RU2283081C1 - Agent and method for whitening teeth - Google Patents

Abstract

FIELD: medicine, stomatology.

SUBSTANCE: invention relates to agents and method for whitening teeth. Agent for whitening teeth represents a film made of combined hydrophobic and hydrophilic layers. Hydrophilic layer comprises hydrogen peroxide or its complexes with organic, inorganic polymeric compounds and fluoride-containing compounds, and/or potassium nitrate. Accessory components are included in both hydrophilic and hydrophobic layers of film wherein the content of a whitening component is 1.2-1.5 mg/cm² as measured for hydrogen peroxide, and the film thickness is 0.2-0.6 mm. For whitening teeth this film is glued on the moister frontal surface of teeth row by gums line for 2-4 h. Agent and method for whitening don't show irritating effect in mouth cavity tissues, injury of teeth or destruct teeth enamel.

EFFECT: improved and valuable properties of agent and method.

7 cl, 16 ex

Description

The invention relates to the field of dentistry and describes a local action for the treatment of dental discoloritis and its delivery method. The treatment of stained teeth is currently identified with cosmetic tooth whitening using various commercial whitening compositions.

Therefore, to achieve a greater effect, compositions with a very high content of the whitening component are often used (gels containing 15-35% carbamide peroxide), the bleaching process is boosted by additional exposure to physical means (activation by light, heat, laser), abrasives are used (a mixture of 10% hydrochloric acid and pumice), varnishes.

It is clear that tooth whitening methods using commercial whitening compositions have a number of significant drawbacks.

1. Excessive use of commercial whitening kits causes erosion of the vestibular surface of teeth, dissolution of enamel, and loss of tooth anatomical integrity (T. Cubbon, D. Ore. CDS Review. 1991, 85 (5), 32-35).

2. Two-thirds of patients using mouthguard whitening systems have increased tooth sensitivity (Haywood V.B., Caugbman F., Frazier K.B., Quintessence Int, 32, 2001, p.105-109). Moreover, changes in the pulp are directly proportional to the exposure time and concentration of the whitening agent: deeper damage to the hard tissues of the tooth occurs when gels with a high content of carbamide peroxide (16% and higher) are used (Cooper JS etal. Journal of endodontics, 1992, 18 (7), p. 315-317)

3. The use of 30% hydrogen peroxide and 10% carbamide peroxide for bleaching leads to a significant change in the chemical composition of the pulp (decrease in the ratio of calcium / dentine phosphate) (I. Rotstein, E. Dunkner, A. Ctolman, etal, J. endodont, 1996, 22, 23-25).

4. No matter how much the mouthguards are adjusted during bleaching, the bleaching gel leaks into the oral cavity: when using mouthguards with a carbamide peroxide concentration of 10% and 15%, approximately 25 to 40 mg of hydrogen peroxide gets into the oral cavity with each application.

In 2001, Procter & Gambell developed whitening strips of polyethylene coated with a whitening gel with a hydrogen peroxide content of 6.5% (marketed under the name “White Strip Professional”) (US Pat. No. 5879691; 5891453 and 6277458). These strips on the teeth are weakly fixed, and just as in the kappa system, the likelihood of the gel getting into the oral cavity is high. Another disadvantage is that the strips are intended only for professional teeth whitening.

The technical task of this invention is to provide a means for whitening teeth:

a) does not irritate and dehydrate the tissues of the oral cavity, does not damage the teeth or does not destroy the enamel;

b) having an adjustable concentration of the whitening component;

c) having the simplest and most convenient way of applying and delivering the whitening composition directly to the dentition.

To solve this problem, a group of inventions is proposed, united by a common inventive concept. The tool is intended for local action, for applying directly to the dentition and is used to whiten teeth. It is made in the form of a film consisting of a combined hydrophilic and hydrophobic layers. The bleaching components of hydrogen peroxide in an amount of 1.2-1.5 mg / cm and its complexes with various organic, inorganic and polymer compounds in an amount equivalent to 1.2-1.5 mg / cm of hydrogen peroxide are included in the hydrophilic, adhesive layer films. Fluorine-containing compounds or potassium nitrate are also included in the hydrophilic layer. It is known that their presence can reduce the observed overall sensitivity of the teeth, practically without affecting the effectiveness of whitening (L.Tamm, Quintessence Int, 2001, 32, No. 10, pp. 766-770).

