Device for delivery of a substance for the maintenance of the oral cavity with the use of strips of material having low flexural rigidity

 

(57) Abstract:

The invention is intended to care for the oral cavity. Device for delivering substance to care for the oral cavity to the surface in the oral cavity includes a strip of flexible material having sufficient flexibility to match the surface profile with the contours of the surface in the oral cavity. The strip of material easily conforms to the surface profile with surfaces in the oral cavity without permanent deformation when placing the device for delivery. Substance for the maintenance of the oral cavity is applied to the strip of material so that when the device for delivery to the surface in the oral cavity active ingredient in contact with the surface. Substance for the maintenance of the oral cavity also provides an adhesive bond between the strip material and the surface in the oral cavity in order to hold the device for delivery to the place for a sufficient period of time to allow the active ingredient to the surface in the oral cavity. The method of delivery of the substance to care for the oral cavity includes the ongoing media pre-coating strip material is directly on the surface in the oral cavity and the immediate imposition of a strip of material over the deposited substances for the care of the oral cavity. The technical result - the provision of effective treatment. 2 C. and 7 C.p. f-crystals, 10 ill.

THE SCOPE OF THE INVENTION

The invention relates to a device for delivery of a substance or composition for the care of the oral cavity on the surface of the oral cavity, including the teeth, gum tissue and mucous membranes, in which the substance to care for the oral cavity is protected from erosion and interaction with the saliva within the oral cavity for a time sufficient to ensure therapeutic effect of the active ingredient substances for the care of the oral cavity. More specifically, the present invention relates to disposable devices for delivery, which are inexpensive and do not cause inconvenience.

BACKGROUND OF THE INVENTION

It is recognized that consumers need affordable commercial device for delivering substance to care for the oral cavity that are comfortable to wear and which can deliver sufficient nutrients for maintenance of the oral cavity, providing quick delivery active ingredient contained in such material. You also need the device for delivery that does not require much effort of the user when it is placed to be the solid fuel for active protection which will enable the user to apply the device during communication without interfering speech user and without changing its appearance. It is also necessary protective means which will prevent the substance to care for the oral cavity from erosion by contact with other surfaces of the oral cavity and/or saliva.

THE INVENTION

When implementing the present invention, the strip of material is applied by the user on the desired surface within the oral cavity. Substance for the maintenance of the oral cavity are covered with either side strips of material addressed in the oral cavity, or substance used in the oral cavity, covered the surface of the oral cavity, and the strip of material is placed immediately on top of this substance for the maintenance of the oral cavity. In any case, the substance to care for the oral cavity is viscous, such as a gel, so it provides a constant dosing of the active ingredient and the adhesiveness between the surface in the oral cavity and a strip of material to hold the strips of material on site. The strip of material preferably has a size that corresponds to the needs. For example, the strip may have a shape and size, rather what is its use, or large enough to cover the surfaces in the oral cavity, such as the entire surface of the upper and lower gums and/or adjacent teeth. A strip of soft plastic material may come into contact with the gums of the user, without causing physical irritation. Slight compression of the strips of material to a surface in the oral cavity, the strip material can quickly be fitted to the profile of this surface. The strip of material easily, without permanent deformation adapts to the shape of the surface in the oral cavity when placing the device for delivery. The strip of material is easily removed by the user after use with the help of her detachment. Preferably, each subsequent treatment session is used fresh strip of material.

Providing a relatively thin coating substance for the maintenance of the oral cavity is used in relatively small amounts compared to the amounts of substances for the care of the oral cavity, typically used with conventional devices for delivery. Using such small amounts excluded non-productive consumption of a substance for the maintenance of the oral cavity, accidental zaglatyvanii fabric with such substances. The strip of material and material for maintenance of the oral cavity can be essentially transparent, so that when wearing them on surfaces in the oral cavity, such as the front teeth and the surrounding tissue of the gums, to be almost invisible to other people.

Device for delivery also includes a substance for the maintenance of the oral cavity, causing the strip of material so that when the device for delivery placed on the surface in the oral cavity, the substance for the maintenance of the oral cavity in contact with the surface, providing the penetration of the active ingredient on the surface. Substance for the maintenance of the oral cavity also provides adhesive connection strips of the material and the surface in the oral cavity for holding the device for delivery to the place for a sufficient period of time to allow the active ingredient to the surface. Preferably, the substance to care for the oral cavity is provided in the form of a gel, which is, essentially, a uniform continuous coating on the strip of material.

Another aspect of the present invention is a method for delivering a substance to care for the oral cavity with the help of Nanea application of substances for the care of the oral cavity directly on the surface in the oral cavity and immediate placement of a strip of material over the deposited substances for the care of the oral cavity. With either method, the substance to care for the oral cavity delivers the active ingredient substances for the care of the oral cavity to the surface in the oral cavity, and also provides adhesion between the strip material and the surface in the oral cavity for holding the device for delivery to the place and sufficient time to allow the active ingredient to the surface.

BRIEF DESCRIPTION OF DRAWINGS

Although the description ends with the claims, which specifies clearly and negotiated aspects of the present invention, it is believed that the present invention will be better understood from the following description of the preferred options for implementation in conjunction with the accompanying drawings in which the same numeric references designate identical elements and in which:

Fig. 1 is a perspective view, essentially flat strip of material having rounded corners;

Fig. 2 is a perspective view of one embodiments of the present invention, showing a flat strip of Fig.1, covered with a substance for the maintenance of the oral cavity for dental treatment;

Fig. 3 is a view of a device having a thickness less than the thickness of the covering substance;

Fig. 4 is a view in cross section showing an alternative implementation of the present invention, illustrating the small pockets in the strip of material, which act as reservoirs for additional substances for the care of the oral cavity on the strip.

