Kits, systems and methods for preparing peroxide-containing compositions and uses thereof

Abstract

Various embodiments of the present disclosure relate to kits, systems, and methods for preparing peroxide-containing compositions and uses thereof. A kit or system (100) for preparing a peroxide composition having an increased viscosity at a pH in the range of 7 to 12 in a nearly instantaneous process is provided. For example, a kit or system may be used to provide a (aqueous) gelled peroxide composition that is almost immediately available. The system includes a first aqueous composition (102) comprising a peroxide agent. The first aqueous composition has a first pH of less than 7. The system additionally includes a second composition (104) comprising an alkaline agent. The second composition is separate from the first aqueous composition. The pH-inducing thickener is included in the kit or system, separate from the second composition. The peroxide composition can be obtained by combining parts of a kit or system. The pH-inducing thickener is capable of increasing the viscosity of the peroxide composition when subjected to a pH in the range of 7 to 12. The kit or system has sufficient alkaline agent for the peroxide composition to bring the pH in the range of 7 to 12. A method for preparing the kit or system and uses thereof are also provided.

Description

[0001] This application is a divisional application of the invention patent application with international application number PCT / EP2020 / 076640, international application date September 24, 2020, which entered the Chinese national phase on May 23, 2022, application number 202080081158.X, and invention title "Kits, systems and methods for preparing compositions containing peroxides and their uses". Technical Field

[0002] This invention relates to systems, kits, and methods for preparing thickened peroxide compositions from at least two separate compositions. The invention also relates to peroxide compositions and such systems, kits, and thickened peroxide compositions for tooth whitening, disinfection, and sterilization purposes, such as for disinfection in the prevention or treatment of oral infections. The invention further relates to methods for preparing peroxide compositions. Background Technology

[0003] Hydrogen peroxide is commonly used for sterilization, disinfection, and teeth whitening based on its oxidizing properties. In teeth whitening, the natural tooth color is restored or whitened to a level exceeding the natural tooth color.

[0004] In oral applications, peroxide compositions comprising hydrogen peroxide and / or urea peroxide are frequently used. For example, peroxides can be included in toothpaste, mouthwash, chewing gum, varnishes, etc. For whitening, peroxide-containing gels with increased viscosity are typically used. The gel can be brought into contact with teeth using trays, plastic strips, or other means. The gel, along with trays, strips, or other means, can be purchased over the counter (for home use or to take home) or obtained from a dental professional (chairside).

[0005] Gels are typically supplied in the form of kits that include a pre-gelled polymer composition. While this gel-like consistency is advantageous for applying such compositions to surfaces, such as dental components, for whitening purposes, supplying such pre-prepared gels to end users has proven problematic because the rheological properties typically deteriorate over time, whereas they are intended to remain stable throughout the product's shelf life, which can often be quite long, such as days, weeks, or months, before the kit is used.

[0006] Therefore, the rheological evolution of gel-like components over time may require the inclusion of stabilizing ingredients and / or refrigerated transport (e.g., at 2–8°C) and storage kits, thereby increasing the complexity and cost of formulation, storage, and transport, as well as the use of conventional kits. Furthermore, the inclusion of such additional stabilizing ingredients in formulations, such as specific thickeners, chelating agents, desensitizing agents, etc., results in components with higher osmotic pressures, which are thought to lead to higher whitening sensitivities (Abd-Elmeguid A, Yu DC.; Journal of the Canadian Dental Association (JADC). 2009; 75(1): 55; Pashley DH et al.; Inside Dentistry (Supplement). October 2008: 4(9) (Special Issue)).

[0007] Furthermore, the increased viscosity of pre-formed gels can make them difficult to prepare, package, and store. The relatively high viscosity can also result in lower blending efficiency with other component materials, such as peroxide compounds. Therefore, precisely controlled production conditions may be required.

[0008] Furthermore, visible gases, such as air bubbles, can be trapped in the pre-formulated gel composition. When polymer-containing components are supplied into transparent compartments, such as transparent syringe barrels, this can impair the appearance of the kit and thus its perceived quality. Bubbles, along with the stickiness of the pre-formulated gel, can also make accurate drug delivery of the composition difficult.

[0009] Therefore, while such pre-prepared gels can achieve their intended purpose based on their viscous properties, further improvements are desired. In particular, improvements in at least one, but preferably multiple, of the following are desirable: ease of manufacture, shelf life, handling, dosage accuracy, and appearance of such gel-based (teeth whitening) products.

[0010] Furthermore, it is desirable to further improve gels that form immediately before or after application, particularly oral application. Conventionally, these gels form slowly and / or do not possess the desired rheological properties. Therefore, it is desirable to improve at least one of the gel formation rate and gel rheological properties, but preferably both. In particular, it is desirable to provide systems capable of rapidly forming gels, preferably substantially immediately. Furthermore, it is desirable to provide systems capable of forming gels with a higher viscosity than known gels prepared immediately before or after application, particularly oral application.

[0011] In addition, it is desirable to provide systems containing pH-induced thickeners that are particularly compatible with high levels of salt, electrolytes, surfactants and / or other additives such as flavorings. Summary of the Invention

[0012] As defined in the claims, the present invention is intended to provide improvements for at least one or more of the problems / disadvantages described above.

[0013] According to one aspect, a system as claimed in claim 1 is provided. The system is a multi-composition system, a multi-component system, or a multi-part system that produces a desired specific peroxide composition for use when a certain amount of each of the compositions, components, or parts is mixed. The system may be a kit of the parts.

[0014] The inventors have recognized that, in view of the above objectives, this objective can be achieved by careful selection of a variety of ingredients and their distribution on at least two individual components of a component system to be mixed together to prepare a desired peroxide composition.

[0015] The system is used to prepare peroxide compositions having a pH in the range of 7 to 12. Peroxide compositions can be obtained by combining or mixing the components of the system as described below. The peroxide composition is a peroxide-containing composition, i.e., a composition containing a peroxide or a peroxide source. The peroxide preferably contains a peroxide reagent. The peroxide reagent preferably contains or consists of hydrogen peroxide and / or a hydrogen peroxide source such as urea peroxide.

[0016] At least in part due to its pH-induced thickener and pH in the range of 7 to 12, the peroxide composition has an increased viscosity at least relative to the composition or component from which it is made, and can be in gel form, and in particular hydrogel form.

[0017] The system comprises a first composition having a peroxide reagent and water and having an acidic pH (a first pH below 7). The peroxide reagent preferably comprises or consists of hydrogen peroxide and / or a hydrogen peroxide source such as urea peroxide.

[0018] The system also includes a second composition containing an alkaline reagent, which acts as a pH modifier because when mixed with the first composition, it makes the resulting peroxide composition less acidic than the pH of the first composition.

[0019] In addition, the system contains a pH-induced thickener, which is generally kept separate from the second composition. If the second composition does not contain a solvent and / or dispersion medium, then the pH-induced thickener can generally be only a part of the second composition. A pH-induced thickener is an agent that provides an increase in viscosity (thickening) when the aqueous composition is subjected to an increased pH. Therefore, it is capable of thickening the peroxide composition at pH values ​​in the range of 7 to 12. In the system, the pH-induced thickener is kept separate from the second composition. It is kept in a form free of solvent and / or dispersion medium, or, if such a medium has an acidic pH, in a composition containing a solvent and / or dispersion medium. When kept in such a form, it provides little or no thickening to the system composition. The amount of alkaline agent is chosen such that any acidic components ultimately present in the peroxide composition are compensated to the extent that the resulting peroxide composition has a pH within the desired range.

[0020] It should be understood that, in the system, the pH-induced thickener may be part of the first composition, part of the second composition which is free of solvent and / or dispersion medium, and / or part of the third composition which may be optional.

[0021] A first quantity of the first composition and a second quantity of the second composition, along with a certain amount of pH-induced thickener, are at least sufficient to provide the desired peroxide composition from the mixture of all three components. In one embodiment, the first and second quantities provide all of the first and second compositions present in the system.

[0022] While the system offers good handling during use and manufacture due to its low-viscosity or solid components, upon use, it provides a peroxide composition with good viscosity that thickens almost immediately. Therefore, the system reduces one or more of the difficulties described above associated with pre-prepared viscous peroxide gels and known peroxide gels that form immediately before or after application (particularly oral application). Thickening can occur within a relatively short time interval after or during the mixing of the system components, and in some embodiments, this can occur almost immediately or instantaneously, which is beneficial for general application, and particularly for oral application.

[0023] Furthermore, the system has a good shelf life because the peroxide reagent in the first aqueous composition is maintained at an acidic pH. Peroxides are generally more stable at such pH levels. For example, preferred peroxide reagents comprise or consist of one or more of hydrogen peroxide and / or hydrogen peroxide sources such as urea peroxide. While hydrogen peroxide is preferably maintained at a pH below 4, and urea peroxide is preferably maintained at a pH below 6, it can also be maintained below 5 or below 4. Therefore, the preferred first pH is in the range of 2 to 6, 2 to 5, or 2 to 4.

[0024] Although stable in the system at low pH during storage, the peroxide reagents in the peroxide composition provide good disinfection, whitening, or sterilization effects when used in the system. This is because in the peroxide composition, the peroxide reagents are exposed to a higher pH in the range of 7 to 12, where the peroxide reagents, and especially hydrogen peroxide and its complexes (such as urea peroxide), are generally activated and have high bleaching, whitening, or disinfecting efficacy.

[0025] The second composition comprises or consists of an alkaline reagent. The alkaline reagent may comprise or consist of one or more alkaline compounds, each capable of generating hydroxide ions (OH-) in an aqueous environment or aqueous solution. - One or more compounds may be Brönsted bases or Arrhenius bases. They may be strong bases, such as alkali metal hydroxides or alkaline earth metal hydroxides or oxides. They may also be weak acids, such as alkali metal carbonates or acetates, or alkaline earth metal carbonates or acetates. Preferably, they are water-soluble.

[0026] The second composition preferably comprises a solvent and / or a dispersion medium in which the alkaline reagent is dissolved and / or dispersed. Preferably, the second composition is an aqueous composition. Preferably, it is an alkaline reagent solution having a second pH higher than 7.

[0027] Alternatively, the second composition may be solvent- and dispersion medium-free, and therefore contains an alkaline reagent in a solvent- and / or dispersion medium-free form. Since many of the bases mentioned herein are typically solids under standard conditions, alkaline reagents having one or more of these compounds are also solids. This dry form of the second composition is useful when it is necessary to reduce or prevent dilution of system components, such as peroxide reagents, due to the combination of the system compositions during use. Sometimes a relatively high peroxide reagent content (e.g., above 20 wt% hydrogen peroxide) is required in the peroxide composition. For systems having a second composition including a solvent and / or dispersion medium and therefore exhibiting significant dilution during use, the peroxide reagent content in the first aqueous composition will need to be even higher. However, it is generally desirable to keep the peroxide reagent content as low as possible, and at least below 20 wt%, as concentrations of, for example, 20 wt% or higher of hydrogen peroxide are considered hazardous.

[0028] In one embodiment, the pH-induced thickener comprises or consists of one or more polymers, each polymer containing monomer residues, wherein at least a portion of the monomer residues contains an acidic group. Depending on pKa, at least a portion of such acidic groups will be protonated at a first pH and deprotonated at a compositional pH in the range of 7 to 12. Deprotonation provides a charged point in the form of a conjugate base of the acidic group, which can participate in polar interactions, believed to be the cause of thickening as explained below. Such polymers having acidic groups can be well-formed ASE and / or HASE polymers as defined below.

[0029] The acidic group comprises or consists of one or more groups selected from carboxylic acid groups, sulfonic acid groups, and phosphate groups. Carboxylic acid groups are particularly preferred. In one or more polymers, specific types of groups (e.g., carboxylic acids) may be all the same or different. For example, the difference may arise from their bonding to polymer residues via different substituents or groups. This can be used to adjust the acidity constant of such groups known in the art. Many polymers having such groups, and especially carboxylic acid groups, are compatible with oral use and / or environmentally acceptable. They may have pKa values ​​suitable for obtaining specific pH values ​​of the corresponding compositions, such as a specific first pH of the composition. Acidic groups may all have the same pKa, but they may also have different pKa values. When dispersed or dissolved in any system composition, such polymers themselves, i.e., without the addition of other acidic agents, can provide such compositions with a pH below 7 (or even below 5). Therefore, the pH of any such system composition may be adjusted to a specific desired level without the addition of any other acidic or basic agents. Conversely, if the pKa value results in a pH of the composition that differs from the desired value, then additional acidic or basic agents may be added.

[0030] In one embodiment, the pH-induced thickener comprises or consists of one or more hydrophobically modified alkali-soluble emulsion (HASE) polymers. In a preferred embodiment, the pH-induced thickener comprises at least 40% by weight of one or more HASE polymers. More preferably, the pH-induced thickener comprises at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or at least 95% by weight of one or more HASE polymers.

[0031] Not wishing to be bound by theory, the inventors believe that including one or more HASE polymers in this system surprisingly allows for rapid gel formation, which can be substantially instantaneous, and / or the formation of gels with desired rheological properties (e.g., high viscosity). This insight is particularly advantageous for oral application.

[0032] In one embodiment, the pH-induced thickener comprises or consists of one or more alkali-soluble emulsion (ASE) polymers and one or more hydrophobically modified alkali-soluble emulsion (HASE) polymers. Such polymers are typically capable of forming viscous hydrogels with water under alkaline conditions, while being solid in dry form, or even forming relatively low-viscosity solutions and / or dispersions (e.g., below 1000 mPa·s) in the presence of water under acidic conditions such as a first pH. In this sense, ASE and HASE polymers having acidic groups (e.g., carboxylic acid groups) as defined above are preferred. Therefore, examples of one or more polymers can be provided, each having monomer residues wherein at least a portion of their monomers contains acidic groups.

[0033] HASE polymers are advantageous because they are able to disperse relatively high amounts of ionic and nonionic components, such as peroxide reagents and other components disclosed herein, during thickening. Furthermore, many HASE polymers, such as the acrylic and cellulose-based polymers described below, are antioxidants and can therefore be incorporated into peroxide-containing (i.e., first) compositions.

[0034] HASE polymers are superior to ASE polymers due to their improved thickening properties, which allow for higher viscosity and / or faster thickening at similar concentrations and lower viscosity under acidic conditions for the first and / or third compositions of the system (if present). These properties can be used to facilitate increasing the peroxide content in the system and peroxide compositions and / or to provide peroxide compositions with higher viscosity. Higher viscosity is sometimes desired for the physical or oral application of the system or peroxide composition because the ambient temperature is almost 40°C, and viscosity is known to decrease with increasing temperature. Furthermore, the peroxide composition must resist mechanical action in the mouth, such as that of the tongue, in order to increase its residence time. HASE polymers can also provide a higher thickening rate due to the inherent additional thickening mechanism of ASE polymers, which facilitates the direct application of the peroxide composition in the oral cavity (e.g., without strips or trays).

