CA3101455A1 - Antimicrobial dental gel - Google Patents

Abstract

ABSTRACT
An antimicrobial dental gel containing from about 20 wt. % to about 50 wt. %
lipid; from about 20 wt. % to about 50 wt. % phospholipid surfactant; from about 20 wt. % to about 48 wt. %
humectant; from about 0.01 wt. % to about 5.0 wt. % antimicrobial agent; from about 0.5 wt. %
to about 10 wt. % buffer; and optionally a palatant, wherein the gel adheres to the gums and provides a topical application of antimicrobial agents.
Date Recue/Date Received 2020-12-01

Description

TITLE
Antimicrobial Dental Gel CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of provisional patent application 62/943,556 filed December 4, 2019, which is hereby incorporated by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
Not Applicable.
APPENDIX
Not Applicable.
BACKGROUND OF THE INVENTION
FIELD OF THE INVENTION
[0001] The present invention relates to a dental care product, and more particularly to a dental gel that clings to gums to topically deliver antimicrobial actives and is suitable for application to canine or feline gums.
RELATED ART

[0002] Teeth are the only mammalian body tissue not subject to metabolic turnover, thus rendering them almost indestructible. Despite this, teeth are constantly subjected to bacterial attack, which may cause decalcification of tooth enamel and erosion of surrounding oral tissues over time.

[0003] The most common disorder that affects the teeth is dental caries (tooth decay). A
widely accepted explanation of the process of tooth decay is that salivary bacteria convert carbohydrate particles in the mouth into lactic acid, which attacks the enamel, dentin, and, if left Date Recue/Date Received 2020-12-01 untreated, the pulp of the teeth. Although several factors may aggravate periodontal disease, the primary cause of periodontal disease is linked to bacteria contained within dental plaque.

[0004] Plaque is a sticky, colorless film of bacteria and sugars that constantly forms on teeth. Plaque causes cavities when the acids from plaque attack teeth after eating, eventually causing the tooth enamel to break down, resulting in tooth decay and halitosis. If left untreated, periodontal disease may develop, eventually leading to tooth loss.

[0005] Microorganisms have an essential role in the development of caries, endodontic and periodontal diseases that can destroy oral tissues. Antimicrobial agents kill or inhibit the growth of microorganisms such as bacteria, fungi, or protozoan. There is a need for a delivery system to apply antimicrobial agents to the gums to kill or inhibit the growth of microorganisms.

[0006] Related patent art includes US 5,057,497 patent which discloses a gel that is effective therapy for gingivitis by absorption of Tissue Respiration Factor (TRF) promoting increased cellular proliferation and growth. The gel disclosed is not the gel claimed in the present invention.
SUMMARY OF THE INVENTION

[0007] The antimicrobial dental gel of the present invention suitable for canine and/or feline use contains from about 20 wt. % to about 50 wt. % lipid; from about 20 wt. % to about 50 wt. % phospholipid surfactant; from about 20 wt. % to about 48 wt. %
humectant; from about 0.01 wt. % to about 5.00 wt. % antimicrobial agent; optionally from about 0.5 wt. %
to about 10 wt. %
buffer and/or flavoring.

[0008] In a preferred embodiment, the antimicrobial dental gel contains from about 20 wt. % to about 50 wt. % petrolatum; from about 20 wt. % to about 50 wt. %
lecithin; from about wt. % to about 25 wt. % sorbitol; from about 10 wt. % to about 25 wt. %
glycerin; from about 0.01 wt. % to about 0.20 wt. % chlorhexidine digluconate; from about 0.5 wt. %
to about 10 wt.

Date Recue/Date Received 2020-12-01 % sodium bicarbonate; and from 0.5 wt. % to about 5.0 wt. % flavoring, wherein the dental gel does not contain breath freshening agents such as Eucalyptol, Methyl Salicylate, Thymol, or Menthol.

[0009] Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.

[0010] DESCRIPTION OF THE FIGURE

[0011] FIG. 1 is a top view of a dispenser of the dental gel of the present invention.

[0012] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.

[0014] The lipids of the present invention may be of animal, vegetable or mineral origin, which are substantially water-insoluble, inert, non-toxic hydrocarbon fats and oils and derivatives thereof, and may comprise any of the commonly commercially available fats or oils approved by the Food & Drug Administration, having melting points in the range of about 90 to 160 F. The lipid may comprise a vegetable oil base commonly known as hard butter. Hard butters are hydrogenated, press fractionated or other processed oils that are processed or recombined to have a solid fat index (percent solid fat vs. temperature) similar to that of cocoa butter. However, other lipids may be used that are relatively hard or solid at room temperature, but melt rapidly in the mouth at a temperature of about 98 F (mouth temperature).

