Dissolvable films containing high concentrations of non-ionic surfactants such as polysorbates to enhance high solid loadings

FIELD: chemistry.

SUBSTANCE: group of inventions relates to an oral care composition and method of making thereof. An oral care composition comprising a film in an amount of 0.1 wt % to 5.0 wt %, entrained in a carrier, wherein the film comprises a non-ionic surfactant polysorbate 80 in an amount from 10.5 wt % of the film to 20 wt % of the film and a solid calcium peroxide in the amount of 20% to 65% of the film weight. The film may further comprise a therapeutic active in the amount of 0.01 to 30 wt % of the film. The method of making an oral care composition being a dental care product, comprises as follows: (a) providing the carrier; (b) adding lamellar fragments of the film comprising polysorbate, in an amount of from 10.5 wt % of the film to 20 wt % of the film and a solid ingredient comprising calcium peroxide in an amount of from 20 wt % of the film to 65 wt % of the film; and (c) homogenizing the mixture, whereas the film is present in the amount of 0.1 wt % to 5.0 wt % of the of the total weigh of the composition.

EFFECT: higher active material loading in the film formula provides benefits, including reduced amount of film needed in a product, which is at the same time delivering improved efficacy with lower (0,1-5,0 wt %) loading of the film in the dental care composition.

6 cl, 5 tbl, 1 ex

 

The level of technology

The present application relates to compositions for the care of teeth and personal hygiene, and more particularly, to compositions containing film held in the carrier, where the film contains a relatively high concentration of non-ionic surfactants, such as Polysorbate. Such compositions include, for example, for cleaning teeth. The high concentration of non-ionic surfactants increases the capacity of the film in relation to the load of solids.

Aesthetic appeal of such compositions is important, and it can have a significant impact on the acceptability and use for consumers. Aesthetic impact, as recognized to play an important role in consumer perception of many products. Although these products can cause the approval of the consumer, the experts in this field are trying to improve aesthetic impact, as well as cosmetic and therapeutic benefits of these products. Indeed, many such compositions are known in this area, have one or more attributes.

Compositions for improving the health, hygiene or appearance, such as compositions for caring for the oral cavity, the composition for skin care and composition for hair care, used by millions l�dei. These compositions are used for a variety of purposes, including improving personal health, hygiene and appearance, and to prevent or treat various diseases and other conditions in humans and in animals.

The preparation of such compositions gives a number of problems. They must be pharmaceutically and/or cosmetically acceptable for their intended use. Compositions that contain a therapeutically active materials, preferably deliver the active materials at effective levels, eliminating unnecessary chemical degradation. Similarly, a composition containing a cosmetically functional materials, must deliver the material, for example, in the oral cavity, on the skin or on the hair with effective levels in the environment in which they, as a rule, are used by the consumer.

Water-soluble film for oral administration of therapeutic agents are well known in this field. It is also well known in this field, the use of such films for the introduction of agent for refreshing the mouth, for example, menthol. Famous film for introducing agents to refresh the oral cavity and/or active pharmaceutical agents typically consist of at least one water-soluble polymer suitable for human consumption, and at least one with�unity, which improves the wettability of the water-soluble polymer, typically selected from polysperchon, surfactants and plasticizers. For example, U.S. patent No. 5948430, the description of which is incorporated herein by reference in its entirety, describes a single-layer film, which can stick in the mouth for the release of pharmaceutically or cosmetically active ingredient, where the film contains at least one water-soluble polymer; at least one element selected from the group consisting of polisport, a surfactant and a plasticizer; at least one cosmetic or pharmaceutically active ingredient and a flavoring agent.

U.S. patent No. 5700478, the description of which is incorporated herein by reference in its entirety, describes a laminated device for controlled release of substances in the body cavity with mucous membrane containing a layer of water-soluble adhesive consisting of a water-soluble polymer and a water-soluble plasticizer, and from a layer of water-soluble polymer. The patent describes a multi-layer laminate, which dissolves relatively slowly for controlled or delayed release of the substance.

U.S. patent No. 4900552, the description of which VC�udaetsa herein by reference in its entirety describes a three-layer laminated film suitable for prolonged and delayed delivery of the active ingredient in the buccal pocket. Three-layer laminate contains hydrotherapy mucoadhesives the core layer; neadgezivnye the reservoir layer and waterproof barrier, enclosed between the base layer and the reservoir layer and the associated. This patent describes slowly retryplease film for extended or delayed release of the substance.

U.S. patent No. 5047244, the description of which is incorporated herein by reference in its entirety, describes a therapeutic dosage form containing anhydrous, but gidratiruta monolithic polymer matrix that contains amorphous, colloidal silicon dioxide, and a therapeutic agent and a water insoluble barrier layer, coupled with the polymer matrix and defines naughtyboy the front side. This patent does not describe quickly retryplease films, but instead involves compositions capable of providing improved availability of therapeutic agents from the system mucoadhesive media controlled release.

U.S. patent No. 6669929 and publication of the patent application U.S. No. 2003/0053962, a description of each is incorporated herein by reference in its entirety, op�attributable to film-forming agents, suitable for use in compositions for the care of the oral cavity. Film dissolve in the mouth and release of functional components, as a rule, flavors.

Know the inclusion of fragrance, dyes and some active components in the films that dissolve in the oral cavity. These films are used either by themselves as strips, refreshing, mouth, stripes, teeth whitening, or as a polymeric flakes, dispersed in a composition for caring for the oral cavity. Also known to the incorporation of zinc salts in preparations of means for brushing your teeth.

Soluble film is able to capture the active substance and other types of solid ingredients. However, this amount of solid foods can overload the matrix film, forming a limit for the quantity of solid foods it may contain. It forms a barrier on how much you can load into film, and this may increase the cost of the films used in the products.

Thus, there is a continuing need for new compositions for the care of teeth and personal hygiene and how to use them.

Summary of the invention

The present invention provides, in various embodiments, the composition for care of teeth and personal hygiene containing film held � media where the film contains a relatively high concentration of non-ionic surfactants, such as Polysorbate. In one of the embodiments, the film is provided in the form of a plurality of portions of the film. In various embodiments, the present invention provides compositions containing a variety of lamellar fragments in the media.

In one embodiment, the implementation of the composition for oral care contains a film held in the carrier, wherein the film contains a nonionic surfactant in an amount of from 5% by weight of the film to 20% by weight of the film. The increase in loading of solid products in the preparation of the film facilitates the delivery of active substances per unit area that is important for superior performance.

Implementation options also provide for methods of obtaining films and methods of administration of active compounds to a subject human or animal in need of this, the method comprises local application of the subject compositions for the care of mouth cavity containing film held in the carrier, where the film contains a nonionic surfactant in an amount of from 5% by weight of the film to 20% by weight of the film. In various ways, such methods include the destruction of the film after the local nanseni�.

Compositions and methods of the present invention provide advantages in comparison with the compositions and methods of those known in this field. Such advantages include one or more of the benefits from improved acceptability to the consumer, improving the number of available active substances, reduce the adverse reactions caused by the presence of active substances, improve aesthetics, improve the stability of active substances or other functional materials, and controlled delivery of active materials. Other advantages and embodiments of the present invention will become clear from the following further description.

Description

The present invention provides compositions and methods for administration to a subject person or other animal, or to use them. Preferably, the specific materials and compositions to be used in the present invention are, respectively, a pharmaceutically or cosmetically acceptable. As used herein, a “pharmaceutically acceptable” or “cosmetically acceptable” component is a component that is suitable for use with humans and/or animals to provide the desired therapeutic, sensory, decorative or cosmetic�th benefits without undue adverse side effects (such as toxicity, astringent taste, irritation and allergic response) corresponding to a reasonable relation to the benefit/risk. The following definitions and non-limiting descriptions should be taken into account when reading and interpreting the description of the present invention contained herein.

The headings (such as “Introduction” and “Essence”) used herein are intended only for General organization of topics in the description of the present invention and are not intended to limit the description of the present invention or any aspect of it. In particular, the subject matter described in the “Introduction” may include aspects of technology within the framework of the present invention and may not be a citation of the literature. The subject matter described in the section “summary of the invention”, does not constitute an exhaustive or complete description of the full scope of the present invention or any of its variants of the implementation.

Citation of references herein does not constitute any acknowledgement of the fact that these links represent the current level of technology or have any relation to the possibility of patenting the invention described herein. All references cited in the Description section of the present description, thus are included as references in the armed forces�th their entirety.

Description and specific examples, although they point to embodiments of the present invention, are intended for illustrative purposes only and are not intended to limit the scope of the present invention. We mentioned many embodiments, having formulated symptoms, not intended to exclude other embodiments having additional features, or other variants of implementation, containing various combinations of the stated features. Specific Examples are given for illustrative purposes of how to obtain, use and implement the compositions and methods of the present invention, if not explicitly formulated a listing of activities that are performed (i.e., using the past tense), they are not intended to represent the fact that these embodiments of the present invention is really implemented or not implemented.