The film additionally contains a number of auxiliary components, which are included in both the hydrophilic and hydrophobic layers of the film. Each of these components play a role.

Thus, the proposed film consists of:

1) from the hydrophilic layer,

2) from a hydrophobic layer,

3) active whitening ingredients,

4) auxiliary components,

5) in addition, the film may contain partially soluble natural or synthetic polymers compatible with the main component of the hydrophilic layer.

1. The main component for the hydrophilic layer are water-soluble natural or synthetic polymers, copolymers and their derivatives, in particular polysaccharides or their derivatives, such as tragacanth, pululan, gelatin resin, denatured gelatin and collagen treated with succinic acid or phthalic anhydride, starch and its esters, cellulose ethers, such as carboxymethyl cellulose (sodium salt), hydroxyethyl cellulose, methyl hydroxypropyl cellulose, gum arabic, agarose, agar-agar, xanthan gum, pectins, succinogl yukan, salts of alginic acid and its esters, propylene glycol alginate, chitin, chitosan and their salts (sodium and ammonium); synthetic polymers and copolymers such as polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycols, copolymers based on vinyl acetate, vinyl pyrrolidone, vinyl esters of maleic acid, polymers of acrylic and methacrylic acids, their salts and esters, water-soluble polymers of lactic and glycolic acids, hydrochloric acid polysaccharides and their derivatives (acetates, alkyl-, hydroxypropyl-carboxymethyl cellulose, starch, amylose, etc.), polyvinyl alcohol and its derivatives.

2. The main component for the hydrophobic layer (substrate) is water-insoluble or sparingly soluble polymers such as ethyl cellulose, propyl cellulose, cellulose acetate, carboxymethyl cellulose, collagen, polymers of acrylic esters, polyvinyl alcohol derivatives, polyurethanes treated with F-gas, polyolefins, crosslinked derivatives of alginic acid, non-woven materials, sparingly soluble modifications of biodegradable polymers of polyglycolic acid, polylactic acid, polytetramethyl glycolamide, poly aprolactone, poly (DL-decanolactone), polyalkylene adipates and their copolymers, some ion-exchanged resins.

3. The active ingredients of whitening are:

- hydrogen peroxide and its complexes with various organic, inorganic and polymer compounds.

- inorganic and organic fluorides or potassium nitrate to reduce tooth sensitivity during whitening

- components for stabilization of hydrogen peroxide and its complexes.

A) Peroxide compounds

Hydrogen peroxide and its complexes formed with alcohols, ethers, ketones, amines, amides, urea (urea) 1,3-dimethylurea, biuret, polyamides, polyurethanes, alkali metal carbonates and hydroxides, ammonium fluoride, sodium pyrophosphate were used as peroxide compounds. as well as complexes with polyvinyl alcohol, poly (vinyl methyl ether), poly (vinyl methyl ketone), poly (acrylic acid), glycine, L-histidine, poly (vinyl acetate), N-vinyl-2-pyrrolidone-vinyl acetate copolymer, N- copolymer blame -2-pyrrolidone with methyl vinyl ether, cellulose acetate, sodium alginate, sodium salt of cellulose sulfate, histamine, glycine anhydride, propionamide, polyacrylamide, polyvinylpyrrolidone, poly (4-vinylpyridine), nylon-6, sodium polyester, carbonate, carbonate rubidium, sodium bicarbonate, calcium hydroxide.

