Component systems and methods for preparing tooth whitening formulations

Abstract

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

Description

[0001] The present invention relates to a component system for preparing a physiologically acceptable tooth whitening preparation, a corresponding method, and a stable active ingredient composition for use in said component system and the use of said component system itself, all according to the preambles of the independent claims. Background Art

[0002] White teeth are an important part of a healthy and neat appearance. Surface stains, such as those formed by coatings on teeth (such as plaque and / or tartar), can be removed within the scope of professional tooth cleaning. In the course of medical tooth cleaning, plaque and / or tartar are mechanically removed by a skilled technician using appropriate tools. However, potential internal discoloration cannot be whitened by this method. Because whitening teeth is very important in cosmetics, methods for further whitening the surface of teeth have been developed. This type of tooth whitening provides good results, even if the darker color of teeth is innate due to genetic predisposition. Such methods for tooth whitening are called "bleaching". Methods suitable for tooth whitening generally use more or less strong oxidants to obtain the desired tooth whitening. It is important that chemically performed tooth whitening is as gentle as possible and does not have long-term adverse effects on the health of teeth and gums.

[0003] Since the chemical treatment of teeth for teeth whitening requires a certain degree of expertise, most countries require that teeth whitening must be performed by specially trained professionals. Dental clinics or dental hygiene studios often use compounds containing hydrogen peroxide as tooth bleaching agents. For cosmetic bleaching and tooth whitening methods, hydrogen peroxide is usually used in the form of urea peroxide. In simple terms, hydrogen peroxide penetrates into the teeth and decomposes, forming active oxygen that reacts with the colorant in the teeth. In the process, oxygen free radicals chemically change the colorant in this way, so that the colorant is no longer distinguishable. 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).

[0004] For practical application, a distinction can be made between methods suitable for end users and home use, and methods reserved for specially trained personnel. In principle, this distinction can be based primarily on the reagents used, with particularly high concentrations of certain active ingredients (e.g., peroxides) requiring professional use, while lower concentrations may be suitable for home use. However, the concentration of the active ingredient (in this case hydrogen peroxide) determines to a large extent the effectiveness and sustainability of teeth whitening. Many countries allow hydrogen peroxide concentrations of 0.1% for home use. For example, hydrogen peroxide concentrations of up to 38% may be reserved for dentists, where, for example, professional treatment of the gums is also necessary in order to protect the gums during treatment. For example, additional auxiliary physical agents are occasionally used, such as treatment with light in the blue and / or ultraviolet spectrum.

[0005] Frequently observed side effects are a particular disadvantage of tooth bleaching using known conventional hydrogen peroxide. Thus, for example, increased tooth sensitivity may persist for several days. The use of tooth whitening agents with a pH in the acidic range is also particularly disadvantageous. These agents may wear away the surface of the tooth enamel or roughen the tooth surface, thereby promoting the penetration of coloring substances.

[0006] EP 155 683 A1 (Thornthwaite, DW et al.) describes alternatives to the customary hydrogen peroxide based on the organic acid phthalimidoperoxycaproic acid (PAP).

[0007] PAP is a peroxy acid with a good oxidation potential. Without being bound by this theory, the oxidation action of the peroxy acid appears to be based on the acidity of the OH bond and the electronegativity of the imide group.

[0008] A particular advantage of phthalimidoperoxycaproic acid (PAP) is that it achieves comparable effects to peroxides but does not weaken tooth enamel or irritate the oral mucosa.

[0009] Qin et al. (Qin, J. et al.; A bio-safety tooth-whitening composite gels with novel phthalimideperoxy caproic acid; Composites Communications 13 (2019) 107–111) describe the role of PAP in a polymer gel used as a tooth whitening mixture. Tooth whitening comparable to that achieved with conventional hydrogen peroxide was achieved; relatively high concentrations of PAP were necessary to achieve similar effects of hydrogen peroxide tooth whitening.

[0010] Since the correspondingly high concentrations are in turn less than ideal for home use by the end user, there is a need for an appropriate point-of-care method that enables cosmetic teeth whitening, is easy to use, and avoids at least one of the disadvantages particularly associated with conventional hydrogen peroxide-based point-of-care teeth whitening methods. Summary of the invention

[0011] It is therefore an object of the present invention to provide a component system that is easy to use and reliable and that enables effective teeth whitening, particularly in a point-of-care setting, and that overcomes at least one of the disadvantages of known systems.

[0012] In particular, the object is to prepare such a component system which can be prepared for use in a few simple steps and requires little training of the skilled worker. A further object is to provide a corresponding method and a stable active ingredient component for the component system mentioned at the outset and its use.

