 99.99% kill). The other acids tested (phosphoric acid, citric acid, oxalic acid, lactic acid, and succinic acid) achieved a reduction of < 1.10 log, demonstrating low levels of antimicrobial efficacy. There is no correlation between the pKa of the acid and antibacterial efficacy.

[0140] [Example 2] The compositions containing salicylic acid were then tested against Klebsiella pneumoniae, a gram-negative bacterium that causes multiple healthcare-associated infections.

[0141] [Table 2]

[0142] These results demonstrate the surprisingly strong antibacterial efficacy of compositions containing salicylic acid.

[0143] [Example 3] Compositions containing water, 0.5% hydrogen peroxide, 0.5% sodium lauryl sulfate, and salicylic acid were prepared at various pH levels and stored at 40° C. for three months to determine the pH range suitable for formulation stability.

[0144] The aged compositions were tested for in vitro antimicrobial efficacy against Candida albicans (60 second contact time as above), as well as for foam appearance after dispensing the liquid compositions through foam pump packaging.

[0145] [Table 3]

[0146] It was observed that formulation pH below pH 2.8 affected foaming properties, leading to a loss of foaming properties after aging of the samples. Without wishing to be bound by theory, it is believed that sodium lauryl sulfate decomposes to insoluble lauryl alcohol below pH 2.8, leading to a gradual loss of foaming properties over time.

[0147] It was also observed that formulations with a pH above 3.5 had lower initial antimicrobial efficacy (3.76 log reduction against Candida albicans at 60 seconds) and declined during storage. Again, without wishing to be bound by theory, it is believed that hydrogen peroxide begins to decompose at less acidic pH, leading to a gradual loss of efficacy over time.

[0148] Accordingly, the optimum pH for stability and antimicrobial efficacy was determined to be in the range of pH 2.8 to pH 3.5.

[0149] [Example 4] A composition containing 0.5% hydrogen peroxide, 0.5% sodium lauryl sulfate, 0.18% salicylic acid, and 98.82% water (pH 2.8-3.2) was prepared and compared with an existing dental appliance cleanser product (FRESHDENT Denture Foam, EverSmile).FRESHDENT contains the following components: water, 3.75% hydrogen peroxide, glycerin, PVP, PEG, sodium lauryl sulfate, sucralose, sodium citrate, sodium benzoate, etidronic acid, and mentha arvensis (peppermint) oil.

[0150] In vitro skin tolerability was measured using a commercially available in vitro EPIDERM skin irritation test (EPI-200-SIT, MatTek Corporation), which was described by Kandarova et al. (Pre-validation of an in vitro skin irritation test for medical devices using the reconstructed human tissue model EpiDerm TMToxicol. In Vitro. 2018;50:407-417). Briefly, 3D tissue models of normal human derived epidermal keratinocytes (NHEK) were cultured and cell viability was measured using well-known cell viability assays. Cultures were then topically exposed to a cleanser solution for 60 seconds and cell viability was remeasured to determine the average % cell viability after product exposure. The target remaining cell viability was defined as 2.71%, which represents the in vitro performance of a reference GSK product that has been on the market for 10 years, with an excellent real-world skin tolerability profile according to GSK adverse event tracking. Accordingly, any viability above 2.71% is expected to have a comparable or better in-market skin tolerability profile.

[0151] Material compatibility testing was performed on a wide range of denture materials, including polymethylmethacrylate, polyamide, stainless steel, silver solder, ethylene vinyl acetate copolymer, thermoplastic polyurethane, cobalt-chromium alloy, and polypropylene. Materials were repeatedly exposed to the composition over multiple cycles by brushing for 60 seconds and then rinsing, representing two years of simulated daily use. Materials were then evaluated for surface damage using optical and electron microscopy. The integrity of the materials after exposure was visually graded as either structurally damaged (poor compatibility), with minor cosmetic damage (moderate / good compatibility), or without damage (excellent compatibility).