Thus, as complexes of hydrogen peroxide for whitening were used; a complex of poly (vinyl alcohol) with hydrogen peroxide, poly (vinyl methyl ether) with hydrogen peroxide, poly (vinyl methyl ketone) with hydrogen peroxide, poly (acrylic acid) with hydrogen peroxide, poly (vinyl acetate) with hydrogen peroxide, cellulose acetate with hydrogen peroxide, sodium alginate with hydrogen peroxide, cellulose sulfate (sodium salt) with hydrogen peroxide, glycine with hydrogen peroxide, poly (vinylpyrrolidone) with hydrogen peroxide, a copolymer of N-vinyl-2-pyrrolidone and vinyl acetate with hydrogen peroxide, a copolymer N-vinyl-2-pyrrolidone and vinyl methyl ether with hydrogen peroxide, histamine with hydrogen peroxide, propionamide with hydrogen peroxide, urea (urea) with hydrogen peroxide, 1,3-dimethylurea with hydrogen peroxide, biuret with hydrogen peroxide, poly (acrylamide) with hydrogen peroxide, nylon-6 with hydrogen peroxide, polyether polyurethane with hydrogen peroxide, L-histidine with hydrogen peroxide, poly (4-vinylpyridine) with hydrogen peroxide, sodium carbonate with hydrogen peroxide, potassium carbonate with hydrogen peroxide, calcium hydroxide cation with hydrogen peroxide, sodium bicarbonate with hydrogen peroxide, sodium pyrophosphate with hydrogen peroxide, rubidium carbonate with hydrogen peroxide, ammonium fluoride with hydrogen peroxide.

The content of hydrogen peroxide and its complexes in the film in terms of hydrogen peroxide is 1.2-1.5 mg / cm ² with a film thickness of 0.02-0.06 mm.

B) fluorine-containing compounds and potassium nitrate

Fluorine compounds intended for

- preventing the action of peroxide compounds on the pulp of the tooth and ultimately on reducing the overall sensitivity of the teeth

- to strengthen tooth enamel.

1. Inorganic and complex fluorine-containing compounds, mixtures of two or more metal fluorides, mixtures of organic and inorganic fluorine-containing compounds were used as sources of fluoride ions in the films.

a) Inorganic water-soluble fluorides of the type MF, MF ₂ , MF ₃ , MF ₄ their complex compounds such as sodium fluoride, potassium fluoride, aluminum fluoride, lithium fluoride, cesium fluoride, ammonium fluoride, copper fluoride, tin fluoride, fluoride iron, nickel fluoride, palladium fluoride, silver fluoride, zinc fluoride, zirconium fluoride, sodium monofluorophosphate, indium fluoride, tin chlorofluoride, calcium fluoride, barium fluoride, sodium fluorosilicate, ammonium fluorosilicate, sodium fluorosilicate, mono and difluorophosphate aluminum phosphorium phosphate.

b) mixtures of inorganic fluorides of the type MFxc MFy, such as sodium fluoride with tin fluoride, ammonium fluoride with tin fluoride, copper fluoride with calcium fluoride, sodium fluoride with indium fluoride.

c) Organic fluorine-containing compounds:

fluorides of quaternary ammonium compounds of various structures of type N F, quaternary ammonium compounds with perfluoroalkyl groups, polycationic polymers containing fluoride ions, fluorophosphates, fluorooctanates of ammonium compounds, water-soluble amino acid complexes with metal fluorides.

d) mixtures of inorganic and organic fluorides, tin fluoride with benzalkonium fluoride, laurylamine hydrofluoride with tin fluoride, betaine hydrofluoride with sodium fluoride.

The content of fluoride compounds in the finished film is 0-0.2 mg / cm with a film thickness of 0.02-0.06 mm

2. Potassium nitrate is used alone or in combination with fluorides.

3. Components for the stabilization of hydrogen peroxide and its complexes.

The most suitable for the stabilization of hydrogen peroxide and its complexes in the presented films were metal salts with inorganic, organic and complex residues: zinc, tin and cadmium salts.

Applied:

a) zinc salts with inorganic anions:

zinc borate, zinc bromide, zinc carbonate, zinc hexafluorosilicate, zinc pyrophosphate, zinc silicate, zinc sulfate, zinc titanate;

zinc salts with organic anions:

zinc acetate, zinc benzoate, zinc citrate, zinc glycinate, zinc lactate, zinc phenol sulfate, zinc salicylate, zinc tartrate, zinc acetylacetonate, zinc maleate, zinc succinate, zinc ascorbate, zinc gluconate.

b) salts of tin with inorganic anions:

tin chloride, tin bromide, tin sulfate, tin pyrophosphate, tin bromate, tin nitrite, tin nitrate, tin carbonate, tin oxide, tin ammonium chloride, sodium stannate

salts of tin with organic anions:

tin oxalate, tin citrate, tin tartrate, tin benzoate, tin sorbate, tin maleate, tin ascorbate, tin lactate, tin acetylacetonate.

c) salts of cadmium-cadmium sulfate, cadmium nitrate, cadmium chloride.