As used herein, the words “preferred” and “preferably” refer to variants of implementation of the present invention, which provide certain advantages under certain circumstances. However, other options for implementation may also be preferable in the same or in other circumstances. In addition, �the remembrance of one or more preferred embodiments does not imply that, other implementation options are not suitable for use, and is not intended to exclude other embodiments from the scope of the present invention. As used herein, the word “include” and its variants is assumed to be non-limiting, so that the reference points in the list shall not preclude other similar items that may also be suitable for use in the materials, compositions, devices and methods of the present invention. Similarly, the description of certain advantages or disadvantages of the known materials and methods is not intended to limit the scope of embodiments of their exclusion. Indeed, some of the options for implementation may include one or more known materials or methods, without suffering from the shortcomings discussed in this document.

As used herein, the term “containing” means that other steps and other components that do not affect the final result, can be used. The term “containing” includes the expression “consisting of” and “consisting essentially of”. The expression “effective amount”, as used herein, means an amount of compound or composition sufficient for significant p�to provide positive benefits, preferably, benefits for oral health, but low enough to avoid any serious side effects, i.e. to provide a reasonable relationship of benefit to risk, within a clear judgment of the person skilled in the art. The use of the singular is not supposed to be constrained to a single component, but may include a variety of components.

Compositions for caring for the oral cavity the various embodiments are preferably in the form of the means for brushing your teeth. The term “dentifrice”, as used in the present description, means paste, gel or liquid drug. The dentifrice may be in any desired form, for example, it may have deep stripes, surface, strips multiple layers, having the gel surrounding the paste, or create any combinations thereof. The film is contained in a composition for caring for the oral cavity may have any desired shape or structure, including a multitude of small strips or one continuous strip.

The expression “carrier” or “aqueous medium” as used in the present description, means any safe and effective materials for use in the present invention. Such materials include, for example, thickening agents, moisturizers, inyectable ingredients buffer agents, anticellulite agents, abrasive polishing materials, peroxide sources, bicarbonate alkali metal salts, surfactants, titanium dioxide, coloring agents, flavors, sweetening agents, antimicrobial agents, herbal agents, desensitizing agents, agents that reduce the staining, and mixtures thereof.

All percentages and rates used in this document, constitute the mass percentage of the composition to care for the oral cavity, unless otherwise specified. All measurements are carried out at 25ºC, unless otherwise indicated.

The present invention provides a composition for caring for the oral cavity or for personal hygiene, containing a film held in the carrier, where the film contains a relatively high concentration of non-ionic surfactants, such as Polysorbate. As mentioned herein, “composition for the care of the oral cavity or for personal hygiene” are any composition which is suitable for administration or application to a subject human or animal to improve the health, hygiene or appearance of the subject, including the prevention or treatment of any physiological condition or disorder, and providing sensory, decorative or cosmetic benefits�, and combinations thereof. The composition of those covered herein include compositions for caring for the oral cavity, the composition for skin care compositions for hair care, pharmaceutical compositions for local application and ocular composition. Under “composition for caring for the oral cavity”, as used herein, means a composition for which the intended use can include care for the oral cavity, oral hygiene or appearance of the oral cavity, or such for which the intended use can include introducing into the oral cavity.

Embodiments of the present invention include film. As mentioned herein, “film” is a material having essentially a lamellar structure. “Lamellar” structure has or may have the size in one or two directions (e.g., x - or y-directions), which is inherently much greater than the thickness of the structure in the third direction (e.g., in the z-direction). Lamellar patterns from those that are suitable for use in the present invention include structures that are essentially planar, have a layered or lamellar form. In one of the embodiments, the lamellar structure is essentially a plan�world, having the size in the x-and y-directions, which is significantly more than in the z-direction. In other embodiments, the lamellar structure is non-planar. In one of the embodiments of the film of this appointment contains essentially continuous surface that can appear as a substantially flat surface, although in some embodiments, the film is deformed. In such embodiments, the film may have any of several forms, including a smooth curved surface.

Films from those that are suitable for use in the present invention can be rigid or plastic, to contain any of a variety of materials, including materials selected from the group consisting of film-forming materials, clays, waxes and their mixtures. In one embodiment of the film contains a film-forming polymer. Film-forming polymers, which are suitable for use in the present invention include materials selected from the group consisting of water-soluble polymers, water-dispersible polymers in water, water-insoluble polymers, and mixtures thereof.

In some embodiments, the film contains at least one film-forming material. In certain embodiments, the film-forming material presented�ing a polymer. Polymers suitable for use in the present invention include hydrophilic polymers and hydrophobic polymers. In certain embodiments, the polymer is a water-soluble polymer. In some embodiments, the polymer is a water-soluble, erodible polymer that dissolves during use, for example, while brushing your teeth brush. The dissolution can be carried out, for example, due to shear effects and/or exposure to a solvent containing a high concentration of water, such as saliva. In some embodiments, the polymer is insoluble, but is destroyed in the water, being water-dispersible, i.e., the polymer breaks down into small fragments, for example, due to shear effects. In some embodiments, the polymer is insoluble, but Nauheim. In configurations in which the polymer is not destroyed during use, the polymer may be a water-repellent polymer or stable in water hydrophilic polymer, such as certain types of cellulose, e.g., paper. In some embodiments, a fragment of the film may contain a mixture of film-forming materials.

Water-soluble polymers, which are suitable for use in the present every�the acquisition, include cellulose ethers, methacrylates, polyvinylpyrrolidone, and mixtures thereof. In one of the embodiments the polymer is a simple cellulose ether including those selected from the group consisting of polymers of hydroxyethylcellulose such as hydroxypropylmethyl cellulose (HPMC), hydroxypropyl cellulose, hydroxyethylcellulose, methylcellulose, carboxymethylcellulose and mixtures thereof. Other polymers, which are suitable for use in the present invention include polyvinylpyrrolidone, cross stitched polyvinylpyrrolidone, copolymer of polyvinylpyrrolidone-vinyl acetate, polyvinyl alcohol, polyacrylic acid, polyacrylate polymer, cross stitched polyacrylate polymer, cross stitched polyacrylic acid (e.g. Carbopol®), polyethylene oxide, polyethylene glycol, a copolymer of a simple polyvinylalcohol ether - maleic acid (such as Gantrez®) and carboxyvinyl polymer; natural resins, such as sodium alginate, carrageenan, xanthan gum, acacia gum, acacia gum, guar gum, pullulan, agar, chitin, chitosan, pectin, gum karaya resin, Zein, hordein, gliadin, gum beans carob, resin tragakant and other polysaccharides; starches such as maltodextrin, amylose, starch with a high content of amylose, corn starch, potato collapse�al, rice starch, tapioca starch, pea starch, potata starch, barley starch, wheat starch, waxy corn starch, modified starch (e.g., hydroxypropyltrimonium starch with high amylose content), dextrin, Levan, Alsina and gluten; and proteins such as collagen, whey protein isolate, casein, milk protein, soy protein and gelatin.

Non-limiting examples of water-dispersible and water swellable polymers include modified starch, alginate complex esters, salts of alginates and divalent or multivalent ions. Non-limiting examples of water insoluble polymers include polymers soluble in at least one organic solvent, such as cellulose acetate, cellulose nitrate, copolymers of ethylene-vinyl acetate copolymer, vinyl acetate homopolymer, ethylcellulose, butyltoluene, isopropylethylene, shellac, silicone polymer (e.g., dimethylsilicone), PMMA (polymethylmethacrylate), acetated cellulose and natural or synthetic rubber; polymers insoluble in organic solvents, such as cellulose, polyethylene, polypropylene, polyesters, polyurethane and nylon.

Films suitable for use in various embodiments, can be obtained according to methods described in us Pat�the USA No. 6669929, and in the publication of the patent application U.S. No. 2003/0053962, the description of each is incorporated herein by reference in its entirety. The nonionic surfactant contained in the film can be incorporated into the film during the reception of a film using technologies known in this field. The person skilled in the art will be able to get film containing high concentrations of nonionic surfactants, using the instructions in this document.

The polymer matrix used in many soluble films, which are preferred in certain embodiments, has a limited capacity for the amount of solid foods she can hold. This creates a barrier as to what may be a burden on the film, and may increase the cost of the films used in the products. However, there may be some modification of the drug, to improve the integrity of the matrix films, to keep a high loading of solid products. The authors present invention found that by increasing the number of non-ionic surfactants, the film can be loaded with a large number of active substances than could be done previously. Film having a higher end�Tracey active substances, enables the delivery of a larger amount of active substances per unit area, and reduces the number of tapes that are required to deliver these higher amounts. Improved drug film with a higher load provides higher deposition on the surfaces to obtain excellent efficiency. The improvement of the preparation of the film to hold a higher load of active substances can reduce the number of films, in General, necessary for the product, while at the same time providing the same efficiency and at lower load film. Without wanting to be limited by any theory of operation, the authors of the present invention suggest that nonionic surfactants are, helping other ingredients to dissolve in a solvent, and contribute to the formation of emulsions by reducing the surface tension of the substances that are to emulsifications. In addition, the nonionic surfactants do not adversely impact other ingredients in the product, as happens with anionic and cationic surfactants. As such, many different active ingredients can be used in the product together with nonionic surfactants.

