Source: http://www.google.com/patents/US6136297?dq=6,799,467
Timestamp: 2016-08-26 07:24:31
Document Index: 723182971

Matched Legal Cases: ['Application No. 0', 'application No. 08870330', 'application No. 08870331', 'application No. 08870664', 'application No. 08870665', 'application No. 09040200']

Patent US6136297 - Delivery system for an oral care substance using a strip of material having ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA system for delivering an oral care substance to the oral surface, the delivery system comprising a strip of flexible material having a sufficient flexibility to form to the contours of the oral surface. The strip of material is readily conformable to oral surfaces without permanent deformation when...http://www.google.com/patents/US6136297?utm_source=gb-gplus-sharePatent US6136297 - Delivery system for an oral care substance using a strip of material having low flexural stiffnessAdvanced Patent SearchPublication numberUS6136297 APublication typeGrantApplication numberUS 09/042,909Publication dateOct 24, 2000Filing dateMar 17, 1998Priority dateJun 6, 1997Fee statusPaidAlso published asCA2293528A1, CA2293528C, CN1170526C, CN1259044A, DE69836584D1, DE69836584T2, EP0996425A2, EP0996425B1, EP1779846A2, WO1998055079A2, WO1998055079A3Publication number042909, 09042909, US 6136297 A, US 6136297A, US-A-6136297, US6136297 A, US6136297AInventorsPaul Albert Sagel, Robert Stanley Dirksing, Frederick James RohmanOriginal AssigneeThe Procter & Gamble CompanyExport CitationBiBTeX, EndNote, RefManPatent Citations (43), Non-Patent Citations (13), Referenced by (134), Classifications (25), Legal Events (5) External Links: USPTO, USPTO Assignment, EspacenetDelivery system for an oral care substance using a strip of material having low flexural stiffness
US 6136297 AAbstract
1. A delivery system for an oral care substance to a surface of the oral cavity said delivery system comprising:a. a strip of flexible material having an array of shallow pockers wherein said strip has sufficient flexibility to form a curved shape on an oral surface, said strip of material being readily conformable to the oral surface without permanent deformation when said delivery system is placed there against; and b. an oral care substance applied to said strip of material and in a plurality of said shallow pockets such that when said delivery system is placed on the oral surface said substance contacts said oral surface providing an active onto said oral surface, said substance also providing adhesive attachment between said strip of material and said oral surface to hold said delivery system in place for a sufficient time to allow said active to act upon said oral surface;wherein said oral surface is the front of a plurality of teeth and its surrounding tissue. 2. The delivery system of claim 1 wherein said strip has a substantially constant flexural stiffness of less than about 5 grams/centimeter as measured on a Handle-O-Meter per ASTM test method D2923-95.
3. The delivery system of claim 2 wherein said strip of material is comprised of materials that are compatible with said oral care substances.
4. The delivery system of claim 3 wherein said strip of material is capable of recovery from said deformed state in the absence of adhesive forces due to said oral care substance.
6. The delivery system of claim 5 wherein said substance is a gel.
8. The delivery system of claim 7 where said active in said substance is selected from the group consisting of teeth whitening actives, phosphates, fluoride ion sources, antimicrobial agents, anti-inflammatory agents, nutrients, enzymes, mouth and throat products, antioxidants, H-2 antagonists and mixtures thereof.
11. The delivery system of claim 10 wherein said strip of material with said substance is removable from said oral cavity surface without the use of an instrument, chemical solvent or excessive friction.
12. The delivery system of claim 11 wherein the delivery system is applied to adjoining soft tissue of said plurality of teeth in addition to tooth surfaces.
13. The delivery system of claim 12 wherein the said tooth surface is not required to be prepared before application of said delivery system.
14. The delivery system of claim 13, wherein said strip of material has shallow pockets on a oral care substance-coated side of said strip of material, said shallow pockets having a oral care substance located therein.
15. The delivery system of claim 14 where said substance comprises an amount of carboxypolymethylene from about 0.5% to about 12%, by weight of the oral care substance.
16. The delivery system of claim 15 wherein said substance comprises an amount of water from about 0.1% to about 95%, by weight of the oral care substance.