The stabilization of hydrogen peroxide and its complex compounds included in the hydrophilic layer of these films is complicated by the fact that fluorine-containing compounds are also included therein. It is known that fluoride anion intensively decomposes hydrogen peroxide (US Pat. US 5372807; 5217710). Thus, the issue of stabilization of hydrogen peroxide and its complex compounds in these films reduces: a) in fact, stabilization of hydrogen peroxide itself;

b) its protection against the destabilizing effect of fluoride ions.

The combination of tin and cadmium zinc salts with various inorganic and organic compounds turned out to be more effective stabilizers of the peroxide-fluorine system than single salts. The most effective salt additives are

a) coplexones-nitrilotriacetic acid, 1,2-diaminocyclohexane tetraacetic acid, pyridinedicarboxylic acid, ethylenediamine tetraacetic acid, (disodium salt);

b) organic acids, amino acids, ascorbic acid, pyridinecarboxylic acid and its derivatives, glycolic acid, pyridinecarboxylic acid, malonic acid, succinic acid, glutaric acid, adipic acid, pimelic acid, azelaic acid, sebacic acid, diglycolic acid and thiodiglycolic acid ;

c) inorganic acids and their salts like pyrophosphoric acid, orthophosphoric acid, sodium polymetaphosphate, sodium pyrophosphate, sodium orthophosphate, phosphoric and phosphinic acid triamides, phenylphosphonic acid, phosphonic and diphosphonic acid esters, nitrile trimethylphosphonic acid, derivatives of alkyl diidene.

The total amount of the mixture of stabilizers ranges from 0.1-10% (preferably 1-2%) of the film weight.

4. Auxiliary components:

a) plasticizers - the content of plasticizers in both the hydrophilic and hydrophobic layers should be no more than 10% of the weight of the main component of this layer;

b) crosslinking agents — used to crosslink a hydrophobic layer with a hydrophilic layer in an amount up to 10% of the total weight of polymers.

5. Partially soluble polymers are mainly biocompatible polymers such as polyglycolic acid, polylactic acid, polytetramethylene glycolide, poly (DL-decanolactone), polyalkylene oxide polymers and their copolymers, ion-exchange resins, butyl cellulose, partially water-soluble polymers and copolymers of vinyl acetate vinyl chloride, and etc.

Their content in the finished film ranges from 0-30% by weight of the main component.

Their introduction into the composition of the film allows to obtain funds with a uniform and prolonged release of the active component of whitening.

All existing methods of teeth whitening (except physical and mechanical) use the same chemical compounds - hydrogen peroxide and its complexes. They differ only in the method of delivery of the whitening composition.

The film developed in this application is the most convenient form of delivery of the whitening composition directly to the surface of the teeth.

Structurally, the film is constructed so that it adheres directly to the wet surface of the dentition:

a) for the upper row of teeth, a strip of 65 mm long and a width of 8-10 mm (or another convenient size) is cut off and applied with adhesive side to the front wet surface of the dentition;

b) for the lower row of teeth, a strip of 50 mm long and 8-10 mm wide (or other convenient size) is cut off and glued onto the dentition (Fig. 1-3);

c) the outer (hydrophobic) layer at the same time prevents the release of the film components into the oral cavity and at the same time prevents the components of the oral fluid from entering the film area.

The film is fixed and held for several hours (on average 2-4 hours). Under the influence of mechanical, chemical and other substances, and mainly under the action of lactoperoxidase and bacterial saliva, decomposition of hydrogen peroxide into oxygen and water occurs (US Pat. 4302441; Tip top, J. of Periodontology, 1995, 66 (9) 766-774 ) The released oxygen penetrates the dentin and enamel, causing oxidative degradation of the coloring pigments.

The advantages of the proposed delivery method.

1. The film is hermetically and firmly fixed on the surface of the dentition along the gum line, without affecting the surface of the mucosa, which:

a) avoids irritation and other negative effects on the gums;

b) significantly reduces the likelihood of a noticeable amount of hydrogen peroxide and other components of the hydrophilic layer entering the tooth space and ultimately into the oral cavity;

c) the whitening process takes place in a gentle manner, without causing damage to the surrounding tissues of the tooth and the enamel itself;

g) allows you to whiten selectively, starting from one or more quantities of teeth.

