Component system and method for preparing a tooth whitening preparation

Abstract

The present invention relates to a component system for preparing a physiologically acceptable tooth whitening preparation. The component system comprises an active ingredient component including an organic tooth whitening substance and an activation component designed to adjust a physiologically acceptable pH of the active ingredient component in the range of between 7 and 10.5. The present invention also relates to a stabilized active ingredient component and a method and use of the component system according to the invention.

Description

[0001] Component system and method for producing a tooth whitening preparation

[0002] The present invention relates to a component system for producing a physiologically acceptable tooth whitening preparation, a corresponding method, as well as stabilized active ingredients for use in said component system and the use of the component system itself, all according to the preambles of the independent claims.

[0003] Technological background

[0004] White teeth are an important part of a healthy and well-groomed appearance. Superficial discoloration, caused by deposits on the teeth such as plaque and / or tartar, can be removed during a professional dental cleaning. In medical dental cleaning procedures, plaque and / or tartar are mechanically removed by a specialist using appropriate tools. However, deeper, internal discoloration cannot be lightened with this procedure. Since white teeth are of great cosmetic importance, procedures have been developed to further whiten the tooth surface. This type of tooth whitening produces good results even if a genetic predisposition causes a naturally darker tooth color. The tooth whitening procedures used are called "bleaching."Suitable tooth whitening procedures typically use a more or less strong oxidizing agent to achieve the desired whitening. It is crucial that chemical tooth whitening is as gentle as possible on the teeth and does not have any long-term negative effects on the health of the teeth and gums.

[0005] Since chemical tooth whitening requires a certain degree of expertise, most countries assume that a specially trained professional performs the whitening. Compounds containing hydrogen peroxide are often used as teeth bleaching agents in dental practices or dental hygiene studios. Hydrogen peroxide is usually used in the form of carbamide peroxide for cosmetic dental bleaching and tooth whitening procedures. Simply put, hydrogen peroxide penetrates the tooth and decomposes, forming reactive oxygen that reacts with pigments in the tooth. The oxygen radicals chemically alter these pigments so that their color is no longer recognizable. The theoretical basis for the use of hydrogen peroxide and its reactivity is described in *The Chemistry of Functional Groups, Peroxides* (Patei, S. et al.; John Wiley & Sons Ltd. 1983).

[0006] In practical terms, a broad distinction can be made between processes that are suitable for end users and home use, and those that are reserved for specially trained personnel. In principle, this distinction can be made mainly on the basis of the reagents used, whereby particularly high concentrations of certain active ingredients, such as peroxide, require use by professionals, while lower concentrations may be suitable for home use. However, the concentration of the active ingredient, in this case hydrogen peroxide, largely determines the effectiveness and long-lasting effect of the tooth whitening. Concentrations of 0.1% hydrogen peroxide are approved for home use in many countries. Concentrations of up to 38% hydrogen peroxide, for example, may be reserved for dentists, in which case professional treatment is required.This also includes the protection of the gums during treatment. Other physical means, such as exposure to light in the blue and / or ultraviolet spectrum, are occasionally used to support this.

[0007] A particular disadvantage of tooth whitening with conventional hydrogen peroxides is the frequently observed side effects. For example, increased tooth sensitivity can persist for days. The use of tooth whitening agents with an acidic pH is also particularly disadvantageous. These can erode the surface of the tooth enamel or roughen the tooth surface, thereby promoting the penetration of coloring substances.

[0008] EP 155 683 A1 (Thornthwaite, DW, et al.) describes an alternative to the commonly used hydrogen peroxide, which is based on an organic acid, namely phthalimidoperoxycaproic acid (PAP). PAP is a peroxycarboxylic acid with a good oxidation potential. Without being bound by this theory, the oxidative effect of peroxycarboxylic acids appears to be based on the acidity of the OH bonds and the electronegativity of the imide group.

[0009] A particular advantage of phthalimidoperoxycaproic acid (PAP) is that it achieves a comparable effect to peroxides without weakening tooth enamel or irritating the oral mucosa.

[0010] Qin et al. (Qin, J. et al.; A bio-safety tooth-whitening composite gels with novel phthalimide peroxy caproic acid; Composites Communications 13 (2019) 107 to 111) describe the effect of PAP in a polymer gel for use as a tooth whitening mixture. Tooth whitening comparable to conventional hydrogen peroxides was achieved, although comparatively higher concentrations of PAP were required to achieve the analogous effect of hydrogen peroxide tooth whitening.

[0011] Since correspondingly high concentrations are not very suitable for use by the end user at home, there is a need for suitable point-of-care solutions that enable cosmetic tooth whitening, which are easy to use and avoid at least one of the disadvantages, in particular of the common point-of-care tooth whitening methods that are based on hydrogen peroxide.