[0152] [Table 4]

[0153] Surprisingly, the compositions of the present invention provided rapid antimicrobial efficacy within 60 seconds (favorable) despite having lower levels of hydrogen peroxide compared to FRESHDENT products (0.5% vs. 3.75%). The compositions of the present invention also provide improved skin tolerability (safety) compared to FRESHDENT products, while also having superior denture material compatibility.

[0154] [Example 5] The stain removal properties of the compositions were evaluated against a commercial toothpaste that is often used to clean dental instruments in a simulated stain removal test. A ceramic tile was stained with a strong tea solution. Half of the tile was treated with either (a) the composition or (b) the toothpaste, and the stained area was brushed, rinsed, and dried (Figure 1). The compositions of the present invention were better at removing the stain than the commercial toothpaste.

[0155] Given this guidance, one of ordinary skill in the art will be able to adjust the parameters given in the examples to achieve similar results within the remit of the claims.

Claims

1. 1. A storage-stable, aqueous dental instrument cleanser composition comprising: (a) about 0.05% to about 4% by weight of hydrogen peroxide; (b) about 0.01% to about 0.25% by weight of at least one acid selected from the group consisting of salicylic acid, furoic acid, and formic acid; and (c) about 0.05% to about 2.00% by weight of an anionic surfactant.

2. 10. The dental instrument cleanser composition of claim 1 having a pH of 2.8 to 3.

5.

3. 10. The dental instrument cleanser composition of claim 1, further comprising: (d) a means for adjusting or maintaining the pH of the composition.

4. 4. The dental instrument cleanser composition of claim 3, wherein the means for adjusting or maintaining the pH of the composition is a pH buffer.

5. 5. The dental instrument cleanser composition of claim 4, comprising about 0.01% to about 0.08% by weight of a pH buffer.

6. 5. The dental instrument cleanser composition of claim 4, wherein the pH buffer is a sodium citrate buffer.

7. 10. The dental instrument cleanser composition of claim 1, wherein the acid is salicylic acid.

8. 10. The dental instrument cleanser composition of claim 1 comprising about 0.1% to about 2% by weight hydrogen peroxide, specifically about 0.25% to 1% by weight hydrogen peroxide.

9. 8. The dental instrument cleanser composition of claim 7, wherein the anionic surfactant is a sodium alkyl sulfate.

10. 10. The dental instrument cleanser composition of claim 9, wherein the sodium alkyl sulfate is selected from the group consisting of sodium lauryl sulfate, sodium lauryl sulfonate, and sodium laureth sulfate.

11. 10. The dental instrument cleanser composition of claim 1, consisting essentially of: (a) about 0.1% to about 2% by weight hydrogen peroxide; (b) about 0.01% to about 0.25% by weight salicylic acid; (c) about 0.05% to about 2.00% by weight anionic surfactant selected from the group consisting of sodium lauryl sulfate, sodium lauryl sulfonate, and sodium laureth sulfate; and (d) a pH buffer having a pH of 2.8 to 3.5 and comprising at least 90%, preferably 95%, by weight water.

12. 10. The dental instrument cleanser composition of claim 1, further comprising (e) a sensory ingredient, specifically a flavoring agent and / or a coloring agent.

13. 13. A dental instrument cleanser composition according to any one of claims 1 to 12 for use in a method of cleaning dentures.

14. 13. A dental instrument cleanser composition according to any one of claims 1 to 12 for use in a method for killing microorganisms, such as Candida albicans, on the surface of a dental instrument, the method comprising contacting the microorganisms on the surface of the dental instrument with the composition for a period of time sufficient to kill the microorganisms.

15. 13. A dispenser comprising, or consisting essentially of, (i) a container defining a reservoir and (ii) a dispenser head in fluid communication with the reservoir, wherein the reservoir contains the dental instrument cleanser composition of any one of claims 1 to 12, and the dispenser head is configured to dispense the aqueous dental instrument cleanser composition from the reservoir in the form of a spray and / or foam.

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