[0013] At least one of these objects has been achieved by a component system, a stable active ingredient component and / or a method for producing and / or using a component system according to the characterizing parts of the independent claims.

[0014] One aspect of the present invention relates to a component system for preparing a physiologically acceptable tooth whitening formulation. This is particularly preferably a point-of-care physiologically acceptable tooth whitening formulation.

[0015] Within the meaning of the present invention, "point of care" may be understood as, for example, the opposite of a mix prepared at the manufacturing site. A point of care is provided, for example, where teeth whitening is performed. This may be a medical practice, but may also be home use. In this sense, a point of care may further be understood as, for example, where the application is performed by a trained professional. Such a trained professional is particularly preferably a dentist, a dental hygienist and / or a dental care assistant. The titles are subject to various requirements and may and can vary from country to country; however, certain official regulations for professional practice and training in the use of chemicals in the method according to the invention are necessary. The point of care may, but does not have to, be carried out in a dental clinic or dental studio. There has been a recent trend towards providing dental hygiene services independently of primary medical care and treatment by a dentist, as occurs in the field of physiotherapy and medical massage. The present invention is particularly suitable for use in dental studios by trained professionals.

[0016] Within the meaning of the present invention, a detectable lightening of the color of teeth may be understood as tooth whitening or bleaching. Effective tooth whitening can be easily checked by using a reference standard. Before the start of treatment, the teeth are assigned a certain color grade using a scale and, after the treatment, a comparison is then made again with a reference scale in order to objectively determine the improvement, i.e. the change in the whiteness of the teeth. Such scales are known in dental practice. Within the meaning of the present invention, tooth whitening is achieved when at least one scale degree (e.g. the VITA color scale with a color from A1 to D4) has been changed in the direction of a lighter value.

[0017] The component system according to the invention comprises an active ingredient component, which comprises an organic tooth whitening substance. The active ingredient component comprising an organic tooth whitening substance is particularly preferably present at an acidic pH, preferably a pH below 7. The component system according to the invention further comprises an activating component for adjusting the physiologically acceptable pH of the active ingredient component to a range between 7 and 10.5. The activating component is particularly preferably an alkaline activating component.

[0018] In a particular embodiment, the activation component is designed to adjust the active ingredient component to a physiologically acceptable pH between 8.5 and 9.5.

[0019] In a particular embodiment, the organic tooth whitening substance is an oxidizing agent, particularly an oxidizing agent at least in an alkaline pH environment.

[0020] Surprisingly, it has been found that by using the component system of the present invention, a tooth whitening formulation, in particular a point-of-care tooth whitening formulation, can be provided that overcomes many disadvantages. For example, organic tooth whitening substances are present at a pH below 7. Such substances are stable at this pH. However, acids are not suitable for application to teeth because the teeth become roughened thereby and discolored substances may easily penetrate into the teeth again. In addition, the use of acids is generally detrimental to dental health because tooth enamel may be affected. However, if the tooth whitening substance is pre-prepared in a physiologically acceptable pH environment, the storage life of the organic tooth whitening substance is significantly shortened. It is assumed that the oxidation effect weakens after only a few hours and disappears completely after a maximum of ten days.

[0021] By using the component system according to the invention, physiologically acceptable tooth-whitening preparations containing organic tooth-whitening substances can be prepared in the necessary amounts at the point of use as required and made directly usable by the professional.

[0022] In a particular embodiment, the activation component is pre-dosed, so a defined amount of the activation component designed to provide the above-mentioned pH in the organic active ingredient component is used.

[0023] In a particular embodiment, the active ingredient component is contained in a first component container. The activation component is preferably contained in a second component container. In use, for example, a defined amount of the activation component or the entire contents of the second component container can be transferred to the first component container. After the two components are carefully mixed, the tooth whitening preparation is ready for use.

[0024] In a particular embodiment, the activating component contains a base in solution having 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 convert it into the alkaline range. Depending on the strength of the base, different predetermined amounts are required to adjust the active ingredient component to a suitable physiologically acceptable pH. A particular advantage of the present invention is that it is possible to operate with relatively higher concentrations of organic teeth whitening substances, in particular PAPs, resulting in overall more effective and / or sustainable teeth whitening. During use, by using a base in solution in the form of an activating component to bring its pH to a physiologically acceptable level, a correspondingly larger amount of PAP can be ready for use. For safety reasons, it is not necessary to limit the amount of organic teeth whitening substance to a pH below 7, since application at the point of care ensures that the pH varies within a physiologically acceptable range during use.