[0012] Description of the invention

[0013] It is therefore an object of the present invention to provide a component system which is simple and safe to use and enables effective tooth whitening, particularly in a point-of-care environment, and overcomes at least one disadvantage of the known system.

[0014] In particular, the aim is to provide such a component system that can be prepared for use in a few simple steps and requires minimal training for specialists. Furthermore, a corresponding method, a stabilized active ingredient component for the aforementioned component system, and a use thereof are to be provided. At least one of these objects has been achieved with a component system, a stabilized active ingredient component, and / or a method for producing and / or using a component system according to the characterizing part of the independent claims.

[0015] One aspect of the present invention relates to a component system for producing a physiologically compatible tooth whitening preparation. This is particularly preferably a point-of-care, physiologically compatible tooth whitening preparation.

[0016] In the context of the present invention, point-of-care can be understood, for example, as the place of manufacture, in contrast to the prepared mixture. The point-of-care is, for example, where the tooth whitening is carried out. This can be a practice or home use. In this sense, point-of-care can also be understood, for example, to mean that the application is carried out by a trained specialist. This trained specialist is particularly preferably a dentist, a dental hygienist and / or a dental nurse. The professional titles are subject to various requirements and can differ from country to country, although a certain regulated licensing to practice the profession and training in the use of the chemicals used in the process according to the invention are crucial. The point-of-care can then, but does not have to, take place in a dentist's office or a dental studio.Recently, there has been a trend toward offering dental hygiene services independently of primary medical care and dental care, as has been the case with physiotherapy and medical massage. The present invention is particularly suitable for use in a dental studio by trained professionals.

[0017] For the purposes of the present invention, tooth whitening or "bleaching" can be understood as a demonstrable lightening of a tooth color. A simple check of effective tooth whitening can be carried out using a reference scale. Before the start of treatment, the teeth are assigned a certain degree using a scale and then compared again with the reference scale after treatment in order to objectively determine an improvement, i.e. a change in the degree of whiteness of the teeth. Such scales are well known in dental practice. For the purposes of the present invention, tooth whitening is achieved when at least one scale degree, e.g. a VITA shade scale with shades from A1 to D4, has changed towards a lighter value.

[0018] The component system according to the invention comprises an active ingredient component comprising an organic tooth whitening agent. Particularly preferably, the active ingredient component comprising an organic tooth whitening agent has an acidic pH, preferably a pH of less than 7. The component system according to the invention further comprises an activating component for adjusting the active ingredient component to a physiologically acceptable pH in a range between 7 and 10.5. The activating component is particularly preferably an alkaline activating component.

[0019] In a particular embodiment, the activation component is designed to adjust the active ingredient component to a physiologically acceptable pH value of between 8.5 and 9.5.

[0020] In a particular embodiment, the organic tooth whitening agent is an oxidizing agent, in particular an oxidizing agent at least in a basic pH environment.

[0021] It was surprisingly found that the present component system makes it possible to provide a tooth whitening preparation, in particular a point-of-care tooth whitening preparation, that overcomes a number of disadvantages. The organic tooth whitening agent, for example, is present at a pH value below 7. At this pH value, this agent is stable. However, an acid is unsuitable for application to the teeth, as this roughens the tooth and makes it easier for discoloring substances to penetrate the tooth again. Furthermore, the use of an acid is generally detrimental to dental health, as it can damage tooth enamel. However, if the tooth whitening agent is pre-packaged in a physiologically acceptable pH environment, the shelf life of the organic tooth whitening agent is significantly reduced.It is assumed that the oxidative effect has already decreased after a few hours and has completely disappeared after ten days at the latest.

[0022] With the component system according to the invention, it is possible to prepare a physiologically compatible tooth whitening preparation with an organic tooth whitening agent at the point of use as needed and in the required quantity and to make it directly applicable to a specialist.

[0023] In a particular embodiment, the activation component is pre-dosed so that it is designed with a defined amount of the activation component to produce the above-mentioned pH value in the organic active ingredient component.

[0024] In a particular embodiment, the active ingredient is housed in a first component container. Preferably, the activation component is housed in a second component container. During use, a defined amount of the activation component or the entire contents of the second component container can then be transferred into the first component container. After careful mixing of the two components, the tooth whitening preparation is ready for use.