[0035] In one embodiment, the pH-induced thickener comprises or consists of one or more polymers, each having at least a portion of monomer residues with an acidic group, wherein the one or more polymers are acrylic copolymers. The acidic group then preferably comprises or consists of a carboxylic acid group. The acrylic copolymer is a polymer having one or more monomer residues of acrylic acid (e.g., acrylic acid and / or methacrylic acid or others) and one or more monomer residues of acrylic acid ester or acrylate (e.g., methyl acrylate and / or methyl methacrylate and / or others). Acrylic copolymers having ester groups with fewer than 6 carbon atoms provide suitable ASE polymers. Examples of commercially available acrylic ASE polymers are Acusol™ 810 and Carbomer™ 940F. Acrylic copolymers having at least a portion of the acrylate monomer residues having hydrophobic ester groups with more than 6 carbon atoms, such as 6 to 40 carbon atoms, provide suitable HASE polymers. An example of an acrylic HASE polymer is commercially available Acusol™ 820.

[0036] In one embodiment, the pH-induced thickener comprises one or more cellulose polymers having at least a portion of hydroxyl-containing residues. In another embodiment, the pH-induced thickener consists of one or more cellulose polymers having at least a portion of hydroxyl-containing residues. The hydroxyl group may be separated from the main chain by an alkyl portion attached to the cellulose main chain, such as hydroxymethyl cellulose (HMC), hydroxyethyl cellulose (HEC), or hydroxypropyl cellulose (HMC). In this embodiment, the pH dependence of the thickening is not dependent on deprotonable groups (such as acidic groups) to generate charged groups. These polymers are preferably supplied separately from the peroxide reagent, i.e., separately from the first composition as described above.

[0037] In one embodiment, the pH-induced thickener is at least partially, but preferably entirely, included in the first composition. Preferably, all of it is in the first quantity. Since the first pH is below 7, the pH-induced thickener will not cause a significant increase in viscosity. Therefore, the system can be simplified, for example, by providing the first composition and the pH-induced thickener separately from each other in, for example, a third composition. This embodiment can provide a two-component or two-part system of only two compositions, namely the first composition and the second composition. It can be used with a simple two-barrel or twin-barrel syringe or a two-compartment dispenser system as defined below. Such a system, having a pre-prepared combination of pH-induced thickener and peroxide reagent in one (first) composition, can result in these components being more tightly mixed or uniformly distributed in the first composition and the final peroxide composition. The minimum number of system compositions to be mixed can provide easier composition mixing when using the system.

[0038] In one embodiment, the system includes a third quantity of a third composition separate from at least the second composition, and the pH-induced thickener is distributed in both the first and third quantities, or is included only in the third quantity, to maintain its separation from the first composition. The third composition may include a solvent and / or a dispersion medium in which the pH-induced thickener is dissolved and / or dispersed. The third composition is preferably an aqueous composition having a third pH of less than 7. The third pH may be the same as the first pH, but this is not required.

[0039] Alternatively or additionally, the third composition and therefore the pH-induced thickener may also be solvent-free and / or dispersion medium-free. Adding a pure (e.g., dry solid) form of the pH-induced thickener is also beneficial in reducing the aforementioned dilution effect. Furthermore, it will reduce or prevent undesirable thickening caused by swelling with a solvent or dispersion medium.

[0040] When the pH-induced thickener is present in a solid state, this can be achieved in many polymers disclosed below, and if the basic reagent is also in a solid state, it can even be mixed with the basic reagent. Thickening may not occur due to the lack of solvent and / or dispersion medium. In yet another variation, when the pH-induced thickener is based on a compound or polymer having an acidic group (such as those disclosed below), it can be provided in the form of a salt, wherein it has reacted with a base such that the conjugate base of the salt can provide at least a portion of the basic reagent of the system. In both cases, the thickener is therefore part of a second composition free of solvent and / or dispersion medium. Thus, simple kits having only two compositions can also be prepared. In particular, non-crosslinked pH-induced thickeners are advantageous if the pH-induced thickener is partially or entirely in a form free of solvent and / or dispersion medium. Generally, non-crosslinked pH-induced thickeners dissolve more quickly and / or mix more easily when reconstituted in a solvent or dispersion medium, which is required to form the peroxide compositions of the present invention.

[0041] When a pH-induced thickener is chemically unstable to a peroxide reagent, it is advantageous to separate the pH-induced thickener from the first composition, for example, in a third composition or as part of a second composition that does not contain a solvent and / or dispersion medium. In this case, an improved shelf life can be achieved compared to a system in which the pH-induced thickener is combined with a peroxide reagent.

[0042] In a preferred embodiment, all compositions of the system comprise a solvent and / or a dispersion medium, and they are preferably all aqueous compositions, thus containing water. Combining system compositions in liquid form is generally easier and / or faster to achieve compared to situations where one or more of the components must be combined in solid form, resulting in more uniform and faster thickening when using the system. Furthermore, improved uniform distribution and / or mixing of each component in the system composition can be achieved. In such embodiments, a pH-induced thickener is preferably present in the first composition, allowing the system to have only two compositions for mixing.

[0043] In any system as defined, the first and second quantities are sufficient to mix them at a ratio of the first quantity to the second quantity that is in the range of 10 to 0.1, preferably in the range of 5 to 0.2, or most preferably in the range of 5 to 0.8. Such a mixing ratio provides an easy-to-use system. These quantities can be measured in volume or weight, but are preferably measured in weight. Such a mixing ratio provides a good balance of the necessary quantities to be mixed and is convenient for use with multi-barrel syringes or dispensers disclosed below.

[0044] Preferred variations of the systems defined herein are those in which the first composition comprises a solvent and / or a dispersion medium and has a viscosity of less than 1000 mPa·s, preferably less than 500 mPa·s, and most preferably less than 100 mPa·s under standard conditions. Such low viscosity greatly improves the manufacture and use of the system. For example, a viscosity of less than 100 mPa·s is particularly desirable because the flowability of such components is close to that of water. The pH-induced thickeners in the form of HASE polymers disclosed below can be particularly suitable for providing such low viscosity in systems, for example, when used as part of the first composition.

[0045] In one embodiment, the amount of pH-induced thickener is selected to give the peroxide composition a viscosity greater than 50,000 mPa·s, more preferably greater than 100,000 mPa·s, under standard conditions. Such high viscosity provides a stable peroxide composition, which is particularly useful in oral application, where mechanical forces, such as those induced by the tongue, can reduce the retention time of the peroxide composition in the mouth. pH-induced thickeners containing HASE polymers are suitable for already achieving such values ​​immediately in the peroxide composition at a suitable concentration, and typically for achieving these values ​​almost immediately, as will be explained below.

[0046] In the embodiments, the first pH is in the range of 2 to 5, and / or when the system contains a third composition having a third pH, the third pH is in the range of 2 to 5. Carboxylic acid polymers, such as, for example, ASE and HASE polymers, are suitable in this regard.

[0047] For the reasons explained above, the system is preferably designed such that the composition pH is in the range of 7 to 12. For sterilization, a composition pH in the range of 8 to 10 can be used. When the system is used on human or animal subjects, such as for oral use as in oral disinfection or whitening of dental components, the composition pH is preferably in the range of 7 to 9.5, or more preferably between 7 and 9, or even more preferably between 8 and 9, to better compatibility with the body and still provide good efficacy and / or sufficient viscosity. The first and second quantities, as well as the amounts of pH-inducing thickener and alkali, are then selected to produce such values. For example, the first and second quantities to be mixed can be fixed as the contents of a twin-barrel syringe, as described below.

[0048] The system is preferably used to prepare peroxide compositions for oral use, such as for oral disinfection and / or teeth whitening. In this case, the system may contain one or more additives selected from: tooth desensitizers, tooth remineralizers, and flavoring agents. One or more additives are used in combination with other corresponding compositions of the kit and a pH-inducing thickener to obtain the peroxide composition. The presence of any of these additives allows the peroxide composition and system for oral use to be tailored to taste, pain sensation, and / or tooth restoration. Desensitizers and tooth remineralizers can respectively contribute to enhancing tooth comfort and protection during oral use. Flavoring agents can trigger taste and / or smell, thereby providing better taste during long-term oral use. Flavoring agents can, for example, add flavor to otherwise tasteless compositions, or can be used to mask any taste or odor that is not desirable from the user's perspective of the system or peroxide composition.

[0049] Any of these one or more additives may be present in the system in one or more additional separate compositions. Preferably, they are combined, for example, in a third composition (when present in the system) to prevent them from being exposed to alkaline (in the second composition) or acidic and / or oxidizing conditions, such as those of the first composition. Preferably, they are combined in an additional system composition, thus limiting the number of compositions in the system to three. Alternatively, one or more additives are included in the first and / or second compositions. This limits the number of components in the system to two and thus provides a simpler system. If sensitive to oxidizing and / or acidic conditions, the flavoring agent is preferably not present in the first composition. If sensitive to alkaline hydrolysis, the flavoring agent is not preferably not present in the second composition. In this case, the shelf life of the system can be improved.

[0050] In the embodiments, the desensitizing agent comprises potassium ions and / or potassium ion sources such as potassium salts. Potassium ions are believed to desensitize nerve fibers that block nerve transmission. For example, potassium ions and / or potassium ion sources may be present in the first composition and / or the second composition. When present in the second composition, they may be in the form of, for example, potassium hydroxide, carbonates, or potassium nitrates.

[0051] In one embodiment, the desensitizing agent comprises or is composed of one or more compounds for occluding dentinal tubules. For example, such compounds can be any of the following: sodium fluoride, stannous fluoride, strontium chloride, silver diamine fluoride, potassium oxalate, calcium phosphate or strontium phosphate, calcium carbonate or strontium carbonate. Most of these compounds, such as phosphates and carbonates, can also act as remineralizing agents.

[0052] In one embodiment, the system comprises calcium ions or calcium ion sources such as calcium salts, and / or strontium ions or strontium ion sources such as strontium salts, and mono- and / or di- and / or ternary phosphate ions (phosphate ions) or such ion sources. Preferably, calcium ions, strontium ions, or their sources are contained in the first composition, and then preferably in a form soluble in an aqueous composition (e.g., in chlorides or nitrates). Phosphate ions or their sources are preferably contained in the second component. Separating phosphate ions and their sources from calcium or strontium ions or their sources prevents calcium phosphate or strontium phosphate from crystallizing and precipitating during the system's shelf life, whereas when the compositions are mixed during use of the system, they will combine to form calcium phosphate (CP) and / or strontium phosphate (SP) in crystalline or preferably amorphous (ACP and ASP) forms in the peroxide composition. Calcium phosphate and strontium phosphate can act as remineralizing agents or desensitizing agents.

[0053] For example, suitable flavoring agents may include natural peppermint oil or artificial sweeteners, preferably non-nutritive, such as saccharin or sucralose, which can provide the user with a clean and refreshing feeling when using the kit, especially when the composition is applied to the teeth to be whitened.

[0054] In one embodiment, the system includes one or more compartments for storing any of the components of the system composition. The compartments may be part of a single container, bottle, or syringe. The system may have vessels or other chambers in which the components of the system are combined to form a peroxide composition. The device may have components for mixing, such as a spatula.

[0055] In one embodiment, the system includes a multi-compartment syringe comprising: a first compartment containing a first quantity of a first composition; a second compartment containing a second quantity of a second composition; and an optional third compartment for containing a third quantity of a third composition when as part of the system; and a mixing compartment capable of being attached to or being attached to the multi-compartment syringe for receiving and mixing appropriate quantities and amounts of pH-induced thickener and having an outlet for allowing the resulting peroxide composition to exit the syringe when the syringe is used.

[0056] The syringe contains plungers for ejecting components from their respective compartments and through the mixing compartment. The plungers can be designed to operate synchronously, for example, because they are mechanically connected to each other. The syringe provides a convenient means for storing, transporting, and using the system. It also provides a simple way to ensure the desired quantity ratio of the compositions to be mixed to achieve the desired peroxide composition. Such quantities can be those disclosed herein.

[0057] The mixing compartment may have a passage arrangement for mixing the contents of the respective compartment of the syringe. For this purpose, the passage may have fixed mixing blades. Such a passage arrangement can be used to mix fluid compositions, such as solutions, emulsions, or dispersions, but can also be arranged to mix such fluid compositions with one or more solid compositions. This will depend on the nature of the compositions to be mixed. The inlet may have two, three, or four sub-inlets, each for each composition to be mixed. The mixing section may be located at the tip of the syringe and may be integrated into the syringe, or may be attached to or be attached to the syringe.

[0058] In a particularly simple embodiment of the system, the syringe contains only two compartments, namely the first and second compartments. Then, any one of the components of the system composition is present in one or more of the first and second quantities. This provides a simple two-barrel syringe system.

[0059] In the case where the system includes a pH-induced thickener, a third syringe may be present for containing the third composition.

[0060] Before combining the resulting mixture with the second composition in the mixing section, the first composition may be combined with a pH-induced thickener (e.g., as part of a third composition) first in the mixing section.

[0061] In one embodiment, the system includes a dispensing system for dispensing a peroxide composition, comprising a mixing unit, a user interface, and a selection module for controlling the mixing unit. The user interface, combined with the selection module, provides the dispenser system, allowing the user to define the peroxide composition to be dispensed when the system's composition is loaded. For example, the user may require the peroxide composition to be for a specific purpose (e.g., oral or routine disinfection) or to have a specific peroxide content (for mild or strong disinfection); or to have a specific alkaline composition pH (lower for oral application) and / or flavor and / or odor (for oral application); or to have a specific viscosity. Such parameters can then be used to determine the mixing ratio of the composition in the system.

[0062] The system preferably includes separate or individual containers, bottles, or other vessels containing the composition of the system as described above. Preferably, these take the form of replaceable cassettes for dispensing the system.

[0063] The dispensing system may have a memory accessible by the dispenser system, wherein the memory is used to store data on the content of the system composition, from which data can be retrieved to calculate the required amount to be mixed in order to achieve the user preference required for specific parameters.

[0064] The user interface allows users to select parameters that determine the properties of the composition ultimately dispensed by the system. For example, the consistency of the composition can be controlled by the pH-inducing thickener included in the composition and / or the pH of the composition. Depending on the user's selection, the selection module can provide an accurate and efficient means of dispensing the corresponding composition constituting the peroxide composition. Specifically, the system can, for example, enable flavor selection when the user has selected and input into the system that the composition is intended for teeth whitening. In a simple example, the user can select to include a flavoring agent in the composition, for example, by selecting to include a second separate component in the composition, or to exclude a flavoring agent from the composition. In more refined examples, the user can select from different flavoring agents. The user interface can, for example, take the form of a touchscreen to enable user-friendly parameter selection.

[0065] In one embodiment, the system is used to provide a peroxide composition for use as an oral-applicable teeth whitening composition or a disinfectant composition for the prevention or treatment of oral infections.

[0066] Therefore, the system can be used to make the peroxide composition an oral-applicable teeth whitening composition or a disinfectant composition for the prevention or treatment of oral infections.

[0067] When a system is used on the body and especially in the oral cavity, such as for oral disinfection or teeth whitening, all components and ingredients of such a system are preferably compatible with such use, and this means that they are substantially non-toxic and / or acceptable for oral, pharmaceutical or cosmetic use.

[0068] In such oral applications, the system is preferably used to prepare a peroxide composition having a composition pH in the range of 7 to 9.5.

