MXPA97008406A - Product den - Google Patents

Abstract

A dental product packaged in a multi-cavity dispensing container disposed telescopically having at least two cylinders in an upper body thereof is provided. The peroxide and sodium bicarbonate are placed as active ingredients of separate respective semisolids, each stream being in one of the separate cylinders. The uniform distribution of each current to supply a relatively equivalent band length of each embodied stream is a synthetic linear anionic polycarboxylate or a polyphosphate to adjust the viscosity. The polycarboxylates are homopolymers of acrylic, methacrylic and maleic acids, more especially a copolymer of vinylmethylether and maleic acid or anhydride, the preferred polyphosphates are tripolyphosphates, hexametaphosphates and pyrophosphate.

Description

DENTAL PRODUCT BACKGROUND OF THE INVENTION FIELD OF THE INVENTION The invention relates to a dental product, more particularly to a multi-cavity dispensing container disposed telescopically from which two cavities are filled with semi-solid dentifrice compositions respectively containing peroxide and sodium bicarbonate as the active ingredient.

RELATED TECHNIQUE Oral compositions with peroxide and sodium bicarbonate (ie, sodium bicarbonate) have become very popular commercially. The combination of the active ingredients has been reported to promote healthy gums. When in contact, the peroxide and sodium bicarbonate are reactive to each other. Therefore, these ingredients must be kept separately until used. Distribution packs have been developed which physically isolate peroxide and sodium bicarbonate by separating them into different compartments. This process has been described in a series of patents for Schaeffer which include U.S. Patent 4,849,213, U.S. Patent 4,528,180 and U.S. Patent 4,687,663. The dosage of flavor, fluoride and other active ingredients has always been a challenge for multi-compartment dispensers that simultaneously extrude more than one of the toothpaste stream. An unbalanced distribution can adversely affect taste, aesthetics and oral hygiene. The most successful packaging for controlled delivery has been a telescopically disposed multiple cavity distribution pump, especially as described in U.S. Patent 5,020,694 and U.S. Patent 5,038,963 and U.S. Patent 5,335,827 (in relation to a filler cartridge), all of which are incorporated herein by reference. Commercially, the pump is exemplified in Mentadent® Peroxide and Sodium Bicarbonate toothpaste. Consumers have noted that even with telescopic pumps it is often difficult to extrude equal lengths of respective bands of peroxide and sodium bicarbonate dentifrices. Accordingly, it is an object of the present invention to provide a dental product of peroxide and sodium bicarbonate based on a multi-cavity dispensing container disposed telescopically where essentially identical toothpaste bands can be distributed from each of the cavities . Another object of the present invention is to provide a peroxide and sodium bicarbonate dental product packaged in a multi-cavity dispensing container telescopically arranged wherein the viscosity of each cavity stream can be better controlled by allowing a further dosing Exact These and other objects of the present invention will become more readily apparent from the consideration of the following summary and detailed discussion.

BRIEF DESCRIPTION OF THE INVENTION A dental product is provided which includes: (i) a distribution container with an upper and a lower body which are telescopically engaged with respect to each other, the upper body including at least two separate and recessed parallel cylinders, the cylinders having a generally closed first end and a second end telescopically and slidably accommodated in at least two parallel pistons, which shape to roll sealingly along the inner walls of the cylinders to force any flowable material to flow towards the first end of the cylinder after the relative compression of the cylinders and pistons, the cylinders that have exit channels; (ii) an exit mechanism in fluid communication with the exit channels, the exit mechanism including adjacent exit openings disconnected from each other and having a means for causing the flowable materials to flow towards each other at the exit openings to form an individual stream, banded, not mixed; (iii) a first semi-solid flowable material containing a peroxide and a second semi-solid flowable material containing sodium bicarbonate; each of the first and second semi-solid materials that are stored in one of at least two parallel hollow cylinders, at least one of the semi-solid materials containing 0.05 to 20% synthetic linear anionic polymeric polycarboxylate or a polyphosphate .

BRIEF DESCRIPTION OF THE DRAWINGS The above features, advantages and objects of the present invention will become fully appreciated through the following detailed discussion, the reference made to the drawing consisting of a single Figure which is an elongated view of a manifold distribution pump. cavity arranged telescopically.