Fig.5 is a view of the device from above in cross section, showing an alternative embodiment for the application of therapeutic substances for the treatment of teeth used in the oral cavity, on the adjacent teeth with the adjacent strip material of the present invention and attached to the teeth by means of a substance for the maintenance of the oral cavity, located between the teeth and the strip of material;

Fig. 6 is a view in vertical projection of the tooth and the surrounding soft tissue in cross section, taken along the section line 6-6 of Fig.5, showing the strip material of the present invention, adjacent and bonded to the teeth by means of substances for the care of the oral cavity, located between the teeth and the strip of material;

Fig. 7 is a view of the device from above, similar to Fig.5, showing the strip material of the present invention, negotiating on the profile p is through the substance to care Yes oral cavity, located between the teeth and the strip of material;

Fig. 8 is a view in vertical projection in cross-section, taken along the line 8-8 of Fig.7, showing the strip material of the present invention, conformed to the surface profile and the teeth and adjacent soft tissue and glued to both sides of the teeth by means of substances for the care of the oral cavity, located between the teeth and the strip of material;

Fig. 9 is a perspective view of an alternative implementation of the present invention, showing depicted in Fig.2 a strip of material for dental treatment covered substance for the maintenance of the oral cavity and with the release strip; and

Fig.10 is a view of an alternative implementation of the present invention in cross-section, taken along the section line 10-10 of Fig. 9, showing the release strip attached to the strip of material using the substance for the maintenance of the oral cavity.

DETAILED DESCRIPTION OF THE INVENTION

Used herein, the abbreviation "cm" means centimeter. Used herein, the abbreviation "mm" means millimeter.

Now turn Ego of the invention, generally indicated by the numeral 10 represents a device for delivery used to deliver to the surface of the oral cavity substances for the care of the oral cavity. Device for delivery 10 has a strip of material 12, which initially is essentially flat, preferably with rounded corners.

The strip of material 12 is applied to the substance 14 to care for the oral cavity, or it is covered with them. As shown in Fig.3, the strip of material 12 preferably evenly and continuously covered with a homogeneous substance 14 to care for the oral cavity. However, the substance 14 to care for the oral cavity may alternatively be a layered material or layers separated components, amorphous mixture of components, separate strips or enable or various other types of components or a combination of these entities, including continuous coating substance 14 to care for the oral cavity along the longitudinal axis of the portion of the strip of material 12.

As shown in Fig.4, in an alternative implementation, the strip of material 12 may be formed in her small pockets 18. When the floor is covered with a substance side strips of material 12 substance 14 to care for ro to provide additional tanks substance 14 to care for the oral cavity.

In Fig.5 and 6 shows a device for the delivery of 24 of the present invention, applied to the surface of the tooth and many of the adjacent teeth. Many of the adjacent teeth 22 are immersed in the surrounding soft tissue 20. Adjacent soft tissue is defined here as the surface of the soft tissue surrounding the tooth structure, comprising: papilla, marginal gingiva, gingival sulcus, internal tooth gums, the structure of the gum tissue on the lingual and buccal surfaces up to and including transitional fold gums and reticulation.

And in Fig.5, and in Fig.6, the device for delivering the 24 is a strip of material 12 and the substance 14 to care for the oral cavity with a substance 14 to care for the oral cavity-side strips of material 12 facing the teeth 22. The substance 14 to care for the oral cavity may be pre-applied to the strip of material 12, or be applied to the strip of material 12 by the user device for the delivery of, or be applied directly to the teeth 22, and then covered with a strip of material 12. In any case, the strip of material 12 has a thickness and bending stiffness, which provide an opportunity to coordinate with profiled surfaces of the teeth 22 and the adjacent soft tissue 20. Polecam in this figure, the surface is a set of adjacent teeth. The strip of material is also easily adapts to the profile of the surfaces of the teeth and the intermediate spaces between the teeth without permanent deformation when applying the device for delivery. Device for delivery superimposed without significant pressure.

In Fig.7 and 8 shows a device for the delivery of 24 of the present invention, superimposed on the front and on the rear surface of many adjacent teeth 22, and adjacent soft tissue 20. Device for delivery 24 is a strip of material 12 and the substance 14 to care for the oral cavity-side strips of material 12 facing the tooth 22.

In Fig.9 and 10 show an optional releasing the gasket 27. Releasing the strip 27 is attached to the strip of material 12 substance 14 to care for the oral cavity. The substance 14 to care for the oral cavity is on the side of the strip of material 12 facing towards liberating the gasket 27. This side is superimposed on the tooth surface after removal of the releasing strip 27.

The strip of material

The strip of material serves as a protective barrier for substances for the care of the oral cavity. It prevents significant leaching and/or erosion of vasectomist action of the active ingredient in the composition for the care of the oral cavity to the surface in the oral cavity over an extended period of time - from several minutes to several hours. The term "action" is defined here as the implementation of the desired changes. For example, if a substance for the maintenance of the oral cavity is a substance against gingivitis, it reduces or eliminates bleeding and promotes healing of the gum tissue.