[0025] In a particular embodiment, the activating component comprises a base in solution with a base constant pKb of at most 4. Preferably, a base is used that is sufficient to neutralize the acidic pH of the active ingredient component and preferably to convert it into the alkaline range. Depending on the strength of the base, a different predefined amount is required to adjust the appropriate physiologically tolerable pH of the active ingredient component. A particular advantage of the invention is that comparatively much higher concentrations of the organic tooth whitening agent, in particular PAP, can be used, making tooth whitening overall more effective and / or more lasting. The correspondingly larger amount of PAP can be made ready for use by adjusting its pH to a physiologically tolerable pH with a base in solution in the form of the activating component.Limiting the amount of organic tooth whitening agent with a pH value below 7 for safety reasons is not necessary, since application at the point of care ensures that the pH value remains within a physiologically acceptable range during use.

[0026] In a particular embodiment, the active ingredient component comprises at least one caproic acid as an organic tooth whitening agent. This is particularly preferably a peroxycarboxylic acid, which is more preferably an imidoperoxycarboxylic acid. The organic tooth whitening agent is particularly preferably PAP. A suitable organic tooth whitening agent is, for example, 6-(phthalimido)peroxyhexanoic acid or, according to IIIPAC, 6-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)hexaneperoxoic acid. For the sake of simplicity, the common abbreviation PAP is used in the present application text to denote all phthalimidoperoxycaproic acids suitable for the present application.

[0027] Other acids are also suitable as alternatives and / or supplements. 4-phthalimidobutyric acid, for example, may also be suitable. Phthalimidoperoxyheptanoic acid could also be used. However, PAP is preferred.

[0028] One advantage of PAP is its comparatively good tolerability, even at higher concentrations. This improved tolerability reduces training requirements and makes its use safer overall.

[0029] In a particular embodiment, the organic tooth whitening agent is present in the active ingredient component at a concentration of at least 7%. For the purposes of the present invention, the percentages in mixtures and solutions are to be understood as percentages by weight. Particularly preferably, the organic tooth whitening agent is present in the active ingredient component at a concentration of at least 10%, preferably between 10% and 40%, more preferably between 10% and 20%, and most preferably approximately 12%.

[0030] In a particular embodiment, the active ingredient additionally comprises other excipients, particularly solvents. The solvent is preferably water and is present in an amount of between 60% and 90%.

[0031] For the purposes of the present invention, the content values ​​in percent can be understood as content values ​​according to DIN 1310.

[0032] In a particular embodiment, the active ingredient is in the form of a gel. Alternatively and / or additionally, the active ingredient is in the form of a mixture comprising the organic tooth whitening agent, which only gels upon addition of a solvent. For example, the active ingredient can be in the form of a powder and, upon addition of a predefined amount of water, can become a gel. Suitable gelling agents are known to those skilled in the art; polysaccharide-based gelling agents, for example, are particularly suitable. A particular advantage of the gel is its ease of application to the dentures and teeth, as well as its appropriate viscosity, which improves the adhesion and retention of the tooth whitening preparation on the teeth.

[0033] Another advantage of a gel is its good mixability, for example, the gel network allows the tooth whitening agent to blend with the active ingredient. The viscoelasticity of the gel also makes application easier and safer.

[0034] In an alternative or additional embodiment, the active ingredient or the resulting tooth whitening preparation is present as a colloid or emulsion. For example, it is conceivable to use glycerin- or fat-based micelles to enclose the PAP, i.e., the organic tooth whitening agent, so that it is subsequently present in a dispersion, e.g., as a colloid, in the tooth whitening preparation to be used. This can be achieved, for example, with the aid of additional aids at the point of care, e.g., by achieving a fine dispersion of the tooth whitening preparation using ultrasound.

[0035] A further alternative and / or supplementary embodiment provides a propellant in which the tooth whitening preparation is foamed into a foam, which is then applied to the dentures and teeth as a foam. One advantage of a foam is that, under physiological conditions, it also exhibits a viscosity that can facilitate its application and retention on the dentures and teeth for a certain duration of action. Furthermore, the foam also allows for a largely homogeneous distribution of the organic tooth whitening agent within the foam, depending on the pore size.

[0036] In an alternative and / or additional embodiment, the tooth whitening preparation is present in a mixed state as a liquid. The liquid can be absorbed, for example, by another absorbent carrier medium, such as a sponge, and applied to the teeth and dentures using the sponge, thus also providing a largely homogenized tooth whitening preparation in the best possible contact with the dentures and teeth.

[0037] Appropriate aids and / or methods for bringing the active ingredient component or the resulting tooth whitening preparation into the physical state which facilitates application and provides the tooth whitening active ingredient in the most homogeneous form possible with the best possible contact with the teeth and dentition are known to the person skilled in the art and can be developed by him depending on the specific preferred application.

[0038] In a particular embodiment, the active ingredient comprises a gelling agent selected from the group consisting of polysaccharides. The gelling agent is particularly preferably xanthan gum.