[0069] In one aspect, a peroxide composition having a composition pH in the range of 7 to 12, preferably in the range of 7 to 9.5, is provided, comprising a peroxide reagent, water, an alkaline reagent, and a amount of a pH-inducing thickener that enables the aqueous composition to thicken as the pH of the aqueous composition increases from an acidic value to an alkaline value.

[0070] The peroxide composition is preferably obtained or acquired by combining or mixing a first quantity of a first composition, a second quantity of a second composition, and a pH-induced thickener as defined in any of the systems described herein.

[0071] According to yet another aspect, the method as described in claims is provided. Combining compositions as defined in any of the systems by the user provides a convenient way to provide peroxide compositions having advantages similar to those described for the systems described above.

[0072] In one embodiment, the combining step comprises preparing an intermediate composition by combining a pH-induced thickener with a first quantity of a first composition and by combining an intermediate composition with a second quantity of a second composition. The step of forming the intermediate composition allows the components contained in the first composition to be effectively, for example, tightly mixed with the pH-induced thickener. Subsequent mixing of the intermediate composition with the second composition can provide a peroxide composition in situ, wherein the components of all compositions are effectively mixed with each other. This can be advantageous when present in a third composition separate from the first composition, for mixing in systems with a separate pH-induced thickener.

[0073] The method may include the additional step of applying a peroxide composition to a subject treated with a peroxide composition, such as a human or animal subject, and / or the oral cavity of a human or animal subject, and / or one or more surfaces of dental components within the oral cavity of a human or animal subject.

[0074] In systems, peroxide compositions, or methods, the use as an oral disinfectant in the prevention or treatment of oral infections may include the treatment of one or more infections, such as gingivitis, periodontitis, peri-implantitis, and peri-implantitis.

[0075] The system and method are designed such that the pH of the peroxide composition is in the range of 7 to 12. The first and second quantities can provide all of the first component and all of the second component present in the system.

[0076] For sterilization, a composition pH in the range of 8 to 10 can be used as a less corrosive alternative. When the system is used on human or animal subjects, such as for oral application as mentioned herein, the composition pH is preferably in the range of 7 to 9.5, or in the range of 7 to 9, or more preferably in the range of 8 to 9, to better compatibility with the body and still provide good oxidative effects and / or provide a peroxide composition with sufficient viscosity.

[0077] Any of the features of the system can be used to define the uses, methods and peroxide compositions disclosed herein, and vice versa, and this can provide associated benefits for the peroxide compositions, uses and methods disclosed herein. Attached Figure Description

[0078] Referring to the accompanying schematic diagrams, the claimed embodiments and examples are described in more detail and by way of example, wherein:

[0079] Figure 1 Describe a kit or system according to one embodiment;

[0080] Figure 2 Describe a kit or system according to another embodiment;

[0081] Figure 3 Describe a kit or system according to yet another embodiment;

[0082] Figure 4 A block diagram depicting a system according to one embodiment;

[0083] Figure 5 A block diagram depicting a system according to another embodiment; and

[0084] Figure 6 A flowchart depicting a method according to one embodiment. Detailed Implementation

[0085] The detailed description and specific examples, while indicating exemplary embodiments of the kits, systems, methods, and uses, are intended for illustrative purposes only and not for limiting the scope of the claims. These and other features, aspects, and advantages of the claimed kits, systems, methods, and uses will become better understood from the following description, the appended claims, and the accompanying drawings. The drawings are schematic and not drawn to scale. In all the drawings, the same reference numerals are used to indicate the same or similar parts.

[0086] Before describing the example in detail, the meaning of several terms will be explained.

[0087] pH-induced thickeners enable a composition to thicken when the pH of the composition is increased. In particular, they thicken aqueous compositions. They may also have other functions, but they at least provide thickening properties.

[0088] The term "thickening" in a composition refers to a composition whose viscosity is increased.

[0089] Unless otherwise stated, the term "within a range" is used to indicate a range of parameter values, such as pH, amount or content, and viscosity values, meaning including the range limits. Therefore, pH in the range of 7 to 12, for example, is intended to specify that pH can be 7, 12, or between these values.

[0090] The term "composition" refers to an entity having one or more components, such as in a pure reagent or compound or a mixture of reagents or compounds.

[0091] The term "acidic reagent" refers to one or more compounds that, when dissolved or dispersed in neutral water with a pH of 7, cause the pH of the water to fall below 7. It can refer to Bronsted or Arrhenius acids.

[0092] The term "alkaline reagent" refers to one or more compounds that, when dissolved or dispersed in neutral water with a pH of 7, make the pH of the water higher than 7.

[0093] The term "reagent" can refer to one or more compounds.

[0094] The term "solvent" can refer to one or more pure solvents.

[0095] The term "dispersion medium" can refer to one or more liquids.

[0096] The term "aqueous composition" can refer to a composition having a solvent and / or dispersion medium containing at least 20% by weight (wt%) water. Preferably, the solvent and / or dispersion medium has at least 30 or 40 wt% water. More preferably, the water content is at least 50, 60, or 70 wt%. In some embodiments, the water content is at least 80, 90, or even 95 wt%. Ultimately, the solvent and / or dispersion medium may be water alone.

[0097] The terms "solvent-free" or "dispersion-medium-free" mean less than 5 wt% solvent and / or dispersion medium. Preferably, less than 1 wt% solvent and / or dispersion medium. Most preferably, substantially no solvent and / or dispersion medium.

[0098] The term "hydrophobic group" refers to a group that is not attracted to or even repelled by large amounts of water. These groups are insoluble in water but can form clusters together to form micelles. Hydrophobic groups are typically nonpolar groups that cannot form a large number of hydrogen bonds.

[0099] The term "dental components" includes teeth, dental caps, crowns, dentures, etc.

[0100] When components are specified as “separate” or “separate” from each other, they are physically separate.

[0101] It should be understood that in this document, when referring to different quantities, namely “a first quantity of the first composition,” “a second quantity of the second composition,” and “a third quantity of the third composition,” the ordinal number preceding the “quantity” is only for ease of reference and to emphasize that the compositions remain separate from each other. It should be understood that, for example, “a second quantity of the second composition” does not imply the existence of “a first quantity of the second composition.” Therefore, it should be understood that “a first quantity of the first composition,” “a second quantity of the second composition,” and “a third quantity of the third composition” are respectively interpreted as “a certain quantity of the first composition,” “a certain quantity of the second composition,” and “a certain quantity of the third composition.” Effectively, the expressions can also be interpreted as “first composition,” “second composition,” and “third composition,” respectively, since the compositions can be considered to exist in a certain quantity according to the definition.

[0102] Unless otherwise stated, the specifications or definitions of parameters are relative to standard conditions. Standard conditions refer to an ambient pressure of 1 atmosphere (1 atm) and a room temperature (e.g., 20°C).

[0103] Whenever the content is expressed in weight % (wt%), such values ​​are converted to other content units, such as moles / weight or moles / volume, or vice versa, using relevant molar weight and density commonly used in the art.

[0104] Any suitable analytical techniques known in the art can be used to analyze chemical compositions, such as those defined herein. For example, the pH of any composition can be determined by immersing a suitably calibrated pH probe into the relevant composition, by titration, or by using litmus paper, etc. Furthermore, the content of peroxide reagents can be determined using, for example, redox titration methods suitable for such purposes. The types of ions present in the composition and / or their content can be determined using, for example, spot testing methods that track ion types or flame ionization techniques. For example, phosphorus, calcium, strontium, and potassium ions can be determined using this method. Organic molecules can be analyzed using chromatography, NMR, IR, mass spectrometry, or other commonly used spectroscopic methods. Viscosity measurements can be performed in various ways, such as with a Brookfield viscometer. As long as the same methods are used to generate the data to be compared, these data can be used to verify whether the composition meets the definition of the claims. All such methods are well known in themselves and will not be described further herein for the sake of brevity.

[0105] Unless otherwise stated, viscosity values ​​mentioned herein refer to Brookfield viscosity measured at approximately 0.6 rpm under standard conditions. Preferably, viscosity measurements are performed on a Brookfield RVDV-I+ #757 viscometer. Preferably, viscosity measurements are performed by placing the sample in a water bath at approximately 25°C and leaving the sample in the water bath for approximately 24 hours. The viscometer is then set to a suitable spindle and speed (0.6 rpm). When using an LV or RV spindle, the spindle is immersed until the indentation is flush with the surface of the test material. When using a T-bar spindle, the spindle is immersed until the crossbar of the T-bar spindle is below ¼” below the surface of the test material. Next, the viscometer motor is turned on, and the spindle is allowed to rotate one or two revolutions before the drive unit is turned on. Then, the reversing lever on the drive unit is pressed and turned on. Several readings are then taken. Typically, the average reading is obtained after 5 revolutions.

[0106] In summary, a kit or system (100) is disclosed for preparing a peroxide composition with an increase in viscosity in the pH range of 7 to 12 in a nearly instantaneous manner. For example, the kit or system can be used to provide a (water) gelled peroxide composition that is nearly immediately available. The kit includes a first aqueous composition (102) comprising a peroxide reagent. The first aqueous composition has a first pH of less than 7. The kit further includes a second composition (104) comprising an alkaline reagent. The second composition is separate from the first aqueous composition. A pH-induced thickener is included in the kit or system, generally separate from the second composition. The peroxide composition is obtained by combining the various parts of the kit or system. The pH-induced thickener modifier enables the peroxide composition to increase in viscosity when subjected to an increased pH, such as in the pH range of 7 to 12. The kit or system has sufficient alkaline reagent for the peroxide composition to maintain a pH in the range of 7 to 12. Peroxide compositions, methods for preparing peroxide compositions, and uses of the kit or system are also provided.

[0107] In this disclosure, the system may be in the form of a multi-part suite.

[0108] Using this system, the pre-production of viscous compositions can be minimized or avoided, as all pH-induced thickeners provided in the system are in a state that prevents them from exercising their thickening properties. This resolves any issues associated with production, storage, transportation, and / or administration. Simultaneously, when used directly, the mixing of components results in thickening of the resulting peroxide composition, offering all the advantages associated with disposal during processing.

[0109] The system comprises at least two mutually separate compositions. In some embodiments, more than two compositions may be present, such as three or even four mutually separate compositions. In particularly preferred embodiments, the system comprises only three or preferably only two compositions. All compositions of the system together comprise all components of the peroxide composition prepared using the system. The third composition can be used for various purposes, such as separating the alkaline reagent from the pH-induced thickener and / or providing an additive separately to the system, as will become apparent below. Having fewer compositions provides a simpler system, which can be advantageous in terms of cost, ease of manufacture, and use. A system having only three, and preferably only two, compositions can be advantageously used with a three- or two-barrel syringe, as described below.

[0110] pH-induced thickeners can be present in the system in several ways. In the first example, the pH-induced thickener is part of the first aqueous composition. Modifiers can be dissolved and / or dispersed. Dispersants and / or surfactants can be present. The aqueous composition can be an emulsion. Since the first pH is below 7, the thickener does not cause a significant increase in viscosity. In principle, even if additional components are added to the system as explained below, this embodiment can provide a system with only two compositions, namely the first aqueous composition and the second composition. This can be advantageously used with a two-barrel syringe as defined below. Furthermore, more efficient, for example, close mixing or uniform distribution of the pH-induced thickener with other components in the first aqueous composition (e.g., peroxide reagents) can be achieved. Furthermore, since many system components are therefore premixed before system use, the final combination with additional compositions is improved.

[0111] In another example, the pH-induced thickener is kept separate from the first composition, for example, as part of a third composition. Such a third composition may include a solvent and / or dispersion medium in which the pH-induced thickener is dissolved and / or dispersed. The third composition is preferably an aqueous composition having a third pH of less than 7. Preferably, the third pH is selected to be less than any of the following values: 6, 5, 4, or 3. The third pH may be greater than or equal to 1 or 2. The third pH may be in the range of 2 to 7, 2 to 6, or 2 to 4. The third pH may be the same as the first pH. The third composition is separate from the second composition.

[0112] Alternatively or additionally, a third composition, and thus a pH-induced thickener, may be provided in the system under conditions free of solvent and / or dispersion medium. Many pH-induced thickeners, such as certain polymers described below, are solid under standard conditions. This again facilitates reducing the aforementioned dilution effects when assembling system compositions, while still reducing or preventing undesirable thickening caused by swelling with solvent or dispersion medium.

[0113] In a variant of the pH-induced thickener in its dry form, it can be combined or mixed with a dry, solid basic reagent. Even though a chemical reaction is theoretically possible, such a reaction can be quite slow in the solid state. In yet another variant, when the pH-induced thickener is based on a compound or polymer having acidic groups (such as those disclosed below), it can be provided in the form of a salt through the reaction of the acidic groups with a basic reagent. The conjugate base of the acidic groups present in the salt can provide at least a portion of the basic reagent.

[0114] In embodiments having a third composition free of solvent and / or dispersion medium, it is preferable that a solvent and / or dispersion medium are present in the system before the third composition is combined with the first aqueous composition or the second composition, so as to pre-prepare the third (e.g., aqueous) composition by adding the solvent and / or dispersion medium. The result can be mixed with the first composition first before being mixed with the third composition. The pre-prepared third composition can have the composition of the third composition as described above. In this way, more efficient, for example, close mixing or uniform distribution of the pH-induced thickener with other components (see below), such as peroxide reagents, can be achieved while the pH-induced thickener remains in dry form. For this purpose, a dispersant can also be added to the respective composition.

[0115] In a preferred configuration, both the first and / or second composition are aqueous compositions. The second composition can be a solution, emulsion, or dispersion. Dispersants and / or surfactants may be present if desired. Because the second pH is below 7, the pH-induced thickener will not cause a significant increase in viscosity upon contact with a solvent or dispersion medium. pH-induced thickeners in dissolved and / or dispersed forms, rather than dried forms, can provide improved mixing properties, such as more uniform and / or tighter and / or faster mixing, and / or can provide easier packaging and disposal in the system. Improved mixing can result in faster thickening and / or more uniform viscosity properties in the peroxide composition. Increased water content can help and promote the swelling of pH-induced thickeners, as the thickening mechanism for many (if not all) pH-induced thickeners is based on water swelling. Good examples of these are ASE and HASE polymers based on polyacrylic acid, as well as cellulose polymers described below.

[0116] When the system is intended for bodily or oral application, the solvent or dispersion medium may be pharmaceutically or cosmetically acceptable. The solvent or dispersion medium of any of the compositions or bulk compositions may comprise or consist of water. For example, more than any of the following water amounts (measured as a percentage of the total weight of the respective composition): 5, 10, 15, 20, 25, 30, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90. The solvent and / or dispersion medium may include other solvents besides water, such as one or more alcohols, such as ethanol, glycerol, propylene glycol, or others. Alcohols generally miscible with water and can improve the solubility of pH-induced thickeners or pH adjusters or other system components. They can also synergistically improve the sterilization effect of peroxide compositions because they are known to disrupt cells.

[0117] The system can be used for a variety of purposes, such as body and / or oral disinfection, teeth whitening, sterilization, or others. Each of these applications may require the use of a specific range of compositions, the amounts of the ingredients, their pH, and the types of the ingredients, as will become apparent below.

[0118] Those skilled in the art will readily understand that the relative amounts of compositions in the system will depend, at least in part, on the nature and amount of the various components present in the respective compositions, with the operational consideration that the final peroxide composition should have a composition pH specified in the desired range of 7 to 12, wherein the peroxide content is within the desired specified range, and the specific final viscosity is within the desired range.