The strip material may include polymers, natural and synthetic woven materials, non-woven material, foil, paper, rubber, and combinations thereof. The strip material may be a single layer of material or a laminate of multiple layers. Regardless of the number of layers of strip material, essentially waterproof. Preferably, the material is any type of polymer or combination of polymers that meet the requirement of rigidity in bending and compatible with the substances to care for the oral cavity. Suitable polymers include polyethylene, ethylvinylacetate, polyesters, ethylenically alcohol, and combinations thereof, but they are not limited. Examples of polyesters include Mylarand fluoropolymers, such as Teflon, both manufactured by DuPont. The preferred material is polyethylene. The thickness of the strips mA preferably a thickness of from about 0.001 to about 0.03 mm. The thickness of the plastic strip material, preferably less than approximately 0.1 mm, and more preferably a thickness of from about 0.005-about 0,02 mm

The strip of material is of any shape and size, which is covered with the desired surface in the oral cavity. The strip of material preferably has rounded corners. Rounded corners are defined as the corners with no sharp edges or places. In one example, the length of the strip of material is from about 2 cm to about 12 cm, and preferably from about 4 cm to about 9 cm Width strips of material will also depend on the subject to the surface coating in the mouth. In one example, the width of the strip of material is from about 0.5 cm to about 4 cm and preferably from about 1 cm to about 2 cm

The strip material may contain small pockets. When the strip material is covered with a substance for the maintenance of the oral cavity, the additional amount of the substance for the maintenance of the oral cavity fills small pockets representing tanks for additional quantities of substances for the care of the oral cavity. In addition to arranged a number of small pockets. In General, small pockets have a transverse size of about 0.4 mm and a depth of 0.1 mm When the strip of material of small pockets and applying substances to care for the oral cavity on a strip of varying thickness the total thickness of the device for delivery is generally less than about 1 mm, Preferably the total thickness is less than approximately 0.5 mm

Bending stiffness is a property of the material, which is a function of the combination of thickness, width and modulus of elasticity of the material strips. This test is a measure of the rigidity of polyolefin film and sheeting. It determines the resistance to bending of the sample by using a load cell attached to the end of the horizontal arm. The opposite end of lever presses strips across the sample, causing the strip to be pressed in a vertical groove and a horizontal platform on which lies the sample. Microammeter connected by wires to a load cell, calibrated in grams force of elastic deformation. Reading the stiffness of the sample is read directly from the microammeter and is expressed in grams per centimeter width of the sample strip. In the intent on the instrument Handle-O-Meter, model #211-300, available from Thwing-Albert Instrument Co. Of Philadelphia, PA, for the test method ASTM D2923-95. Preferably, the strip of material has a bending stiffness less than about 3 g/cm, more preferably less than about 2 g/cm and most preferably from about 0.1 g/cm to about 1 g/see Preferably bending stiffness of the strip of material is essentially constant and does not change during normal use. For example, the strip of material does not require hydration to strip reached a low stiffness in bending, in the above defined ranges.

This relatively low stiffness allows the strip of material to cover the contours of the surface in the oral cavity when subjected to a strip of very small forces. That is, the agreement on the contours of the surface in the oral cavity of the user is supported because inside strips of material there is little residual force in order to cause a return to form immediately prior to its application to the surface in the oral cavity, i.e., essentially planar form. Flexible strips of material allows it to contact with a soft cloth for a long period of time Botova cavity.

The strip of material is held in place on the surface in the oral cavity with an adhesive connection is provided by using substances for the care of the oral cavity. Viscosity and General stickiness of the substance for the maintenance of the oral cavity causes the adhesive connection of the strips of material to a surface in the oral cavity without substantial slip in the friction forces created by the lips, teeth, tongue and other surfaces in the oral cavity, the friction of the strip of material while talking, drinking, etc. However, this adhesion to surfaces in the oral cavity is small enough, allowing easy removal of the strip of material by the user through a simple detachment of the strip material using a finger nail of a finger or soft friction device, such as cotton balls and swabs or gauze pads. Device for delivery can be easily removed from surfaces in the oral cavity without the use of tools, chemical solvent or tools or excessive friction. Chemical solvents include organic solvents, are known for use in the oral cavity, such as alcohols, and other safe solvents, such as water, Katariina 1.5 cm, - this app forces peeling required to remove strips of material from a surface in the oral cavity, which comprises from about 1 g to about 50 g (approximately 17 g/cm). Preferably the power of exfoliation is from about 10 g to about 40 g, and more preferably from about 20 g to about 30 g Small force of exfoliation desirable in the interests of convenience for the user when handling the device. A small force of exfoliation is possible due to the aggressive nature of the matter to care for the oral cavity is necessary for adhesion of the strips of material having a lower bending stiffness. That is, the strip of material having a high bending stiffness would require aggressive adhesive to prevent its displacement from the contours of the surface in the oral cavity to which it is attached.

The strip of material can be fabricated using several methods of making film, known in the prior art. Preferably the strip of material made of polyethylene, manufactured using the method of blowing or casting method. Feasible also other ways, including the extras the maintenance of the oral cavity may be involved in the strip during the technological process of manufacturing of the strips. Substance for the maintenance of the oral cavity can be a layered material on the strip.

Substances for the care of the oral cavity

Substance for the maintenance of the oral cavity contains the active ingredient at a level which, when used in accordance with instructions contributes to the favorable effect sought by the user, without harm to the surface in the oral cavity to which it is applied. Examples of conditions of the oral cavity, which affect the active ingredients include changes in the appearance and structure of the teeth, whitening, bleaching pigmentation, removal of pigmentation, removal of plaque, plaque removal, prevention and treatment of cavities, inflamed and bleeding gums, wounds, lesions, ulcers, aphthous ulcers of the mucous membrane, herpetic fever and alveolar abscesses, but are not limited to.