[0039] In a particular embodiment, the activating component comprises a base in aqueous solution. The base is particularly preferably an inorganic base selected from the group consisting of: ammonia, sodium bicarbonate, calcium bicarbonate, magnesium bicarbonate, sodium hydroxide, potassium hydroxide, calcium hydroxide, magnesium hydroxide, and barium hydroxide. The base is particularly preferably sodium hydroxide. As a strong base, sodium hydroxide has the advantage of being able to adjust the appropriate pH value in the basic range for the active ingredient even in small amounts.

[0040] Alternatively or additionally, the activation component comprises a mixture of a plurality of the above-mentioned inorganic bases.

[0041] Further alternatively and / or additionally, the activating component comprises an inorganic base mixed with an organic base, or as the sole base an organic base selected from the group consisting of: pyridine, methylamine, imidazole, histidine, guanidine and organic ammonium hydroxides.

[0042] In a particular embodiment of the component system according to the invention, the organic tooth whitening agent is selected such that it does not form hydrogen peroxide upon oxidation. For the purposes of the present invention, this means that no hydrogen peroxide is formed in an intermediate reaction either.

[0043] In a particular embodiment, the active ingredient component and / or the activation component comprises at least one indicator. The indicator is preferably designed to indicate a specific pH value, in particular a pH range, e.g., by means of a color. A change in the pH value from a first range to a second range can be indicated, for example, by means of a color change.

[0044] In a particularly preferred embodiment, the indication agent is designed to indicate a color change at a pH value above 7, preferably at a pH value between 8.5 and 9.5. A particular advantage of this solution is that a user can be sure that the pH value is within the physiologically acceptable range – and thus that the tooth whitening preparation is ready for use. For example, an indication agent can be added to either the active ingredient component or the activating component, which has a specific color in an acidic environment, e.g., turning the active ingredient component red or at least imparting a red color, and changes at a basic pH, preferably at a pH above 8.5, and, for example, has a blue color, or at least imparts a blue color. This further has the advantage that the tooth whitening preparation is color-recognizable, which facilitates application of the tooth whitening preparation.This allows the user to see, for example, where the tooth whitening preparation has been applied to the teeth and dentures. The color change makes the inventive component system safer and easier to use.

[0045] In a particular embodiment, the active ingredient comprises an organic tooth whitening agent in a solution with a pH in the range of between 5 and 7. Particularly preferably, the active ingredient has a pH in the range of approximately 5.5. In this pH range, the PAP is largely stabilized and has good storage stability. This active ingredient can preferably be stored at room temperature, but refrigerated storage at a temperature between 0°C and 18°C ​​is also suitable.

[0046] In a particular embodiment, the organic tooth whitening agent is a peroxycarboxylic acid, which exerts its oxidative effect by rapid conversion into a carboxylic acid, without forming hydrogen peroxide, nor as an intermediate. Particularly preferred is the organic tooth whitening agent £-phthalimidoperoxyhexanoic acid (PAP). In use, it would react to form phthalimidohexanoic acid, without forming hydrogen peroxide, nor as an intermediate. In a particular embodiment, the second component container comprises a dosing device for dropwise addition of the activating component into the first component container. Particularly preferably, the activating component is present in a predefined concentration, which, in a specific amount, is suitable for converting the active ingredient into a tooth whitening preparation with a physiologically acceptable pH.A dosing device can, for example, be designed to dispense a specific number of drops with a defined drop volume so that the physiologically acceptable pH value can be reliably adjusted.

[0047] Particularly preferably, the second component container has a mini-dropper.

[0048] In a particularly preferred embodiment, the first component container is designed to contain a volume of active ingredient suitable for one tooth whitening application. This allows a fresh tooth whitening preparation to be provided at all times, which can then be used directly by the user. The amount can also be adjusted to allow for multiple applications. For example, in order to maximize contact of the teeth and dentures with the tooth whitening preparation and the active agent therein, i.e., the organic tooth whitening active ingredient, one active ingredient can provide a quantity of tooth whitening preparation suitable for multiple applications.

[0049] Particularly preferably, the first component container is designed for a volume of between 4 and 25 ml, preferably 8 to 15 ml, particularly preferably substantially 10 ml of active ingredient components.

[0050] In another particular embodiment, the second component container is designed to bring a plurality of first containers containing active ingredients into the physiologically acceptable pH range as described above. In particular, the second component container can be suitable for bringing between 1 and 100 second containers into the physiologically acceptable pH range. For this purpose, the second component container can ideally have a volume of substantially 5 ml.

[0051] Particularly preferably, the component containers are made of a material that is essentially inert, particularly with regard to the materials stored therein, that does not release and / or absorb any substances. The component containers are particularly preferably made of glass or plastic.