[0015] Examples of suitable lipids include tallow, hydrogenated tallow, hydrogenated vegetable oil, almond oil, coconut oil, corn oil, cottonseed oil, light liquid petrolatum, heavy liquid petrolatum, olein, olive oil, palm oil, peanut oil, persic oil, sesame oil, vitamin E, soybean oil or Date Recue/Date Received 2020-12-01 safflower oil. Additionally, stearines can be used as a lipid in the present invention. The addition of stearines to the product provides the favorable property of mold-release.
Further, the addition of stearines raises the melting point of the composition as high as about 100 degree F, which is particularly beneficial when the product is shipped or stored in unrefrigerated compartments.

[0016]
Preferred examples include petrolatum, a mineral oil (Vaseline oil), which may be any petroleum based product; modified or unmodified vegetable oils such as peanut oil, wheat germ oil, linseed oil, jojoba oil, apricot kernel oil, walnut oil, palm oil, pistachio oil, sesame oil, colza oil, cade oil, corn germ oil, peach kernel oil, poppy seed oil, pine oil, castor oil, soya oil, safflower oil, coconut oil, hazelnut oil, grapeseed oil, avocado oil, soy oil, sweet almond oil, calophyllum oil, castor oil, olive oil, sunflower oil, or animal oils such as whale oil, seal oil, menhaden oil, halibut liver oil, cod liver oil, cod, tuna, turtle tallow, horse's hoof, sheep's foot, mink, otter, marmot oil and the like; synthetic oils such as silicon oil such as dimethylpolysiloxane;
alkyl and alkenyl esters of fatty acids, such as isopropyl esters of myristic, palmitic and stearic acids and fatty esters which are solid at room temperature; waxes such as lanolin wax, candelilla wax, spermaceti, cocoa butter, karite butter, silicon waxes, hydrogenated oils which are solid at room temperature, sucro-glycerides, oleates, myristates, linoleates, stearates, paraffin, beeswax, carnauba wax, ozokerite, candelilla wax, microcrystalline wax; fatty alcohols such as lauryl, cetyl, myristyl, stearyl, palmityl and ()ley' alcohols; polyoxyethylated fatty alcohols; and wax esters, lanolin and its derivatives, perhydrosqualene and saturated esters, ethyl palmitate, isopropyl palmitate, alkyl myristates such as isopropyl myristate, butyl myristate and decyl myristate, hexyl stearate, triglyceride esters, triglycerides of octanoic and decanoic acid, cetyl ricinoleate, stearyl octanoate (Purcellin oil), fatty acids, polyhydric alcohols, polyether derivatives, fatty acid monoglycerides, and hydrogenated palm oil (Paramount XX), and mixtures of waxes and oils. The preferred lipids are a combination of hydrogenated palm oil and vitamin E. The preferred dental Date Recue/Date Received 2020-12-01 gel contains from about 20 wt. % to about 50 wt. % petrolatum. The more preferred dental gel contains from about 25 wt. % to about 35 wt. % petrolatum.

[0017] The surfactant suitable for the present canine and feline product selected from phospholipids. Other well-known surfactants are not suitable for consumption by dogs and cats.
Suitable phospholipids include any of a group of phospholipids occurring in animal and plant tissues and egg yolk, composed of units of choline, phosphoric acid, fatty acids, and glycerol. This includes a commercial form of phospholipids obtained chiefly from soybeans, corn, and egg yolk, specifically including lecithin. The preferred dental gel contains from about 20 wt. % to about 50 wt. % lecithin. The more preferred dental gel contains from about 20 wt. % to 30 wt. % lecithin.

[0018] Suitable humectants include, but are not limited to glycerin, lactic acid, polyols, propylene glycol, corn syrup, high fructose corn syrup (HFCS), including Comsweet 55 and Comsweet 42, and sorbitol. The preferred form of humectant is a combination of non-crystallizing liquid sorbitol (70 wt. % sorbitol in water) and glycerine. The preferred dental gel has about 20 to 48 wt. % humectant. The more preferred preferred dental gel has from about 10 wt. % to about 40 wt. % sorbitol and from about 10 wt. % to about 40 wt. % glycerin. The most preferred dental gel has from about 15 wt. % to about 25 wt. % sorbitol and from about 15 wt. % to about 25 wt. %
glycerin.