The number of substances for the care of the oral cavity, applied to the strip material, or a surface in the oral cavity depends on the size and capacity of the cut material, the concentration of the active ingredient and determined by the desire of the desired favorable effect. Generally requires less than priblizitelen preferably from about 0.1 to about 0.4 g of substance for the maintenance of the oral cavity. The number of substances for the care of oral cavity 1 cm2material is less than about 0.2 g/cm2preferably from about 0.005-0.1 g/cm2and more preferably from about 0.01 g/cm2to about 0.04 g/cm2.

Substance for the maintenance of the oral cavity of the present invention may be in the form of a viscous liquid, paste, gel, solution, or another appropriate form, which can provide sufficient adhesion. Preferably the substance for the maintenance of the oral cavity has the form of a gel. Substance for the maintenance of the oral cavity will have a viscosity from about 200 to about 1000000 SP with a low rate of shear (less than one 1/s). Preferably the viscosity ranges from approximately 100,000 to approximately 800,000 SP, and more preferably from about 400,000 to about 600000 SP.

Active ingredients substances for the care of the oral cavity

Suitable for the care of oral cavity active ingredients include any material that is generally considered safe for use in the oral cavity and which provides the changes in the overall health of the oral cavity and OTU. The levels of a substance for the maintenance of the oral cavity in the present invention ranges from about 0.01 wt.% to about 40 wt.%, preferably from about 0.1 wt.% to about 20 wt.%, more preferably from about 0.5 wt. % to about 10 wt.% and more preferably from about 1 wt.% to about 7 wt.% substances for the care of the oral cavity.

Compositions and substances for the care of the oral cavity of the present invention may include many of the active ingredients described in the prior art. Below is a non-exhaustive list of active substances for the care of the oral cavity, which can be used in the present invention:

1. Active substances, bleaching teeth

Active substances, whitening teeth may be included in the substance to care for the oral cavity of the present invention. Active substances that are suitable for teeth whitening selected from the group consisting of peroxides, metal chlorite, perborates, percarbonates, peroxyketal and combinations thereof. Suitable peroxide compounds include hydrogen peroxide, calcium peroxide, carbamide peroxide, and mixtures thereof. The preferred switch is, the sodium chlorite and potassium chlorite. Additional bleaching active substances can be hypochlorite and chlorine dioxide. The preferred chlorite is sodium chlorite.

2. Phosphate

Known substances against Tartar used in products for the care of the oral cavity include phosphates. The phosphates include pyrophosphates, polyphosphates, polyphosphonates and mixtures thereof. To the best phosphates for use in products for the care of the oral cavity are known, pyrophosphates. Ions pyrophosphates delivered to the teeth stand out from pyrophosphate salts. Pyrophosphate salt that can be used in these compositions include di - and tetrazole alkali metal pyrophosphoric acid and mixtures thereof. Preferred species are disodium-dihidrogenofosfat (Na2H2P2O7), tetranitro-pyrophosphate (PA4P2O7), and terkaly-pyrophosphate (K4P2O7in their UN-hydrated and hydrated forms. Although you can use any of the above pyrophosphate salts, preferred tetranitro-pyrophosphate.

More pyrophosphate salt described in the book Kirk &Othmer, Encyclopedia of Chemical Technology, Third is to the book Kirk & Othmer. Additional funds against Tartar include pyrophosphates or polyphosphates disclosed in U.S. patent 4590066, issued may 20, 1986, Parran & Sakkab; polyacrylates and other polycarboxylate, such as compounds disclosed in U.S. patent 3429963, issued February 25, 1969 Shedlovsky, and in U.S. patent 4304766, issued December 8, 1981, Chang, and in U.S. patent 4661334, issued April 28, 1987, Benedict & Sunberg; polyepoxysuccinic, such as the compounds disclosed and U.S. patent 4846650, issued July 11, 1989, Benedict, Bush & Sunberg; ethylenediaminetetraacetic acid, as disclosed in UK patent 490384, issued February 15, 1937; nitrilotriacetic acid and related compounds, disclosed in U.S. patent 3678154, issued July 18, 1972, Widder & Briner; polyphosphonate disclosed in U.S. patent 3737533, issued June 5, 1973, Francis; U.S. patent 3988443, issued October 26, 1976, Ploger, Schmidt-Dunker & Gloxhuber and U.S. patent 4877603, issued October 31, 1989, Degenhardt & Kozikowski; all of these patents are incorporated here by reference. Phosphates against Tartar include pyrophosphates, potassium and sodium; sodium tripolyphosphate; diphosphonates, such as ethane-1-hydroxy-1,1-diphosphonate, 1-azacycloheptane-1,1-diphosphonate and linear alkyl diphosphonates; linear carboxylic acid and sodium zinc citrate.

3. The source of fluoride ions

The sources of fluoride ions are well known for use in compositions for the care of the oral cavity as a means against caries. Fluorine ions are contained in a number of compositions intended for the care of the oral cavity, in particular in toothpastes. Patents disclosing such toothpastes include U.S. patent 3538230, issued November 3, 1970, Pader et. al.; U.S. patent 3689637, issued September 5, 1972, Pader; U.S. patent 3711604, issued January 16, 1973 Colodney et. al.; U.S. patent 3911104, issued October 7, 1975 Harrison; U.S. patent 3935306, issued January 27, 1976, Roberts et al.; and U.S. patent 4040858, issued August 9, 1977, Wason.