[0052] In a particular embodiment, the active ingredient component and / or activation component and / or the tooth whitening preparation comprises at least one excipient selected from the group consisting of: desensitizing agents, remineralizing agents, gum strengthening agents, cosmetic effect agents and / or whitening enhancers.

[0053] In a particular embodiment, the desensitizing agent is an agent suitable for minimizing the sensitivity of the gums and tooth necks. Such agents are known in dental practice and can be selected by the specialist as needed. For the present invention, a desensitizing agent selected from the group consisting of potassium nitrate, calcium carbonate, and / or zinc chloride is particularly suitable.

[0054] In a particular embodiment, a remineralizing agent is an agent suitable for counteracting decalcification (demineralization) of the teeth, for example, by providing lost calcium and / or phosphate ions to the tooth enamel in a usable form. Remineralizing agents suitable for the solution according to the invention include, for example, remineralizing agents selected from the group consisting of: hydroxyapatite, fluoride, theobromine, xylitol, and / or tricalcium phosphate.

[0055] In a particular embodiment, gum tonics are agents suitable for relieving inflammation of the gums and strengthening the gums overall. Suitable gum tonics for the inventive solution are extracts, e.g., from chamomile, echinacea, peppermint, sage, lemon balm, pepper, mallow, and other plant substances with anti-inflammatory and / or antibacterial effects. Also suitable as tonics are, for example, dexpanthenol, pantothenic acid, and / or hyaluronic acid.

[0056] In a particular embodiment, cosmetic effect agents are additives that achieve an additional, special cosmetic effect. For example, color pigments can be used to create special color effects with at least a temporary cosmetic effect. Suitable examples include luster particles that leave a pearly sheen or a brilliant shine on the teeth. Suitable cosmetic preparations are known to those skilled in the art. Also suitable are dyes that impart a cosmetic color effect to the teeth.

[0057] In a particular embodiment, a blue light filter containing, for example, disodium distyrylbiphenyl disulfonate is added as a cosmetic effect agent. Particularly preferred is a filter that filters out yellow and red tones, so that the teeth appear whiter overall.

[0058] In a particular embodiment, the solution according to the invention comprises a tooth whitening enhancer, e.g. sodium chloride, sodium bicarbonate or sodium carbonate, which enhances the effect of the active ingredient component and thus improves the tooth whitening effect.

[0059] In a particular embodiment, the component system further comprises an application element for applying the tooth whitening preparation to the teeth and / or dentures, a stirring element for mixing the active ingredient component and the defined amount of the activation component, and an indicator element for checking the pH value of the tooth whitening preparation.

[0060] For the purposes of the present invention, the tooth whitening preparation is a component mixture comprising the active ingredient component and a predefined amount of the activating component.

[0061] Particularly preferably, the tooth whitening preparation is a component mixture of an active ingredient component comprising an imidoperoxycarboxylic acid as an organic tooth whitening agent and an alkaline activating component comprising at least one strong base, preferably sodium hydroxide.

[0062] In a particular embodiment, the activation component is designed to raise the pH of the active ingredient component to a value of between 7 and 10.5, in particular between 8.5 and 9.5, in particular from approximately 5.5 to approximately 9.5, with a defined amount of an alkaline activation component. The activation component particularly preferably comprises sodium hydroxide solution for this purpose. Both the active ingredient component and the activation component can comprise further excipients which can serve to ensure physical and / or chemical properties of the corresponding component. For example, buffers or complexing agents can be provided which keep the pH in the corresponding components at a certain value or stabilize substances and at least temporarily protect them from reaction.

[0063] It is self-evident to a person skilled in the art that, in an embodiment of the inventive teaching, a component system may have any combination of the features described above, as long as they are not mutually exclusive.

[0064] A corresponding method, as well as further aspects of the present invention related to the teachings of the invention, are described below. A person skilled in the art can also derive further structural features for a component system according to the invention from this description.

[0065] A further aspect of the present invention relates to a stabilized active ingredient for use in a component system as described above for producing an activated, physiologically acceptable tooth whitening preparation. The stabilized active ingredient comprises at least one organic tooth whitening active ingredient, which is an oxidizing agent at least in a basic environment. It further comprises a carrier for stabilizing a substantially homogeneous mixture of the organic tooth whitening active ingredient at a pH of less than 7, in particular approximately 5.5.

[0066] In a preferred embodiment, the stabilized active ingredient component is formulated in such a way that essentially the entire formulation is consumed in one tooth whitening application. This allows the active ingredient component to serve as a consumable. The activation component, however, can be used to activate a plurality of active ingredients, or to convert them into a physiologically acceptable pH range. Accordingly, the volume of the active ingredient component is designed to essentially completely cover an average set of teeth with a layer of the tooth whitening preparation. Preferably, only the front of the teeth is covered with such a layer. To ensure that a certain exposure time for the tooth whitening preparation can be maintained, various aids can be used, such as:a lip spreader to keep the lip away from the teeth and / or a suction device to suck out saliva.