Preferred pionni� surfactants include Polysorbate, such as Polysorbate 20, 40, 60, 80, or combinations thereof. Particularly preferred embodiments of include Polysorbate 80. Typical concentrations of polysorbates, previously used in preparations of soluble films, approximately 2% of dry mass to help in the loosening of the film. The authors found that by increasing the concentration of nonionic surfactants in the preparation of the film can be obtained a higher solids load and the speed of ripping is not affected by the loading of solid products. The amount of nonionic surfactants included in the film may vary from 5% by weight of the film to 20% by weight of the film is preferably from 10% by weight of the film up to 18% by weight of the film, and most preferably, to reach 14% by weight of the film.

The amount of solid products included in the film, can vary from 20% to 65% by weight of the film is preferably from 30% to 55% by weight of the film, and most preferably 45% by weight of the film. The number of films included in the composition for oral care, can also be changed in the range from 0.1% to 5.0%, more preferably, from 0.25% to 3.0%, and most preferably from 0.5% to 2.0% of mass. The amount of solid ingredients used in compositions for oral care in General and, therefore, may change�trust from 0.02% to 3.25%, in relation to the total weight of the composition, typically from 0.08% to 1.5%, relative to the total weight of the composition to care for the oral cavity.

In various embodiments, the composition for caring for the oral cavity contains many lamellar fragments of the film held in the carrier. In one embodiments, the composition comprises a film, where the film contains lamellar fragments of the film material. In one of the embodiments the composition comprises a carrier in which is distributed a variety of lamellar fragments, where the fragments contain a matrix and a therapeutically active substance. In one of these embodiments, the matrix contains the film. Such fragments can be in any of many forms or shapes, including semi-solid or solid portions, fragments, particles, flakes, or combinations thereof. In various embodiments, the film contains the first fragments and second fragments, where the fragments is different in composition or appearance from the second plurality of fragments. This difference in composition or appearance may occur in any aspect of the composition of the fragment (for example, the various components of the film, various functional materials, various dyes of the drug), the difference in appearance (for example, f�PMS, color, texture, refractive index, reflection coefficient) or a combination thereof.

In various embodiments, the fragments show a noticeable contrast with the media. A marked contrast can be a touch of contrast, such as optical contrast, tactile contrast, gustatory contrast or olfactory contrast. In some configurations, the optical contrast can be a color contrast or the difference in refractive index or reflectance. In some configurations, the color contrast may be given one or more dyes that make up the various components of the composition. In various embodiments, the present invention provides compositions comprising a plurality of film fragments in the media, where these fragments are distinguishable by eye. As mentioned herein, “visible to the eye” refers to one or more characteristics of the fragment, which give the fragment physically distinguishable appearance, preferably distinguishable to the naked eye, compared to media, which is retained fragment. These characteristics include color, turbidity, refractive index, reflectivity, size, shape, and combinations thereof.

In various embodiments implemented�I fragments have a non-random shape. In one of the embodiments, “non-random” shape is a shape which results from the production method, molding, cutting or other method of forming, by means of which the fragment is given a specific shape. In such embodiments, a non-random form differs from these forms, which are obtained by simple precipitation or decomposition of the material. In one embodiment, the implementation of “non-random” shape is “repeated”, when the composition contains multiple fragments, which have essentially the same shape. Kind of repetitive form can be any of the many forms and can be selected on the basis of various aesthetic or functional criteria. In certain embodiments, the shape of the piece of film can be a distinct form. In certain embodiments, a fragment of the film may have a non-random shape. These include simple geometric shapes, such as polygons and elliptical shapes, such as triangles, quadrilaterals (such as square, rectangle, rhombus), pentagons, hexagons, ovals and circles. In one of the embodiments of the repeating shape is a square. Duplicate forms include, in other embodiments, forms,�, who represent shapes or living or nonliving objects such as stars, hearts, gems, flowers, trees, Shamrock letter of the alphabet, numbers, animals, people and faces. In various embodiments, the composition comprises a single repeating shape. In other embodiments, the composition comprises multiple fragments having a plurality of repetitive shapes. In one of the embodiments of the compositions of the present invention contain a lot of first film fragments having a first repeated shape, and a lot of second film fragments having a second repeated shape, where the first repeating shape is different from the second duplicate of the form.

In various embodiments, the size of the fragments is not critical and may be determined based on any criteria from a variety of criteria, including ease of obtaining, the impact on the external appearance, surface area, effect on the texture of the composition, and combinations thereof. In some embodiments, the film fragments can be up to 1 inch (25.4 mm) in the longest direction. As mentioned herein, the direction along the length” represents the direction of the fragment of the length or width (i.e., in the x - and y-directions when the fragment is or is deformed so that it is in a planar shape) in a direction essentially perpendicular to the thickness�� or the shortest direction of the fragment (i.e., z-direction). It is clear that in various embodiments comprising a plurality of fragments, the fragments may be present in a range of sizes due to many factors, including random variation in the dimensions, tolerances in the manufacture and intentional sizing or mixing fragments by sieving or similar tools. As mentioned in this document, the sizes refer to the average size of fragments in a given set of fragments.

In various embodiments, the fragments are from 0.2 mm to 15 mm in the direction along the length. In various embodiments, the direction of the fragments in the length range from 0.2 mm to 10 mm, from 0.5 mm to 10 mm from 0.8 mm to 8 mm, 0.9 mm to 5 mm, from 1.0 mm to 5 mm, or from 1.5 mm to 2.5 mm. In some embodiments, the direction of the fragments by length is at least 3 mm, and can range from 6 mm to 13 mm. In certain embodiments, multiple portions of the film are greater than 600 microns in the direction of the greatest length. In certain embodiments, multiple fragments of the films are larger than 1 millimeter in the direction of the greatest length.

In various embodiments, the fragments of the present invention have a thickness of from 1 mil (thousandths of an inch, 25.4 micrometers) to 3 mils (76.2 per ICRI�n). In various embodiments, the fragments have a thickness less than 4 mils or less than 100 microns and from 0.1 mil (2.54 microns) to 10 mils (254 microns), from about 0.5 mil (12.7 microns) to 5 mils (127 microns), from 1.4 mil (35.6 micron) 2.0 mil (50.8 micron).

In some embodiments, the compositions of the present invention contain fragments having an aspect ratio of at least 5:1. As referred to herein, "aspect ratio" of a fragment is the ratio of the diameter of the smallest imaginary sphere that encloses the object to the diameter of the largest imaginary sphere that can be completely inside the object and touch the surface of the object. For example, the aspect ratio of a sphere is 1:1; in another example, the aspect ratio of a cylinder that has a length of 2 inches (50.8 mm) diameter and 1/4 inch (6.35 mm) slightly more than 8:1; in another example, a fragment of film of the present invention, which has a thickness of 1 mil (25.4 micron), length 1 inch (25.4 mm) and a width of 1 inch (25.4 mm), has an aspect ratio 1414:1.

In some embodiments, the compositions of the present invention contain fragments having an aspect ratio of at least 10:1. In various embodiments, the fragments have an aspect ratio of from 5:1 to 10000:1, from 5:1 to 500:1, from 10:1 to 1000:1, from 10:1 to 100:1, from 20:1 to 100:1, Il� from 25:1 to 35:1.