[0119] The first guideline for designing a desired system includes the following considerations or steps that do not necessarily need to be followed in the order stated.

[0120] The amount of pH-induced thickener required to provide the desired viscosity for such a composition is determined from the desired quantity (volume or weight) of the peroxide composition. Furthermore, the amounts of peroxide and / or its source, as well as possible additives, are determined. The amounts of the components in the different compositions of the system can be determined, taking into account any ratio of the quantities of the compositions mixed in order to achieve a particular peroxide composition. When appropriate, dilution that occurs during mixing of the system compositions is considered according to commonly used methods known to those skilled in the art. The calculations can be checked by testing the composition, and, for example, the pH of the final composition can be measured, and corrections can be made if the pH is not at the desired value. If necessary, corrections can be made by, for example, changing (adding or removing) the amount of alkali.

[0121] Peroxide reagents may comprise or consist of one or more peroxide compounds. Preferably, the peroxide reagent comprises hydrogen peroxide (H2O2) and / or a source of hydrogen peroxide. Suitable sources of hydrogen peroxide are its complexes, such as complexes with urea (e.g., urea peroxide with the molecular formula H2O2-CO(NH2)2). Hydrogen peroxide and urea peroxide, whether alone or in combination, have been shown to be effective disinfectants and teeth whitening agents. They are orally acceptable. Additionally or alternatively, other peroxide compounds may be used. Examples include, but are not limited to, peroxides in solid form, including alkali metal or alkaline earth metal peroxides, or peracids, such as peracetic acid. The peroxide-containing component may include, for example, peroxide compounds that do not contain metal ions. Examples of peroxide compounds that do not contain metal ions include hydrogen peroxide and organic peroxides, including urea peroxide (urea peroxide), glycerol peroxide, benzoyl peroxide, etc.

[0122] The content of peroxide reagent in any composition is expressed as molality, i.e., the number of moles of peroxide groups / ions per gram of composition (M).pg The content is expressed in units of g ( / g). This allows for consideration of the different molar weights of each peroxide compound and the number of peroxide groups / ions for calculating the content based on weight percentage. Thus, for example, 0.00294 M can be present in the composition. pg / g peroxide reagent. This is converted to 10 wt% hydrogen peroxide because hydrogen peroxide has Mw=34.01 g / mol and one peroxide group per molecule, while it is converted to 28 wt% urea peroxide because urea peroxide has Mw=94.07 g / mol and one peroxide group per molecule.

[0123] The peroxide content in the peroxide composition is preferably less than about 0.0147 M. pg / g (approximately 50 wt% H2O2). Higher levels of peroxides are generally considered harmful. For household use, the peroxide content in the peroxide composition is preferably below any of the following values ​​(corresponding H2O2 weight percentage values ​​are in parentheses): 0.0132M pg / g (45 wt% H2O2), 0.0118 M pg / g (40 wt% H2O2), 0.00882 M pg / g(30 wt% H2O2)、0.00588M pg / g (20 wt% H2O2), 0.00294 M pg / g and (10 wt% H2O2). The content can be as low as 0.00588 M. pg / g (20 wt% H2O2) and 0.000882 M pg / g (3.0 wt% H2O2) or within the range of 0.00294 M pg / g (10 wt% H2O2) and 0.00147M pg Within the range of / g (5.0 wt% H2O2). This can be used, for example, for teeth whitening purposes in the home. Above 0.00294M pg A concentration of / g (10 wt% H2O2) is suitable for chairside (dental professional) whitening purposes. These concentrations can be as low as 0.00294 M. pg / g (10 wt% H2O2) and 0.0118 M pg Within the range of / g (40 wt% H2O2), or within 0.00294 M pg / g (10wt% H2O2) and 0.00588 M pg Within the range of / g (20 wt% H2O2), or within 0.00588 M pg / g (20 wt% H2O2) to 0.0118 M pg Within the range of / g (40 wt% H2O2). Higher concentrations of this type offer shorter processing times and / or better whitening effects, but are also more dangerous to use. When the system is applied, for example, in fresh instant whitening toothpaste, peroxide content below any of the following values ​​may be appropriate: 0.00147 M pg / g(5 wt% H2O2)、0.000588M pg / g (2 wt% H2O2) or 0.000294 M pg / g (1 wt% H2O2). The corresponding range values, expressed in wt% urea peroxide or mixtures of any other peroxides or compounds, can be calculated from the molar concentration of the peroxide reagent as shown above. Within the ranges above, content refers to concentration, regardless of whether the peroxide reagent is in a dissolved and / or dispersed state. Clearly, for compositions in which the dissolved peroxide reagent is in a dissolved state, the range increases to a maximum based on the maximum solubility of the reagent in the relevant solvent.

[0124] pH-induced thickeners comprise or consist of one or more compounds having chemical groups that respond to changes in pH from less than 7 to within the range of 7 to 12 by causing an increase in the viscosity of the medium to which they belong.

[0125] One or more compounds are preferably oligomers or polymers. The polymer can be a homopolymer having a single type of monomer residue or a copolymer having multiple different monomer residues. The polymer can be a regular or random copolymer. The polymer can be a ternary polymer. The polymer can be crosslinked or uncrosslinked.

[0126] The chemical groups are preferably distributed along at least a portion of the polymer, but more preferably along the entire main chain of the polymer. The chemical groups can be part of the main chain, directly attached to the main chain using direct chemical bonds, or they can be attached via spacer groups, for example, saturated hydrocarbon chain portions. Preferably, such spacer groups have fewer than 5 carbon atoms or even fewer than 3 carbon atoms. Therefore, the polymer can have monomer residues that partially or entirely contain chemical groups.

[0127] A particularly suitable class of polymers comprises acidic groups as chemical radicals, which, according to their pKa values, can be at least partially deprotonated at pH values ​​ranging from 7 to 12. The acidic groups have pKa values ​​such that a greater proportion of deprotonation occurs at pH values ​​above 7 than at pH values ​​below 7. In compositions with pH values ​​equal to or below pKa⁻², the acidic groups are considered fully protonated. Conversely, in compositions with pH values ​​equal to or above pKa⁺², the groups are considered fully deprotonated. Preferably, the pKa values ​​of the acidic groups are below any of the following values: 7, 6.5, 6, 5.5, or even 5. A pKa value at most equal to the second pH of the second component ensures an excess of protonated acidic groups, since approximately 50% of the acidic groups will be deprotonated at pH = pKa. The acidic groups can be selected to have pKa values ​​ranging from 2 to 7, or 3 to 7, or 4 to 7, or 5 to 7. Preferably, the upper limit within these ranges is 6 or 5. Preferably, all acidic groups are carboxylic acid groups.

[0128] The deprotonation of acidic groups at alkaline pH levels can lead to higher water solubility of polymers at alkaline pH levels (7 to 12) compared to acidic pH levels (below 7). This enhanced water solubility results in greater swelling of the polymer with solvent (water) molecules, for example, relative to swelling at lower pH levels. This polymer swelling is then accompanied by the formation of a gel-like composition with increased viscosity.

[0129] Suitable acidic groups can be sulfonic acid groups, phosphate groups, and carboxylic acid groups. The polymer can have a single type or a combination of two or more such groups. Preferably, all groups are carboxylic acid groups having the same or different pKa. For example, carboxylic acid groups attached to saturated carbon spacers have different pKas than carboxylic acid groups attached to aromatic spacers. Such groups can be, for example, part of the polymers disclosed below.

[0130] pH-induced thickeners may contain alkali-soluble emulsion (ASE) polymers.

[0131] ASE polymers can form alkali-soluble emulsions when dispersed in aqueous compositions at pH values ​​below 7. Without being bound by theory, it is believed that the thickening properties of ASE polymers are based on a non-associative mechanism, which is based on polar repulsive interactions (e.g., charge-charge interactions) between polar groups that occur when subjected to increased pH values ​​such as above 7.

[0132] A group of ASE polymers contains, for example, the aforementioned acidic groups in the form of carboxylic acid groups to provide polar groups. Due to the reduction in deprotonation of the acidic groups, such ASE polymers can form solutions or emulsions at acidic pH. The solutions or emulsions can have relatively low viscosity, for example, below 1500 mPa·s. Increasing the pH leads to the aforementioned deprotonation, and thus the formation of charged groups (conjugate bases of the acidic groups) and an accompanying increase in polymer solubility, accompanied by a much greater degree of swelling than at acidic pH. This greater degree of swelling results in viscosity increases to values ​​above 5000 mPa·s or even higher, as disclosed herein.

[0133] A group of polymers having acidic groups and providing good ASE polymers are acrylic acid copolymers, which comprise or consist of: at least one acrylic acid and monomer residues having at least one acrylate (acrylate residue) having an alcohol residue with fewer than 6 carbon atoms. Such acrylic acid copolymers can have structures as shown in Formula 1, where x represents the fraction of acrylic acid monomer residues and y represents the fraction of acrylate monomer residues. The different monomer residues can be randomly or non-randomly distributed along the polymer chain. Formula 1

[0134] The sum of fractions x and y can be less than 0.9 or less than 0.8, allowing for the presence of other monomer residues, for example, for crosslinking purposes. If no other monomer residues are present, then the sum of fractions x and y is 1. A portion of the carboxylic acid group can react with pentaerythritol or other di, tri, or tetraols for crosslinking the polymer chain. In this case, when the polymer is crosslinked, the sum of x and y can still be 1.

[0135] The thickening properties of the polymer can be customized by selecting fractions x and y. Therefore, x and y can be equally large. Alternatively, x can be smaller than y, or vice versa; at up to a certain maximum value, a higher x can increase solubility with increasing pH.

[0136] Each of the acrylic acid and / or acrylate monomer residues may be partially or completely substituted with fluorine and / or an alkyl group at its carbonyl α-carbon atom. Therefore, R1 and R2 may each be independently selected as H, F, or a straight-chain or branched alkyl or alkoxy group having fewer than 6 carbon atoms, preferably fewer than 4 carbon atoms. The alkyl or alkoxy group may contain one or more ether groups. Ether groups are generally considered nonpolar. Preferably, the alkyl group is methyl and / or ethyl, and / or the alkoxy group is methoxy and / or ethoxy. Most preferably, R1 and R2 are methyl and / or ethyl.

[0137] Therefore, for example, the fraction x of acrylic monomer residues can include a first sub-fraction of monomer residues with R1=H and a second sub-fraction of monomer residues with R1=methyl. Similarly, the fraction y of acrylate monomer residues can include a first sub-fraction of residues with R2=H and a second sub-fraction of residues with R1=methyl.

[0138] The alcohol residue R3 has fewer than 6 carbon atoms, and preferably even fewer than 5, 4, or even 3 carbon atoms. R3 can be aryl, alkyl, cycloalkyl, or a combination thereof, and may contain an ether moiety, but this is not preferred. Preferably, R3 is one or more of methyl, ethyl, propyl, butyl, and / or pentyl, and may be straight-chain or branched where possible.

[0139] Examples of suitable ASE copolymers of acrylic acid are the family of commercially available polymers sold under the trade name Carbopol®. Other similar acrylic acid copolymers are available under other trade names. For example, Carbopol® 940 NF polymer can be used. The pH of 0.5 to 1 wt% Carbopol® 940 NF aqueous solutions or dispersions is in the range of 2.5 to 5, with 1 wt% solution or dispersion having a pH in the range of 2.5 to 3.0. At these pH values, the viscosity of 1 wt% polymer solution / dispersion is well below 1500 mPa·s. For the 0.5 wt% polymer variant, the viscosity has increased to 40,000–60,000 mPa·s at pH values ​​in the range of 7.5 to 10.0. At approximately pH 7, a 1 wt% colloidal solution of Carbopol® 940 NF polymer takes the form of a hard gel. Such Carbopol® 940 NF and other suitable Carbopol® polymers can be included in the peroxide composition, for example, in amounts ranging from 0.5 wt% to 5.0 wt%, preferably from 0.5 to 5.0 wt% to 2.0 to 5.0 wt%. Thus, the polymer content of the system is selected such that, after combining the components of the system, the resulting peroxide composition has a desired viscosity, while in the first or third composition of the system, the polymer does not cause a viscosity exceeding, for example, the desired maximum viscosity of 1500 mPa·s, 1000 mPa·s, or even 500 mPa·s.

[0140] Other suitable acrylic polymers can be used, such as commercially available polymers sold under the trade names ACUSOL™ 810A, ACUSOL™ 830, ACUSOL™ 835, and ACUSOL™ 842. Other ASE-type polymers from other suppliers can also be used.

[0141] Additionally or alternatively, pH-induced thickeners may comprise hydrophobically modified alkali-soluble emulsion (HASE) polymers. When dispersed in aqueous compositions with a pH below 7, HASE polymers are capable of forming hydrophobically modified alkali-soluble emulsions. HASE polymers can be superior to ASE polymers because they can provide higher viscosity gels, typically in a shorter time, while providing lower viscosity solutions and / or suspensions (e.g., viscosity below 100 mPa·s in acidic environments) at similar concentration levels to ASE polymers. Compared to ASE polymers, HASE polymers typically have additional, relatively large hydrophobic groups. Without being bound by theory, the improved thickening effect compared to ASE polymers is believed to be due to HASE polymers providing thickening not only through a non-associative mechanism based on polar interactions similar to those occurring in ASE polymers, but also through an associative mechanism based on non-polar interactions between the large hydrophobic groups themselves and between them and other non-polar components of the composition to which they belong (e.g., solvents, dispersion media, surfactants, dispersants, etc.).

[0142] A group of HASE polymers contains the aforementioned acidic groups, for example, in the form of carboxylic acid groups. These polymers can form emulsions at acidic pH values ​​below 7 due to their reduced deprotonation and hydrophobic modification. The emulsions can have relatively low viscosity, typically lower than that of the ASE polymers described above. For example, the viscosity can be below 500 mPa·s or even below 30 mPa·s. Adding a base to such emulsions results in the deprotonation of the aforementioned acidic groups and an increase in the polymer solubility, accompanied by a swelling degree much greater than 5000 mPa·s. With these polymers, it is believed that hydrophobic groups are released upon dissolution, allowing them to participate in the formation of networks based on hydrophobic group interactions, due to intramolecular and intermolecular hydrophobic interactions between such hydrophobic groups and interactions with other hydrophobic entities / molecules in the composition, such as surfactants, particles, emulsion droplets, fragrances, flavorings, dyes, etc. Due to this thickening association mechanism, which ASE polymers typically do not possess, HASE polymers generally produce more viscous gel compositions than ASE polymers.