[0067] In a particular embodiment, the stabilized active ingredient is present at room temperature as a solution, a dispersion, or a colloid. It is particularly preferably present as a dispersion, e.g., in a gel.

[0068] In a particular embodiment, the stabilized active ingredient component comprises at least one excipient selected from the group consisting of: water, thickeners, in particular at least one polysaccharide, alcohols, gelators, emulsifiers, binders, film formers and / or stabilizers.

[0069] A further aspect of the present invention relates to a process for producing an activated physiologically acceptable tooth whitening preparation.

[0070] The method comprises the step of providing an active ingredient component comprising an organic tooth whitening agent.

[0071] The method further comprises the step of providing an activation component, in particular an alkaline activation component, for setting a physiologically acceptable activated pH value of the active ingredient component.

[0072] Finally, the method according to the invention comprises the step of adding a defined amount of the activating component to the active ingredient component and mixing these two components to obtain the tooth whitening preparation.

[0073] Particularly preferably, the active ingredient component is designed to exhibit strong oxidation capacity at a basic pH value. The method according to the invention is preferably used for cosmetic tooth whitening, i.e., to achieve visible whitening and increased whiteness of the teeth. For this purpose, the active ingredient component can be used with the organic tooth whitening agent to oxidize coloring substances and thus neutralize them. In particular, the consumption of coffee, tea, and tobacco, as well as certain medications, can cause teeth to take on a yellowish hue, regardless of genetic predisposition.

[0074] The method according to the invention makes it possible to lighten this shade along a color scale. It is also possible to further lighten a shade that is darker than desired for genetic reasons. In special applications, the medical use of the solution according to the invention is conceivable, for example, when tooth discoloration occurs for medical reasons. This can also have genetic causes or be due to a specific treatment, such as radiation therapy or the use of certain medications, such as tetracyclines, which are known to cause tooth discoloration.

[0075] In a particular embodiment, the method according to the invention comprises exposing the teeth to light, preferably to light in the spectral range of between 400 nm and 500 nm. Particularly preferably, the exposure of the teeth to light takes place while the tooth whitening preparation is applied thereto, i.e. during the exposure period.

[0076] A further aspect of the present invention is the use of a component system mentioned above for the production of a physiologically acceptable tooth whitening preparation for the medical treatment of tooth discoloration. For this purpose, an active ingredient component with a minimum PAP concentration in the range of 10 to 20 wt.% is used. A PAP concentration in the range of between 12 and 14% is particularly preferred in the process according to the invention.

[0077] The present invention will now be explained in more detail using specific examples and embodiments. Further advantageous combinations of features will become apparent to a person skilled in the art. These specific embodiments and examples are not to be considered limiting the implementation of the inventive teaching of the present invention.

[0078] Description of the figures Embodiments of the invention are described with reference to the following figures.

[0079] They show:

[0080] Fig. 1 : Schematic sequence of a method according to the invention, and

[0081] Fig. 2: an exemplary assembly of the component system according to the invention.

[0082] Implementation of the invention

[0083] Example 1

[0084] In the present example, an application case as shown schematically in Fig.1 is described as an example, and how it can be used, for example, in training of specialist personnel or as concrete operating instructions for the application of a component system according to the invention.

[0085] In the present example, the active ingredient component is in the form of a gel, and a liquid activating component is packaged separately in a container. The active ingredient component is present in an amount sufficient to carry out a complete dental treatment. The dentures can be applied essentially completely, but preferably in the area of ​​the front rows of teeth. An exemplary application within the meaning of the invention can, for example, comprise application to the visible area of ​​the teeth by asking the patient to smile before treatment so that the width of the smile can be seen and whether, for example, the 2nd premolars can also be seen and need to be treated. As a rule, eight teeth per jaw are labially whitened, namely the outer surfaces (labial, towards the lip) in the upper jaw from 14-24 and the lower jaw from 34-44. For preparation, approx. 10-15 ml, preferably approx.For example, in a 10 ml dose, two drops of the activating component are added to the active ingredient. In professional use, e.g., in pharmacies, the drop quantity is a defined quantity, referred to as gutta (gtt). With precise droppers, the dispensed quantity is approximately 0.05 ml. In this example, the concentration of the activating component according to the invention is selected such that an amount of n times 0.05 ml is suitable for converting the active ingredient to the desired physiologically acceptable pH value. In this example, the amount of 4 drops is sufficient, i.e., a total of approximately 0.2 ml (4 gtt). Specific exemplary mixture compositions are described in the further examples below.