[0025] In a particular embodiment, the active ingredient component contains at least one caproic acid as an organic tooth whitening substance. This is particularly preferably a peroxy acid, and the peroxy acid is more preferably an iminoperoxycarboxylic acid. The organic tooth whitening substance is particularly preferably PAP. An example of a suitable organic tooth whitening substance is 6-(phthalimido)peroxycaproic acid according to IUPAC, or 6-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)hexaneperoxyacid. In this patent application, for the sake of simplicity, the general abbreviation PAP is used to designate all phthalimidoperoxycaproic acids suitable for this patent application.

[0026] Alternatively and / or additionally, other acids are suitable. An example of another suitable acid is 4-phthalimidobutyric acid. It is likewise possible to use terephthalimidoperoxyheptanoic acid. However, PAP is preferred.

[0027] One advantage of PAP is its relatively good tolerability, even at elevated concentrations. Due to the improved tolerability, training efforts are reduced and the overall application is made more reliable.

[0028] In a particular embodiment, the organic tooth whitening substance is present in the active ingredient component in a concentration of at least 7%. Within the meaning of the present invention, percentages in mixtures and solutions are to be understood as percentages by weight in each case. The organic tooth whitening substance is particularly preferably present in the active ingredient component in a concentration of at least 10%, preferably between 10% and 40%, more preferably between 10% and 20%, and particularly preferably about 12%.

[0029] In a particular embodiment, the active ingredient composition additionally comprises further auxiliary substances, in particular solvents. The solvent is preferably water and is present in an amount of between 60% and 90%.

[0030] Within the meaning of the present invention, percentage contents are to be understood as contents according to DIN 1310.

[0031] In a particular embodiment, the active ingredient component is present in the form of a gel. Additionally and / or alternatively, the active ingredient component is present in the form of a mixture that includes an organic tooth whitening substance and only gels after the addition of a solvent. Thus, the active ingredient component may be present, for example, in powder form and becomes a gel when a predetermined amount of water is added. Suitable gelling agents are known to those skilled in the art, with polysaccharide-based gelling agents being particularly suitable.

[0032] A particular advantage of gels is the ease of application to the dentition and teeth, and a corresponding viscosity which improves the adhesion and durability of the tooth whitening formulation on the teeth.

[0033] Another advantage of gels is good miscibility, for example the mixing of tooth whitening substances in the active ingredient components can be achieved through the gel network. The viscoelasticity of the gel also makes application easier and more reliable.

[0034] In an alternative or complementary embodiment, the active ingredient component or the resulting teeth whitening preparation is present in the form of a colloid or emulsion. Thus, it is conceivable, for example, to use glycerol-based or fat-based micelles to include the PAP, i.e. the organic teeth whitening substance, so that it is then present in the teeth whitening preparation to be used in the form of a dispersion, for example as a colloid. This can be done, for example, at the point of care using additional adjuvants, such as ultrasound to obtain a fine dispersion of the teeth whitening preparation.

[0035] Further alternative and / or supplementary embodiments provide foaming agents wherein the teeth whitening formulation is formed into a foam and then applied to the dentition and teeth as a foam. An advantage of the foam is that the viscosity exhibited under physiological conditions can facilitate application and durability of the foam on the dentition and teeth after a certain duration of action. In addition, the foam enables the teeth whitening substance to be very evenly distributed within the foam, regardless of pore size.

[0036] In an alternative and / or additional embodiment, the tooth whitening formulation is present in the form of a liquid in a mixed state. For example, the liquid can be absorbed through an additional absorbent carrier medium (such as a sponge) and by using the sponge placed on the teeth and dentition, so that a largely homogenized tooth whitening formulation is also provided for the best possible contact with the dentition and teeth.

[0037] Those skilled in the art are familiar with appropriate adjuvants and / or methods for bringing the active ingredient components or the resulting tooth whitening formulation into a physical state that facilitates application and provides the tooth whitening substance in a largely homogenized form for the best possible contact with the teeth and dentition, and may select them according to the particular preferred application.

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

[0039] In a particular embodiment, the activating component contains a base in aqueous solution. The base is particularly preferably an inorganic base selected from the group comprising 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 that even in small amounts, a suitable pH can be adjusted within the alkalinity range of the active ingredient component.

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

[0041] Alternatively or additionally, the activation component further comprises an inorganic base mixed with an organic base, or as a single base comprising an organic base selected from the group comprising 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 substance is selected in such a way that it does not form hydrogen peroxide upon oxidation. Within the meaning of the present invention, it is understood that no hydrogen peroxide is formed in the intermediate reaction either.