In various embodiments, the film contains a dye of the drug, which gives color to the film composition, or both that and another. In various embodiments, portions of the film are contrasted with the carrier and are white, black or any color that is visible against the carrier or contrasts with it. The dyes of the drug from those that are suitable for use in the present invention include non-toxic water-soluble dyes or pigment, such, for example, how "lucky" of metal oxide. In certain embodiments, the dye is approved for inclusion in a food product or a drug regulatory authority, for example, pigments and dyes FD&C or D&C approved by the FDA for use in the United States of America. Dyes, which are suitable for use herein include FD&C Red No. 3 (sodium salt of tetraiodofluorescein), Food Red 17, disodium salt of 6-hydroxy-5-{(2-methoxy-5-methyl-4-sulfophenyl)azo}-2-naphthalenesulfonate acid, Food Yellow 13, sodium salt of mixture of mono - and disulfonic acids chieftain or 2-(2-chinolin)indandiona, FD&C Yellow No. 5 (sodium salt of 4-p-sulfophenylazo-1-p-sulfophenyl-5-hydroxypyrazol-3-carboxylic acid), FD&C Yellow No. 6 (sodium salt of p-sulfophenylazo-B-naphthol-6-monosulphate), FD&C Green No. 3 (di�freeway salt of 4-{[4-(N-ethyl-p-sulfanilamide)-phenyl]-(4-hydroxy-2-sulfonatophenyl)-methylene}-[1-(N-ethyl-N-p-sulfobutyl)-∆-3,5-cyclohexadienone], FD&C Blue No. 1 (disodium salt of the anhydrite dibenzylidene- acid), FD&C Blue No. 2 (sodium salt disulfonate acid and indigotine) and their mixtures, in varying proportions. In one of the embodiments of the dye contains water-insoluble inorganic pigment, such as titanium dioxide, chromium oxide green, phthalocyanine green, ultramarine blue, iron (III) oxide or water-insoluble coloring varnish. In some embodiments, dyes, varnishes include calcium or aluminum salt of the dye FD&C, such as lacquer FD&C Green #1, lacquer FD&C Blue #2, Lac D&C Red #30 or lacquer FD&C # Yellow 15. In certain embodiments, the water-soluble dye, such as FD&C Blue #1, contained in the water-insoluble polymer, such as polyethylene, as can be found in plastic beads (e.g., Microblue Spectrabeads sold by Micropowders, Inc.). In certain embodiments, the film contains a dye such as D&C Red #30. In certain embodiments, uses the white dye, for example, titanium dioxide (TiO2), mica covered with titanium dioxide (for example, Timiron), mineral or clay. In certain embodiments, the dye is neraspavsheysya dye. In various embodiments, the film contains to�acetel at a level of from 0.5% to 20% by weight of the film or from 1% to 15% by weight of the film, or from 3% to 12% by weight of the film. In one of the embodiments of the compositions of the present invention contain a first set of portions of the film having the first color and the second set of film fragments having a second color. Preferably, the second color different from the first color.

Film of the present invention, in various embodiments, loosened during use of the composition. In other embodiments, the film is not loosened during use of the composition. In some embodiments, the film releases a material, such as a therapeutically active substance in a carrier. As mentioned in this document, “razryhlitelya” refers to the physical destruction of the material film or fragment to produce a film or film fragments of reduced size compared to the original film. Such destruction may be accomplished by mechanical, chemical or physical-chemical means. Loosening can occur, for example, due to shear impact, crushing, or exposure to elevated temperatures during use. In various embodiments, the means for cleaning teeth according to the present invention this loosening occurs as a result of the distribution of the composition with a toothbrush on the teeth of subje�the one using the composition. In one of the embodiments, the film is loosened to release therapeutically active substance. In some embodiments, a fragment of a film can razryhlitelya in the form of small pieces that are not visually distinguishable. In some embodiments, the film fragments are loosened to collectively form a colloid or gel.

In various embodiments, the film may contain a therapeutically active substance. As mentioned herein, therapeutically active substance is a material which is suitable for the prevention or treatment of a physiological disorder or condition. Such disorder or condition include problems of the oral cavity (including teeth and gums), skin, hair and eyes. The specific therapeutically active substance is preferably determined in accordance with the desired utility of the composition. Such active substances include the following:

A. antimicrobial agents, such as triclosan, cetylpyridinium chloride, domiphen bromide, Quaternary ammonium salts, sanguinarine, fluorides, alexidine, octenidine, EDTA, essential oils such as thymol, methyl salicylate, eucalyptol and menthol, and zinc compounds and the like;

B. nonsteroidal anti-inflammatory drug with�of estva, such as aspirin, acetaminophen, ibuprofen, Ketoprofen, diflunisal, calcium fenoprofen, naproxen, sodium of tolmetin, indomethacin and the like;

C. remedies against cough, such as benzonatate, caramiphen edisylate, menthol, dextromethorphan hydrobromide, chlophedianol hydrochloride and the like;

D. decongestants, such as pseudoephedrine hydrochloride, phenylepherine, phenylpropanolamine, pseudoephedrine sulfate, and the like;

E. antihistamines, such as brompheniramine maleate, chlorpheniramine maleate, carbinoxamine maleate, clemastine fumarate, dexchlorpheniramine maleate, diphenhydramine hydrochloride, diphenylpyraline hydrochloride, azatadine maleat, diphenhydramine citrate, doxylamine succinate, promethazine hydrochloride, pyrilamine maleate, tripelennamine citrate, triprolidine hydrochloride, acrivastine, loratadine, brompheniramine, dexbrompheniramine and the like;

F. expectorants, such as guaifenesin, the ipecac, potassium iodide, Turpin hydrate and the like;

G. anti-diarrhoeal agents such as loperamide, and the like;

H. H2 antagonists, such as famotidine, ranitidine, and the like; and

I. proton pump inhibitors such as omeprazole, lansoprazole and the like;

J. General nonselective CNS depressants (Central nervous system), such as aliphatic alcohols, BA�barbiturates and the like;

K. General nonselective CNS stimulants, such as caffeine, nicotine, strychnine, picrotoxin, pentylenetetrazol and the like;

L. drugs that selectively modifying the functioning of the CNS, such as frigidity, phenobarbital, primidone, carbamazepine, ethosuximide, methsuximide, phensuximide, trimethadione, diazepam, benzodiazepines, phenacemide, ventured, acetazolamide, Altium, bromide and the like;

M. antiparkinsonian drugs such as levodopa, amantadine and the like;

N. drugs-analgesics, such as morphine, heroin, hydromorphone, metopon, Oxymorphone, Levorphanol, codeine, hydrocodone, xycodone, nalorphine, naloxone, naltrexone and the like;

O. analgesic-antipyretics such as salicylates, phenylbutazone, indomethacin, phenacetin and the like; and

P. psychopharmacological drugs such as chlorpromazine, methotrimeprazine, haloperidol, clozapine, reserpine, imipramine, tranylcypromine, phenelzine, lithium and the like.

The amount of drug that can be used in film may depend on the dose necessary to obtain effective amounts of the medication.

In various embodiments, therapeutically active substances suitable for use in the present invention include anticaries agents, �Genty for control of cream of Tartar, agents against dental plaque, periodontal active agents, agents for refreshing the mouth, the agents for the control of bad breath, whitening agents, antibacterial agents, steroids, anti-inflammatory agents, vitamins, proteins, conditioning agents, moisturizers, antiperspirant active substances, desodorante active substances, anesthetics and mixtures thereof.

In certain embodiments, care for the oral cavity film or a composition for caring for the oral cavity may contain the active substance to care for the oral cavity, which is suitable for preventing or treating disorders or condition of the oral cavity. Active substances for the care of mouth from those that are suitable for use in the present invention include abrasives, anticaries agents, agents for cream of Tartar control agents against dental plaque, periodontal active agents, agents for refreshing the mouth, the agents for the control of the breath, desensibilization teeth, salivation stimulants, whitening agents, and combinations thereof. Active materials from those that are suitable for use in the present invention are described in U.S. patent No. 6596298, Leung et al.

Agents for the control of cream of Tartar from those that are suitable for use in the present invention include Dujos�IOD salt or chetyrehskatnye pyrophosphate alkali metal salts, such as Na4P2O7, K4P2O7, Na2K2P2O7, Na2H2P2O7and K2H2P2O7; long chain polyphosphates such as sodium hexametaphosphate; and cyclic phosphates such as sodium trimetaphosphate. In some configurations, the polyphosphate is a calcium pyrophosphate is in beta phase, such as described in U.S. patent No. 6241974, White Jr. In some embodiments, the film contains anticellulitis agent at a level from 15 to 20% by weight of the film.

Agents to reduce unpleasant mouth odor, suitable for use in the present invention include agents for the precipitation of sulfur. The agents for the precipitation of sulfur include metal salts such as a salt of copper or zinc salt. Such salts include copper gluconate, zinc citrate and zinc gluconate. These zinc salts may be used in combination with zinc compounds included in the film, or in addition to them. In various embodiments, the film contains agents for the precipitation of sulfur at a level of from 0.01 to 30% by weight of the film, from 2% to 2.5% by weight of the film or 10% to 20% by weight of the film.

In certain embodiments, the film and/or the composition for oral care may include an agent for stimulating salivation (“succulent”). The agents in�exclude those which are described in U.S. patent No. 4820506, Kleinberg et al. In some configurations, the agents for stimulating salivation may include a food acid such as citric, lactic, malic, succinic, ascorbic, adipic, fumaric and tartaric acid. In various embodiments, the film contains an agent for stimulation of salivation at the level of from 0.01 to 12% by weight of the film, from 1% to 10% by weight of the film or from 2.5% to 6% by weight of the film. In some embodiments, an agent for stimulating salivation can be used to ease dry mouth.