[0143] A group of polymers having acidic groups and providing good HASE polymers are acrylic copolymers comprising or composed of: at least one acrylic acid and monomer residues having at least one acrylate (acrylate residue) having a hydrophobic alcohol residue with 6 or more carbon atoms. Such acrylic copolymers can have a structure as shown in Formula 2, where x represents the fraction of acrylic monomer residues, y represents the fraction of acrylate monomer residues as defined for ASE polymers of Formula 1 above, and z represents the fraction of acrylate residues having a hydrophobic alcohol residue with 6 or more carbon atoms. Therefore, for HASE polymers, z may be non-zero, while y may be zero. The different monomer residues may be randomly or non-randomly distributed along the polymer chain. Formula 2

[0144] The sum of fractions x, y, and z is at most 1, indicating the optional presence of other monomer residues. The sum of fractions x, y, and z can be 1, indicating the absence of other monomer residues. Alternatively, the sum can be less than 1, such as 0.9, or less than 0.8, allowing the presence of other monomer residues, for example, for crosslinking purposes. A portion of the carboxylic acid group can react with pentaerythritol or other di, tri, or tetraols for crosslinking the polymer chains. In this case, the sum of x, y, and z can still be 1 when the polymer is crosslinked.

[0145] The thickening properties of the polymer can be customized by selecting fractions x, y, and z. These fractions can all be equal in value. Alternatively, z can be less than x and y, or vice versa. Similar to ASE polymers, a higher x in HASE polymers can increase solubility with increasing pH. As mentioned earlier, z can be non-zero, while y can be zero. However, y is typically not zero either.

[0146] Similar to ASE polymers, each of the acrylic acid and / or acrylate monomer residues in Formula 2 may be partially or entirely substituted with fluorine and / or alkyl groups at its carbonyl α-carbon atom. Therefore, for such monomer residues, R1, R2, and R4 may each be independently selected as H, F, or a straight-chain or branched alkyl or alkoxy group having less than 6 carbon atoms, preferably less than 5 carbon atoms, and more preferably less than 4 carbon atoms. The alkyl or alkoxy group may contain an ether group. Preferably, the alkyl group is methyl and / or ethyl, and / or the alkoxy group is methoxy and / or ethoxy. Most preferably, R1, R2, and R4 are selected from methyl and / or ethyl. Thus, in one example, monomer residue fraction x, and one or more of fractions y and z, may each comprise a first sub-fraction of monomer residues with R1 = H and a second sub-fraction of monomer residues with R1 = methyl.

[0147] The alcohol residue R3 can be selected as defined in Formula 1.

[0148] The alcohol residue R5 has 6 or more carbon atoms, preferably 10 or more, or even 15 or more carbon atoms. R5 can be a C-type straight-chain or branched alkyl, cycloalkyl, aryl, or a combination thereof. 10 -C 40 Or C 15 -C 40 Or C 15 -C 30 Or C 20 -C 40 Or C 20 -C 30 R5 may contain an ether moiety, but this is not preferred. In one embodiment, the R5 group is an alkyl or cycloalkyl group.

[0149] A particularly desirable set of HASE polymers has Formula 3, and a subgroup of polymers having the structure of Formula 2 is defined. In this case, the fraction x of Formula 2 is given by the sum of x1 and x2 in Formula 3. The Rx groups can be selected as groups similar to those of Formula 2 having the following specifications. The fraction y is not 0. A portion of the monomer residues in fractions y and z have R4 and R6 as H, respectively. Formula 3

[0150] Typically, x1, x2, y, and z are all non-zero together, and their sum is 1. However, alternatively, their sum can be 0.9 or 0.8 to allow for the presence of other monomers.

[0151] Preferably, in Formula 3, R6 is selected as H, F, or a straight-chain or branched alkyl or alkoxy group having less than 6 carbon atoms, preferably less than 5 carbon atoms, and more preferably less than 4 carbon atoms, wherein optionally the alkyl or alkoxy group has an ether group therein. In another preferred embodiment, in Formula 3, R4 and R6 are H or methyl, and most preferably in Formula 3, R4 and R6 are H.

[0152] Examples of acrylic copolymer-type HASE polymers are commercially available as polymers sold under the trade name Acusol™. Other polymers are available and may also be used from other suppliers. Acusol™ 820 forms a viscosity >1.0 × 10⁻⁶ in such gels at a pH range of 7.5 to 12.5 with an active polymer content of about 2 wt%. 5Extremely viscous gels at mPa·s. In contrast, in acidic compositions used to prepare such gels at pH 3.0 with contents up to 30 wt%, very low viscosities of less than 50 mPa·s or even less than 30 mPa·s can be observed for these polymers. The content of Acusol™ 820, 823 and / or other HASE polymers in the peroxide composition can range, for example, from 0.5 to 20 wt%. A preferred range is 1 to 10 wt%, and a more preferred range is 1 to 6 wt%. Other content ranges of the HASE polymers mentioned above in the peroxide composition can range, for example, from 0.5 wt% to 20.0 wt%, depending on the viscosity behavior of the polymer. Preferably, this content is in the range of 0.5 wt% to 20.0 wt%, or in the range of 0.5 wt% to 8.0 wt%, or between 0.5 wt% to 5.0 wt% or 0.5 to 3.0 wt%. The lower limit of these ranges is preferably 1.0 wt%.

[0153] As an example of how HASE polymers work, consider combining equal amounts of an aqueous composition containing 6.0 wt% ACUSOL 820 with an aqueous composition containing 0.74 wt% sodium hydroxide. This produces a transparent, foam-free gel with a viscosity >100,000 mPa·s, while containing only 0.9 wt% of active polymer solids from ACUSOL 820. Note the dilution factor resulting from the combination of equal amounts of ACUSOL and hydroxide compositions.

[0154] All pH-induced thickeners, such as the aforementioned ASE and HASE polymers, preferably do not contain chemical groups or entities that are easily oxidized by peroxides within 15 minutes or less. In fact, this is generally the case for the specific groups of ASE and HASE polymers described above. Polymers with saturated bond backbones and acidic groups typically exhibit relatively good oxidant resistance even at high concentrations. Compared to ASE polymers, HASE-type polymers, such as those described above, have increased tolerance to salt or electrolyte content; that is, their viscosity decreases less with increasing electrolyte content. This is advantageous for high-ionic-content compositions used in oral applications (where peroxides are ionic substances in free form). After all, oral application systems can benefit from certain additives in salt or electrolyte form, such as remineralizers and desensitizers, as will become apparent below. HASE polymers are also more compatible with surfactants and fragrances, which is also useful for oral application systems.

[0155] Another group of pH-induced thickeners contains or consists of hydroxyalkyl celluloses such as hydroxyethyl cellulose or hydroxypropyl cellulose. Although these compounds may be less stable to oxidizing peroxides, they are uncharged when the composition reaches a pH of 7 to 12. This can be advantageous compared to the polymers containing acid groups described above. Hydroxyethyl cellulose powders, such as Natrosol™ 250 (Ashland®) and CELLOSIZE™ QP 100MH (DOW®), have been found to be effective. These can also be dispersed and / or dissolved in suitable solvents and dispersants such as water-alcohol mixtures.

[0156] The peroxide composition is a thickening or viscous composition. It is preferably a gel, such as a hydrogel. The viscosity of the peroxide composition is preferably higher than that of one or more of the system compositions, and most preferably higher than that of all kit compositions (excluding compositions in dry form). Preferably, the peroxide composition has a viscosity of at least 1500 mPa·s. More preferably, such viscosity is higher than any of the following values ​​in mPa·s: 2000, 5000, 10,000, 20,000, 50,000, 75,000, 100,000, 200,000, 500,000, 1,000,000.

[0157] When mixing system components, thickening can occur at a certain rate of viscosity increase. For pH-induced thickeners under standard conditions, the thickening period can be defined as the time between the moment the system components are mixed and the moment the minimum viscosity specified for the peroxide composition is reached. The shorter the thickening period, the faster the viscosity increases, i.e., the higher the rate. For example, the thickening period is less than any of the following maximum values ​​in minutes: 5, 2, 1, and 0.5. Preferably, it is less than 10 seconds. Preferably, such a period is achieved for minimum viscosities of 5000 mPa·s, 50,000 mPa·s, or even 500,000 mPa·s. This period can be customized by the type of pH-induced thickener used, which typically provides a shorter period than ASE polymers due to its content (at the same or even lower content, HASE polymers generally provide a shorter period than ASE polymers) and the resulting pH change. For example, as mentioned above, under similar pH conditions, HASE-type polymers generally thicken faster than ASE-type polymers.

[0158] The peroxide composition obtained using the system has a pH in the range of 7 to 12. When the kit is intended for use in living human or animal subjects, such as for body disinfection or oral disinfection, or teeth whitening (whitening of dental components), a pH in the range of 7 to 9.5, or more preferably in the range of 8 to 9, is used to be more suitable for the body. Otherwise, a peroxide composition having a pH in the range of 8 to 12, more preferably in the range of 8 to 10, can be used.

[0159] Such pH values ​​typically destabilize, or in other words, activate, peroxide reagents. This is useful, for example, for hydrogen peroxide in its free or complexed form (e.g., urea peroxide). Therefore, in systems where peroxide reagents are stored at an acidic pH, their degradation is reduced or minimized and shelf life extended. The activity of peroxide reagents as brighteners or bactericides is enhanced by adjusting the pH of the peroxide composition to an alkaline value before use.

[0160] Furthermore, for example, the alkaline pH in the peroxide composition directly promotes its viscosity increase compared to either the first or second composition. A more viscous or thicker peroxide composition can be more easily applied to a surface.

[0161] The system has at least two compositions containing all the components of the peroxide composition. This is the simplest variation of the system. More compositions can be present in the system, such as three, four, or five compositions. These can be used to dispense the components as needed.

[0162] Furthermore, all compositions preferably contain a solvent and / or dispersion medium, such as water. In this case, there may be a preferred mixing ratio for the amounts of the respective compositions. When mixing of compositions occurs during the preparation of peroxide compositions, such ratios define the dilution factor of the components of the respective compositions.

[0163] Preferably, a first ratio of the first quantity to the second quantity is selected such that the dilution factor is in the range of 0.1 to 10. In this case, a suitable first ratio of the first quantity of the first composition to the second quantity of the second composition is in the range of 0.1 to 10, or 1 to 5, or 2 to 3, or 3 to 4. For example, the ratio can be selected from the group of ratios of the following components: 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1. Such ratios can be conveniently used, for example, in two-component systems. However, they can also be selected for three-component systems.

[0164] For a three-component system having a third component in a third quantity, a second ratio between the first and third quantities can be defined. Its value can be defined as the value of the first ratio, and can be the same or different. Thus, for example, the second ratio can also be in the range of t to 10, preferably 1 to 5. Preferably, the ratios are the same, such as both being 1.

[0165] One reason for having a third composition is that certain components that are not well compatible when used together over long periods can be provided in separate system compositions. For example, some pH-induced thickeners can slowly degrade when in contact with strong oxidizing peroxide reagents, especially when the peroxide content is high.

[0166] Furthermore, whenever dilution of the components occurs due to the combination of kit compositions, such dilution effects can be reduced by loading the components into multiple compositions.

[0167] Two preferred system configurations consist of two or three compositions. Table 1 lists such configurations with the presence of a peroxide reagent and a pH-induced thickener. Other ingredients may be present, but these are not shown. Table 1

[0168] The range disclosed above can be used to narrow down the ratio range; for example, the first ratio and / or the second ratio can be in the range of 5 to 1.

[0169] Quantities can be expressed in units of volume or weight, and relative quantities can be expressed in units of corresponding volume ratios or weight ratios. When all compositions have a solvent and / or dispersion medium, the relative amounts of the compositions can be expressed in units of volume or volume ratios. In this case, the density of each composition needs to be considered to calculate the weight-based dilution, unless such densities are substantially the same for the compositions.

[0170] Depending on the ratio, the dilution or thinning effect of peroxides and / or pH-induced thickeners, as well as other components, will occur when combining system compositions. As is commonly practiced in the art, the component content of the system composition can be calculated from the content in the peroxide composition prepared with the corresponding system, or vice versa, using an appropriate dilution or thinning factor based on the composition ratios provided above.

[0171] The quantity of system compositions and / or their combination ratio during use can be predetermined so that a fixed viscosity and a fixed component content are produced in the peroxide composition when the system is used.

[0172] Alternatively, the relative amounts of the compositions can be selected by the user to some extent, although this ensures that the pH of the final composition is within a desired range of 7 to 12. For example, the amount of the second composition relative to the total amount of the other compositions can be selected by the user, allowing the pH and / or the content of the active ingredient to be modified by the user. Controlling the pH in this way allows the user to control the properties of the peroxide composition, such as the activation of the peroxide compound and the rheological behavior of the composition. The latter is possible because a stronger alkaline pH can lead to a greater degree of viscosity change or thickening, as described herein. A dispenser device for user-selected composition ratios will be described below.

[0173] Preferably, the peroxide content in the first composition is selected such that, taking into account any dilution when combining the composition and system components to achieve the peroxide composition, the total peroxide content in the peroxide composition is within any range described for the peroxide composition. For systems in which only a single composition includes a peroxide reagent, the total peroxide content is contained in this single composition as the first composition. For systems of three or more compositions in which more than one composition includes a peroxide reagent, the total combined peroxide content in the peroxide composition is therefore distributed across the more than one system composition. For all these configurations, the actual peroxide reagent content in a particular composition can be calculated from the combined content in a commonly used manner using the dilution factor as shown above and the weight of the composition.

[0174] Preferably, based on the weight of a single system composition, the peroxide reagent content in a single system composition, such as the first composition, does not exceed 0.0176 M. pg / g (approximately 60 wt% H2O2), of which M pg / g defines the molar concentration as the number of moles of peroxide groups per weight of the composition.

[0175] The peroxide reagent content in the composition, such as the first aqueous composition or the third composition, is preferably less than one of the following values: 0.0147 M pg / g (50 wt% H2O2), 0.0132 M pg / g (45 wt% H2O2), 0.0118 M pg / g (40 wt% H2O2), 0.00882 M pg / g (30 wt% H2O2), 0.00588 M pg / g (20 wt% H2O2), 0.00294 M pg / g and (10 wt% H2O2). The content can be as low as 0.00588 M. pg / g (20 wt% H2O2) and 0.000882 M pg / g (3.0 wt% H2O2) or within the range of 0.00294 M pg / g (10 wt% H2O2) and 0.00147 M pg Within the range of / g (5.0 wt% H2O2). This can be used, for example, for teeth whitening purposes in the home. Above 0.00294 M pg A concentration of / g (10 wt% H2O2) is suitable for chairside (dental professional) whitening purposes. These concentrations can be as low as 0.00294 M. pg / g (10 wt% H2O2) and 0.0118 M pg Within the range of / g (40 wt% H2O2), or within 0.00294 M pg / g (10 wt% H2O2) and 0.00588 M pg Within the range of / g (20wt% H2O2), or within 0.00588 M pg / g (20 wt% H2O2) to 0.0118 M pg Within the range of / g (40 wt% H2O2). Higher concentrations of this type offer shorter processing times and / or better whitening effects, but are also more dangerous to use. When the system is applied, for example, in fresh instant whitening toothpaste, peroxide content below any of the following values ​​may be appropriate: 0.00147 M pg / g (5 wt% H2O2), 0.000588 M pg / g (2 wt% H2O2) or 0.000294 M pg / g (1wt% H2O2). The corresponding range of values, expressed in wt% urea peroxide or mixtures of any other peroxides or compounds, can be seen above from M... pg The peroxide reagent content is calculated in units of / g. Within the above range, the content refers to the amount of peroxide reagent per unit weight of the peroxide composition, regardless of whether such amount of peroxide reagent is in a dissolved and / or dispersed state. Obviously, for compositions in which the dissolved peroxide reagent is in a dissolved state, the range is maximized by the maximum solubility of the reagent in the relevant solvent.