18. The delivery system of claim 17 further comprising a release liner.
19. A method of delivering an oral care substance to a surface of the oral cavity said method comprising the steps of:a. applying said substance onto a conformable strip of material having an array of shallow pockets wherein said strip has a sufficient flexibility to conform to tie contours of the oral surface; b. applying said conformable strip of material with said substance thereon to the oral surface without permanent deformation of said strip of material such that said substance contacts said oral surface, said substance providing an active onto said oral surface, said substance also providing adhesive attachment between said strip of material and said oral surface to hold said delivery system in place for a sufficient time to allow said active to act upon said oral surface;wherein said oral surface is the front of a purality of teeth and its surrounding tissue. 20. A delivery system for an oral care substance to a surface of the oral cavity, said delivery system comprising:a. a strip of flexible material having an array of shallow pockets wherein said strip has a sufficient flexibility to conform to the contours of the oral surface, said strip of material being readily conformable to the oral surface without permanent deformation when said delivery system is placed there against; b. an oral care substance applied to said strip of material and in a plurality of said shallow pockets such that when said delivery system is placed on the oral surface, said substance contacts said oral surface providing an active onto said oral surface, said substance also providing adhesive attachment between said strip of material and said oral surface to hold said delivery system in place for a sufficient time to allow said active to act upon said surface; and c. a release liner;wherein said oral surface is the front of a plurality of teeth and its surrounding tissue. Description
This application is a continuation-in-part of the co-pending prior application, Ser. No. 08/870,664, filed on Jun. 6, 1997.
The present invention relates to a system for the delivery of an oral care substance or composition to oral surfaces including teeth, gingival and mucosal tissues wherein the oral care substance is protected from erosion and interaction with saliva within the mouth for a time sufficient for the active in the oral care substance to provide a therapeutic benefit. Even more particularly, the present invention relates to disposable delivery systems that are inexpensive and unobtrusive.
In practicing the present invention, a strip of material is applied by the wearer to a desired oral surface within the oral cavity. The side of the strip of material facing the oral surface is either coated with an oral care substance or the oral surface is coated with the oral care substance and the strip of material is immediately placed over this oral care substance. In either case, the oral care substance is viscous, such as a gel, so that it provides even dosing of the active and tackiness between the oral surface and the strip of material for holding the strip of material in place. The strip of material is preferably of a size that fits the need. For example, the strip may be the shape and size large enough to completely cover a small lesion on the oral surface it is to be used for, or large enough to cover oral surfaces such as the entire upper or lower gingival surfaces and, or its adjoining teeth. As a soft, conformable material, the strip may come into contact with the wearer's gums without causing physical irritation. The strip of material readily conforms to the oral surface by lightly pressing it there against. The strip of material is readily conformable without permanent deformation to a shape the oral surface when the delivery system is placed there against. The strip of material is easily removed by the wearer after use by peeling it off. Preferably each successive treatment uses a fresh strip of material is used in.
Another aspect of the,present invention is the method for delivering the oral care substance to the oral surface by applying the oral care substance onto a conformable strip of material. An alternative step is applying the oral care substance directly to the oral surface and immediately placing the strip of material over the applied oral care substance. Either way the oral care substance delivers an oral care active onto the oral surface and also provides adhesive attachment between the strip of material and the oral surface to maintain the delivery system in place for a sufficient time to allow the active to act upon the surface.
FIG. 2 is a perspective view of an embodiment of the present invention, disclosing the flat strip of FIG. 1 coated with an oral care substance for treating teeth;
FIG. 6 is a cross-sectional elevation view of a tooth and adjoining soft tissue, taken along section line 6--6 of FIG. 5, disclosing the strip of material of the present invention conforming to and adhesively attached to the teeth by means of the oral care substance located between the teeth and the strip of material;
FIG. 9 is a perspective view of an alternative embodiment of the present invention, disclosing the flat strip of material coated with an oral care substance of FIG. 2 for treating teeth having a release liner; and
FIGS. 9 and 10 shows optional release liner 27. Release liner 27 is attached to strip of material 12 by oral care substance 14. Oral care substance 14 is on the side of strip of material 12 facing release liner 27. This side is applied to the tooth surface once release liner 27 is removed.
The strip of material serves as a protective barrier for the oral care substance. It prevents substantial leaching and/or erosion of the oral care substance by for example, the wearer's lips, tongue, as well as saliva. This allows the active in the oral care composition to act upon the oral surface for an extended period of time, from several minutes to several hours. The term "act upon" is herein defined as bringing about a desired change. For example, if the oral care substance is an anti-gingivitis substance, it reduces or eliminates bleeding and promotes healing of the gingival tissue.