Application of fluoride on the tooth e is storymy compositions can be used with a wide variety of materials, providing fluoride ion. Examples of materials suitable for providing output fluoride ion can be found at the Briner et. al.; U.S. patent 3535421, issued October 20, 1970, and the Widder et. al.; U.S. patent 3678154, issued July 18, 1972, both patents incorporated here by reference. Preferred sources of fluoride ion for use in this invention include sodium fluoride, potassium fluoride and ammonium fluoride.

Particularly preferred sodium fluoride. Preferably instant compositions provide from about 50 million-1up to 10 000 m-1more preferably, from about 100 to 3000 million-1of fluoride ions in aqueous solutions in contact with the tooth surfaces when used with a strip of material used in the mouth.

4. Antimicrobial drugs

Antibacterial agents may also be present in the compositions or substances for the care of the oral cavity of the present invention. Such means may include triclosan, 5-chloro-2-(2,4-dichlorophenoxy)-phenol, as described in The Merck Index, 11th ed. (1989), pp. 1529 (entry no. 9573), in U.S. patent 3506720 and in European patent application 0251591 Beecham Group, PLC, published January 7, 1988; chlorhexidine (Merck Index, no. 2090), alexidine (Merck Index Indk, no. 8299); domiphen bromide (Merck Index, no. 3411); cetylpyridium chloride (CPC) (Merck Index, no. 2024); tetradecylbenzene chloride (TPC); N-tetradecyl-4-ethylpyridine chloride (TDEPC) ; octenidine; delmopinol, Octafinal and other derivatives of piperidine; drugs Nizina; products containing zinc ion/divalent tin; antibiotics such as Augmentin, amoxicillin, tetracycline, doxycycline, minocycline, and metronidazole; and analogs and salts of the above antimicrobial agents and anti-plaque, but are not limited to.

5. Anti-inflammatory drugs

Anti-inflammatory agents may also be present in the compositions or substances for the care of the oral cavity of the present invention. Such means may include non-steroidal anti-inflammatory drugs (NSPs) such as Ketorolac, flurbiprofen, ibuprofen, naproxen, indomethacin, aspirin, Ketoprofen, piroxicam and meclofenamic acid, but are not limited to. Application NSPs, such as Ketorolac, stated in U.S. patent 5626838, issued may 6, 1997, included here as a reference. It revealed the prevention and treatment of primary and recurrent squamous cell carcinoma of the oral cavity or oropharynx with the matter

Nutrients can improve the condition of the oral cavity and can be included in the composition or substance for the maintenance of the oral cavity of the present invention. Nutrients include minerals, vitamins, oral nutritional supplements, enteral nutritional supplements and mixtures thereof.

Mineral substances that can be included in compositions of the present invention include calcium, phosphorus, fluoride, zinc, manganese, potassium and mixtures thereof. These minerals are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 10-17, included here as a reference.

Vitamins may be incorporated with mineral substances or used separately. Vitamins include vitamins C and D, thiamine, Riboflavin, calcium Pantothenate, Niacin, folic acid, nicotinamide, pyridoxine, cyanocobalamin, para-aminobenzoic acid, bioflavonoids, and mixtures thereof. These vitamins are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 3-10, included here as a reference.

Oral nutritional supplements include amino acids, lipotropic substances, fish oil, and mixtures thereof, as disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St, carnitine or L-carnitine and mixtures thereof, but are not limited to. Lipotropic substances include choline, Inositol, betaine, linoleic acid, linolenic acid and mixtures thereof. Fish oil contains large amounts of omega-3 (N-3) polyunsaturated fatty acids, eykozapentaenovuyu acid and docosahexaenoyl acid, but are not limited to.

Enteral nutritional supplements include protein products, glucose polymers, corn oil, safflower, medium chain triglycerides, as disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 55-57, included here as reference, but are not limited to.

7. Enzymes

In the composition or substance for the maintenance of the oral cavity of the present invention may include a separate or a combination of several compatible enzymes. Enzymes are biological catalysts of chemical reactions in living systems. Enzymes interact with the substrates on which they act, forming an intermediate enzyme-substrate complex. Then this complex is transformed into the reaction product and the released enzyme, which continues its specific enzymatic function.

Put proteins of saliva, which are absorbed on the surface of the teeth and form a film, the first layer of plaque. Protease along with lipases destroy bacteria by lysis of proteins and lipids, which form a structural component of the walls and membranes of bacterial cells. Dextranase decompose organic skeletal structure formed by bacteria, which form a scaffold for adhesion of bacteria. Protease and amylase to not only prevent the formation of plaque, but also prevent the development of dental calculus by cleavage of the carbohydrate-protein complex, which binds calcium, preventing mineralization.

Enzymes that can be used in the present invention include any of the commercially available proteases, glucanohydrolase, endoglycosidase, amylases, mutans, lipases and Mucins or compatible mixtures. Preferred are proteases, dextranase, endoglycosidase and atanazy, and the most preferred is papain, an endoglycosidase, or a mixture of dextranase and atanazy. Additional enzymes suitable for use in the present invention are disclosed in U.S. patent 5000939, issued March 19, 1991, Dring et al. ; U.S. patent 4992420, issued February 12, 1991, Neeser; in U.S. patent 43550 the 1977 Colodney, in U.S. patent 3991177, issued November 9, 1976 Virda et. al. and in U.S. patent 3696191, issued on 3 October 1972 Weeks, all of which are included here as a reference.