[0176] The peroxide content in the first aqueous composition and the third composition may be the same or different.

[0177] The combined content of pH-induced thickeners present in all compositions of the system, as a percentage of the total weight or volume of all compositions in the system, including compositions such as the second composition that do not contain pH-induced thickeners, can be selected as a pH-induced thickener for the peroxide composition, as described above.

[0178] In the system composition, the amount of pH-induced thickener is preferably in the range of 1 to 50 wt%, more preferably in the range of 1 to 30 wt%, and most preferably in the range of 5 to 25 wt%. These ranges can be well combined with suitable dilution factors and mixing ratios provided above. Therefore, the combined content can be in the range of 0.5 to 20 wt% of the system composition, more preferably in the range of 0.5 to 10 wt% or 2 to 10 wt%. The contents may be present only in the first composition and / or the third composition.

[0179] The first aqueous composition requires a first pH less than 7 to stabilize the peroxide reagent, and if present, a pH-induced thickener is also required. For example, hydrogen peroxide and its complexes, such as urea peroxide, are more stable at pH below 7 than at pH above 7. Preferably, the first pH is less than any of the following values: 6, 5, 4, 3, 2. Preferably, it is less than 5 or 4. The first pH can be in the range of 2 to 5, such as in the range of 2 to 4. For example, hydrogen peroxide can be particularly stable at pH below 4. The first pH reduces the degradation of the peroxide reagent and may even eliminate the need for adding a peroxide stabilizer. The system thus has an increased shelf life and a high peroxide content, even after long-term storage. The first pH also reduces, minimizes, or prevents significant thickening of the first aqueous composition caused by pH-induced thickeners.

[0180] Whenever a third composition, such as a third aqueous composition, is present in the system, and that composition contains a peroxide reagent and / or a pH-inducing thickener, then such a composition preferably has a third pH similar to the first pH. The third pH may be equal to the first pH, but it does not have to be.

[0181] After the addition of any peroxide reagent or pH-induced thickener, it may be necessary to adjust the first and third pH values ​​to the desired values. Such adjustments can be made using suitable acids and / or bases. Strong acids, such as phosphoric acid, can be used, and weak acids, such as acetic acid or citric acid, or others, can be used. However, for some of the acidic polymers disclosed herein (e.g., ASE or HASE type acrylic copolymers), the adjustment of the first or third pH may be reduced or not necessary at all due to the inherent acidity of the polymer.

[0182] The alkaline reagent is part of the second composition. The second composition may have a second pH higher than 7, for example, when it includes water. The alkaline reagent may contain or consist of the following: capable of releasing or causing the release of hydroxide ions (OH-) in an aqueous environment. - One or more bases or basic compounds. Each of these bases may be a Brönsted or Arrhenius base and / or may be a weak or strong base.

[0183] Suitable strong bases include, but are not limited to, hydroxides of alkali metals and alkaline earth metals, as well as ammonium cations. Particularly suitable are NaOH, KOH, Ca(OH)₂, Sr(OH)₂, and NH₄OH. These bases allow for easy and low-toxicity adjustment of the pH of the composition, which is useful for systemic oral applications such as whitening. Except for Sr(OH)₂, all of these are readily soluble in water under standard conditions.

[0184] The aforementioned alkali metal and alkaline earth metal hydroxide precursors can also be used, for example, as solid alkaline reagents. These oxides typically convert to hydroxides upon contact with water, i.e., during system use.

[0185] Suitable weak bases include, but are not limited to, salts of the conjugate bases of weak acids. These can include, for example, salts of the conjugate bases of carboxylic acids and / or phosphoric acids. Example carboxylic acid salts include carbonates, bicarbonates, acetates, and citrates. Salts of the conjugate acids of phosphoric acids include di- and tri-cationic phosphates. However, other examples include sulfates, (divalent) borates, and silicates.

[0186] The second composition may contain a solvent and / or a dispersion medium in which the alkaline reagent is dissolved and / or dispersed. Preferably, the second composition is an aqueous composition. More preferably, the second composition is an alkaline reagent solution having a second pH higher than 7. When dispersed, a suitable dispersant and / or surfactant may be present.

[0187] The second composition may be solvent-free and / or dispersion-free. Since many of the bases mentioned above are typically solids under standard conditions, basic reagents containing one or more of these compounds will generally be solids. Such a dry second composition is useful when it is necessary to reduce or prevent dilution of system components (e.g., peroxide reagents) due to the combination of system components during use.

[0188] The amount of alkaline reagent is chosen to be sufficient to compensate for any acidic entities in the final peroxide composition, so that the pH of the composition is in the desired range of 7 to 12. A second composition may provide such an amount of alkaline reagent, such that the final pH of the peroxide composition can be adjusted by changing the relative amounts (i.e., the first and second volume or weight ratios) of the second composition with the first aqueous composition and / or the third composition, as described above. The hydroxide content in the second composition may be in the range of 0.001 to 1.0 M, preferably in the range of 0.01 to 1.0 M, or in the range of 0.1 to 1.0 M. In one example, a range of 0.01 to 0.05 M is used. In a preferred embodiment, the second composition comprises 0.01 to 1.0 M of potassium hydroxide, sodium hydroxide, or ammonium hydroxide.

[0189] The first aqueous composition may have a first viscosity, and the third composition having a solvent and / or dispersion medium may have a third viscosity. These viscosities are lower than the viscosity of the final peroxide gel composition. The viscosity of such compositions is preferably independently selected to be below 2000 mPa·s, more preferably below 1500 mPa·s or below 1000 mPa·s, and even more preferably below 500 mPa·s or 100 mPa·s. Such low viscosity values, and particularly values ​​below 500 mPa·s, provide improved composition flowability, thereby making the composition easier to handle during manufacturing and use. In some embodiments, for example using an acrylic copolymer HASE-type pH-induced thickener, the viscosity of the first aqueous composition including the pH-induced thickener may have a viscosity of less than 50 mPa·s.

[0190] Due to the use of pH-induced thickeners, the induced change in viscosity from the system composition to the peroxide composition can occur rapidly during system use. For pH-induced thickeners under standard conditions, the time period for thickening to the aforementioned minimum viscosity in the peroxide composition, calculated as a combination of system compositions, is, for example, less than any of the following maximum values ​​(in minutes): 5, 2, 1, and 0.5. Preferably, it is less than 10 seconds or even virtually instantaneous. Instantaneous can mean immediately upon exiting the peroxide composition from the tip of the mixing syringe. The rate of viscosity increase of the peroxide composition can depend on the type of pH-induced thickener used, their concentration, and the resulting pH change. For example, as mentioned above, under similar pH conditions, HASE-type polymers can thicken faster than ASE-type polymers. Without being bound by theory, it is believed that HASE polymers have an additional associative thickening mechanism compared to ASE polymers, and therefore can thicken faster.

[0191] In one embodiment, the system is used to prepare a peroxide composition for oral use, such as for oral disinfection and / or teeth whitening. In this case, the system optionally but preferably contains one or more additives selected from the group consisting of: tooth desensitizers; tooth remineralizers; and colorants and flavorings.

[0192] Any one or more of these additives may be added to the first aqueous composition and / or the second and / or the third composition (if present in the system), provided that such additives are at least partially chemically compatible with the chemical conditions (e.g., pH or oxidative properties) within such compositions. Alternatively, when chemical compatibility decreases and, for example, slow degradation occurs, the additives may be added to the third composition or to another fourth or fifth composition that does not possess such degradation properties. For example, such compositions may have a neutral pH or be free of peroxide reagents.

[0193] The additive may be present entirely in a single system composition. Alternatively, due to some comprising sub-parts of the additive, such as different ions of the additive in salt form, the different sub-parts of the additive may be distributed in two or more system compositions, as will become apparent below.

[0194] In one embodiment, the desensitizer comprises or is composed of potassium ions or one or more potassium ion sources such as potassium salts. Potassium ions are believed to desensitize nerve fibers that block neurotransmission. One or more potassium salts may be selected from the group consisting of potassium chloride, potassium fluoride, potassium citrate, potassium nitrate, potassium carbonate, and potassium hydroxide. Other potassium salts may be used. The desensitizer or a portion thereof may be present in two or more compositions. Thus, the second composition may have, for example, potassium hydroxide, while the first composition comprises potassium chloride or potassium nitrate. Alternatively, potassium ions may be part of the first component, for example, as potassium chloride and nitrate ions, while counterions such as hydroxide ions, chloride ions, and / or nitrate ions are part of the second composition having cations different from potassium, such as sodium or ammonium ions.

[0195] The content of potassium ions and counterions should be controlled in their respective compositions such that they will produce no more than 5 wt% potassium nitrate equivalent in the peroxide composition to meet regulatory requirements. The preferred range of potassium ions in the system composition corresponds to an equivalent of 1.0 wt%–4.5 wt% potassium nitrate in the peroxide composition. Similarly, dilution factors and mixing ratios as described above may need to be considered.

[0196] In one embodiment, the desensitizing or remineralizing agent comprises or is composed of one or more compounds that are also suitable for clogging dentinal tubules. For example, such compounds can be any of the following: sodium fluoride, stannous fluoride, strontium chloride, diamine silver fluoride, potassium oxalate, calcium phosphate, calcium carbonate. Preferably, the system comprises calcium ions or calcium ion sources and / or strontium ions and mono- and / or di- and / or ternary phosphate ions (phosphate ions) or any one or more of these sources. Preferably, calcium and / or strontium ions or their sources are contained in acidic compositions such as the first and / or third compositions, if the latter are acidic, for example, in the form of soluble salts such as calcium nitrate and / or strontium nitrate. If such compounds are required to be in solution, then they require an acidic environment. Phosphate ions and their sources are preferably contained in an alkaline environment, such as in the second and / or third compositions, if the composition is alkaline. The separate source (precursors to desensitizers and / or remineralizers) system allows for convenient storage, while when the system is used, it forms calcium phosphate (CP) and / or strontium phosphate (SP) in situ in the peroxide composition in crystalline or, more preferably, amorphous (ACP and ASP) form when the composition is mixed.

[0197] Typically, the calcium ion content and the phosphate or carbonate ion content in the system composition should be within the range that can generate 0.1 wt% to 1.0 wt% CP or ACP (preferably about 0.5 wt%) in the finished peroxide composition.

[0198] US9138386B2 discloses detailed materials and amounts of additives such as ACP or potassium nitrate that can be used in present systems, and how they are distributed in various compositions of the system, which is incorporated herein by reference in its entirety.

[0199] In one embodiment, the desensitizing agent comprises or is composed of one or more compounds for occluding dentinal tubules and potassium ions and / or a potassium ion source.

[0200] Surfactants suitable for use in peroxide compositions or any of the system compositions include polyol surfactants such as Pluronic F-127. Other surfactants may also be used, such as Cremophor RH-40, USP, and Crodateric CAB 30-LQ. Peroxide compositions and systems may additionally include flavoring agents. Flavoring agents may be present in one or more compositions of the system. Flavoring agents may be included, for example, in the first and / or second composition. Alternatively, they may be present in an optional third composition. The possibility of including flavoring agents in compositions separate from the first and / or second compositions allows for greater flexibility in flavor options, as providing flavoring agents separately in this way reduces the risk of degradation by strong oxidants and / or strong acids or bases. This contrasts with conventional systems, which tend to have limited flavor options due to the need to select flavoring agents based on their stability over relatively long storage periods in the presence of other ingredients.

[0201] Suitable flavoring agents may include natural peppermint oil, which can provide users with a clean and refreshing feeling, especially when the peroxide composition is applied to treat oral diseases that may be accompanied by halitosis. In some non-limiting examples, sweeteners such as xylitol and sodium saccharin may also be used, although usually in smaller amounts compared to other sweeteners, because excessive sweetness can be undesirable for oral products due to the negative perception of sweetness in relation to dental health.

[0202] Example systems are provided in Tables 2 and 3 below. In these examples, all compositions are aqueous compositions. Preferably, the second aqueous composition is a solution of an alkaline reagent. These kits can be used for whitening or sterilization purposes. Table 2 Table 3

[0203] At least one additive must be compatible with the pH of the peroxide reagent and the composition to which such additives belong.

[0204] In the examples above, the first and / or third pH is preferably in the range of 2 to 5. In alternatives to the three-composition system in Table 3, the first and third compositions include a pH-induced thickener for the reasons stated above. In yet another alternative, the third composition also contains a peroxide agent for the reasons stated above.

[0205] At least one additive may be present in all compositions, or only in one or two of the compositions. For example, if an additive is incompatible with certain compositional characteristics such as alkaline or acidic pH, it may be added to the appropriate composition or not at all. Thus, in one alternative, the third composition has a third pH of 7 or about 7 and does not contain peroxide reagents, making any additives such as flavoring agents stable in such a third composition. This can be advantageous for sweeteners such as non-nutritive sucralose or sodium saccharin.

[0206] In one example, more than three compositions may be present. For instance, the flavoring agent may be separated from the first, second, and third compositions in a fourth composition. This composition may have a pH of 7. Alternatively, such a fourth composition may be without any solvent and / or dispersion medium. If the additive is incompatible with either alkaline or acidic conditions, it may be separated from such alkaline or acidic compositions in such a fourth composition. A further fifth composition may be present, containing all at least one of these additives, while the other compositions do not contain any of these additives. A system 100 having more than five compositions is also conceivable. Providing each ingredient separately may be beneficial for the storage stability of the ingredients.

[0207] There can be a trade-off between the number of compositions in a system and the ease of preparing peroxide compositions using such systems. Two- and three-composition systems are most preferred when convenience is involved. The complexity of the drug delivery system design can also increase when several separate compartments are required to accommodate the respective components.

[0208] System 1 in Table 4 provides a specific example of a two-component kit or system. The wt% values ​​of the components are relative to the total weight of the respective first and / or second compositions to which the component belongs. The kits in Table 4 can be used for whitening or sterilization purposes. Table 4

[0209] For System 1, the compositions are aqueous compositions and have approximately the same density, such that the dilution based on the volume ratio is approximately equal to the weight ratio. Regarding System 1, the volume ratio of the first aqueous composition 102 to the second composition 104 can be, for example, 2. This will provide System 1 with a final peroxide composition having 26.7 wt% hydrogen peroxide. A volume ratio of 1 will result in a final peroxide content of 20 wt% for System 1. As previously stated, other volume or weight ratios of compositions can be used.

[0210] The content of potassium hydroxide (alkali) may sometimes need to be adjusted to bring the pH of the composition into the desired range of 7 to 12. As demonstrated in System 1, the content of the peroxide reagent in the first aqueous composition can be increased or decreased to adjust the final peroxide content in the peroxide composition. Urea peroxide can be used in place of H2O2 or added to H2O2, and the content is calculated as described above. The pH of the first aqueous compositions in Table 4 is typically in the range of 2.0 to 4.0, depending on the grade and quality of the raw material components hydrogen peroxide and Acusol™ 820, which is a pH-induced thickener in the form of an acrylic copolymer containing carboxylic acid groups. If it is desired to change the type or content of such a pH-induced thickener, then, in order to change, for example, viscosity requirements, the pH of the first aqueous composition can be adjusted using a suitable acid, such as phosphoric acid.