DETAILED DISCUSSION It has now been found that in the context of multi-cavity dispensing pumps arranged telescopically, control of the contents of the flowable toothpaste can be obtained through the use of synthetic anionic linear polymer polycarboxylates or polyphosphates in the formulation. The polycarboxylates or polyphosphates allow very close matching of fluid properties between a stream that contains the active peroxide and sodium bicarbonate. The flavors, the fluoride and the active ingredients formulated in either one or both of the flowable streams, can therefore be dosed regulated with high accuracy. Both streams can be extruded with much better control. The distribution container, of the present invention as shown in the Figure, includes an upper body 2 and a lower body 4, the former telescoping with the latter. Within the lower body 4 are a pair of parallel piston rods 6 remaining rigidly, and preferably molded unitarily with the lower body. These rods can be hollowed out or solid. While the configuration shown is round, the rods can be rectangular or of any other polygonal shape. The upper body 2 includes a pair of parallel cylinders 8 separated each having a first end 10 generally closed and a second end 12 which telescopically and slidably accommodates the heads 14 of the piston. These heads are shaped to run sealingly along the inner walls of the cylinders to force flowable materials to flow towards the first end of the cylinder. The walls of the cylinder can be formed as the upper body part or can be formed as separate and removable filling cartridges of the upper body. The activation of the flow is carried out by a manual downward pressure on the upper part of the upper body in which the pressure forces the upper body to descend telescopically into the lower body. The movement of the bodies causes the upward movement of the pistons 6 against each of the heads 14 of the respective piston along the respective cylinders 8. The flowable material in each of the cylinders is then pushed through a pair of output channels 16. The flowable toothpaste exits through the outlet channels passing in unmixed streams through an outlet nozzle having a septum 18 which holds the respective toothpastes in an unmixed relationship towards the outlet openings.

The first and second semi-solid extrudable currents of the dentifrice will be stored in each of the respective cylinders 8. The first of the streams will include a peroxide component such as alkali metal perborate, percarbonate, urea peroxide, persilicate, perfosphate, calcium peroxide or hydrogen peroxide. The most suitable for this invention is hydrogen peroxide. The amounts of peroxide may be in the range of 0.01 to 1 5%, preferably 0.5 to 3% by weight of the first material. The peroxide-containing composition can be either a paste or gel, preferably the latter. When it is a gel, the water will be present in amounts in the range of 20 to 70%, preferably 30 to 55%, optimally between 30 to 40% by weight of the first material. For anti-caries protection, a source of fluorine ions will normally be present in one or both of the flowable materials of the total oral composition. Fluoride sources include sodium fluoride, potassium fluoride, calcium fluoride, stannous fluoride, stannous monofluorophosphate, and sodium monofluorophosphate. These sources will release anywhere from 25 to 3500 ppm of the fluoride ion. The anti-caries agent will be present in an amount of about 0.05 to about 3% by weight, preferably 0.2 to 0.6% by weight of the total oral composition.