[0019] Suitable antimicrobials include antiplaque and anti-tartar actives such as cetyl pyridinium chloride and related quaternary salts such as chlorhexidine; zinc salts such as zinc chloride and zinc sulfate monohydrate; stannous salts such as stannous chloride and stannous fluoride; and peroxygens such as hydrogen peroxide, carbamide peroxide; sodium percarbonate;
magnesium perphthalate; and sodium perborate. These antiplaque agents are generally present at levels ranging from about 0.01 weight % to about 5 weight %. The preferred antimicrobial is chlorhexidine digluconate (CHD) in the range of from about 0.01 wt. % to about 0.20 wt. %.
Date Recue/Date Received 2020-12-01

[0020] Optionally, the dental gel of the present invention contains a buffer to raise the pH
and to provide antimicrobial properties. Suitable buffers include sodium bicarbonate, sodium carbonate, and sodium silicate. Mixtures of the above alkali metal compounds can also be used.
The preferred buffer is sodium bicarbonate. The buffer is present in the gel in the range of about 0.5 wt. % to 10.0 wt. %. More preferably, the buffer is present from about 0.5 wt. % to 5.0 wt. %.

[0021] Optionally, the gel of the preset invention contains at least one palatant. Palatants are ingredient systems that are specially designed to make pet dental products, foods, treats, and supplements taste better, ensuring that pets receive the treatment they need.
Palatants can be meat or vegetable based, and may be designed to meet a variety of claims (grain-free, limited ingredient, non-GMO, natural, low fat, etc.). Palatant components include proteins, yeasts, phosphates, antioxidants, antimicrobials, processing agents, and other ingredients.
Palatant protein sources vary depending on desired performance targets, cost requirements, and brand claims. The protein can be vegetable or animal derived. Vegetable derived proteins come from many sources, including corn, soy, potato, and specialty grains. The desired vegetable protein source often depends on customer-specific needs. Common animal derived proteins are poultry, pork, and fish.
A preferred palatant is Bioflavor B20012 made by AFB International, a dry palatant for dog and cat food. Preferably, the palatant is added to the gel in the range of about 0.5 wt. % to 5.0 wt. %.

[0022] CONTROL SAMPLES USING Breath Freshener

[0023] Table 1 Component (wt. %) C-1 C-2 C-3 C-4 C-5 C-6 C-7 C-8 Petrolatum Lipid 40.0 32.0 24.0 28.5 40.0 38.8 22.8 25.5 Atmos 300 40.0 32.0 24.0 28.5 Surfactant Lecithin Surfactant 40.0 38.8 22.8 25.5 Breath Freshener 20.0 16.0 12.0 3.0 20.0 19.4 11.4 6.0 Glycerin Humectant 10.0 20.0 20.0 20.0 20.0 Sorbitol (70%) 10.0 20.0 20.0 20.0 20.0 Humectant BioFlavor Palatant 3.0 3.0 3.0 Date Recue/Date Received 2020-12-01 Breath Freshener Formula Table 2 Weight Ingredient Eucalyptol 71.32 35.66 Methyl Salicylate 46.52 23.26 Thymol NF Fine Powder, 80 Mesh 49.62 24.81 Menthol (5-Methyl-2-[1-methyl-ethyl]
cyclohexanol) 32.56 16.28 Total 100.00

[0024] The Control samples C-1 to C-8 of Table 1 were prepared by the following process:

[0025] 1. Weigh all Petrolatum and Surfactant directly into Kitchen Aid Precise Heat Mixing Bowl.

[0026] 2. Turn heat setting to 165 F.

[0027] 3. Attach the blade and begin slow mixing.

[0028] 4. When product temperature reaches at least 160 F, turn heat OFF.

[0029] 5. In a suitable bowl or beaker, add the Breath Freshener, Sorbitol, or Glycerin and warm to 130 F

[0030] 6. Screen Palatant using a 30 mesh screen, weigh out in to a suitable container and set aside.

[0031] 7. Gradually add the Breath Freshener, Sorbitol, Glycerin or Palatant to the Petrolatum/Surfactant in the Kitchen Aid Precise heat bowl, while stirring continuously.

Date Recue/Date Received 2020-12-01

[0032] 8. Maintain a product temperature of 130 F during the process.

[0033] 9. Once all of the solution is added, add the Palatant (Step 6) and mix well.

[0034] 10. With the heat turned OFF, allow to cool while continuously stirring.

[0035] 11. When the product temperature cooled to 110 F, pour into storage containers.