[0211] Furthermore, although the viscosity of the aqueous composition of System 1 will typically be below 50 mPa·s (e.g., only in the range of 15 to 20 mPa·s), at such mixing ratios, the resulting peroxide composition for System 1 will be a hydrogel with a high viscosity of >200,000 mPa·s. The formation of such a gel will be almost instantaneous (see below).

[0212] Depending on the grade and quality of Acusol™ 820, the pH of the aqueous second component in the system is typically in the range of 2.0 to 4.0. Acusol™ 820 is a pH-induced thickener in the form of a HASE acrylic copolymer. If it is desired to change the type or content of such a pH-induced thickener, then, in order to change, for example, viscosity requirements, a suitable acid such as phosphoric acid can be used to adjust the first pH. Table 5

[0213] For both Systems 2 and 3, both compositions are aqueous and have approximately the same density, such that the dilution based on volume ratio is approximately equal to the weight ratio. The volume ratio of the first aqueous composition 102 to the second composition 104 can be, for example, 1. This will provide Systems 2 and 3 with final peroxide compositions containing 7.5 wt% and 15 wt% hydrogen peroxide, respectively. System 2 (as with System 1) thickens immediately upon mixing the system compositions into a highly viscous peroxide composition. The stability of the gel tested with System 3 was at least 18 months, and substantially no loss of peroxide content was observed. As previously stated, compositions with other volume or weight ratios can be used.

[0214] Table 6 provides a specific example of a 3-component system, namely System 4. The wt% values ​​of the components are relative to the total weight of the respective first and / or second compositions to which the component belongs. Table 6

[0215] The pH of the third composition in System 4 is typically about 3.0 to 4.0.

[0216] The volume ratio of the first aqueous composition, the third aqueous composition, and the second composition can be, for example, 1:1:1, to provide a final peroxide composition having 10 wt% H2O2.

[0217] Figure 1 The kit or system 100 is described, wherein a first aqueous composition 102 is separated from a second composition 104 by a partition wall 105, which ensures that the first aqueous composition 102 does not come into contact with or combine with the second composition 104 before the respective components 102, 104 are combined.

[0218] The separation of the first aqueous composition 102 and the second composition 104 can be achieved in any suitable manner. For example, a single device may contain multiple containers or bottles or multiple compartments. A single multi-compartment device may, for example, comprise a multi-compartment bottle, a multi-compartment syringe, or an alternative multi-compartment dispensing system capable of containing a composition or component of the system individually. The compartments may be made of any material suitable for storing the system composition and components. Particularly suitable are materials that are substantially resistant to peroxide reagents and / or acidic and / or alkaline conditions, such as plastics (e.g., polyethylene, polypropylene, or others) or glass.

[0219] Kit or system 100 includes (and is optional) a mixing chamber 106 (which may be a simple container or compartment) in which the respective compositions 102, 104 can be combined or mixed. Arrow 107A indicates a channel for the first aqueous composition 102 to enter the mixing chamber 106. Arrow 107B indicates a channel for the second composition 104 to enter the mixing chamber 106. Once the respective compositions are combined or mixed in the mixing chamber 106, the alkaline pH activates the peroxide reagent and triggers the pH-induced thickener to cause an increase in viscosity. The resulting mixture can then be removed from the chamber and used. Arrow 107C schematically indicates the removal or passage of the composition from or through the container 106. The mixing chamber 106 may be included or incorporated therein, for example, as the mixing tip of a syringe, as will be referred to Figure 3 To explain in more detail: The composition can be removed from the mixing chamber during mixing, before the full viscosity increase has been reached. This can be advantageous because many kit embodiments will end up with a high-viscosity peroxide composition that can sometimes be difficult to maneuver or remove from the chamber, for example, if it needs to flow through a narrow opening or chamber outlet. Alternatively, it may be necessary to wait for the mixture to reach its final viscosity. Then maneuvering with a spatula can be much easier.

[0220] The pH-induced thickener is included in the first aqueous composition 102. As previously stated, this simplifies kit 100 compared to the situation where the first aqueous composition 102 and the pH-induced thickener are provided separately from each other.

[0221] Figure 2 An example is shown in which the pH-induced thickener is provided separately from the first aqueous composition 102 and the second composition 104. In this case, the pH-induced thickener is provided in a third composition 108, which is separated from the first aqueous composition 102 by an additional partition wall 109. Both the pH-induced thickener and the first aqueous composition 102 are separated from the second composition 104 by a partition wall 105.

[0222] The first aqueous composition 102, the second composition 104, and the third component 108 may, for example, be contained in the respective compartments of a three-compartment bottle, a three-compartment syringe, or an alternative three-compartment dispensing system capable of containing the respective compositions 102, 104, and 108 individually. For example, in a three-compartment syringe, there will be three compartments, each having an outlet toward the mixing chamber 106, such that the contents of these compartments are mixed together simultaneously during use.

[0223] The initial formation of the pre-combination of the first aqueous composition 102 and the pH-induced thickener under acidic conditions allows it to be effectively, for example, tightly, mixed with the peroxide reagent and any other components contained in the first aqueous composition 102. This effective mixing may be due to the acidic conditions ensuring that the pH-induced thickener induces a relatively low viscosity state in the pre-combination upon mixing. Subsequent mixing of the pre-combination with the second composition 104 can provide a peroxide composition with a higher viscosity, very similar to that described for the first system.

[0224] This pre-combination in Figure 2 The arrow 107D between the third component 108 and the first aqueous composition 102 indicates this. Pre-combination can be carried out in any suitable manner, such as by manually dispensing the pH-induced thickener into the first aqueous composition 102, or vice versa. More refined means of pre-combination are also conceivable, such as by providing a fragile additional separator 109; the user breaks the additional separator 109 to allow the first aqueous composition 102 and the third composition 108 to combine with each other.

[0225] As schematically indicated by arrow 107A, the pre-combined composition is supplied to mixing chamber 106. A second composition 104 is also supplied to mixing chamber 106, as indicated by arrow 107B. After combining, for example, the pre-combined composition and the second composition 104, the resulting peroxide composition can be removed from the mixing chamber, much like... Figure 1The example described herein. Similarly, the mixing chamber 106 may be included or incorporated therein, for example, as the mixing tip of a syringe, as will be referred to. Figure 3 A more detailed explanation.

[0226] Figure 3 Kit 100 includes a dual-compartment syringe 114. The first compartment 116 of syringe 114 contains a first aqueous composition 102. The second compartment 118 of syringe 114 contains a second composition 104. Although in Figure 3 The diagram shows a dual-barrel syringe 114, but it may also include a third barrel (not shown), for example, for a third composition 108, as previously described, but not shown for simplicity. According to... Figure 2 and Figure 3 The description of the kit and syringe will give those skilled in the art the ability to implement a three-barrel syringe with the desired contents.

[0227] As mentioned above Figure 3 In the kit, the third composition 108 is preferably a composition having a solvent and / or dispersion medium with a pH less than 7.

[0228] In an alternative example, the third composition 108 may be solvent-free and / or dispersion-free; for example, a pH-induced thickener included in powder form.

[0229] The syringe 114 includes a mixing tip 120 for receiving the contents of the respective cartridges 116, 118, and, in the presence of a third composition, the contents of another cartridge. In this respect, the mixing tip 120 includes a mixing chamber 106. Furthermore, an outlet 122 is provided in the mixing tip 120 to allow the peroxide composition to exit the syringe 114.

[0230] In this example, any two-composition kit described herein can be used. Similarly, in a three-barrel syringe, any of the three-composition kits described herein can be used.

[0231] Such a multi-barrel syringe 114 provides the user with a convenient means of supplying kit 100. The respective compositions 102, 104, and optionally 108 can be combined in the mixing tip 120, i.e., when the respective compositions 102, 104, 108 are supplied to the mixing tip 120. For example, plungers 124, 126 can be used to eject the composition from the respective barrel and into the mixing tip 120. For example, continuous pushing via plungers 124, 126 can cause the composition to flow out from outlet 122, thus making the composition usable.

[0232] Detailed descriptions of how to design and use such syringes and / or appropriate mixing tips are provided, for example, in US8581998 and US6698622, which are incorporated by reference.

[0233] Various alternative means of implementing kit 100 are also conceivable, such as using a multi-chamber system, for example a dual-chamber system, a bottle, or a dispensing system with multiple compartments. For example, the system may include two compartments serving as respective reservoirs for the first composition 102 and the second composition 104; reservoirs filled according to the desired mixing ratio of the respective compositions 102, 104.

[0234] Figure 4 A block diagram of a system 200 for dispensing peroxide compositions is shown. In the dispensing system 200, the compartments can be separate from each other and can be separated (e.g., using individual bottles), or can be integrated as three reservoirs in the same device. The system may, for example, include a suitable pump or vacuum arrangement for simultaneously recovering the composition from each compartment via separate extraction tubes, and for subsequently discharging the respective compositions into a mixing chamber 106, which may be part of the system or separate from the system. Figure 1 As illustrated in the example, the resulting mixture can be discharged or removed from the mixing chamber. System 200 may include kit 100 as described above and a dispensing pump 202 for dispensing the composition from mixing chamber 106.

[0235] For example, kit 100 may take the form of a replaceable box of system 200, with the corresponding compositions 102, 104 and optionally 108, as well as individual components (if present), contained in separate compartments of the box.

[0236] like Figure 4 As shown in the block diagram, system 200 includes a user interface 204 for enabling a user to select parameters relating to one or more of the first aqueous composition 102, the second composition 104, and the third composition 108 (if present). Alternatively or additionally, parameters relating to the first individual portion and / or the second individual portion can be selected via the user interface 204. Parameters may, for example, relate to which of the various components 102, 104, 108, and portions are included in the composition, and / or their respective amounts.

[0237] Figure 4 The system 200 shown includes a selection module 206 coupled to a user interface 204. The selection module 206 controls the administration of the corresponding composition and / or a first individual portion and / or a second individual portion to the container / mixing chamber 106 based on user selection. The selection module 206 may, for example, enable the simultaneous retrieval of compositions 102, 104, 108 from their respective compartments via separate extraction tubes and the discharge of fluid into the container / mixing chamber 106.

[0238] For example, user interface 204 can enable a user to select parameters that determine the properties of the composition ultimately dispensed by system 200. For example, the consistency of the composition can be controlled by the pH-inducing thickener included in the composition and / or the pH of the composition. Depending on the user's selection, selection module 206 can provide an accurate and efficient means of dispensing the corresponding compositions 102, 104, 108 and the portions constituting the compositions.

[0239] Specifically, the parameters may include the selection of one or more flavorings. As previously mentioned, the possibility of including flavorings in, for example, a second separate component allows for greater flexibility in terms of flavor options, as providing flavorings separately in this way reduces the risk of degradation by other components of kit 100, such as peroxide compounds, over a relatively long storage / shelf life. Therefore, system 200 can allow a user to select the flavor of the composition dispensed by system 200 according to personal preference, similar to selecting the flavor of a soft drink using a beverage cooler.

[0240] In a simple example, a user can choose to include a flavoring agent in the composition, for example, by selecting to include a second separate component in the composition, or to exclude a flavoring agent from the composition. In a more refined example, a user can choose from different flavoring agents included in kit 100. The user interface 204 can, for example, take the form of a touchscreen to enable user-friendly parameter selection. Since flavor and / or odor can play an important role in consumer product preferences, the touchscreen options of a peroxide-based gel vending machine can be designed as flavor or aroma selection.

[0241] Figure 5 A block diagram of a system 200 according to one embodiment is shown. In this non-limiting example, system 200 includes a first aqueous composition 102 and a second composition 104. Furthermore, a first separate portion 130 and a second separate portion 132 are included in system 200. A dispensing pump 202 dispenses the composition from a mixing chamber 106.

[0242] Depending on the desired peroxide content, pH, and the content of any other functional ingredients included in the composition, any suitable mixing ratio of the first aqueous composition 102, the second composition 104, and the third composition 108 can be used, provided that the pH of the desired peroxide composition is within the desired range when using a particular set of kit compositions. The mixing ratio can be selected as disclosed above.

[0243] The mixing ratio of each component in the kit or system composition can be determined by the desired properties of the peroxide composition, which are relevant to its intended purpose, such as teeth whitening or sterilization. System 200 can precisely control the dosage of each of the respective compositions 102, 104, 108 and portions 130, 132. Each of compositions 102, 104, 108 and portions 130, 132 can be supplied, for example, in the form of a box to facilitate dosage control and replacement of compositions 102, 104, 108 and portions 130, 132 in system 200. Such a replaceable box-based system 200 can further facilitate the selection of the aforementioned flavoring agents.

[0244] The kit examples and the devices and systems described herein are preferably designed to accommodate any of the aforementioned kits and specific amounts of their compositions and other ingredients.

[0245] Figure 6 A flowchart of method 300 according to one embodiment is shown. Method 300 is used to prepare a peroxide composition having a pH in the range of 7 to 12. In step 310, a first aqueous composition comprising a peroxide reagent is provided, for example, purchased from a supplier or made to order. For the reasons described above, the first aqueous composition has a first pH of less than 7.

[0246] In step 320, the second composition containing the alkaline reagent is provided by a supplier or made to order, for example.

[0247] In step 330, a pH-induced thickener as described above is provided. It can be obtained from a supplier or made to order. The pH-induced thickener can be dissolved and / or dispersed in a solvent or dispersion medium and / or in dry form at a first pH. Many polymers are available as acidic emulsions from various suppliers, and these polymers can be used as is when the pH is consistent with the first pH.

[0248] In step 340, the first aqueous composition and the second composition are combined, preferably mixed, with a pH-induced thickener to form a peroxide composition having an alkaline pH in the range of 7 to 12. Thus, the peroxide composition thickens (e.g., because it forms a gel) to provide the advantages described above.

[0249] Combination 340 may include a pre-combination forming a first aqueous composition and a pH-induced thickener. The pre-combination can then be combined with a second composition to provide a peroxide composition. The initial formation of the pre-combination of the first aqueous composition and the pH-induced thickener allows for effective, for example, close mixing of components contained in the first component, such as the peroxide reagent, with the pH-induced thickener, such that subsequent mixing of the pre-combination with the second composition can provide a gel-like composition in situ, wherein the components of the first aqueous composition are uniformly mixed.

[0250] The peroxide composition, and therefore the kits and systems thereon, can thus be formulated for teeth whitening and are therefore suitable for retail, take-home, or chairside teeth whitening products in the fields of oral care and cosmetics. The peroxide composition, and therefore the kits and systems thereon, can also be formulated for sterilization application, for example, when a relatively long sterilization time is required during the application of the gel composition to a surface. The peroxide composition, and the kits and systems thereon, can therefore be used for sterilization of surfaces (including human surfaces, such as hands, feet, etc., where applicable) in places such as dental clinics, hospitals, nursing homes, sports venues, food processing plants, etc. As described above, the kit 100 and system can be designed, for example, as a system 200 similar to a vending machine, which can be placed in those facilities.