[0043] In a particular embodiment, the active ingredient component and / or the activation component includes at least one indicator. The indicator is preferably designed to indicate a certain pH, in particular a pH range, for example, by color. For example, a change in pH from a first range to a second range can be indicated by a color change.

[0044] In a particularly preferred embodiment, the indicator is designed to show a color change when the pH is above 7, preferably between 8.5 and 9.5. A particular advantage of this method is that the user can ensure that the pH is within a physiologically acceptable range and that the tooth whitening preparation is therefore ready for application. Thus, for example, an indicator can be added to the active ingredient component or to the activation component, the indicator having a certain color in an acidic environment; for example, the active ingredient component is red or at least imparts a reddish color, and at an alkaline pH, preferably at a pH above 8.5, changes color and, for example, has a blue color or at least imparts a blue color. This has the additional advantage that the presence of the tooth whitening preparation makes the tooth whitening preparation identifiable by color, which facilitates the application of the tooth whitening preparation. Thus, for example, the user can see anywhere that the tooth whitening preparation has been applied to the teeth and dentition. The color change makes the component system according to the present invention easier and more reliable in application.

[0045] In a particular embodiment, the active ingredient component comprises an organic tooth whitening substance in a solution having a pH in the range between 5 and 7. The active ingredient component particularly preferably has a pH in the range of about 5.5. In this pH range, the PAP is largely stable and has a good shelf life. Such an active ingredient component can preferably be stored at room temperature, but storage under refrigerated conditions between 0° C. and 18° C. is also suitable.

[0046] In a particular embodiment, the organic tooth whitening substance is a peroxyacid that undergoes oxidation by rapid conversion to a carboxylic acid without generating hydrogen peroxide and without generating hydrogen peroxide as an intermediate product. The organic tooth whitening substance is particularly preferably ε-phthalimidoperoxycaproic acid (PAP). In use, it will react to form phthalimidoperoxycaproic acid without generating hydrogen peroxide and without generating hydrogen peroxide as an intermediate product.

[0047] In a particular embodiment, the second component container comprises a dosing device for adding the activation component dropwise to the first component container. The activation component is particularly preferably present in a predetermined concentration, the given amount of the activation component being suitable for converting the active ingredient component into a tooth whitening preparation having a physiologically acceptable pH. The dosing device can be designed, for example, to dispense a specific number of drops having a defined drop volume, so that a physiologically acceptable pH can be reliably adjusted.

[0048] The second component container particularly preferably comprises a mini dropper.

[0049] In a particularly preferred embodiment, the first component container is designed to have a volume of active ingredient components suitable for one teeth whitening application. Thus, a fresh teeth whitening preparation can always be provided, which the user can then directly use. The amount can also be set to allow multiple passes. Thus, for example, in order to maximize the contact of teeth and dentition with the teeth whitening preparation and the active agent therein (i.e., the organic teeth whitening substance), the amount of active ingredient components can be specified to produce a teeth whitening preparation suitable for several applications.

[0050] The first component container is particularly preferably designed for a volume of the active ingredient component of between 4 mL and 25 mL, preferably between 8 mL and 15 mL, particularly preferably substantially 10 mL.

[0051] In a further specific embodiment, the second component container is designed to bring a plurality of first containers with active ingredient components to a physiologically acceptable pH range as described above. Specifically, the second component container may be suitable for transferring the container to a physiologically acceptable pH between 1 second and 100 seconds. For this purpose, the second component container may ideally have a volume of substantially 5 mL.

[0052] The component container is particularly preferably made of a material which is substantially inert and which, in particular, does not emit and / or absorb any substances with respect to the materials stored therein. The component container is particularly preferably made of glass or plastic.

[0053] In a particular embodiment, the active ingredient component and / or the activating component and / or the tooth whitening preparation comprises at least one auxiliary substance selected from the group comprising: a desensitizing agent, a remineralizing agent, a gum strengthening agent, a cosmetic effect agent and / or a whitening enhancing agent.

[0054] In a particular embodiment, the desensitizing agent is an agent suitable for minimizing the sensitivity of the gums and tooth neck to pain. Such agents are known for use in dentistry and can be selected by the technical expert as required. A desensitizing agent selected from the group comprising potassium nitrate, calcium carbonate and / or zinc chloride is very suitable for the present invention.

[0055] In a particular embodiment, the remineralizing agent is an agent suitable for combating tooth decalcification (demineralization), for example by providing the loss of calcium and / or phosphate ions of tooth enamel in a usable form. Remineralizing agents selected from the group comprising hydroxyapatite, fluoride, theobromine, xylitol and / or tricalcium phosphate are examples of suitable remineralizing agents according to the method of the invention.