8. Products for the treatment of oral cavity and throat

Other materials that can be used with the present invention include well-known products for the treatment of oral cavity and throat. Such products are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 520b-527; included here as a reference. These products include antifungal agents, antibiotics and analgesic funds, but are not limited to.

9. Antioxidants

It is generally recognized that antioxidants can be used in compositions similar to the compositions of the present invention. Antioxidants are disclosed in publications such as Cadenas and Packer, The Handbook of Antioxidants, 1996 by Marcel Dekker, Inc., included here as a reference. Antioxidants that may be included in the composition or substance for the maintenance of the oral cavity of the present invention include vitamin E, ascorbic acid, uric acid, carotenoids, vitamin a, flavonoids and polyphenols, herbal antioxidants, melatonin, aminoindoles, lipaemia acid and mixtures thereof, but does not exhaust the ina-2 (H-2 or h 2 (antagonists N-2)), can be used in compositions for the care of the oral cavity of the present invention. Used here, selective H-2 antagonists are compounds that block N-2 receptors, but do not have significant activity in the blockade of histamine receptors-1 (H-1 or HI). Selective H-2 antagonists stimulate smooth muscle contraction of various organs, such as intestines, and bronchi; this effect can be suppressed low concentrations mepyramine - typical antihistamine drug. Pharmacological receptors involved in these sensitive mepyramine histamine reactions were defined as N-1 receptors (Ash, A. S. F. & H. O. Schild, Brit. J. Pharmacol Chemother., Vol. 21 (1966), p. 427, included here as a reference). Histamine also stimulates the secretion of acid by the stomach (Loew, E. R. & Chickering, Proc. Soc. Exp. Biol. Med., Vol. 48 (1941), p. 65, included here as a reference), increases the heart rate (Trendelenburg, U., J. Pharmacol., Vol. 130 (1960), R. 450, included here as a reference), and to inhibit uterine contractions in rats (Dews, P. C. & J. D. P, Graham, Brit. J. Pharmacol. Chemother., Vol. 1 (1946), p. 278, included here as a reference); these types of actions can not resist mepyramine and related drugs. H-2 antagonists, is soedineniya, which block the receptors involved in insensitive to mepyramine not-N-1 (N-2) histamine reactions and do not block the receptors involved in sensitive mepyramine histamine reactions.

Selective H-2 antagonists are compounds which are N-2 antagonists, which are installed in the classic preclinical screening tests for detection of antagonistic action on H-2 receptors. Selective H-2 antagonists are defined as compounds that can function as a competitive or non-competitive inhibitors mediated by histamine effects on those screening models that specifically depend on the function H-2 receptors, but do not have significant antagonistic activity against histamine on those screening models, which depend on the function H-1 receptors. In particular, they include compounds that could be classified as described by Black, J. W., W. A. M. Duncan, C. J. Durant, C. R. Ganellin & E. M. Parsons, "Definition and Antagonism of Histamine H2-Receptors", Nature, Vol. 236 (April 21, 1972), pp. 385-390 (Black) and included here as a reference. They are identified as H-2 antagonists in the evaluation in accordance with the description by Black test is the first secretion of the stomach of rats in vivo. But according to an evaluation in accordance with the description of Black according to the method of reducing the ileum of the Guinea pig in vitro or method of reduction of muscles of the stomach of rats in vivo was shown by the absence of their aragonites activity against H-2 receptors. Preferably selective antagonists N-2 receptors in the above-mentioned methods of action on N-1 receptors do not exhibit significant activity against N-1 receptor with the appropriate dose level. Typical suitable level of dose is the lowest dose at which of the above methods of action on the H-2 receptors is achieved by the inhibition of histamine 90%, preferably inhibition of histamine at 99%.

Selective antagonists of N-2 receptors include compounds meeting the above criteria which are disclosed in U.S. patents 5294433 and 5364616, issued respectively on March 15, 1994 November 15, 1994, Singer et al. and assigned to the Procter & Gamble; both are included here as a reference, in which selective antagonist of H-2 receptor selected from the group consisting of cimetidine, identigene, ranitidine, ICIA-5165, tiotidine, ORF-17578, lopitalya, donativa, famotidine, roksatidina, piperidine, lutidine, BL-in, DA-4634, bisentina, attidiya, aprotinine, HE-30-256, D-16637, FRG-8813, FRG-8701, impromidine, L-643728 and HB-4084. Especially preferred is cimetidine (SKF-92334), N-cyano-N'-methyl-N"-(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)guanidine:

< / BR>
Cimetidine is also disclosed in the Merck Index, 11th edition (1989), R. 354 (article no. 2279) and Physicians' Desk Reference, 46th edition (1992), p. 2228.

Related H-2 antagonists include burimamide and metiamide.

As mentioned earlier, the substance for the maintenance of the oral cavity of the present invention may be provided in various forms, but the most preferred is a gel, especially water-based gel. Gel is a matrix with a high viscosity is formed from thickeners known in the prior art. These thickeners are safe for oral use, do not dissolve easily in saliva and do not react or not inactivate included in each connection for the care of the oral cavity. In General, the thickener is nabuhay polymer. Moreover, the gel formed by these means provides sufficient adhesive connection of the film material with the target region of the oral cavity. The content of the thickener for the formation of a gel composition is the 10 wt.%, more preferably from about 2 wt.% to about 8 wt. % and most preferably from about 4 wt.% to about 6 wt.% compositions or substances for the care of the oral cavity.