[0251] In summary, a kit or system (100) is provided for preparing a peroxide composition with a viscosity increase in the pH range of 7 to 12 in a nearly instantaneous manner. For example, the kit or system can be used to provide a (water) gelled peroxide composition that is nearly immediately available. The system includes a first aqueous composition (102) comprising a peroxide reagent. The first aqueous composition has a first pH of less than 7. The system further includes a second composition (104) comprising an alkaline reagent. The second composition is separate from the first aqueous composition. A pH-induced thickener is included in the kit or system, separate from the second composition. The peroxide composition is obtainable by combining the various parts of the kit or system. The pH-induced thickener enables the peroxide composition to increase in viscosity when subjected to a pH range of 7 to 12. The kit or system has sufficient alkaline reagent for the peroxide composition to maintain a pH range of 7 to 12. Methods for preparing the kit or system and their uses are also provided.

[0252] By studying the accompanying drawings, the disclosure, and the appended claims, those skilled in the art can understand and implement other variations of the disclosed embodiments in practicing the claimed invention. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite articles "a" or "an" do not exclude a plurality. The fact that certain measures are enumerated in mutually different dependent claims does not indicate that a combination of these measures cannot be used advantageously. Any reference numerals in the claims should not be construed as limiting the scope. List of non-limiting embodiments

[0253] Example 1.

[0254] A system (100) for preparing a peroxide composition, the system comprising: - A first composition (102) in a first quantity, comprising a peroxide reagent and water and having a first pH of less than 7; - A second quantity of a second composition (104) separate from the first composition, the second quantity containing a certain amount of alkaline reagent; - A certain amount of pH-induced thickener enables the aqueous composition to thicken when the pH of the aqueous composition increases from an acidic value to an alkaline value, wherein the pH-induced thickener is present in the system in at least one of the following: - In a form free of solvents and / or dispersion media; and - In the form of a solvent and / or dispersion medium, wherein the pH-induced thickener is dissolved and / or dispersed at the first pH. - The peroxide composition can be obtained by combining the first quantity of the first composition, the second quantity of the second composition, and the specified amount of pH-induced thickener; and - The amount of the alkaline reagent is sufficient to give the peroxide composition a composition pH in the range of 7 to 12.

[0255] Example 2.

[0256] According to the system of Example 1, the pH-induced thickener comprises or is composed of one or more polymers, each polymer comprising monomer residues, wherein at least a portion of the monomer residues comprises an acidic group.

[0257] Example 3.

[0258] According to the system of Example 2, the acidic group comprises or is composed of one or more groups selected from carboxylic acid groups, sulfonic acid groups, and phosphate groups.

[0259] Example 4.

[0260] According to any one of Examples 1 to 3, the pH-induced thickener comprises or is composed of one or more alkali-soluble emulsion (ASE) polymers and / or one or more hydrophobically modified alkali-soluble emulsion (HASE) polymers.

[0261] Example 5.

[0262] According to any one of Examples 2 to 4, the pH-induced thickener comprises one or more acrylic copolymers having at least a carboxylic acid group in the form of an acidic group.

[0263] Example 6.

[0264] According to any one of Examples 1 to 5, the system (100) wherein the pH-induced thickener comprises one or more cellulose polymers having at least a portion of hydroxyl residues.

[0265] Example 7.

[0266] According to any one of Examples 1 to 6, the system (100) wherein the first composition (102) comprises the pH-induced thickener in the form of the solvent and / or dispersion medium.

[0267] Example 8.

[0268] The system according to any one of Examples 1 to 6, wherein the system comprises a third quantity of a third composition separate from the first composition, and the third composition comprises at least a portion and preferably all of the pH-induced thickener.

[0269] Example 9.

[0270] The system according to any one of Examples 1 to 8, wherein the second composition comprises water and has a second pH higher than 7.

[0271] Example 10.

[0272] According to any one of embodiments 1 to 9, the first quantity and the second quantity are sufficient to be mixed at a ratio of the first quantity to the second quantity in the range of 10 to 0.1, preferably in the range of 5 to 0.2, or most preferably in the range of 5 to 0.8.

[0273] Example 11.

[0274] According to any one of Examples 1 to 10, the first composition comprises a solvent and / or a dispersion medium and has a viscosity of less than 1000 mPa·s, preferably less than 500 mPa·s, and most preferably less than 100 mPa·s under standard conditions.

[0275] Example 12.

[0276] According to any one of Examples 1 to 11, the amount of the pH-induced thickener is sufficient to give the peroxide composition a viscosity greater than 50,000 mPa·s, more preferably greater than 100,000 mPa·s, under standard conditions.

[0277] Example 13.

[0278] According to any one of Examples 1 to 12, the first pH is in the range of 2 to 5, and / or when the system contains the third composition having a third pH, the third pH is in the range of 2 to 5.

[0279] Example 14.

[0280] The system (100) according to any one of Embodiments 1 to 13 comprises one or more of the following: - Tooth desensitizer; - Tooth remineralizer; - Flavoring agent;

[0281] Example 15.

[0282] The system (100) according to any one of embodiments 1 to 14 includes a multi-compartment injector (114), said injector comprising at least: - A first compartment (116) containing the pH-inducing thickener; - A second compartment (118) containing the second composition (104); - A mixing compartment (120) is capable of being attached to or attached to the syringe for receiving and mixing the contents of at least the first and second compartments and has an outlet (122) for allowing the peroxide composition to exit the syringe when the syringe is used.

[0283] Example 16. The system according to any one of Examples 1 to 14 includes a dispensing system (200) for dispensing the peroxide composition, the dispensing system comprising: - A mixing unit for combining a certain amount of the first composition, the second composition and the pH-induced thickener to provide the peroxide composition; - User interface (204) for enabling the user to provide input parameters related to at least one of the following: - Use of the peroxide composition; - The peroxide reagent content in the peroxide composition; - pH of the composition; - The viscosity of the peroxide composition; and - The flavor and / or odor of the peroxide composition; - Selection module (206) for controlling the mixing unit to determine the amount of the components to be combined in the peroxide composition based on the input parameters.

[0284] Example 17.

[0285] The system according to any one of Examples 1 to 16 is used to provide the peroxide composition for use as an oral-applicable teeth whitening composition or a disinfectant composition for the prevention or treatment of oral infections.

[0286] Example 18.

[0287] Use of the system according to any one of Examples 1 to 17 for preparing a peroxide composition having a composition pH in the range of 7 to 12, preferably in the range of 7 to 9.5.

[0288] Example 19.

[0289] According to the use described in Example 18, the peroxide composition is an oral-applicable teeth whitening composition or a disinfectant composition for the prevention or treatment of oral infections.

[0290] Example 20.

[0291] A peroxide composition having a composition pH in the range of 7 to 12, preferably in the range of 7 to 9.5, comprising a peroxide reagent, water, an alkaline reagent, and a certain amount of a pH-inducing thickener, said pH-inducing thickener being capable of thickening the aqueous composition as the pH of the aqueous composition increases from an acidic value to an alkaline value.

[0292] Example 21.

[0293] The peroxide composition according to Example 20 can be obtained or is obtained by combining or mixing a first quantity of the first composition, a second quantity of the second composition, and the pH-induced thickener according to any one of System Examples 1 to 17.

[0294] Example 22. A method (300) for preparing a peroxide composition having a pH in the range of 7 to 12, the method comprising combining the following steps: - A first composition (102) in a first quantity, comprising a peroxide reagent and water and having a first pH of less than 7; - A second quantity of a second composition (104) separate from the first composition, the second quantity containing a certain amount of alkaline reagent; - A certain amount of pH-induced thickener is capable of thickening a composition comprising water when the pH of the composition increases from an acidic value to an alkaline value, wherein, prior to assembly, the pH-induced thickener has at least one of the following: - In a form free of solvents and / or dispersion media; and - In the form of a solvent and / or dispersion medium, wherein the pH-induced thickener is dissolved and / or dispersed at a first pH below 7.

Claims

1. A system (100) for preparing a peroxide composition, the system comprising: - A first quantity of a first composition (102), comprising a peroxide reagent and water, and having a first pH of less than 7; - A second quantity of a second composition (104) separate from the first composition, the second quantity comprising a certain amount of an alkaline reagent; - A certain amount of pH-induced thickener enables the aqueous composition to thicken when the pH of the aqueous composition increases from an acidic value to an alkaline value, wherein the pH-induced thickener is present in the system in at least one of the following: - In a form free of solvents and / or dispersion media; and - In the form of a solvent and / or dispersion medium, wherein the pH-induced thickener is dissolved and / or dispersed at the first pH. The pH-induced thickener comprises one or more hydrophobically modified alkali-soluble emulsion (HASE) polymers; - The peroxide composition can be obtained by combining the first quantity of the first composition, the second quantity of the second composition, and the amount of the pH-induced thickener; and - The specified amount of the alkaline reagent is sufficient to give the peroxide composition a composition pH in the range of 7 to 12.

2. The system of claim 1, wherein the pH-induced thickener is composed of one or more HASE polymers.

3. The system according to any one of the preceding claims, wherein the one or more HASE polymers are not crosslinked.

4. The system according to any one of the preceding claims, wherein the one or more HASE polymers comprise one or more acrylic acid copolymers having at least an acidic group in the form of a carboxylic acid group.

5. The system according to any one of the preceding claims, wherein the one or more HASE polymers comprises one or more cellulose polymers having residues, at least a portion of which comprises hydroxyl groups.

6. The system according to any one of the preceding claims, wherein the one or more HASE polymers are acrylic copolymers, the acrylic copolymers comprising at least one acrylic acid and monomer residues of at least one acrylate having a hydrophobic alcohol residue having six or more carbon atoms.

7. The system according to any one of the preceding claims, wherein the one or more HASE polymers satisfy formula 2: Where z is not zero; The sum of fractions x, y, and z is at most 1, and preferably the sum of fractions x, y, and z is 1; R1, R2 and R4 are each independently selected as H, F or a straight-chain or branched alkyl or alkoxy group having less than 6 carbon atoms, preferably less than 5 carbon atoms and more preferably less than 4 carbon atoms, and optionally the alkyl or alkoxy group has an ether group in the HASE polymer; The alcohol residue R3 has fewer than 6 carbon atoms, preferably fewer than 5 carbon atoms; The alcohol residue R5 has 6 or more carbon atoms, preferably 10 or more, or even 15 or more carbon atoms; Optionally, different monomer residues are randomly distributed along the polymer chain.

8. The system of claim 7, wherein one or more HASE polymers satisfy formula 3: ； The fraction x in equation 2 is given by the sum of x1 and x2 in equation 3; The fraction y is not 0; R1, R3, R4 and R5 are defined as in Equation 2; R6 is selected as H, F, or a straight-chain or branched alkyl or alkoxy group having less than 6 carbon atoms, preferably less than 5 carbon atoms, and more preferably less than 4 carbon atoms, wherein optionally the alkyl or alkoxy group has an ether group in the HASE polymer; and The monomer residues in fractions y and z each have R4 and R6 as H, respectively.

9. The system (100) according to any one of the preceding claims, wherein the first composition (102) comprises the pH-induced thickener in the form of the solvent and / or dispersion medium.

10. The system according to any one of claims 1 to 8, wherein the system comprises a third quantity of third compositions separate from the first composition, and the third composition comprises at least a portion and preferably all of the pH-induced thickener.

11. The system according to any one of the preceding claims, wherein the second composition comprises water and has a second pH higher than 7.

12. The system according to any one of the preceding claims, wherein the first quantity and the second quantity are sufficient to mix them in a ratio of the first quantity to the second quantity in the range of 10 to 0.1, preferably in the range of 5 to 0.2, or most preferably in the range of 5 to 0.

8.

13. The system according to any one of the preceding claims, wherein the first composition comprises a solvent and / or a dispersion medium, and has a viscosity of less than 1000 mPa·s, preferably less than 500 mPa·s, and most preferably less than 100 mPa·s under standard conditions.

14. The system according to any one of the preceding claims, wherein the amount of the pH-induced thickener is sufficient to give the peroxide composition a viscosity greater than 50,000 mPa·s, more preferably greater than 100,000 mPa·s, under standard conditions.

15. The system according to any one of the preceding claims, wherein the first pH is in the range of 2 to 5, and / or when the system includes the third composition having a third pH, the third pH is in the range of 2 to 5.

16. The system according to any one of the preceding claims, comprising one or more of the following: - Tooth desensitizer; - Tooth remineralizer; - Flavoring agent.

17. The system according to any one of the preceding claims, comprising a multi-compartment injector, the injector comprising: - A first compartment, containing the first quantity of the first composition. - A second compartment, containing the second quantity of the second composition; - An optional third compartment for including a third quantity of the third composition when it is part of the system; and - A mixing compartment, capable of being attached to or being attached to the multi-compartment syringe for receiving and mixing a corresponding amount and the stated amount of pH-induced thickener, and having an outlet for allowing the resulting peroxide composition to exit the syringe when the syringe is used.

18. The system according to any one of claims 1 to 16, comprising a dispensing system (200) for dispensing the peroxide composition, the dispensing system comprising: - A mixing unit for combining a certain amount of the first composition, the second composition and the pH-induced thickener to provide the peroxide composition; - User interface (204) for enabling the user to provide input parameters related to at least one of the following: - Use of the peroxide composition; - The peroxide reagent content in the peroxide composition; - pH of the composition; - The viscosity of the peroxide composition; and - The flavor and / or odor of the peroxide composition; - Selection module (206) for controlling the mixing unit to determine the amount of the components to be combined for the peroxide composition based on the input parameters.

19. The system according to any one of claims 1 to 18, for providing the peroxide composition as an oral-applicable teeth whitening composition or a disinfectant composition for the prevention or treatment of oral infections.

20. Use of the system according to any one of the preceding claims for preparing a peroxide composition having a composition pH in the range of 7 to 12, preferably in the range of 7 to 9.

5.

21. The use according to claim 20, wherein the peroxide composition is an oral-applicable teeth whitening composition or a disinfectant composition for the prevention or treatment of oral infections.

22. A peroxide composition having a composition pH in the range of 7 to 12, preferably in the range of 7 to 9.5, the peroxide composition comprising a peroxide reagent, water, an alkaline reagent, and a amount of a pH-inducing thickener, the pH-inducing thickener being capable of thickening an aqueous composition as the pH of the aqueous composition increases from an acidic value to an alkaline value, wherein the pH-inducing thickener comprises one or more hydrophobically modified alkali-soluble emulsion (HASE) polymers.

23. The peroxide composition of claim 22, which can be obtained or is obtained by combining or mixing a first quantity of the first composition, a second quantity of the second composition, and the pH-induced thickener of any one of claims 1 to 19.

24. A method (300) for preparing a peroxide composition having a pH in the range of 7 to 12, said method comprising the step of combining the following: - A first quantity of a first composition (102), comprising a peroxide reagent and water, and having a first pH of less than 7; - A second quantity of a second composition (104) separate from the first composition, the second quantity comprising a certain amount of an alkaline reagent; - A certain amount of pH-induced thickener enables a composition comprising water to thicken when the pH of the composition increases from an acidic value to an alkaline value, wherein, prior to being combined, the pH-induced thickener has at least one of the following: - In a form free of solvents and / or dispersion media; and - In the form of a solvent and / or dispersion medium, wherein the pH-induced thickener is dissolved and / or dispersed at a first pH below 7; The pH-induced thickener comprises one or more hydrophobically modified alkali-soluble emulsion (HASE) polymers.

Images