In certain embodiments, to care for the oral cavity, the film contains other active materials, such as antibacterial agents such as Magnolia extract, triclosan, extract of grape seeds, thymol, methyl salicylate, eucalyptol, menthol, acid hop, cetylpyridinium chloride, (including CPC/Zn and CPC + enzymes) and osinova acid; anti-inflammatory agents, such as agents for the refreshment of the oral cavity (for example, zinc gluconate, zinc citrate, zinc chlorite and alpha ionone); desensibilization teeth such as potassium nitrate, desensitizing polymers, and desensitizing minerals; anti-inflammatory agents such as Magnolia extract, ortoleva acid; aloe, and cranberry extract; vitamins such as Pantheon, remineralised, folic acid, tocopherol acetate and Vitamin A; herbal preparations or herbal extracts, such as rosemary, oregano, chamomilla recutita, mentha piperita, salvia officinalis, orcommiphora and myrrh; proteins such as milk proteins and enzymes such as peroxide-producing enzymes, amylase, agents that Deplete plaque, such as papain, glucoamylase, glucose oxidase, and enzymes "next generation"; whitening agents such as hydrogen peroxide, urea peroxide and phosphate salts; medicines such as aspirin (acetylsalicylic acid), caffeine, and benzocaine; probiotics; abrasives such as silicon oxide (including silicon dioxide with a high cleaning effect); anti-caries agents such as salts of tin (e.g., tin fluoride) or amino; synthase inhibitor of nitrogen oxides, such as guanidinoacetate; calcium; ingredients for anti-adhesion, such as polimerbetonov acid; preservatives such as Solbrol® (Bayer Chemicals AG); silicones; compounds of chlorophyll, agents against leukemia, such as beta-carotene; antioxidants, such as Vitamin E; and combinations thereof. In some embodiments, the films contain such active materials at a concentration of from 0.01 to 30% by weight of the film, from 2% to 25% by weight of the film or from 10% to 20% by weight of the film.

Compositions for caring for the oral cavity from the definition�Lenno embodiments include compound of zinc in the film, which provides a source of zinc ions. A compound of zinc may be a soluble or poorly soluble compound of zinc with an inorganic or organic counterions. Examples include fluoride, chloride, chloridoideae, acetate, hexaferrite, sulfate, tartrate, gluconate, citrate, lactate, Malatya, glycinate, pyrophosphate, metaphosphate, oxalate, phosphate, carbonate salts and oxides of zinc. Preferably, the compound of zinc is a zinc oxide and is used as a substitute for conventional antibacterial agents such as triclosan.

Zinc ions are derived from zinc compounds, present in the film in the composition for cleaning teeth in an effective amount. An effective amount of zinc ions is defined as at least 1,000 M. D. zinc ion, preferably, M. D. 2000 to 15000 M. D. More preferably, the zinc ions are present in an amount of from M. D. 3000 to 13,000, M. D., and even more preferably from 4000 to 10000 M. D. M. D. This represents the total number of ions of zinc, which is present in the compositions for delivery to the tooth surface.

Examples of suitable zinc compounds that serve as sources of ions of zinc are zinc oxide, zinc sulfate, zinc chloride, zinc citrate, La�tat zinc, zinc gluconate, malate zinc, zinc tartrate, zinc carbonate, zinc phosphate, and other salts listed in U.S. patent No. 4022880.

In certain embodiments, the film and/or a composition for caring for the oral cavity includes a preservative. A preservative may be added in amounts from 0.001 wt% to 5 wt%, preferably from 0.01% by weight to 1% by weight of the film. Non-limiting examples of preservatives include sodium benzoate and potassium sorbate.

In certain embodiments, the retention therapeutically active substances in the matrix films, suspended in the dentifrice or other composition isolates these agents from interaction with reactive ingredients present in the composition so that the agents are kept essentially separate from chemically active ingredients of the composition during preparation and storage, and they subsequently released from the matrix film, when the composition is used. Isolation not only prevents unwanted reactions that can occur between therapeutically active substances and other components that are present in the base material, but also prevents the dissolution of therapeutically active substances and premature release of the active substances.

The compositions of the present invention contain�at the media in which film is held or fragments. As mentioned herein, a “carrier” is any material or composition that can resist film and which is suitable for administration or application, for the subject is human or animal to whom the composition is injected or applied. As mentioned in this document “withholding” refers to the dip or suspendirovanie film in the media. In various embodiments, containing multiple fragments, such fragments can resist by immersion, suspending, dispersing or other distribution of fragments in the media. In various embodiments, the fragments are distributed in the carrier essentially homogeneous. In other embodiments, the fragments are not distributed homogeneously in the carrier. In certain embodiments, the distribution of a plurality of portions of the film is essentially isotropic in the media. Composition means for brushing your teeth, which include a variety of film fragments, dispersed or suspended in a carrier, are commercially available under the trade name Max Fresh® or Max White®, Colgate-Palmolive Company, New York, N. Y.

The compositions of the embodiments may be described as containing two phases, where one phase contains�it media and the second phase contains discussed above film or a fragment. The term “phase” as used herein means the physical phase, as is understood in physics and materials science, that is, the portion of material whose properties and composition are homogeneous. But the phase, as used herein, may be dispersed, that is, the phase can contain many individual components. For example, multiple fragments of the polymer film, identical to the composition, as is, is one phase. In some embodiments, a fragment of the film can be fully immersed in the material constituting the first phase, or fully or partially exposed on the surface of the first phase. For example, if the composition is a dentifrice containing the gel, and the fragments of a film, a film fragment can be completely surrounded by a gel or partially or fully exposed on the surface of the gel. In certain embodiments, the compositions contain more than two phases. Such multiphase compositions include those which contain two media, each of which contributes a phase to the composition, in addition to the portions of the film, as described herein. Other multiphase compositions include those that have one carrier and two or more of m�of egesta fragments, where many fragments have different compositions.

In various embodiments, the carrier is a liquid, semi-solid or solid. “Liquid” may be a liquid of low or high viscosity. The fluid can be a liquid, whose flow is solid at ambient conditions. For example, soap, such as an ordinary bar Soaps or liquid soap may be considered as the liquid in this document. The liquid may be a thixotropic fluid. “Semi-solid” as used herein may be a gel, a colloid, or resin. As used herein, semi-solid foods and liquids are fluids, identified on the basis of viscosity: semi-solid product is a fluid medium of high viscosity, while the fluid has a lower viscosity. A definite dividing line between these two types of fluids do not exist. Semi-solid products may, in certain embodiments, to have a viscosity of up of thousands MPa·sec. Media from those that are suitable for use in the present invention include liquids, pastes, ointments and gels, and they can be transparent, translucent or opaque.

In certain embodiments, be implemented thr�of the compositions of the present invention are a composition for caring for the oral cavity, suitable for introduction into the oral cavity. Such compositions include means for brushing your teeth, mouthwash, dental gels, pellets, balls, chewing gum, strips to care for the oral cavity, flavored chewing gum, liquid toothpastes, sprays, dyes, gels, hygienic lipstick, whitening strips, strips to freshen the mouth, chewing the means to care for the oral cavity, and combinations thereof. Composition for caring for the oral cavity, described herein, can be used, for example, to prevent the formation of cavities, whitening, prevent or reduce the formation of plaque, prevent or reduce gingivitis, control, cream of Tartar, prevent or reduce tooth sensitivity, or prevent or reduce unpleasant mouth odor and to prevent staining of teeth.

The specific composition of the carrier preferably depends on the intended use of the composition. In various embodiments, the carrier is water containing from 5% to 95% water or 10% to 70% water. In other embodiments, the carrier is essentially non-aqueous. In media for cleaning teeth, the water content may range from 5% to 70%, from 10% to 50%, or from 20% to 40%. When the presence of water will cause the film once�ecletica, is particularly preferred that the dried film did not contain free water, wherein the amount of water essentially equal to 0% or is negligibly small.

The carrier may contain any of a variety of materials, including emulsification, thickening agents, fillers and preservatives. In some embodiments, the carrier may include functional or active material such as those described above. In some embodiments, the media contains the same functional material as the film.

In one of the embodiments of the carrier is suitable for use as a means for brushing your teeth. In some embodiments, the media contains a humectant, such as glycerin, sorbitol or allenglish, such as polyethylene glycol or propylene glycol. In some configurations, the media contains a humectant at a level of from 10% to 80 wt%, or 20% to 60% by weight of the composition. The composition of those carriers that are suitable for use in the present invention are described in U.S. patents 5695746, Garlick, Jr. et al. and 4839157, Mei-King Ng et al.