[0086] Using a medical spatula, the active ingredient is mixed as homogeneously as possible. Ideally, a specific mixing time is specified, which can be checked, for example, with a timer. For the purposes of this example, a mixing time of 60 seconds has proven suitable. For safety reasons, the pH value of the gel is measured with a pH test strip.

[0087] In this specific embodiment, the pH value is preferably between 8.5 and 9.5. As an alternative to measurement using a pH strip, the active ingredient component can already be provided with an indicator. Suitable chemical indicators that display a specific color at a specific pH value are known to those skilled in the art.

[0088] A pH test strip, indicator, or pH electrode is used to ensure that the pH value is within this defined range. Once the pH value is determined to be within the appropriate range, a series of application cycles are carried out over a certain period of time.

[0089] The application cycles can each last between 15 and 30 minutes. A total application period of 60 minutes has proven particularly suitable for this example, with two to four application cycles of 15 to 30 minutes each being possible. Between application cycles, the used active ingredient is removed from the oral cavity by rinsing. A suitable rinsing solution can be provided for rinsing, which is suitable for breaking down the polysaccharides of the active ingredient gel and thus preventing the active ingredient from adhering to the teeth. However, rinsing with water or a simple dental rinse, e.g., a NaCl solution, is also effective.

[0090] Ideally, the rinse should be performed for a certain period of time, although in this example, a period of 60 seconds has been shown to be ideal. To ensure that the active ingredient adheres to the teeth during treatment, the mouth is held open using a cheek retractor.

[0091] The method according to the invention is shown schematically in Fig. 1. The method steps can be carried out as follows, according to the example: A) preparing the active ingredient component. B) filling a crucible or dish with the active ingredient component, e.g. 10g of the active ingredient component; C) adding an activating component, such as a predefined amount of 25% sodium hydroxide solution, e.g. 0.29 to 0.37g of 25% sodium hydroxide solution, for example using a dropper, and then D) mixing or stirring for a period of 60s. The resulting physiologically compatible tooth whitening preparation is applied to the teeth in a step E) and left to act for a period of 10-20 minutes. After the exposure time, F) rinsing is carried out and E) application / acting on is repeated two to five, preferably four times until G) finally rinsing is carried out.

[0092] Example 2 Stabilized active ingredient component for use with a component system according to the invention: Example 3

[0093] Alternative stabilized active ingredient component for use with the component system according to the invention:

[0094] Example 4 An activation component according to the invention for use in a component system as described above can be an aqueous solution of a strong base

[0095] In this example, the activation component comprises an alkaline substance as its essential component, in this case a strong base in the form of 25% or 50% sodium hydroxide solution in water. Depending on the initial concentration of the base in the activation component, a different number of drops may be required to adjust the desired pH value.

[0096] At 25% NaOH, 3-4 drops are sufficient to raise the pH value of the active ingredient from 5.5 to 8.5 to 9.5. Figure 2 shows an example of how a component system according to the present invention can be formulated and how it is converted into a tooth whitening preparation. The component system comprises an active ingredient component, which is contained in a first component container 2, and an activating component, which is contained in a second component container 1. The active ingredient component is present in the first component container 2 in an amount sufficient for four application cycles, i.e. approximately 10g. The activating component can be present in an amount of 5ml. The second component container 1 accordingly also comprises a dosing tip 1.1 for the dropwise dispensing of activating component. In the present example, the dosing tip 1.1 is selected so that an amount of between 0.29 and 0.37g can be dispensed with 3 to 4 drops.This amount is chosen so that, when used as an activating component with a 25% NaOH solution in water, a pH value of 8.5 to 9.5 is achieved in the resulting tooth whitening preparation. The two components are mixed in a bowl 3 using a stirring rod.

[0097] In another particular embodiment, a pH value of 9.6 to 9.9 is set; particularly preferably, a pH value of 9.9 is set. In this particular embodiment, an amount sufficient for four application cycles, for example, i.e., approximately 10g, is pre-portioned into four portions of approximately 2.5g each, and each portion is adjusted to the desired pH value, in particular to a pH of 9.9, with 3 to 4 drops of 25% NaOH solution before each application cycle.

[0098] In a particular embodiment, the first component container 2 is designed as a crucible and can replace the bowl or be used directly for mixing the tooth whitening preparation.

[0099] The present invention provides a system for safely applying in a point-of-care situation an active component comprising an organic tooth whitening agent which, by itself and stably in an aqueous solution, has a pH that is physiologically unacceptable and may be detrimental to the treatment of teeth (stabilized pH of PAP in aqueous solution of between 3.3 and 5.5).