Flexural stiffness is a material property that is a function of a combination of strip thickness, width, and material modulus of elasticity. This test is a method for measuring the rigidity of polyolefin film and sheeting. It determines the resistance to flexure of a sample by using a strain gauge affixed to the end of a horizontal beam. The opposite end of the beam presses across a strip of the sample to force a portion of the strip into a vertical groove in a horizontal platform upon which the sample rests. A microammeter, wired to the strain gauge is calibrated in grams of deflection force. The rigidity of the sample is read directly from the microammeter and expressed as grams per centimeter of sample strip width. In the present invention, the strip of material has a flexural stiffness of less than about 5 grams/cm as measured on a Handle-O-Meter, model #211-300, available from Thwing-Albert Instrument Co. of Philadelphia, Pa. as per test method ASTM D2923-95. Preferably, the strip of material has a flexural stiffness less than about 3 grams/cm, more preferably less than about 2 grams/cm, and most preferably from about 0.1 grams/cm to about 1 grams/cm. Preferably, the flexural stiffness of the strip of material is substantially constant and does not change during normal use. For example, the strip of material does not need to be hydrated for the strip to achieve the low flexural stiffness in the above-specified ranges.
The oral care substance preferably contains an active at a level where upon directed use, promotes the benefit sought by the wearer without detriment to the oral surface it is applied to. Examples of the oral conditions these actives address include, but, are not limited to appearance and structural changes to teeth, whitening, stain bleaching, stain removal, plaque removal, tartar removal, cavity prevention and treatment, inflamed and, or bleeding gums, mucosal wounds, lesions, ulcers, aphthous ulcers, cold sores and tooth abscesses.
Antimicrobial agents can also be present in the oral care compositions or substances of the present invention. Such agents may include, but are not limited to, 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. Pat. No. 3,506,720, and in European Patent Application No. 0,251,591 of Beecham Group, PLC, published Jan. 7, 1988; chlorhexidine (The Merck Index, no. 2090), alexidine (The Merck Index, no. 222; hexetidine (The Merck Index, no. 4624); sanguinarine (The Merck Index, no. 8320); benzalkonium chloride (The Merck Index, no. 1066); salicylanilide (The Merck Index, no. 8299); domiphen bromide (The Merck Index, no. 3411); cetylpyridinium chloride (CPC) (The Merck Index, no. 2024; tetradecylpyridinium chloride (TPC); N-tetradecyl-4-ethylpyridinium chloride (TDEPC); octenidine; delmopinol, octapinol, and other piperidino derivatives; nicin preparations; zinc/stannous ion agents; antibiotics such as augmentin, amoxicillin, tetracycline, doxycycline, minocycline, and metronidazole; and analogs and salts of the above antimicrobial antiplaque agents.
Nutrients may improve the condition of the oral cavity and can be included in the oral care compositions or substances of the present invention. Nutrients include minerals, vitamins, oral nutritional supplements, enternal nutritional supplements, and mixtures thereof.
Oral nutritional supplements include amino acids, lipotropics, fish oil, and mixtures thereof, as disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., �1997, pp. 54-54e; incorporated herein by reference. Amino acids include, but, are not limited to L-Tryptophan, L-Lysine, Methionine, Threonine, Levocarnitine or L-carnitine and mixtures thereof. Lipotropics include, but, are not limited to choline, inositol, betaine, linoleic acid, linolenic acid, and mixtures thereof. Fish oil contains large amounts of Omega-3 (N-3) Polyunsaturated fatty acids, eicosapentaenoic acid and docosahexaenoic acid.
Enternal nutritional supplements include, but, are not limited to protein products, glucose polymers, corn oil, safflower oil, 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; incorporated herein by reference.
Antioxidants are generally recognized as useful in compositions such as those of the present invention. Antioxidants are disclosed in texts such as Cadenas and Packer, The Handbook of Antioxidants, �1996 by Marcel Dekker. Inc., incorporated herein by reference. Antioxidants that may be included in the oral care composition or substance of the present invention include, but are not limited to Vitamin E, ascorbic acid, Uric acid, carotenoids, Vitamin A, flavonoids and polyphenols, herbal antioxidants, melatonin, aminoindoles, lipoic acids and mixtures thereof.