2. a) No devices, adhesives, or other means are needed to deliver the whitening composition to the surface of the dentition;

b) there is no need to dry the dentition before bleaching;

c) there is no need to brush your teeth before whitening, which in most methods of whitening is the cause of increased sensitivity of the teeth;

g) you can glue the film at the same time as the upper and lower dentition.

3. The whitening procedure is simplified:

the patient can independently apply a film on the dentition, which makes home-based removal of tooth discoloration accessible to many patients.

4. The film is colorless and invisible on the surface of the teeth. It can be glued at a time convenient for the patient, for example during the day, and conduct social activities.

The results achieved in this application.

1. A two-layer biocompatible hydrophilic-hydrophobic film "uniform" in structure was created, without signs of delamination of the layers under operating conditions.

2. The hydrophilic layer is compatible with peroxide compounds (hydrogen peroxide and its complexes), does not decompose under their influence and serves as a stable source of peroxide compounds.

3. When applied to a wet surface of the teeth, the film emits strictly dosed amounts of peroxide compounds during the entire period of time to eliminate tooth discoloration.

4. The film hydrophilic side is hermetically glued to the teeth; the hydrophobic layer at the same time prevents the likelihood of a noticeable amount of hydrogen peroxide (and its complexes) and other components of the hydrophilic layer entering the tooth space and ultimately into the oral cavity.

5. The proposed film makes it possible to eliminate the discolorite at the same time a group of teeth on both the upper and lower jaws, as well as the selective number of teeth, starting from one.

6. No devices or tools (the manufacture of mouthguards and care for them, the use of special physical means, adhesives, varnishes, etc.) when whitening teeth with films are not required.

7. The procedure is simple - the patient independently puts a film on the dentition. The dentist provides training in gluing techniques and defines home whitening tactics.

8. There is no need to brush your teeth before whitening, which is the main cause of damage to the enamel and increase the sensitivity of the teeth, regardless of the method of whitening.

9. Unlike the “kappa” method, it is easily tolerated by patients with an increased emetic reflex.

Examples of the preparation of films.

1. Preparation of stock solutions:

a) for casting a hydrophobic layer

45 g of the polymer selected for casting the hydrophobic layer, and 5 g of plasticizer are dissolved in 500 cm ^{3 of} isopropyl alcohol (s.c.h. brand) with stirring and heating in a water bath at 30-35 ° C. The resulting solution is cooled to 25 ° C and filtered through a nylon cloth for screens No. 49-67 (GOST 1748-82);

b) for casting a hydrophilic layer

To 830 cm ^{3 of} deionized water, 120 g of the polymer selected for casting the hydrophilic layer and 13.4 g of plasticizer are added with stirring. Dissolution is carried out at a temperature of 40-45 ° C for 6 hours; if necessary, mixing can be carried out for another 2 hours at 80-85 ° C. Cool the solution to 25 ° C, filter through a nylon cloth.

2. Film casting

a) applying a hydrophobic layer

On a horizontal surface of polished glass with a release coating 300 × 400 mm in size, 15 cm ^{3 of the} prepared solution for casting a hydrophobic layer is applied, evenly distributed with a glass rod. Drying is carried out in a chamber in an inert gas stream at a temperature of no higher than 30 ° C for 5 hours.

b) casting a hydrophilic layer

The calculated amounts of the components intended for bleaching and auxiliary components are added to the solution prepared in advance for casting the hydrophilic layer, before applying them to the hydrophobic layer; specific amounts of components are given in the examples.

The following are specific examples of the preparation of films.

Example 1

13.5 ml of 37% hydrogen peroxide (TU 6-02-570-75 grade OSCH), 0.2 g of zinc sulfate, 0.2 g of sodium fluoride and 0.15 g of gluconolactone are introduced into a 100 cm ³ solution for casting the hydrophilic layer . The mixture is stirred, evaporated (in vacuum 30-40 mm of the remaining mercury column) part of the water (not more than 10 cm ³ ). 90 cm ^{3 of the} resulting solution is applied to the surface of a pre-prepared dried hydrophobic layer 300 × 400 mm in size, evenly distributed over the surface and dried for 48 hours in an inert gas stream at 25 ° C.