[0056] In a particular embodiment, the gum strengthening agent is an agent suitable for relieving gum inflammation and strengthening the gums as a whole. Suitable gum strengthening agents for use in the method according to the invention are extracts, such as extracts of chamomile, echinacea, mint, sage, lemon balm, pepper, mallow and other botanicals with anti-inflammatory and / or antibacterial effects. For example, dexpanthenol, pantothenic acid and / or hyaluronic acid are also suitable as strengthening agents.

[0057] In a particular embodiment, the cosmetic effect agent is an additive that achieves another specific cosmetic effect. Thus, for example, a specific color effect with at least a temporary cosmetic effect can be achieved by using, for example, pigments. For example, smooth particles that leave a pearlescent sheen or a bright sheen on the teeth are suitable. Suitable cosmetic preparations are known to those skilled in the art. Also suitable are colorants that give the teeth a cosmetic color effect.

[0058] In a particular embodiment, a blue light filter, for example containing disodium distyrylbiphenyl disulfonate, is added as a cosmetic effect agent. It is particularly preferred to add a filter that filters yellow and red tones, so that the teeth have an overall whiter appearance.

[0059] In a particular embodiment, the methods according to the present invention include a teeth whitening enhancer, such as sodium chloride, sodium bicarbonate, or sodium carbonate, which enhances the action of the active ingredient component and, thus, enhances the teeth whitening effect.

[0060] In a particular embodiment, the component system further comprises an application element for applying the tooth whitening formulation to the teeth and / or dentition, an agitation element for mixing the active ingredient component and a defined amount of an activating component, and an indicator element for checking the pH of the tooth whitening formulation.

[0061] Within the meaning of the present invention, a tooth whitening preparation is a mixture of components comprising an active ingredient component and a predetermined amount of an activating component.

[0062] The tooth whitening preparation is particularly preferably a component mixture of an active ingredient, which includes an imidoperoxycarboxylic acid component as the organic tooth whitening substance, and an alkaline activating component, which includes at least one strong base, preferably sodium hydroxide.

[0063] In a particular embodiment, the activation component is designed to increase the pH of the active ingredient component to a value between 7 and 10.5, in particular between 8.5 and 9.5, in particular about 5.5 to about 9.5 using a defined amount of alkaline activation component. For this purpose, the activation component particularly preferably comprises a sodium hydroxide solution.

[0064] The active ingredient components and the activation components may include further auxiliary substances which may be used to ensure the physical and / or chemical properties of the components in question. Thus, for example, a buffer or a complexing agent may be provided which maintains the pH in the components in question at a certain value, or which stabilizes the substance and at least temporarily protects it from undergoing a reaction.

[0065] It goes without saying to a person skilled in the art that, in an embodiment according to the teachings of the present invention, the component system may have any given combination of the features described above, as long as the features are not mutually exclusive.

[0066] The corresponding methods and further aspects associated with the teaching according to the invention are described below. From this description, a person skilled in the art can also deduce further structural features of the component system according to the invention.

[0067] Another aspect of the invention relates to a stable active ingredient component, which is used in a component system as described at the beginning to produce an activated physiologically acceptable tooth whitening preparation. The stable active ingredient component includes at least one organic tooth whitening substance that is an oxidizing agent at least in an alkaline environment. The stable active ingredient component also includes a carrier, which is used to stabilize the substantially uniform mixture of organic tooth whitening substances at a pH below 7, especially about 5.5.

[0068] In a preferred embodiment, the stable active ingredient component is prepared in such a way that substantially all of the prepared amount is consumed in one tooth whitening application. Therefore, the active ingredient component can be used as a consumable material. In contrast, the activation component can be used to activate a variety of active ingredient components or to convert them into a physiologically acceptable pH range. Therefore, the active ingredient component is designed so that its volume substantially completely covers an average group of teeth with a layer of tooth whitening formulation.

[0069] Preferably, only the front side of the teeth is covered with such a layer. To ensure that the teeth whitening formulation remains exposed for a certain period of time, various aids may be used, such as lip retractors for holding the lips away from the teeth and / or suction devices for aspirating saliva.

[0070] In a particular embodiment, the stable active ingredient component is present in the form of a solution, dispersion or colloid at room temperature. It is particularly preferably present in the form of a dispersion, for example in a gel.