[0036] TESTING THE SAMPLES OF TABLE 1

[0037] The gels prepared in Table 1 were applied to the gums of a male yellow lab dog.
The dog clearly did not like the taste of the gels with breath freshener. The concentration of the breath freshener was reduced and a palatant was added, but the dog still did not like the taste of the gel. The next samples were prepared without breath freshener.

[0038] SAMPLES WITHOUT Breath Freshener

[0039] Table 3 Component (Wt. %) C-9 Ex-1 Ex-2 Ex-3 Ex-4 Petrolatum 28.5 28.2 33.8 28.5 27.0 Lecithin Surfactant 28.5 28.2 22.6 28.5 27.0 Glycerin Humectant 20.0 20.0 20.0 20.0 20.0 Sorbitol (70%) Humectant 20.0 20.0 20.0 20.0 20.0 BioFlavor Palatant 3.0 3.0 3.0 3.0 3.0 Chlorhexidine Digluconate 0.60 0.60 (20%) Antibacterial Agent Perma Canaliculus 3.0 Antimicrobial Agent Resolvinol Canaliculus 3.0 Antimicrobial Agent

[0040]
Preferred Embodiment - Ex-5 Table 4 Ingredient Weight I Snow White PET USP, Bulk - Petrolatum 80.25 26.75%

Yelkin Gold Lecithin 86.55 28.85%

Date Recue/Date Received 2020-12-01 20.75% (14.575% Sorbitol, Sorbitol Solution 70% USP 62.25 6.225% Water) Glycerin, USP 99.7% Excipient/Food use 62.25 20.75%
Chlorhexidine Digluconate (CHD) 0.60% (0.12% CHD, 20% Aqueous Solution 1.80 0.48% water) Sodium Bicarbonate, USP 1.50 0.50%
BioFlavor B20012 5.40 1.80%
Total 300 100

[0041] Process:

[0042] 1. Weigh all Petrolatum and Lecithin directly into Kitchen Aid Precise Heat Mixing Bowl.

[0043] 2. Turn heat setting to 165 F.

[0044] 3. Attach the blade and begin slow mixing.

[0045] 4. When product temperature reaches at least 160 F, turn heat OFF.

[0046] 5. In a suitable bowl or beaker, add Sorbitol and Glycerin and warm to 130 F

[0047] 6. Optionally, add the Sodium Bicarbonate and mix well to dissolve.

[0048] 7. Add the Antimicrobial Agent solution and mix well.

[0049] 8. Screen the Palatant using a 30 mesh screen, weigh out in to a suitable container and set aside.

[0050] 9. Gradually add the Sorbitol/Glycerin/Sodium Bicarbonate/Antimicrobial agent Solution to the Petrolatum/Lecithin mix in the Kitchen Aid Precise heat bowl, while stirring continuously.

[0051] 10. Maintain a product temperature of 130 F during the process.

[0052] 11. Once all of the solution is added, add the Palatant (Step 8) and mix well.

[0053] 12. With the heat turned OFF, allow to cool while continuously stirring.

Date Recue/Date Received 2020-12-01

[0054] 13. When the product temperature cooled to 110 F, pour into storage containers.

[0055] TESTING THE SAMPLES OF TABLES 3 AND 4

[0056] The taste of the samples of Tables 3 and 4 were liked by the dog and were easily applied to its gums. The preferred sample was Ex-5, which also contained sodium bicarbonate.
The sodium bicarbonate raised the pH, which was more favorable to the dog's gums and had more antimicrobial properties. The sodium bicarbonate was dissolved, and did not provide any abrasive properties. None of the samples had any breath freshening ingredients.

[0057] In a preferred embodiment, as shown in FIG. 1, the dental gel is placed in a container that has slots or openings at the top. At the bottom of the container is a tightening mechanism that forces the gel up through the openings at the top. The top is smooth and configured to easily fit inside a mouth to apply the gel to the tongue, teeth and gums.
In a preferred embodiment, this container is used to apply the gel the mouth, teeth and gums of an animal, such as a dog. As the dog licks the gel off the container, the licking motion topically applies the gel to the gums of the dog, where it adheres to the gums and provides a topical application of antimicrobial agent to the gums to prevent plaque formation.

[0058] The embodiments were chosen and described to best explain the principles of the invention and its practical application to persons who are skilled in the art.
As various modifications could be made to the exemplary embodiments, as described above with reference to the corresponding illustrations, without departing from the scope of the invention, it is intended that all matter contained in the foregoing description and shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.
Date Recue/Date Received 2020-12-01

Claims (20)

What is claimed is:

1. An antimicrobial dental gel comprising:
from about 20 wt. % to about 50 wt. % lipid;
from about 20 wt. % to about 50 wt. % phospholipid surfactant;
from about 20 wt. % to about 48 wt. % humectant; and from about 0.01 wt. % to about 5.00 wt. % antimicrobial agent.