Example 2

Analogously to example 1, a hydrophilic layer is cast from a mixture of 100 cm ^{3 of a} solution for casting a hydrophilic layer of 16.2 ml of 37% hydrogen peroxide (grade OSCH) 0.2 g of zinc sulfate, 0.2 g of cadmium sulfate, 0.1 g of NaF and 0, 1 g of Trilon B. The mixture is stirred, evaporated (in vacuum 30-40 mm of the remaining mercury column) part of the water (not more than 10 cm ³ ). 90 cm ^{3 of the} resulting solution is applied to the surface of a pre-prepared dried hydrophobic layer 300 × 400 mm in size, uniformly distributed over the surface and dried for 48 hours in an inert gas stream at 25 ° C.

Example 3

Analogously to example 1, a hydrophilic layer is cast from a mixture of 100 cm ^{3 of a} solution for casting a hydrophilic layer, 20 g of pharmacopeia hydroperit (FS 42-2140-98), 0.4 g of potassium nitrate, 0.2 g of sodium stannate (Na ₂ SnO ₃ · 3H ₂ O), 0.2 g of phosphoric acid. The mixture is stirred, evaporated (in vacuum 30-40 mm of the remaining mercury column) part of the water (not more than 10 cm ³ ). 90 cm ^{3 of the} resulting solution is applied to the surface of a pre-prepared dried hydrophobic layer 300 × 400 mm in size, evenly distributed over the surface and dried for 48 hours in an inert gas stream at 25 ° C.

Example 4

Analogously to example 1, a hydrophilic layer is cast from a mixture of 100 cm ^{3 of a} solution for casting a hydrophilic layer, 0.4 g of tin chloride, 0.2 g of sodium fluoride, 0.1 g of gluconolactone and 20 g of a complex of polyvinylpyrrolidone (K-30) with hydrogen peroxide ( the complex is prepared by mixing 12.5 g of polyvinylpyrrolidone K-30 (BASF) with 14 g of 50% hydrogen peroxide in 50 ml of isopropyl alcohol at 35-40 ° C for 2 hours; after cooling, the precipitated complex is isolated). The mixture is stirred, evaporated (in vacuum 30-40 mm of the remaining mercury column) part of the water (not more than 10 cm ³ ). 90 cm ^{3 of the} resulting solution is applied to the surface of a pre-prepared dried hydrophobic layer 300 × 400 mm in size, evenly distributed over the surface and dried for 48 hours in an inert gas stream at 25 ° C.

Example 5

Analogously to example 1, the hydrophilic layer is cast from a mixture of 100 cm ^{3 of a} solution for casting a hydrophilic layer, 10 g of hydroperit, 12 cm of 37% hydrogen peroxide, 0.25 g of zinc citrate, 0.2 g of sodium fluoride and 0.15 g of trilon B. The mixture mix, evaporate (in vacuum 30-40 mm of the remaining mercury column) part of the water (not more than 10 cm ³ ). 90 cm ^{3 of the} resulting solution is applied to the surface of a pre-prepared dried hydrophobic layer 300 × 400 mm in size, evenly distributed over the surface and dried for 48 hours in an inert gas stream at 25 ° C.

Example 6

Analogously to example 1, the hydrophilic layer is cast from a mixture of 100 cm ^{3 of a} solution for casting a hydrophilic layer, 3 g of hydroperit, 0.22 g of zinc citrate, 0.2 g of potassium nitrate, 0.1 g of trilon B and 12 g of K-15 polyvinylpyrrolidone complex hydrogen peroxide (the complex is prepared by mixing 7.4 g of lolivinylpyrrolidone K-15 (FLUKA) with 9.5 g of 50% hydrogen peroxide and 30 ml of isopropyl alcohol at 35-40 ° C for 2 hours; after cooling, a precipitate is formed. 90 cm ^3, the resulting solution is applied onto the surface of a previously prepared hydrophobic layer dried size of 300 × 400 m Uniformly distributed over the surface and dried for 48 hours in a stream of inert gas at 25 ° C.