In various embodiments, the means for cleaning teeth media contains thickening agents, gelling agents, or combinations thereof. Thickening agents or gelling agents suitable for use�with the unit in the present invention, include inorganic, natural or synthetic thickening agents or gelling agents. In some configurations, the media contains a thickening and gelling agent in the overall levels from 0.10% to 15% wt., or from 0.4% to 10 wt%. composition. Examples of thickening agents and gelling agents suitable for use in the present invention include inorganic thickening silica, such as amorphous silicon dioxide, for example, Zeodent® 165 (Huber Corporation); Irish moss; iota-carrageenan; resin tragakant or polyvinylpyrrolidone. In certain embodiments, the media contains a polishing agent, such as silica, calcined alumina, sodium bicarbonate, calcium carbonate, dicalcium phosphate or calcium pyrophosphate. In various embodiments, the carrier can be a visually transparent composition.

In various embodiments, the means for cleaning teeth, containing visually transparent carrier, the composition comprises at least one polishing agent. Polishing agents from those that are suitable for use in the present invention include colloidal silica, such as Zeodent® 115 (Huber Corporation), and complexes of alkali metals and silicates (that is, silica containing alumina). � some configurations, the polishing agent may have a refractive index, close to gelling agent is combined with water and/or humectant. In various embodiments, the media contains a polishing agent at a level from 5% to 70% by weight of the composition.

In certain tools for cleaning teeth media contains an additional surfactant or mixture of surfactants. Surfactants, which are suitable for use in the present invention include water-soluble salt of at least one monoglyceride of monosulfate higher fatty acids such as the sodium salt monoculturing monoglyceride hydrogenated fatty acids of coconut oil; cocamidopropylbetaine; high alkylsulfate, such as sodium lauryl sulfate; alkyl aryl sulfonate, such as sodium dodecylbenzenesulfonate; high alkylsulfonate; sodium'foacetata; an ester of higher fatty acids and 1,2-dihydroxy propanesulfonate and substantially saturated higher aliphatic acylamide lower aliphatic aminocarbonyl acids such as those having 12-16 carbon atoms in the fatty acid, the alkyl or acyl radicals, and mixtures thereof. Amides may be, for example, N-lauroylsarcosine and sodium, potassium, and secondary water ethanolamine salts of N-lauroyl-, N-myristoyl - or N-palmitoylcarnitine. In different options�the ants implementation the carrier contains a surfactant at a level of from 0.3% to 5% by weight of the composition, or 0.5% to 3% by weight of the composition.

The present invention also provides methods of obtaining media for cleaning teeth. In one of the embodiments, water and at least one humectant are dispersed in a conventional mixer until then, until a first homogeneous gel phase. The first homogeneous gel phase is added to the polishing agent. The first homogeneous gel phase and the polishing agent are mixed until then, until a second homogeneous gel phase. Second homogeneous gel phase is added thickening agent, sweetening agent and a surfactant. These ingredients are mixed at high speed under vacuum of from 20 to 100 mm Hg.PT.

The compositions of the present invention are preferably stable under normal storage conditions. As mentioned herein, “stable” refers to the absence of significant negative impact on one, and preferably all, of the attributes of the composition, such as appearance, aroma, rheology, and chemical composition. Preferably, the stability of the compositions of the present invention includes a composition and physical stability of the film (including fragments, if�and present) in the composition. In various embodiments, the composition containing film is stable upon storage at ambient temperature for at least two years. It is clear, however, that in some embodiments, stable in other respects, the film can razryhlitelya during use (as discussed above), for example, while brushing your teeth brush using the composition for cleaning teeth.

In certain embodiments, the composition may contain, in addition to the portions of the film, as described herein, two or more carriers, each of which contributes a phase in the composition. The composition can be stable to loss of color. For example, the composition may include portions of the film and the means for brushing your teeth with strips, such as that described in U.S. patent 6315986, Wong et al. In certain embodiments, the film fragments can have a color (color) than that of the strips (strips), to enhance aesthetic appeal.

Options for implementation include methods of obtaining compositions comprising a film held in the carrier. In various embodiments, multiple fragments are combined with a carrier. In some configurations, the media, and many portions of the film can mix�me. In some configurations, the mixing can include slow stirring. In one of preferred embodiments a method of obtaining a composition containing a carrier having distributed therein multiple lamellar fragments, include:

(a) receiving media;

(b) adding lamellar fragments of films containing a relatively high concentration of non-ionic surfactants, such as Polysorbate to the media with the formation of the mixture and

(c) homogenization of the mixture.

The term “homogenization”, as used herein, refers to the mixing of fragments and native with obtaining essentially homogeneous distribution of fragments in the media. However, it should be noted that the resulting composition still retains the characteristics of two-phase compositions. Homogenization may be performed using any of a variety of conventional homogenizers.

In another way to the component carrier (for example, to the humidifier for cleaning teeth) is added to the film. Then can be obtained the rest of the media, and the mix tape is then added to the media.

In various embodiments, the present invention provides methods of introducing a functional material to a subject human or animal in need inthis, includes local application of a specified subject a composition containing a film held in the carrier, where the film includes a relatively high concentration of non-ionic surfactants. As mentioned in this document, “introduction” refers to any method by which the composition is applied or administered to a subject. In various embodiments, the introduction is local, when the composition is applied to the outer surface of the subject, for example, on the surface of the oral cavity (e.g., teeth, gums and tongue). Specific process and method of administration will depend, of course, on the intended use of the composition. In one embodiment of the method additionally includes the destruction of the film after the film deposition to the local way. Such destruction may be accomplished using any of a variety of ways, including chemical and/or mechanical means. Chemical means include the degradation film via contact with water or other material that is present at the injection site (e.g., saliva when applying to care for the oral cavity). Physical means include mixing, grinding and shearing of the impact with the application of physical energy to the composition during use (e.g., brush when s�changes in the dentifrice).

In various embodiments, the present invention provides for methods of treating the condition of oral cavity. As mentioned in this document, “state of the oral cavity” is any disorder or condition that can be prevented or treated by administration of the composition in the oral cavity, including disorder or condition of the teeth, the mucous membrane of the mouth, gums and tongue. Such conditions include caries, gingivitis, periodontitis, and cosmetic conditions, such as yellowing and bad breath.

The variants of implementation, described herein, can further be explained with reference to the following non-limiting examples.

Example 1

This example illustrates various preparations of polymer films containing a therapeutically active substance and different amounts of nonionic surfactants, in particular Polysorbate 80.

Table 1
18% Menthol 2% of Polysorbate 80
Raw materials% of the mass. suspension% of the mass. dry matter
Water80,0 --
Methocel E5 (HPMC)8,140,2
Methocel E50 (HPMC)2,412,1

Corn starch3,216,1
Menthol3,517,6
Titanium dioxide0,84,0
Propylene glycol1,68,0
Polysorbate 80 (Tween 80)0,42,0
Total:100100

Table 2
51% of calcium Peroxide with a 1.6% Polysorbate 80
Raw materials% of the mass. suspension% of the mass. dry matter
Water69,0--
Methocel E5 (HPMC)8,326,8
Methocel E50 (HPMC)2,99,3
Calcium peroxide15,851,0
Titanium dioxide1,03,2
Propylene glycol2,58,1
Polysorbate 80 (Tween 80)0,51,6
Total:100100

Table 3
45% of calcium Peroxide with 14% of Polysorbate 80
Raw materials% of the mass. suspension% of the mass. dry matter
Water64,5--
Methocel E5 (HPMC)8,3 23,4

Methocel E50 (HPMC)2,98,2
Calcium peroxide15,844,5
Titanium dioxide1,02,8
Propylene glycol2,57,0
Polysorbate 80 (Tween 80)5,014,1
Total:100100

Table 4
31% calcium Peroxide plus 15% Zeodent 105 14% of Polysorbate 80
Raw materials% of the mass. suspension% of the mass. dry matter
Water63,5--
Methocel E5 (HPMC)8,322,7
Methocel E50 (HPMC)2,98,0
Calcium peroxide11,331,0
Titanium dioxide1,02,7
Zeodent 105 (silicon dioxide)5,515,1
Propylene glycol2,56,8
Polysorbate 80 (Tween 80)5,013,7
Total:100100

Table 5
5% Carbopol 974 with 10% Polysorbate 80
Raw materials% of the mass. suspension% of the mass. dry matter
Water81,0--
Methocel E5 (HPMC)8,042,2
Methocel E50 (HPMC)2,412,7
Calcium peroxide3,217,0
Titanium dioxide0,84,2
Carbopol 9741,05,0
Propylene glycol1,68,4
Polysorbate 80 (Tween 80)2,010,5
Total:100100

Table 1 represents the drug is currently available commercial product films containing 2 wt%. Polysorbate 80 (commercially available in preparations of toothpaste MaxFresh®, available from Colgate-Palmolive Company, New York, NY). The film contains a low level of Polysorbate 80 (2% wt.) and contains a high loading of solid products (17.6% of the mass. menthol).