The salts of linear anionic polymeric polycarboxylate polymers or polyphosphates are essential for the present invention. The synthetic anionic linear polymeric polycarboxylates operative herein are well known, which are employed in the form of their metal salts (eg potassium or sodium) or ammonium, water-soluble alkali partially or most preferably neutralized. Preferred are 1: 4 to 4: 1 copolymers of anhydride or maleic acid with another ethylenically polymerizable unsaturated monomer, especially methylvinylether (methoxyethylene) having a molecular weight (M.P.) of about 30,000 to about 1,000,000. These copolymers are commercially available as Gantrez AN 1 39 (P, M, 500,000), A. N. 1 19 (P.M. 250,000) and preferably S-97 (P.M. 70,000), from ISP Corporation. The terms "synthetic" and "linear" are intended to exclude known gelling agents or thickeners comprising carboxymethylcellulose and other cellulose derivatives and natural gums, as well as Carbopols which are crosslinked. Other operative polymeric polycarboxylates include those described in U.S. Patent 3,956,180 incorporated herein by reference, such as the 1: 1 copolymers of maleic anhydride with ethyl acrylate, hydroxyethyl methacrylate, N-vinyl-2-pyrrolidone, or ethylene, the latter being commercially available as Monsanto EMA No. 1103 (P .M. ,000) and EMA No. 61, and 1: 1 copolymers of acrylic acid with methyl methacrylate or hydroxylmethyl, methyl or ethyl acrylate, isobutylvinyl ether or N-vinyl-2-pyrrolidone. Additional functional polymeric polycarboxylates are disclosed in U.S. Patents 4,138,477 and 4,183,914, incorporated herein by reference, which include copolymers of maleic anhydride with styrene, isobutylene or ethylvinyl ether, polyacrylic, polyitaconic and polymaleic acids, and sulfoacrylic oligomers of P.M as low as 1, 000 available as Uniroyal ND-2. The olefinically or ethylenically polymerized unsaturated carboxylic acids are generally suitable to contain a carbon-to-carbon olefinic double bond in at least one carboxyl group, that is, an acid containing an olefinic double bond which functions easily in the polymerization due to the presence of the monomer molecule either in the alpha-beta position with respect to a carboxyl group or as part of a terminal methylene group. Illustrative of such acids are acrylic, methacrylic, ethacrylic, alpha-chloroacrylic, crotonic, beta-acryloxy propionic, sorbic, alpha-chlorosorbic, cinnamic, beta-styrylactyl, muconic, itaconic, citraconic, mesaconic, glutaconic, aconitic, alpha-phenylacrylic, 2-benzyl acrylic, 2-cyclohexylacrylic, angelic, umbelic, fumaric, maleic acids and anhydrides. Other different olefinic monomers copolymerizable with such carboxylic monomers include vinyl acetate, vinyl chloride, dimethyl maleate and the like. The copolymers should contain sufficient carboxylic salt groups for water solubility. The synthetic anionic linear polymeric polycarboxylate component is primarily a hydrocarbon with an optional halogen and substituents containing O and bonds as present in the ester, ether and OH groups, and is generally employed in the actual compositions in amounts of approximate weight of 0.05. to 20%, preferably 0.05 to 5%, more preferably 0.1 to 2%. The most suitable polyphosphate salts for the present invention are hexametaphosphates, tripolyphosphates and pyrophosphates. The counterions for these phosphates may be alkali metal, alkaline earth metal ammonium, C2-Cß alkanolammonium salts and mixtures thereof. They are representative of the polyphosphates in sodium tripolyphosphate, sodium hexametaphosphate, potassium acid phosphate, sodium acid phosphate, sodium pyrophosphate, dipotassium pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate and mixtures of these salts. The amounts of the polyphosphate may be in the range of 0.05 to 20%, preferably 1 to 8%, optimally from 1.2 to 4.5% by weight of the respective stream. The viscosity as measured in a Brookfield RVT, E Bar 2.5 RPM, for each of the semi-solid material streams can be in the range of 20,000 to 1, 500,000 centipoise, preferably 50,000 to 800,000 centipoise at 25 ° C. . A variety of other ingredients normally present in dentifrices may be selected for the semi-solid peroxide and bicarbonate streams of the present invention. When the semi-solid is a gel, it usually employs a thickening agent with the water which is a crosslinked acrylic polymer. Alternatively, and more preferably, the gels can be constructed with a polyoxyethylene-polyoxypropylene copolymer. Commercially, the copolymers are available from BASF Corporation under the trademark Pluronic F88, F99, F108 and F127. Most preferred is Pluronic F127 (more commonly described by the CTFA name, Poloxamer 407) which has a molecular weight in the range of 10,000 to 15,000, and which contains 70% of the hydrophilic portion of polyoxyethylene. The amounts of the copolymer can be anywhere in the range of 18-25% by weight, preferably between 19 and 24%. Poloxamers are particularly suitable for this invention because of their wide pH tolerance, high compatibility with hydrogen peroxide and unique gel properties. Advantageously, the glycerol may also be present in the gel component in an amount of 15 to 60%, preferably in an amount greater than 30%, but less than 50%, optimally between 35 to 45% by weight of the gel component . A low pH, preferably a pH no greater than 4, optimally less than 3.3, should be maintained in the gel component. Acidification is best carried out through the use of an inorganic or organic acid based on phosphorus. Where Carbomer is used as a gel structurant, the pH can be as high as 7.5. The second component of the oral compositions of the invention will preferably be an opaque paste containing bicarbonate. The elements of this compound are indicated later. Advantageously, the bicarbonate will be the salt of an alkali metal such as potassium or sodium. Normally, the bicarbonate is included in the composition in an amount sufficient to provide a neutral or basic pH when the composition is in contact with water, preferably a pH of 7. 0 to 9.5, more preferably 8.0 to 9.0. Typically, the concentration will be in the range of 0.5 to 80%, preferably 5 to 50%, optimally between 8 and 20% by weight of the second semi-solid material. A humidifier and water system will normally be included. The humectants are usually polyols which, for example, may include glycerol, sorbitol, propylene glycol, lactitol, xylitol, polypropylene glycol, polyethylene glycol, hydrogenated corn syrup and mixtures thereof. Generally the amount of humectant will be in the range of 25 to 90%, preferably 40 to 70% by weight of the first or second semi-solid material. Particularly preferred is a liquid mixture of 3 to 30% in water, 0 to 80% glycerol and / or 20 to 80% sorbitol. A natural or synthetic thickening agent may be present in an amount of 0.1 to 10%, preferably 0.5 to 5% by weight of the second semi-solid material. Thickeners may include hydroxypropyl methylcellulose, hydroxyethyl cellulose, sodium carboxymethyl cellulose, xanthan gum, tragacanth gum, karaya gum, gum arabic, Irish paste, starch, alginates and carrageenans. Surfactants are also normally included in the semi-solid materials, especially the second component of the oral compositions of this invention. These surfactants can be of the anionic, nonionic, cationic or amphoteric type. Most preferred are sodium lauryl sulfate, sodium dodecylbenzene sulfonate and sodium lauryl sarcosinate. The surfactants are usually present in an amount of 0.5 to 5% by weight of the respective semi-solid component. Normally an abrasive will be included in addition to the bicarbonate in the second component paste. The abrasives can be selected from alkaline or alkaline earth metal salts insoluble in carbonate, aluminate and silicate water. Especially preferred are silica and alumina. The amounts of abrasive will be in the range of 5 to 80% by weight of a respective semi-solid component. Sweetening agents such as saccharin, sodium cyclamate, aspartame, sucrose and the like can be included in levels of 0.1 to 5% by weight of a respective semi-solid component. Other additives may also be incorporated into oral compositions including preservatives, silicones and anti-gingivitis active ingredients such as triclosan and stannous gluconates. The following examples will more fully illustrate the embodiments of this invention. All parts, percentages and proportions referred to herein and in the appended claims are by weight of the total composition unless otherwise stated.