Suitable thickeners that can be used in the present invention include carboxypolymethylene, carboxymethylcellulose, carboximetilzellulozu, poloxamer, carragenin, Veegum, carboxyvinyl polymers and natural resins such as gum karaya, xanthan gum, guar gum, gum Arabic resin tragakant and mixtures thereof. The preferred thickener for use in the present invention is carboxypolymethylene obtained in the B. F. Goodrich Company under the trade name Carbopol. Especially preferred brands include Carbopol Carbopol 934, 940, 941, 956, and mixtures thereof. Especially preferred is Carbopol 956. Carboxypolymethylene is a weak acid vinyl polymer with active carboxyl groups. According to the manufacturer, the normal concentration of various carboxypolymethylene

resins in water is less than about 2%. However, it was found that by obtaining a supersaturated carboxypolymethylene compose composition with high viscosity.

In addition to the high viscosity of concentrated carboxypolymethylene gels have several important characteristics. In the oral gel composition is added enough carboxypolymethylene in excess of that required to provide a high viscosity, so that a significant amount of saliva or water required to reduce the viscosity to the point at which the composition may be dissolved and washed away by saliva. Concentrated carboxypolymethylene composition also has an unusual tackiness or stickiness, which holds and tightly stick a strip of material to the target surface in the oral cavity to which it is attached, in particular to the teeth. However, care should be taken to avoid too much of carboxypolymethylene, which makes inserting and removing strips of material.

If the substance to care Yes oral cavity is a water-based gel, the water present in the gel compositions should preferably be deionized and free of organic impurities. The water content is from about 0.1 wt. % to 95 wt.%, preferably, from about 5 wt.% to about 90 wt.% and most prefer the water include the free water, which is added, plus the amount which is introduced with other materials.

To optimize the stability during storage of the gel and security agents to the tissues of the mouth can also be added tool to adjust the pH. These means for adjusting the pH or the buffer can be any material which is suitable for adjusting the pH of a substance for the maintenance of the oral cavity. Suitable materials include sodium bicarbonate, sodium phosphate, sodium hydroxide, ammonium hydroxide, stannate sodium, triethanolamine, citric acid, hydrochloric acid, sodium citrate and combinations thereof. Means for adjusting the pH are added in sufficient quantity to bring the pH of the gel composition to a range from about 4.5 to about 11, preferably from about 5.5 to about 8.5, and more preferably from about 6 to about 7. Means for adjusting the pH is generally present in an amount of from about 0.01 wt.% to about 15 wt.% and preferably from about 0.05 wt. % to about 5 wt.% substances for the care of the oral cavity.

Although the above-described gel provides sufficient adhesions who's ingredients to the tissues of the oral cavity. Suitable agents include polymers with limited solubility in water, as well as polymers that are not soluble in water. When mixing saliva with this instant the composition of these polymers is coated with a thin film of soft and hard tissues of the oral cavity. Suitable binders with limited solubility in water include hydroxyethyl or propylethylene. Binder insoluble in water, include ethylcellulose and polyxenia resin. Another possible binder suitable for use in the instant compositions is polyvinylpyrrolidone with a molecular weight of from about 50,000 to about 300000. Another possible binder suitable for use in the instant compositions is a combination of Gantrez and semi-synthetic, water-soluble polymer is carboxymethylcellulose.

In substance for the maintenance of the oral cavity can also add additional carrier material. Materials-the media can be a humidifier. Suitable humectants include glycerin, sorbitol, polyethylene glycol, propylene glycol, and other edible polyhydric alcohols. Humidifiers are generally present in colachel 80 wt. % of a substance or composition for the care of the oral cavity. In addition to the above materials of the gel of the present invention in a substance for the maintenance of the oral cavity may also be added a number of other components. Additional components include flavoring agents, sweetening means, xylitol, substances that make the material opaque coloring tools and chelating compounds such as ethylenediaminetetraacetic acid. These additional ingredients may also be used instead of the disclosed above compounds.

Liberating strip

Releasing the strip may be made of any material that exhibits a lower affinity for the substance to care for the oral cavity than the substance to care Yes oral cavity reveals to itself and to the strip of material. Liberating the gasket preferably includes a rigid sheet material such as polyethylene, paper, polyester or other material, which is then covered with a non-sticky material type. Material liberating strip may be coated with wax, silicone, Teflon, fluoropolymers, or other materials with a non-sticky type. Preferred liberating gasket is Scotc and forms, as the strip of material, or releasing the strip may be cut off larger than the strip of material to facilitate the availability of funds for the Department of material from the strip. Releasing the strip may be made of fragile material that is cracking at the bend of the strip, or from multiple pieces of material, or from having a notch piece of material. Alternatively, releasing the strip may consist of two overlapping pieces, such as a typical design headbands from lakoplastyrna tape. Further description of materials suitable as the releasing means can be found in Kirk-Othmer Encyclopedia of Chemical Technology, Fourth Edition, Volume 21, pp. 207-218, included here as a reference. EXAMPLES

The strip of material 12 preferably is a piece of plastic film with a thickness of 0.013 mm Film preferably has a number of small pockets cross-sectional dimension of typically 0.4 mm and a depth of 0.1 mm Strip of material 12 has a bending stiffness of approximately 0.6 g/cm, as measured on the instrument Handle-O-Meter, model #211-300, manufacturer Thwing-Albert Instrument Co. of Philadelphia, PA, when a research method ASTM D2923-95.