Example 7

Analogously to example 1, a hydrophilic layer is cast from a mixture of 100 cm ^{3 of a} solution for casting a hydrophilic layer, 0.22 g of cadmium sulfate, 0.2 g of nitrilotriacetic acid and 20 g of a complex of nylon-6 with hydrogen peroxide (the complex is prepared by mixing 12 g of nylon-6, 15 g of 50% hydrogen peroxide and 50 ml of isopropyl alcohol at 35-40 ° C for 2 hours; after cooling, a precipitate is formed). The mixture is stirred, evaporated (in vacuum 30-40 mm of the remaining mercury column) part of the water (not more than 10 cm ³ ). 90 cm ^{3 of the} resulting solution is applied to the surface of a previously prepared dried hydrophobic layer 300 × 400 mm in size, uniformly distributed over the surface and dried for 48 hours in an inert gas stream at 25 ° C.

Example 8

Analogously to example 1, the hydrophilic layer of the film is cast from a mixture of 100 cm ^{3 of a} solution for casting a hydrophilic layer, 0.4 g of tin benzoate, 0.4 g of 1,2-diaminocyclohexantetraacetic acid, 0.2 g of potassium nitric acid and 20 g of histidine complex hydrogen peroxide (the complex is prepared by mixing 14 g of L-histidine (FLUKA), 16 g of 50% hydrogen peroxide and 50 ml of isopropyl alcohol at 35-40 ° C for 2 hours; after cooling, a precipitate is formed). The mixture is stirred, evaporated (in vacuum 30-40 mm of the remaining mercury column) part of the water (not more than 10 cm ³ ). 90 cm ^{3 of the} resulting solution is applied to the surface of a pre-prepared dried hydrophobic layer 300 × 400 mm in size, evenly distributed over the surface and dried for 48 hours in an inert gas stream at 25 ° C.

In the following examples, a complex of hydrogen peroxide with various compounds was obtained directly in solution for casting a hydrophilic layer.

Example 9

26 g of 1,3-dimethyl carbamide, 28 g (37%) of hydrogen peroxide are added to a 100 cm ³ solution for casting a hydrophilic layer. The mixture is stirred for 2 hours at 25-30 ° C, 0.25 zinc gluconate, 0.1 g of pyridinecarboxylic acid are added, and stirred for 1 hour. The resulting mixture is evenly distributed on the surface of a previously prepared and dried hydrophobic layer with a size of 300 × 400 mm; dried at 25 ° C for 48 hours in a stream of inert gas.

Example 10

Analogously to example 9, to a 100 cm ³ solution for casting a hydrophilic layer, 2.5 g of polyvinylpyrrolidone (K-30), 13.5 ml of 37% hydrogen peroxide are successively added and stirred at a temperature of 25-30 ° C for 4 hours. 0.2 g of zinc citrate, 0.2 g of succinic acid, 0.2 g of potassium nitric acid are added to the resulting mixture, and a film is cast on the surface of a dried hydrophobic layer 300 × 400 mm in size.

Example 11

Analogously to example 9, 5.1 g of a vinylpyrrolidone-vinyl acetate copolymer (Kollidon VA 64, BASF), 13.5 ml of 37% hydrogen peroxide and 3 g of hydroperite are successively added to a 100 cm ³ solution for casting a hydrophilic layer. The mixture is stirred at a temperature of 25-30 ° C for 4 hours. 0.4 g of potassium nitric acid, 0.2 g of sodium stannate, 0.2 g of pyrophosphoric acid are added to the resulting mixture, stirred at 25-30 ° C for 1 hour, and the film is cast on the surface of a dried hydrophobic layer 300 × 400 mm in size.

Example 12

Analogously to example 9, 5.1 g of polyvinylpyrrolidone (Kollidon 90 F, BASF), 13.5 ml of 37% hydrogen peroxide and 7 g of hydroperite are successively added to a 100 cm ³ solution for casting a hydrophilic layer. The mixture is stirred at a temperature of 25-30 ° C for 4 hours. To the resulting mixture, 0.9 g of zinc sulfate, 0.8 g of Trilon B, 0.4 g of potassium nitric acid are added, stirred at a temperature of 25-30 ° C for 1 hour and the film is cast on the surface of a dried hydrophobic layer 300 × 400 mm in size .

Example 13

Analogously to example 9, 6 g of poly (vinyl methyl ether) and 13.5 ml of 37% hydrogen peroxide are successively added to a 100 cm ³ solution for casting a hydrophilic layer and stirred at a temperature of 25-30 ° C for 4 hours. 0.2 g of sodium stannate, 0.2 g of succinic acid, 0.2 g of tin fluoride are added to the resulting mixture, stirred at a temperature of 25-30 ° C for 1 hour and the film is cast.