EXAMPLE 1 Typical gel and paste components of the present invention whose formulations are detailed under Tables I and I I. The same formulations, but without the Gantrez materials, are also typical of the present invention.

TABLE I Component of Bicarbonate Paste INGREDIENT% IN WEIGHT Polyol II (sorbitol and other sugars 48.70 Syloid 63XX (silica abrasive) i 15.00 Sodium Bicarbonate 10.00 PFG 32 (polyethylene glycol) 5.00 Sylox 15x (silica thickening) 4.60 Flavor 1.0 Tetrasodium Pyrophosphate 0.50 Sodium Lauryl Sulfate 2.98 SD Alcohol 38B 2.85 Cellulose Gum 0.80 Gantrez S-97 0.10 Sodium Saccharin 4.00 Sodium Fluoride 0.44 Titanium Dioxide 0.30 Deionized Water Rest TABLE II Component of Perioxide Gel COMPONENT% IN WEIGHT Pluronic F127 20.00 Glycerin 20.00 PEG-600 10.00 PEG 1450 10.00 Hydrogen Peroxide (35% food grade) 5.285 FD Blue &C 0.005 Phosphoric Acid (85% w / w) 0.15 Deionized Water Rest EXAMPLE 2 Another set of formulations suitable for the present invention are the paste and gel components detailed under Tables III and IV.

TABLE III COMPONENT% BY WEIGHT Sorbitol 52.80 Syloid 63XX (silica abrasive)) 15.00 Sodium Bicarbonate 15.00 PEG 32 (polyethylene glycol) 5.00 Sylox 15x (silica thickening) 4.00 Sodium Hexametaphosphate 4.00 Sodium Lauryl Sulfate 2.98 SD Alcohol 38B 2.85 Gantrez AN-139 1. 00 Cellulose Gum 0.80 Sodium Saccharin 0.50 Sodium Fluoride 0.46 Titanium Dioxide 0.30 TABLE IV COM SPEAKER% IN WEIGHT Carbopol 940 (2% solution) 20.00 Glycerin 40.00 Hydrogen peroxide 4.30 Blue FD &C 0.005 Sodium hydroxide (50% solution) adjusted to a pH of 7.0 Deionized water Rest EXAMPLE 3 This example illustrates a paste and gel combination incorporating pyrophosphate in the gel, the formulations which are detailed under Tables V and VI.