Table 2 represents the preparation of the whitening of the film, which contains calcium peroxide as a bleaching agent. This drug has a low level of Polysorbate 80 (1.6% of the mass.) and high level of calcium peroxide (51% wt.). The resulting film does not stand up and crack during drying.

Table 3 represents the preparation of the whitening of the film, which contains calcium peroxide as a bleaching and�yente. This drug has a higher level of Polysorbate 80 (14.1% of the mass.) and high level of calcium peroxide (45% wt.). The resulting film is resistant and may contain high loads of solids calcium peroxide.

Table 4 represents the drug another bleach film, which contains two bleaching agent, calcium peroxide and Xeodent 105. The film contains elevated levels of Polysorbate 80 (13.7% of the mass.) and high level of calcium peroxide and Xeodent 105 (46% of the mass. in combination). The resulting film is resistant.

Table 5 represents the drug mucoadhesive film, which contains mucoadhesive agent called Carbopol 974. The film contains elevated levels of Polysorbate 80 (10,5% wt.), and the drug is persistent.

Examples of other variants of implementation, described herein, are illustrative and are not intended to be limiting in describing the full scope of compositions and methods of the present invention. Equivalent changes, modifications and variations of specific embodiments, materials, compositions, and methods can be implemented in the framework of the present invention with essentially similar results.

1. Composition for the care of mouth cavity containing film held in the carrier, where the film contains non-ionic surface-active�e substance in an amount of from 10.5 percent by weight of the film to 20% by weight of the film, where the nonionic surfactant contains Polysorbate 80,
where the film includes a solid product in an amount of from 20% by weight of the film up to 65% by weight of the film, where the solid product is a calcium peroxide
and the film is present in amounts from 0.1% to 5.0 wt%. of the total weight of the composition.

2. Composition for caring for the oral cavity according to claim 1, wherein the film further comprises a therapeutically active substance in an amount of from 0.01 to 30% by weight of the film.

3. Composition for caring for the oral cavity according to claim 1, wherein the film is present in amounts from 0.25% to 3.0% of the mass. of the total weight of the composition.

4. Composition for caring for the oral cavity according to claim 3, wherein the film is present in an amount of from 0.5% to 2.0 wt%. of the total weight of the composition.

5. A method of obtaining a composition for caring for the oral cavity containing film held in the carrier, where the film contains a nonionic surfactant in an amount of from 10.5 percent by weight of the film to 20% by weight of the film, where the nonionic surfactant contains Polysorbate 80, the method includes:
(a) receiving media;
(b) adding lamellar fragments of a film containing a non-ionic surfactant in an amount of from 10.5 percent by weight of the film to 20% by weight of the film; and
(c) homogenization of the mixture,
where the film includes a solid product in an amount of from 20% by weight of the film� to 65% by weight of the film, where a solid product is a calcium peroxide
and the film is present in amounts from 0.1% to 5.0 wt%. of the total weight of the composition,
and where the composition is to care for the oral cavity is a tool for cleaning teeth.

6. A method according to claim 5, where the film further comprises a therapeutically active substance in an amount of from 0.01 to 30% by weight of the film.



 

Same patents:

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to dentistry, therapeutic-prophylactic preparation for tooth and oral cavity care, and can be applied for prevention and complex treatment of inflammatory diseases of gums, parodentium, stomatitis or elimination of gingival hemorrhage. Therapeutic-prophylactic toothpaste includes glycerin, laurylglycoside, sorbitol, xylite, aerosol, calcium hydrogen phosphate, xanthane resin, sodium benzoate, CO2-extracts of thyme, sage, rosemary, white clay, green clay, red clay and water with specified content of components. For CO2-extracts of thyme, sage and rosemary fulfilled is ratio Wt/Ws/Wr=(0.40-0.50)/(0.25-0.35)/0.20-0.25), where Wt, Ws, Wr are weight parts of respectively CO2-extracts of thyme, sage and rosemary, with particles of green, white and red loam having sizes in interval 0.1-100 mcm and being obtained from clay, dried at 80-400°C.

EFFECT: technical result consists in increased efficiency of prevention and treatment of inflammatory diseases of oral cavity, parodentium, in particular gingivitis, periodontitis, as well as increase of cleaning ability of toothpaste with simultaneous reduction of abrasive influence on tooth enamel; and technical result consists in extension of arsenal or toothpastes of complex action, which render healing and preventive action on organs and tissues of oral cavity.

9 cl

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to oral care agents. What is presented is using an oral care composition in the form of a mouthwash containing a fluoride ion source and a ternary polymer system consisting of xanthane gum, carboxymethyl cellulose and copovidone for dental erosion and/or wear control. This composition is also effective in dental caries control.

EFFECT: using fluoride ions in a combination with the ternary polymer system provides the better protection of the dental surface against dental erosion as compared to using fluoride ion only.

7 cl, 4 dwg, 5 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to the chemical-pharmaceutical industry and represents an agent for preventing or reducing pigmentation, containing a compound presented by the following formula (1) its stereoisomer and/or its pharmacologically acceptable salt, wherein: R1 represents a hydrogen atom or an alkyl group with a linear or branched chain having 1-4 carbon atoms; R2 represents a hydrogen atom or an unsubstituted aliphatic hydrocarbon group having 1-4 carbon atoms; R3 represents an unsubstituted aromatic group having 5-15 carbon atoms, substituted by an alkyl group having 1-6 carbon atoms, by an alkoxy group containing an alkyl chain having 1-6 carbon atoms, or by a phenyl group; R3 also represents an aromatic group having 5-15 carbon atoms; n is equal to 1 or 2, and m represents an integer falling within 0 to 3.

EFFECT: preparing the agent for preventing or reducing pigmentation.

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Hair care product // 2553347

FIELD: cosmetology.

SUBSTANCE: hair care product is made in the form of gel, shampoo, lotion. All embodiments comprise aqueous vegetable extracts, phosphonate complex containing potassium-sodium salts of oxyethylidenebisphosphonic acid or their mixture with trisodium salt hexahydrate of phosphonformic acid and a cosmetically acceptable base.

EFFECT: hair care product is recommended for use in medicinal and cosmetic purposes for all ages for prevention and treatment of dystrophic changes in hairy part of the head.

5 cl

FIELD: cosmetology.

SUBSTANCE: cosmetic product contains an aqueous solution of trace elements in amounts close to the daily demand of the human body, succinic acid which provides a high level of energy production (ATP), and also a bioregulatory complex obtained from hair follicles of calves, which stimulates proliferation of dormant cells of hair follicles.

EFFECT: increased efficiency of cosmetic product for complete prevention of hair loss caused by a wider range of reasons, and for partial or complete restoration of hair.

5 ex

FIELD: chemistry.

SUBSTANCE: group of inventions relates to a two-phase mouth wash liquid and a method for use thereof. The disclosed two-phase mouth wash liquid contains a hydrophilic phase, a hydrophobic phase, a hydrotrope and a preservative, wherein the preservative contains (i) sodium benzoate and (ii) potassium sorbate and/or methylisothiazolinone (MIT), and the hydrotrope component contains glycerine and/or propylene glycol. The mouth wash liquid contains (a) 0.05-0.11 wt % sodium benzoate and (b) 0.05-0.2 wt % potassium sorbate and/or 0.0005-0.01 wt % MIT. The hydrophilic phase of the mouth wash liquid can additionally contain cetylpyridinium chloride in amount of 0.01-0.1 wt %, wherein the disclosed method of improving oral health includes using an effective amount of said liquid in the mouth of a subject to reduce the level of cariogenic bacteria.

EFFECT: use of said combination of preservatives coupled with said hydrotrope provides good resistance to microbial contamination without any adverse effect on taste properties or appearance of the mouth was liquid.

12 cl, 1 ex

FIELD: chemistry.

SUBSTANCE: invention relates to organic chemistry and specifically to 5-benzyl-1,3-diazaadamantan-6-one derivatives of formula , where X is hydrogen (1a), methoxyl (1c) substitutes.

EFFECT: obtaining novel fragrant 5-benzyl-1,3-diazaadamantan-6-ones, which can be used in perfume compositions, as medicinal substances, repellents and as starting substances for producing novel 1,3-diazaadamantan derivatives.

6 ex

FIELD: chemistry.

SUBSTANCE: composition of preparation for teeth cleaning contains effective quantity of arginine in free form or in form of salt; abrasive substance, containing (i) natural sodium carbonate (NSC) with the average size of particles 3-7 mcm and moisture absorption 12-25 g/100 g and (ii) precipitated calcium carbonate (PCC) with the average particle size 1-5 mcm and water absorption higher than 25 g/100 g. Ratio of natural calcium carbonate to precipitated calcium carbonate constitutes from 1:2 to 1:3. Composition has pellicle cleaning ratio (PCR), at least, 70 and value of abrasivity of isotope-labelled dentin (RDA) lower than 140. Method of oral cavity care includes application of effective quantity of said composition in oral cavity of individual requiring it.