[0071] In a particular embodiment, the stabilized active ingredient composition comprises at least one auxiliary substance from the group comprising water, a thickener, in particular at least one polysaccharide, an alcohol, a gelator, an emulsifier, a binder, a film former and / or a stabilizer.

[0072] A further aspect of the invention relates to a method for preparing an activated physiologically acceptable tooth whitening formulation.

[0073] The method includes the steps of providing an active ingredient component including an organic teeth whitening substance.

[0074] The method further comprises providing an activation component, particularly an alkaline activation component, for adjusting a physiologically acceptable activated pH of the active ingredient component.

[0075] Finally, the method according to the invention comprises the steps of adding a defined amount of the activating component to the active ingredient component and mixing the two components to obtain a teeth whitening preparation.

[0076] The active ingredient components are particularly preferably designed in such a way that they have a high oxidizing power at alkaline pH. The method according to the invention is preferably used for cosmetic tooth whitening, i.e. to obtain visible whitening of teeth and a more intense white coloration. For this purpose, the active ingredient components can be used together with organic tooth whitening substances to oxidize staining substances and thus neutralize the color. In particular, drinking coffee, tea, tobacco and certain drugs may lead to yellowing of teeth regardless of genetic predisposition.

[0077] By using the method according to the invention, it is possible to lighten this chromaticity along the color scale. Likewise, it is also possible to lighten a chromaticity that is darker than the desired chromaticity due to genetic reasons. The medical use of the method according to the invention is conceivable in specific applications, for example when tooth discoloration occurs due to medical reasons. This may also have a genetic origin or may be due to, for example, specific treatments, such as radiation therapy or the administration of certain drugs (such as tetracycline), which are known to cause tooth discoloration.

[0078] In a particular embodiment, the method according to the invention encompasses impinging the teeth with light, preferably light in the spectral range between 400 nm and 500 nm. It is particularly preferred that the teeth are impinged with light when the tooth whitening preparation is applied to the teeth, ie during the exposure period.

[0079] A further aspect of the invention is the use of the component system mentioned at the outset for the preparation of a physiologically acceptable tooth whitening preparation for the medical treatment of tooth discoloration. Among other substances, active ingredient components with a minimum PAP concentration in the range of 10 wt % to 20 wt % are used for this purpose. In the method according to the invention, it is particularly preferred to use a PAP concentration in the range of between 12% and 14%.

[0080] The present invention is explained in more detail below based on specific examples and embodiments. Other advantageous feature combinations are provided for those skilled in the art. These special embodiments and examples should not be interpreted as limiting the creative teachings for implementing the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0081] Exemplary embodiments of the present invention are described with reference to the following drawings.

[0082] In the attached picture:

[0083] Figure 1 shows a schematic sequence of the method according to the invention, and

[0084] Figure 2 An example of the preparation of a component system according to the invention is shown. DETAILED DESCRIPTION

[0085] Example 1

[0086] In this example, the Figure 1 The application schematically shown in FIG. 1 can be used, for example, for the training of technicians or as a detailed operating instruction for the use of the component system according to the invention.

[0087] In this example, the active ingredient component is present in the form of a gel, and the liquid activation component is prepared separately in a container. The active ingredient component is present in an amount sufficient to perform a complete treatment of the teeth. The dentition can be treated substantially completely, but preferably in the area of ​​the front teeth. An example application within the meaning of the present invention can be, for example, applied to the visible area of ​​the teeth by prompting the patient to smile before treatment, so that it can be seen how wide the smile is, and whether, for example, the second premolar is also visible and must also be treated. However, for each jaw, the labial surfaces of eight teeth are usually whitened, i.e., the outside (labial surface, facing the lips) of the teeth 14-24 of the upper jaw and the teeth 34-44 of the lower jaw. During preparation, two drops of the activation component are added to about 10-15mL (preferably about 10mL) of the active ingredient component gel, and the two drops of the activation component are added to the active ingredient component. In professional use, also in the pharmaceutical field, for example, the amount of the droplet is a defined variable called "drop" (gtt). In a precision dropper, the dispensing amount is about 0.05mL. In this example, the concentration of the activation component according to the present invention is selected so that n multiplied by the amount of 0.05 mL is suitable for converting the active ingredient component into a desired physiologically acceptable pH. In this example, the amount of 4 drops, i.e. 0.2 mL (4 gtt) in total, is enough. The specific example of the mixture composition is described in the other examples below.

[0088] Use a medical spatula to blend the active ingredient components as evenly as possible. It is ideal to specify a certain mixing time, which can be checked with a timer, for example. Within the meaning of this example, a mixing time of 60 seconds has been found to be suitable. Of course, the pH of the gel is measured using a pH test strip.