TABLE V INGREDIENT% IN WEIGHT Polyol II (sorbitol and other sugars) 48.71 Sodium Bicarbonate 20.00 Calcium Carbonate 15.00 PEG 32 (polyethylene glycol) 5.00 Sodium Lauryl Sulfate 3.00 SD Alcohol 38B 3.00 Sodium monofluorophosphate 2.10 Taste 1 .00 Cellulose Gum 0.80 Sodium Saccharin 0.50 Titanium dioxide 0.30 Deionized Water Rest TABLE VI COMPONENT% IN WEIGHT Pluronic F127 25.00 Glycerin 25.00 PEG 1450 10.00 Hydrogen peroxide (35% in food grade) 4.00 Gantrez AN-116 1 .00 Dípotasio pyrophosphate 0.750 Disodium pyrophosphate 0. 750 Blue FD &C 0.005 Phosphoric acid (85% w / w) 0. .10 Deionised water R this EXAMPLE 4 This example illustrates a paste and gel combination that incorporates phosphates in both formulations as detailed under Tables VII and VIII.

TABLE VII INGREDIENT% BY WEIGHT Sorbitol 40.00 Glycerin 15.00 Syloid 63XX (silica abrasive) 15.00 Sodium Bicarbonate 15.00 PEG 32 (polyethylene glycol) 5,000 Sylox 15x (silica thickening) 4.60 Sodium Lauryl Sulfate 2.50 SD Alcohol 38B 2.50 Sodium Hexametaphosphate 2.00 Gantrez S-97 2.00 Cellulose Gum 0.80 Sodium Saccharin 0.50 Sodium Fluoride 0.46 Titanium Dioxide 0.30 Deionised Water Rest TABLE VIII COMPONENT% IN WEIGHT Pluronic F127 25,000 Glycerin 35.00 Hydrogen peroxide (35% in food grade) 10.00 Tetrapotasium pyrophosphate 4.00 Blue FD &C 0.005 Phosphoric acid (85% w / w) 0.10 Deionized water Rest The aforementioned description and the illustrated Examples select embodiments of the present invention and in the light thereof various modifications will be suggested by those skilled in the art, all of which are within the spirit and point of view of this invention.

Claims (9)

1 . A dental product characterized in that it comprises: (i) a distribution container with an upper and a lower body which are telescopically engaged with one another, the upper body including at least two separate and recessed parallel cylinders, the cylinders having a first end generally closed and a second end telescopically and slidably accommodated in at least two parallel pistons, which are shaped to roll sealingly along the inner walls of the cylinders to force any flowable material to flow towards the first end of the cylinder. cylinder after the relative compression of the cylinders and pistons, the cylinders have exit channels; (ii) an outlet means in fluid communication with the exit channels, the exit means including the adjacent exit openings disconnected from each other and having a means for causing the flowable materials to flow to each other at the exit openings to form an individual current, banded, not mixed; (iii) a first semi-solid flowable material containing a peroxide and a second semi-solid flowable material containing bicarbonate salt, each of the first and second semi-solid materials that are stored separately from at least two cylinders hollowed parallel, at least one of the semi-solid materials containing 0.05 to 20% of a synthetic linear anionic polycarboxylate or a polyphosphate.

2. The dental product, according to claim 1, characterized in that the polycarboxylate is a copolymer formed of the monomers which in their acid form are selected from the group consisting of acrylic, methacrylic, ethacrylic, succinic, maleic acid and mixtures thereof .

3. The dental product, according to claim 1, characterized in that the polycarboxylate comprises a copolymer of vinyl methyl ether and maleic acid or anhydride.

4. The dental product, according to claim 1, characterized in that the polycarboxylate is an alkali metal or ammonium salt of a copolymer of vinylmethylether and maleic acid or anhydride having a molecular weight of about 30,000 to 500,000.

5. The dental product, according to claim 1, characterized in that the polyphosphate is selected from the group consisting of tripolyphosphate, hexametaphosphate and pyrophosphate.

6. The dental product, according to claim 5, characterized in that the pyrophosphate is an alkali metal salt selected from the group consisting of tetrasodium pyrophosphate, tetrapotassium pyrophosphate, dipotassium pyrophosphate, disodium pyrophosphate and mixtures thereof.

7. The dental product, according to claim 1, characterized in that at least one of the two semi-solid flowable materials additionally comprises fluoride present in an amount effective to be an anti-caries agent.

8. The dental product, according to claim 1, characterized in that the peroxide is selected from the group consisting of hydrogen peroxide, urea peroxide, percarbonate, perfosphate, persilicate, calcium peroxide and mixtures thereof.

9. The dental product, according to claim 1, characterized in that the semi-solid material streams each have a viscosity range of 20,000 to 1, 500,000 centipoise at 25 ° C.