EFFECT: effective teeth cleaning and strengthening without injuring abrasive action, which makes it possible to apply it, in particular, for individuals with increased teeth sensitivity.

13 cl, 2 tbl, 2 ex

FIELD: chemistry.

SUBSTANCE: composition contains a) surface-active substances, including a salt of C10-16 alcohol ethoxylate sulphate, a betaine surface-active substance and alkylpolyglicoside, and b) a fatty C12-18 acid, constituting at least 15% of the total composition weight.

EFFECT: composition, possessing an increased viscosity and capable of producing a stable foam, is created.

10 cl, 1 tbl, 4 ex, 2 dwg

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions refers to medicine, particularly to cosmetology, and describes a method for stabilising an anhydrous antiperspirant composition involving: (a) preparing a mixture of at least one substance having the antiperspirant action, containing a metal salt, and an anhydrous carrier for at least one substance possessing the antiperspirant action, wherein dissolved is at least one substance having the antiperspirant action, a carrier containing an eutectic mixture of carbamide and trimethylglycine; (b) heating this mixture for preparing the eutectic mixture of at least one substance having the antiperspirant action, and the anhydrous carrier.

EFFECT: invention can be used to reduce the body perspiration; the compositions can be applied by hands or with a package.

22 cl, 3 dwg, 2 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to pharmaceutical industry, in particular to phytomixture with sedative effect. Phytomixture contains mixture of Leonurus cardiaca herb, hop cones, Origanum vulgare herb, and hawthorn fruit, taken in specified quantity.

EFFECT: claimed phytomixture possesses increased sedative effect, improved organoleptic properties, as well as reduced side effects.

3 cl, 3 ex

FIELD: medicine.

SUBSTANCE: a phytopreparation containing bee wax 1.9 g and a herbal extract 0.1 g with the above herbal extract containing common oak bark, common St. John's wort herb and creeping thyme (Thymus) herb in equal proportions is used.The preparation is used as a chewing substrate (a chewing gum) for two weeks 3 times a day 15 minutes after meals.

EFFECT: using the invention improves clinical manifestations of the disease; oral inflammations are supposed to relieve or reduce; the length of erosion and ulcer epithelisation is reduced; the oral fluid structural properties are normalised by increasing phosphorus and magnesium, reducing protein, calcium and TBA.

1 tbl, 1 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions relates to pharmaceutical industry, namely to composition for treating skin ageing. Composition for treating signs of skin ageing, increase of cytikin IL-1α secretion, contains: NF-kB inhibitor, selected from the group, consisting of substituted resorcinols, (E)-3-(4-methylphenylsulphonyl)-2-propenenitrile, tetrahydrokurkuminoids, extracts of Paulownia tomentosa wood, as well as their combinations, and anti-inflammatory compound, which is not NF-kB inhibitor. Composition for treating signs of skin ageing, increase of cytokine IL-1α, containing NF-kB inhibitor, selected from the group, consisting of substituted resorcinols, and anti-inflammatory compound (versions).

EFFECT: compositions are effective for treating signs of skin ageing.

4 cl, 9 tbl, 9 ex

FIELD: chemistry.

SUBSTANCE: invention relates to method of obtaining 7-hydroxyroyleanon, possessing antimicrobial action. said method includes extraction of crushed roots of salvia officinalis with 96% ethyl alcohol with further extract evaporation, processing with water, alcohol distillation and processing with hydrophobic solvent or extraction of said raw material with chloroform with further extract processing with water and evaporation; after which target product is extracted from organic phase by transfer into water-soluble phenolates, with processing with sodium hydroxide water solution; alkali solution is washed with chloroform; acidified with hydrochloric or sulphuric acid; obtained sediment is filtered; dried and crushed.

EFFECT: invention is characterised by improved process manufacturability and provides obtaining individual substance with higher antimicrobial activity than previously extracted royleanon derivatives from salvia officinalis.

2 tbl, 6 ex

FIELD: chemistry.

SUBSTANCE: group of inventions relates to a process of producing organic substrate particles bonded to switchable ferromagnetic nanoparticles with a mean particle diameter ranging from 10 to 1000 nm, to the use of such nanoparticles for hyperthermic treatment of an organism and to a drug for the hyperthermc treatment. As the ferromagnetic nanoparticles used are nanoparticles, which are non-ferromagnetic at first, but become ferromagnetic when the temperature is lowered, these initially non-ferromagnetic dispersed nanoparticles are bonded to the organic substrate particles, and then the nanoparticles bonded to the substrate particles become ferromagnetic as a result of the temperature decrease, initially the switchable ferromagnetic nanoparticles at the temperature of 22°C or higher are not ferromagnetic and become ferromagnetic as a result of cooling down to the temperatures below 22°C. The switchable ferromagnetic nanoparticle comprises Mn and additionally Fe and/or As and preferably have the Fe2P-structure or Na-Zn-13-structure, alternatively, or may comprise La, Fe and Si.

EFFECT: invention prevents the agglomeration of particles and an increase in the mean particle size.

10 cl, 1 dwg, 2 ex

FIELD: medicine.

SUBSTANCE: using dense extract of cowslip primrose (Primula veris L.) herb as a hepatoprotective agent.

EFFECT: agent is effective as a hepatoprotector.

1 tbl

FIELD: chemistry.

SUBSTANCE: invention represents method of obtaining thermosensitive iodine-containing radiopharmaceutical (RP) with radiochemical purity 95-98%, consisting in covalent binding of radioactive iodine isotopes to tyrosine groups, included into chain of poly-N-isopropylacrylamide, with further separation of labelled polymer component from low molecular compounds on chromatographic gel column by elution with water, characterised by the fact that as mobile phase used are water solutions of chemical compounds, mainly inorganic salts, possessing coefficient of polymer-hydrate-iodine complex γ=dTftdCs destabilisation from the interval γ=30-60 degree·l/mol, where Tft is temperature of phase transition in solution, containing destabilising additive, Cs is concentration of additive, limited from above by condition γCs<Tft0Tк (Tft0=Tft, at Cs=0, Tc is temperature in column).

EFFECT: creation of RP with high radiochemical frequency and reduction of radioactive pollution of the environment.

6 dwg, 2 tbl, 9 ex

FIELD: medicine.

SUBSTANCE: 20-25 minutes after surgical intervention, a mouth bath of an implantation area with the Tonsinal phytopreparation diluted in an amount of 2.5 g in 100 ml of boiled water of room temperature is executed. 20-25 minutes later the Plastin CM-1 phytopreparation is applied on the alveolar process mucosa within the implantation area from the vestibular side for 1.5-2 hours. That is preceded by the desalivation of the oral cavity and mouth rinsing carefully with the Tonsinal solution trying to avoid any dynamic movements. The above procedures are performed 3-4 times a day for at least 10 days.

EFFECT: more effective dental implantation by improving microcirculation, fast normalising of oral microbiocoenosis, wound surface healing by immediate union, reliable implant attachment to gums and providing the implant stability.

3 ex

FIELD: medicine.

SUBSTANCE: ointment contains wax 13-15 wt %, glycerol 15-20 % and vegetable oil; the prepared ointment mass is exposed to ozone for 15-20 min in a yield amount of 10 mg/l.

EFFECT: invention provides the advanced healing efficacy with no side effects by reducing the time of wound cleansing from purulo-necrotic tissues.

3 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to the pharmaceutical industry, particularly to a composition for treating asthenic syndrome in patients with dyscirculatory encephalopathy. An ester-oil composition for treating asthenic syndrome in the patients with dyscirculatory encephalopathy contains eucalyptus, mint, pine, cedar, lavender, carnation, flax essences taken in certain relations.

EFFECT: composition is effective for treating asthenic syndrome in the patients with dyscirculatory encephalopathy; it causes the selective harmonising action on the central nervous system, regulates the emotional status, improves cognitive functions, reduces clinical manifestations of asthenic syndrome considerably and improves the quality of life in the patients with dyscirculatory encephalopathy.

1 tbl, 1 ex

FIELD: medicine, oncology, amino acids.

SUBSTANCE: invention relates, in particular, to the development of an antitumor preparation based on natural substances. Invention relates to an amino acid preparation comprising at least one modified essential amino acid obtained by treatment of amino acid by ultraviolet radiation (UV) at wavelength 250-350 nm for 12-80 h at temperature 15-30oC or with ozone at temperature 15-25oC. The modified amino acid has no toxicity for health cells. Also, invention relates to a method for preparing such preparation. Invention provides the development of an antitumor preparation based on modified amino acids and expanded assortment of antitumor preparations being without cytotoxicity for normal cells.

EFFECT: valuable medicinal antitumor properties of preparation.

8 cl, 4 tbl, 2 dwg, 4 ex

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