[0089] In this particular exemplary embodiment, the pH is preferably between 8.5 and 9.5. As an alternative to using a pH strip for measurement, the active ingredient component may have been provided with an indicator. Suitable chemical indicators that display a certain color at a given pH are known to those skilled in the art.

[0090] Use pH test strips, indicators or a pH electrode to ensure that the pH is within the specified range. When the pH is determined to be within the appropriate range, a series of application cycles are performed over a period of time.

[0091] The application cycle can be carried out in a time period between 15 minutes and 30 minutes respectively. For the present embodiment, it has been found that a total application time period of 60 minutes is particularly suitable, wherein two to four application cycles can be carried out, each cycle lasting 15 minutes to 30 minutes. Between application cycles, the used active ingredient components are removed from the oral cavity by rinsing the mouth. For rinsing the mouth, a suitable rinse solution can be provided, which is suitable for decomposing the polysaccharides of the active ingredient gel, and therefore prevents the active ingredient components from adhering to the teeth. However, rinsing the mouth with water or a simple tooth rinse solution (e.g., NaCl solution) is equally effective.

[0092] The gargling is ideally performed for a period of time; in the present example, a period of 60 seconds has proven to be ideal.

[0093] To ensure that the active ingredient components remain on the teeth during treatment, the mouth is kept open by a cheek retractor.

[0094] Figure 1 The method according to the present invention is schematically shown. The method steps can be carried out as follows according to the example: A) providing an active ingredient component, B) filling the active ingredient component (e.g., 10 g of the active ingredient component) into a crucible or dish, C) adding an activating component, such as a predetermined amount of 25% sodium hydroxide solution, such as 0.29 g to 0.37 g of 25% sodium hydroxide solution, for example by using a dropper, and then D) mixing or stirring for a period of 60 seconds. In step E), the resulting physiologically acceptable tooth whitening preparation is applied to the teeth and acts within a period of 10-20 minutes. After the exposure period, F) rinse the mouth, and repeat the application / exposure of step E) two to five times, preferably four times, until G) the final rinse is performed.

[0095] Example 2

[0096] Stable active ingredient components for use with the component system according to the invention:

[0097]

[0098]

[0099] Example 3

[0100] Alternative stable active ingredient components for use with the component system according to the invention:

[0101] Element wt% H2O (distilled water) 73.6％ 6-(Phthaloimido)peroxycaproic acid 12％ glycerin 10％ Xanthan gum 3.2％ Sodium Citrate 0.4％ PVM / MA copolymer 0.4％ Sodium hydroxide 0.3％ C12-15 Pareth-3 0.1％

[0102] Example 4

[0103] The activating component used according to the invention in the component system as described at the outset may be an aqueous solution of a strong base.

[0104] In this example, the activation component includes as an essential component an alkaline substance, in this case a strong base in the form of a 25% or 50% aqueous sodium hydroxide solution. Depending on the starting concentration of the base in the activation component, different numbers of drops may be required to adjust to the desired pH.

[0105] For 25% NaOH, 3-4 drops are sufficient to raise the pH of the active ingredient component from 5.5 to 8.5–9.5.

[0106] Figure 2 An example of how to prepare a component system according to the present invention and how to convert the component system into a tooth whitening preparation is shown. The component system includes an active ingredient component contained in a first component container 2 and an activation component 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 10 g. The activation component can be present in an amount of 5 mL. The second component container 1 correspondingly also includes a quantitative pipette tip 1.1 for dropwise dispensing of the activation component. In this example, the quantitative pipette tip 1.1 is selected so that an amount of 0.29 g to 0.37 g is dispensed with 3 to 4 drops. The amount selected in this way is such that for a 25% NaOH aqueous solution as an activation component, the pH is set to 8.5 to 9.5 in the resulting tooth whitening preparation. The two components are mixed in a dish 3 by using a stirring rod.

[0107] In a further special embodiment, the pH is set to 9.6 to 9.9, particularly preferably to pH 9.9. In this special embodiment, an amount sufficient for four application cycles (i.e., approximately 10 g) is pre-divided into four portions of approximately 2.5 g each, and before each application cycle, each portion is set to the desired pH, in particular to pH 9.9, using 3 to 4 drops of 25% NaOH solution.

[0108] In a particular embodiment, the first component container 2 is designed as a crucible and can replace a dish or can be used directly for mixing the teeth whitening preparation.

[0109] The present invention provides a system for reliably applying an active ingredient component containing an organic tooth whitening substance in a point-of-care situation, which active ingredient component itself has a stable pH in aqueous solution, is physiologically harmless, and may not have adverse effects on dental treatment (the stable pH of PAP in aqueous solution is between 3.3 and 5.5).