Example 14

Analogously to example 9, to 100 cm ^{3 of a} solution for casting a hydrophilic layer, 6 g of sodium alginate, 13.5 ml of 37% hydrogen peroxide are successively added and stirred at a temperature of 25-30 ° C for 4 hours. 0.2 g of zinc sulfate, 0.2 g of cadmium sulfate, 0.1 g of NaF and 0.2 g of Trilon B are added to the resulting mixture, stirred at 25-30 ° C for 1 hour and the film is cast.

Example 15

Analogously to example 9, to 100 cm ^{3 of a} solution for casting a hydrophilic layer, 12 g of propionamide, 13.5 ml of 37% hydrogen peroxide are successively added and stirred at a temperature of 25-30 ° C for 4 hours. 0.25 g of zinc citrate, 0.2 g of sodium fluoride, 0.2 g of nitrilotriacetic acid are added to the resulting mixture; stirred at a temperature of 25-30 ° C for 1 hour and the film is cast.

Example 16

Analogously to example 9, to 100 cm ^{3 of a} solution for casting a hydrophilic layer, 6 g of calcium hydroxide, 13.5 ml of 37% hydrogen peroxide are successively added and stirred at a temperature of 25-30 ° C for 4 hours. To the resulting mixture, 0.2 sodium stanate is added. 0.2 g of sodium salt of pyrophosphoric acid (Na ₄ P ₂ O ₇ ), stirred at a temperature of 25-30 ° C for 1 hour and the film is cast.

Claims (7)

1. A tool for teeth whitening in the form of a film containing hydrogen peroxide, characterized in that the film is made of combined hydrophobic and hydrophilic layers, while the hydrophilic layer includes hydrogen peroxide or its complexes with organic, inorganic and polymeric compounds, as well as fluorine-containing compounds and / or potassium nitrate, and auxiliary ingredients are included both in the hydrophilic and hydrophobic layers of the film, and the content of the whitening ingredient in terms of hydrogen peroxide is 1.2-1 5 mg / cm ² with a film thickness of 0.2-0.6 mm 2. The tool according to claim 1, characterized in that it further comprises partially soluble natural or synthetic polymers biocompatible with the active component of the hydrophilic layer in an amount of not more than 30% of its weight, selected from the group: polyglycolic acid, polylactic acid, polytetramethylene glycolide, poly (DL-decanolactone), polyalkylene oxide polymers and their copolymers, ion exchange resins, butyl cellulose, partially water-soluble polymers and copolymers of vinyl acetate, vinylpyrrolidone. 3. The tool according to claim 1, characterized in that the use of hydrogen peroxide complexes selected from the group with polyvinyl alcohol, polyvinyl methyl ether, polyvinyl methyl ketone, polyacrylic acid, polyvinyl acetate, cellulose acetate, sodium alginate, cellulose sulfate (sodium salt), glycine, polyvinylpyrrol , a copolymer of N-vinyl-2-pyrrolidone with vinyl acetate, a copolymer of N-vinyl-2-pyrrolidone with vinyl methyl ether, histamine, propionamide, carbamide, 1,3-dimethylurea, biuret, polyacrylamide, nylon-6, poly irpoliuretanom, L-histamine, poly-4-vinylpyridine, sodium carbonate, potassium carbonate, calcium gidroksidrom, sodium bicarbonate, sodium pirrofosfatom, rubidium carbonate, ammonium fluoride. 4. The tool according to claim 1, characterized in that as the fluorine-containing compounds, it contains inorganic and complex fluorine-containing compounds, mixtures of two or more metal fluorides, mixtures of organic and inorganic fluorine-containing compounds. 5. The tool according to claim 1, characterized in that as auxiliary substances the hydrophilic and hydrophobic layers of the film contain plasticizers in an amount of not more than 10% by weight of the active ingredient in the layer. 6. A method of whitening teeth by applying a film with a bleaching agent to their surface, characterized in that the agent according to claim 1 is glued onto the moist front surface of the dentition along the gum line with a hydrophilic layer for 2-4 hours 7. The method according to claim 6, characterized in that the film can be applied simultaneously on the upper and lower dentition.