Histamine-2 (H-2 or H@) receptor antagonist compounds (H-2 antagonists) may be used in the oral care composition of the present invention. As used herein, selective H-2 antagonists are compounds that block H-2 receptors, but do not have meaningful activity in blocking histamine-1 (H-1 or H!) receptors. Selective H-2 antagonists stimulates the contraction of smooth muscle from various organs, such as the gut and bronchi; this effect can be suppressed by low concentrations of mepyraminc--a typical antihistaminic drug. The pharmacological receptors involved in these mepyramine-sensitive histamine responses have been defined as H-1 receptors (Ash, A. S. F. & H. O. Schild, Brit. J. Pharmacol Chemother., Vol. 27 (1966), p. 427, incorporated herein by reference). Histamine also stimulates the secretion of acid by the stomach (Loew, E. R. & O. Chickering, Proc. Soc. Exp. Biol. Med., Vol. 48 (1941), p. 65, incorporated herein by reference), increases the heart rate (Trendelenburg, U., J. Pharmacol., Vol. 130 (1960), p. 450, incorporated herein by reference), and inhibits contractions in the rat uterus (Dews, P. B. & J. D. P. Graham, Brit. J. Pharmacol. Chemother., Vol. 1 (1946), p. 278, incorporated herein by reference); these actions cannot be antagonized by mepyramine and related drugs. The H-2 antagonists useful in the oral care compositions or substances are those that blockade the receptors involved in mepyramine-insensitive, non-H-1 (H-2), histamine responses, and do not blockade the receptors involved in mepyramine-sensitive histamine responses.
Selective H-2 antagonists are those compounds found to be H-2 antagonists through their performance in classical preclinical screening tests for H-2 antagonist function. Selective H-2 antagonists are identified as compounds which can be demonstrated to function as competitive or non-competitive inhibitors of histamine-mediated effects in those screening models specifically dependent upon H-2 receptor function, but to lack significant histamine antagonist activity in those screening models dependent upon H-1 receptor function. Specifically, this includes compounds that would 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 H@-Receptors", Nature, Vol. 236 (Apr. 21, 1972), pp. 385-390 (Black), incorporated herein by reference, as H-2 antagonists if assessed as described by Black through testing with the guinea pig spontaneously beating right atria in vitro assay and the rat gastric acid secretion in vivo assay, but shown to lack in significant H-1 antagonist activity relative to H-2 antagonist activity, if assessed as described by Black with either the guinea pig ileum contraction in vitro assay or the rat stomach muscle contraction in vivo assay. Preferably selective H-2 antagonists demonstrate no significant H-1 activity at reasonable dosage levels in the above H-1 assays. Typical reasonable dosage level is the lowest dosage level at which 90% inhibition of histamine, preferably 99% inhibition of histamine, is achieved in the above H-2 assays.
Selective H-2 antagonists include compounds meeting the above criteria which are disclosed in U.S. Pat. Nos. 5,294,433 and 5,364,616 Singer et al., issued Mar. 15, 1994 and Nov. 15, 1994 respectively and assigned to Procter & Gamble; both herein incorporated by reference, wherein the selective H-2 antagonist is selected from the group consisting of cimetidine, etintidine, ranitidine, ICIA-5165, tiotidine, ORF-17578, lupitidine, donetidine, famotidine, roxatidine, pifatidine, lamtidine, BL-6548, BMY-25271, zaltidine, nizatidine, mifentidine, BMY-52368, SKF-94482, BL-6341A, ICI-162846, ramixotidine, Wy-45727, SR-58042, BMY-25405, loxtidine, DA-4634, bisfentidine, sufotidine, ebrotidine, HE-30-256, D-16637, FRG-8813, FRG-8701, impromidine, L-643728, and HB-408. 4. Particularly preferred is cimetidine (SKF-92334), N-cyano-N'-methyl-N"-(2-(((5-methyl- 1H-imidazol-4-yl)methyl)thio)ethyl)guanidine: ##STR1##
As previously mentioned, the oral care substance of the present invention can be in a variety forms, but, most preferable is a gel, particularluy an aqueous gel. The gel is a high viscosity matrix formed from gelling agents known in the art. These gelling agents are safe for oral use, do not readily dissolve in saliva, and do not react with or inactivate the oral care compounds incorporated into them. Generally, the gelling agent is a swellable polymer. Furthermore, the gel formed with these agents provide sufficient adhesive attachment of the film material to the targeted area of the mouth. The level of gelling agent to form the gel composition is from about 0.1% to about 15%, preferably from about 1% to about 10%, more preferably from about 2% to about 8%, and most preferably from about 4% to about 6%, by weight of the oral care composition or substance.
In practicing the present invention, a strip of material is applied to the desired oral surface by the wearer. The side of the material facing the oral surface is coated with a oral care substance that is preferably in a highly viscous state. This oral care substance provides a vehicle for the active as well as tackiness between the oral surface and the strip of material, holding the strip of material in place for extended periods of time. For oral care actives other than teeth whiteners, the period over which the strip of material is used is from about one to thirty minutes. For actives that require long term diffusion into the oral surface, such as teeth whiteners, the strip of material is used for periods necessary to deliver the active in the dose required for providing the benefit sought. This period may be for a half an hour to several hours.
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