[0110] For this purpose, a component system is provided in which the active ingredient component in its stable form is prepared separately from an activating component which brings this active ingredient component to a physiologically acceptable pH and gives the organic tooth whitening substance a full oxidation potential.

[0111] By using the component system according to the invention, a tooth whitening preparation is provided, which has high efficiency, can be used with organic tooth whitening substances in sufficient concentrations, and is reliable to use. The preparation is also advantageous in that the activation component can be selected in such a way that even a small amount of a few drops is sufficient to set the required pH, and the activation component is thus prepared so that the activation component can be used multiple times. At the same time, the amount of the active ingredient component can be prepared so that it is just enough for one application or a series of continuous application cycles. The oxidation potential is then exhausted, and in each case, before each use or each series of continuous application cycles, the active ingredient component is freshly activated as a tooth whitening preparation.

[0112] Due to the stabilization of the active ingredient component, it is also possible to plan to include further auxiliary substances in the activating component or directly in the active ingredient component, so that these auxiliary substances also exert their desired effect. Thus, for example, a supplementary tooth whitening substance (such as sodium carbonate) can be provided, which can also serve as a base for activating the active ingredient component. Within the scope of the present invention, other active ingredients for cosmetic and / or medical effects can also be provided.

[0113] Thus, the product can meet stringent safety requirements and provide an ideal alternative for point-of-care application with fewer side effects than conventional hydrogen peroxide-based teeth whitening products.

Claims

1. A component system for preparing a physiologically acceptable tooth whitening preparation, the component system comprising: a. Active ingredient components, particularly active ingredient components having a pH below 7, wherein the active ingredient components include organic tooth whitening substances; b. An activating component, in particular an alkaline activating component, for adjusting the physiologically acceptable pH of the active ingredient component to a range between 7 and 10.5, in particular between 8.5 and 9.

5.

2. The component system according to claim 1, wherein the activation component contains a base constant pK b The maximum is 4 bases in the solution.

3. The component system according to claim 1, wherein the active ingredient component contains at least one caproic acid as organic tooth whitening substance, in particular a peroxyacid dissolved in aqueous solution, and in particular an iminoperoxycarboxylic acid, preferably PAP.

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

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

6. The component system according to claim 1, wherein the activated component contains a base in aqueous solution, the base being selected from the group of inorganic bases, in particular from the group comprising ammonia, sodium bicarbonate, sodium hydroxide, potassium hydroxide, calcium hydroxide, magnesium hydroxide and barium hydroxide.

7. The component system according to one of claims 1 to 6, wherein the pH of the active ingredient component including the organic tooth whitening substance is between 5 and 7, in particular 5.

5.

8. The component system according to one of claims 1 to 7, wherein the active ingredient component is in a first component container and the activation component is in a second component container.

9. A component system according to claim 8, wherein the second component container comprises a dosing device for adding the activation component dropwise into the first component container.

10. The component system according to one of claims 1 to 9, wherein the component system further comprises: a. an application element for applying the mixture of components to the teeth, and / or b. a stirring element for mixing the active ingredient component with a defined amount of the activation component, and / or c. Indicator element for checking the pH of the component mixture.

11. The component system according to claim 1, wherein the activating component is designed to increase the pH of the active ingredient component to a value between 7 and 10.5, in particular between 8.5 and 9.5, in particular about 5.5 to about 9.5, using a defined amount of alkaline activating component.

12. A stable active ingredient component for use in a component system for preparing an activated physiologically acceptable tooth whitening preparation, in particular a component system according to claim 1, wherein the stable active ingredient component comprises: a. an organic tooth whitening substance which is an oxidizing agent in an alkaline environment; b. A carrier for stabilizing the substantially homogeneous mixture of the organic tooth whitening material at a pH below 7, particularly about 5.

5.

13. The stable active ingredient composition according to claim 12, wherein the stable active ingredient composition exists in the form of a solution, dispersion or colloid at room temperature.

14. The stable active ingredient composition according to claim 12, comprising at least one auxiliary substance from the group consisting of water, thickeners, in particular polysaccharides, alcohols, chelating agents, emulsifiers, binders, film formers and stabilizers.

15. A method for preparing an activated physiologically acceptable tooth whitening formulation, the method comprising the steps of: a. Providing an active ingredient component comprising an organic tooth whitening substance; b. providing an activation component, particularly an alkaline activation component, for adjusting the physiologically acceptable activated pH 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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