[0100] For this purpose, a component system is provided which contains the active ingredient in its stable form separately from an activation component which brings this active ingredient to a physiologically acceptable pH value and unfolds the full oxidation potential of the organic tooth whitening agent.

[0101] The component system according to the invention provides a tooth whitening preparation that is highly effective, can operate with a sufficient concentration of organic tooth whitening agent, and is safe to use. The packaging is also particularly advantageous, with the activation component being selected such that even a small amount, just a few drops, is sufficient to adjust the required pH value, thus enabling the activation component to be packaged so that it can be used multiple times. At the same time, the active ingredient component can be packaged in such a quantity that it is precisely sufficient for one application or a series of consecutive application cycles.The oxidation potential is then exhausted and the active ingredient is freshly activated as a tooth whitening preparation before each application or each series of consecutive application cycles.

[0102] By stabilizing the active ingredient component, it is also possible to incorporate additional excipients either in the activation component or directly into the active ingredient component, so that they also exert their desired effect. For example, additional tooth whitening agents such as sodium carbonate can be included, which can also serve as a base for activating the active ingredient component. Other active ingredients for cosmetic and / or medicinal effects can also be included within the scope of the present invention.

[0103] The product can therefore meet high safety requirements and offers an ideal alternative with fewer side effects to conventional hydrogen peroxide-based tooth whitening products for point-of-care applications.

Claims

Patent claims 1. A component system for producing a physiologically acceptable tooth whitening preparation, comprising: a. An active ingredient component comprising an organic tooth whitening agent, in particular having a pH of less than ?; b. An activating component, in particular an alkaline activating component, for adjusting a physiologically acceptable pH of the active ingredient component in a range of between 7 and 10.5, in particular between 8.5 and 9.

5.

2. Component system according to claim 1, wherein the activating component comprises a base in solution with a base constant pKb of at most 4.

3. Component system according to one of claims 1 or 2, wherein the active ingredient component comprises as organic tooth whitening agent at least one caproic acid, in particular a peroxycarboxylic acid dissolved in an aqueous solution, which is in particular an imidoperoxycarboxylic acid, preferably PAP.

4. Component system according to one of claims 1 to 3, wherein the organic tooth whitening active ingredient is present in the active ingredient component in a concentration of at least 7%, in particular in a concentration of between 10% and 30%, in particular between 10% and 20%.

5. Component system according to one of claims 1 to 4, wherein the active ingredient component is present as a gel.

6. Component system according to one of claims 1 to 5, wherein the activating component comprises a base in aqueous solution selected from the group of inorganic bases, in particular from the group consisting of: ammonia, sodium bicarbonate, sodium hydroxide, potassium hydroxide, calcium hydroxide, magnesium hydroxide and barium hydroxide. Component system according to one of claims 1 to 6, wherein the active ingredient component comprising an organic tooth whitening active ingredient has a pH of between 5 and 7, in particular of 5.

5. Component system according to one of claims 1 to 7, wherein the active ingredient component is in a first component container and the activating component is in a second component container. Component system according to claim 8, wherein the second component container has a dosing device for dropwise addition of the activating component into the first component container. Component system according to one of claims 1 to 9, wherein the component system further comprises: a. an application element for applying a component mixture to the teeth, and / or b. a stirring element for mixing the active ingredient component with a defined amount of the activating component, and / or c. an indicator element for checking the pH of a component mixture.Component system according to one of claims 1 to 10, wherein the activating component is designed to raise the pH of the active ingredient component to a value of between 7 and 10.5, in particular between 8.5 and 9.5, in particular from approximately 5.5 to approximately 9.5, with a defined amount of an alkaline activating component. Stabilized active ingredient component for use in a component system, in particular a component system according to claim 1, for producing an activated, physiologically compatible tooth whitening preparation comprising: a. an organic tooth whitening active ingredient which is an oxidizing agent in a basic environment;. b. a carrier for stabilizing a substantially homogeneous mixture of the organic tooth whitening active ingredient at a pH of less than 7, in particular of approximately 5.

5. Stabilized active ingredient component according to claim 12, wherein the stabilized active ingredient component is present at room temperature as a solution, a dispersion, or a colloid. Stabilized active ingredient component according to either of claims 12 and 13, comprising at least one excipient selected from the group consisting of: water, thickeners, in particular polysaccharides, alcohols, chelators, emulsifiers, binders, film formers, and stabilizers. A process for producing an activated, physiologically acceptable tooth whitening preparation, comprising the steps of: a. providing an active ingredient component comprising an organic tooth whitening active ingredient; b.Providing an activation component, in particular an alkaline activation component, to adjust a physiologically acceptable activated pH value of the active ingredient component; c. Adding a defined amount of the activation component to the active ingredient component and mixing the two components.

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