Example bleach teeth gel is described as obrazowe. Mix until a homogeneous mass. Using the delivery devices of the present invention can also be used commercially available tooth whiteners, such as Opalescence and Nu-Pro-Gold.

Example receiving oral gel composition which is the subject of the invention and containing H-2 antagonists, using conventional processing techniques involves mixing of 2.50% of hydroxyethyl cellulose, and 0.09% sodium fluoride, 0.05% saccharin sodium, and 1.00% of the ranitidine and purified water as needed.

Example receiving oral gel composition which is the subject of the invention and containing enzymes, using conventional processing techniques involves mixing 61,814% of sorbitol, 0,314% Carbopol 956, 0,534% xanthan resin, 1,132% citric acid, 6,291 % of sodium citrate, 5,033% of acryloylsarcosine (30% solution), 7,864% endoglycosidase (3,2% solution), 0,305% of sodium fluoride, water as needed.

Method of application

When implementing the present invention, the strip of material is applied by the user on the desired surface in the oral cavity. Side of the material facing surface in the oral cavity is covered with a substance for the maintenance of the oral cavity, which predpochtiteljno, as well as the adhesion between the surfaces of the oral cavity and a strip of material, holding the strip of material in place over long periods of time. For the active ingredients to care EA oral cavity, non-bleach the teeth, the period during which you use the strip of material is from about 1 to 30 minutes For active ingredients that require a long diffusion in the oral cavity, such as bleaches the teeth, the strip of material is used during periods required for delivery of the active ingredient in the dose required to produce the desired favorable action. This period can vary from half an hour to several hours.

The strip of material tightly and accurately repeats the profile of the subject to therapeutic effects of the surface in the oral cavity after a slight compression of the strips to the surface. The strip of material is easily removed by the user by exfoliation using your finger or finger nail. Preferably, each subsequent treatment uses fresh strip of material.

In a situation where the surface of the subject to therapeutic effects, the surface in the oral cavity predstavlja delivery of the present invention. For example, the user can choose to brush your teeth or rinse your mouth before applying the device to deliver or not to do it. There is no need for drying the surfaces of the teeth or their rich wetting with saliva or water before applying strips of material.

When placed in the oral cavity, the strip of material and substances preferably are almost invisible, preferably transparent. The thinness of the strips of material may also provide a higher surface temperature in the oral cavity, and the higher temperature accelerates the diffusion rate of the active material in the surface of the oral cavity.

When the user removes a strip of material with teeth on their surface may remain a residual amount of a substance for the maintenance of the oral cavity. However, the residual quantity of the substance to care for the oral cavity is not large, because it has an affinity to the film, and to himself. Any residual substance for the maintenance of the oral cavity can be easily removed by wiping, brushing with a toothbrush or rinse the surface of the oral cavity.

Although there have been illustrated and described specific options for implementing the major changes and modifications without deviating from the essence and scope of the claims of the invention and in the appended claims will cover all such modifications, within the range of the claims of the invention.

1. Device for delivering substance to care for the oral cavity to the surface in the oral cavity, comprising a strip of flexible, waterproof material having sufficient flexibility for the formation of a curved surface in the oral cavity, having essentially constant bending stiffness less than 5 g/cm, measured at the device Handle-O-Meter in accordance with the method of ASTM D2923-95 and which is easily adjusted according to the surface profile in the mouth, without permanent deformation, when the device for delivery placed on it; and the substance to care for the oral cavity, caused by the mentioned strip of material, so that when the device for delivery placed on the surface in the oral cavity, the substance is in contact with the surface of the oral cavity, providing the effect of the active ingredient to the surface so that the substance also provides adhesive bonding strips of material with the surface of the oral cavity for holding the device for delivery to the place in a period of time sufficient to allow the action of the active ingredient on the surface, and a strip of material coated with the substance of the Xia teeth, the substance to care for the oral cavity presents in the form of an aqueous gel and the strip has a length of from 4 to 9 cm and width from 1 to 2 cm

2. Device for delivery under item 1, in which the active ingredient for the care of the oral cavity is selected from the active substances, bleaching teeth, phosphates, sources of fluoride ions, antimicrobial agents, anti-inflammatory drugs, nutrients, enzymes, products for the care of the throat and oral cavity, antioxidants, H-2 antagonists and mixtures thereof.

3. Device for delivery under item 1 or 2, in which the strip material is a polyethylene film having a nominal film thickness less than 0.1 mm

4. Device for delivery to any of the preceding paragraphs, in which the strip material width of 1.5 cm with a substance has the power of exfoliation of less than 50 g, preferably from 10 to 40 g, and more preferably from 20 to 30 g

5. Device for delivery to any of the preceding paragraphs, in which the device is adapted for delivery to appliciable in addition to the surfaces of the teeth on the adjacent soft tissue of the teeth.

6. Device for delivery to any of the preceding paragraphs, in which the strip material, the strip is placed in them substance to care for your mouth.

7. Device for delivery to any of the preceding paragraphs, in which the substance to care for the oral cavity includes carboxypolymethylene in the amount of from 0.5 to 12% by weight of the substance.

8. Device for delivery to any of the preceding paragraphs, further comprising releasing the strip.

9. The method of delivery of the active ingredient for the care of the oral cavity on the tooth surface applying device for delivery to any of the preceding paragraphs on the front surface of the teeth and adjacent soft tissue, where the method includes wrapping device for delivery through the top of the teeth.

Priority points:

06.06.1997 on PP. 1, 3, 5-7, 9;

17.03.1998 on PP. 2, 4, 8.

 

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