2. The antimicrobial dental gel of claim 1, further comprising from about 0.5 wt. 5 to 10.0 wt. % buffer.

3. The antimicrobial dental gel of claim 2, further comprising from about 0.5 wt. % to about 5.0 wt. % palatant.

4. The antimicrobial dental gel of claim 3, wherein the antimicrobial dental gel does not contain breath freshening agents.

5. The antimicrobial dental gel of claim 4, wherein the breath freshening agents are selected form the group consisting of Eucalyptol, Methyl Salicylate, Thymol and Menthol, or a mixture thereof.

6. An antimicrobial dental gel comprising:
from about 20 wt. % to about 50 wt. % lipid;
from about 20 wt. % to about 50 wt. % phospholipid surfactant;
from about 20 wt. % to about 48 wt. % humectant;
from about 0.01 wt. % to about 5.00 wt. % antimicrobial agent;
from about 0.5 wt. 5 to 10.0 wt. % buffer; and from about 0.5 wt. % to about 5.0 wt. % palatant.

Date Recue/Date Received 2020-12-01

7. The antimicrobial dental gel of claim 6, wherein the humectant is selected from the group consisting of glycerin, lactic acid, propylene glycol, corn syrup, high fructose corn syrup, and sorbitol, or a combination thereof.

8. The antimicrobial dental gel of claim 7, wherein the antimicrobial agent is selected from the group consisting of cetyl pyridinium chloride, chlorhexidine digluconate, zinc chloride, zinc sulfate monohydrate, stannous chloride, stannous fluoride, sodium percarbonate, magnesium perphthalate, and sodium perborate, or a mixture thereof.

9. The antimicrobial dental gel of claim 8, wherein the buffer is selected from the group consisting of sodium bicarbonate, sodium carbonate and sodium silicate, or a mixture thereof.

10. The antimicrobial dental gel of claim 9, wherein the antimicrobial dental gel does not contain breath freshening agents.

11. The antimicrobial dental gel of claim 10, wherein the breath freshening agents are selected form the group consisting of Eucalyptol, Methyl Salicylate, Thymol and Menthol, or a mixture thereof.

12. An antimicrobial dental gel comprising:
from about 20 wt. % to about 50 wt. % petrolatum;
from about 20 wt. % to about 50 wt. % lecithin;
from about 10 wt. % to about 40 wt. % sorbitol;
from about 10 wt. % to about 40 wt. % glycerin;
from about 0.01 wt. % to about 0.20 wt. % chlorhexidine digluconate;
from about 0.5 wt. % to about 10 wt. % sodium bicarbonate; and from 0.5 wt. % to about 5.0 wt. % palatant.

Date Recue/Date Received 2020-12-01

13. The antimicrobial dental gel of claim 12, wherein the antimicrobial dental gel is placed in a container, wherein the container has a top with multiple openings wherein the container has a bottom with a tightening mechanism that forces the antimicrobial dental gel through the openings at the top;
wherein the top is smooth and configured to fit in a dog's mouth;
wherein the top is placed in the dog's mouth; and wherein the antimicrobial dental gel is applied to the dog's tongue, teeth and gums so as to treat the dog's teeth and gums to prevent plaque formation.

14. The antimicrobial dental gel of claim 13, wherein the lecithin is present from about 20.0 wt. % to 30.0 wt. %.

15. The antimicrobial dental gel of claim 14, wherein the petrolatum is present from about 25.0 wt. % to about 35.0 wt. %.

16. The antimicrobial dental gel of claim 15, wherein the sorbitol is present from about 15.0 wt. % to 25.0 wt. %.

17. The antimicrobial dental gel of claim 16, wherein the glycerin is present from about 15.0 wt. % to 25.0 wt. %.

18. The antimicrobial dental gel of claim 17, wherein the chlorhexidine digluconate is present from about 0.01 wt. % to 0.20 wt. %.

19. The antimicrobial dental gel of claim 18, wherein the antimicrobial dental gel does not contain breath freshening agents.

20. The antimicrobial dental gel of claim 19, wherein the breath freshening agents are selected form the group consisting of Eucalyptol, Methyl Salicylate, Thymol and Menthol, or a mixture thereof.

Date Recue/Date Received 2020-12-01