Dental preparation, article and method for storage and delivery thereof

• US 4,983,379 A
• Filed: 06/20/1989
• Issued: 01/08/1991
• Est. Priority Date: 03/01/1983
• Status: Expired due to Fees

• Current Assignee: Block Drug Company Incorporated (GlaxoSmithKline PLC)
• Original Assignee: Block Drug Company Incorporated (GlaxoSmithKline PLC)
• Inventors: Schaeffer, Hans A.
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US07/369,185
• Time in Patent Office: 567 Days
• Field of Search: 424/52, 424/53
• US Class Current: 424/52
• CPC Class Codes: A61C 5/64 for multi-component compositions
• CPC Class Codes: A61K 2800/88 Two- or multipart kits
• CPC Class Codes: A61K 8/042 Gels
• CPC Class Codes: A61K 8/19 containing inorganic ingredients
• CPC Class Codes: A61K 8/22 Peroxides; Oxygen; Ozone
• CPC Class Codes: A61K 8/26 Aluminium; Compounds thereof
• CPC Class Codes: A61K 8/42 Amides
• CPC Class Codes: A61K 8/731 Cellulose; Quaternized cellulose derivatives
• CPC Class Codes: A61K 8/8147 Homopolymers or copolymers of acids; Metal or ammonium salts thereof, e.g. crotonic acid, (meth)acrylic acid; Compositions of derivatives of such polymers
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
• CPC Class Codes: B65D 35/22 with two or more compartments
• CPC Class Codes: B65D 35/242 for mixing or discharging of two or more components
• CPC Class Codes: B65D 81/325 Containers having parallel or coaxial compartments, provided with a piston or a movable bottom for discharging contents

Abstract

A composition useful in combatting gum disease comprising:

(a) a non-neutralized gel component consisting essentially of hydrogen peroxide; an acrylic acid copolymer cross-linked with polyallyl sucrose; a polyol (glycerin, sorbitol, propylene glycol, polypropylene glycol, polyethylene glycol, an ethoxylated lower fatty alcohol, a propoxylated lower fatty alcohol and mixtures thereof); and purified water;

(b) a paste component comprising: (i) sodium bicarbonate; (ii) a salt (NaCl, KCl, MgCl₂, MgSO₄, Na₂ SO₄, and K₃ SO₄); (iii) a humectant (glycerin, sorbitol, polyethylene glycol, propylene glycol, polypropylene glycol, an ethoxylated lower fatty alcohol, a propoxylated lower fatty alcohol and mixture thereof); (iv) a thickener stabilizer (cellulose gum, magnesium aluminum silicate and mixtures thereof); (v) a stabilizing polishing agent (bentonite, titanium dioxide, silica, magnesium oxide and mixtures thereof); (vi) a fluorine-containing compound (NaF, KF, sodium monofluorophosphate, potassium monofluorophosphate, sodium fluorosilicate, sodium fluorozirconate and mixtures thereof); and (vii) purified water; said paste component being combined with said gel component immediately prior to use.

Alternatively, the gel component comprises urea peroxide; an acrylic acid copolymer crosslinked with polyallyl sucrose and glycerin.

Claims

1. A composition useful in combatting gum disease comprising:

(a) a non-neutralized gel component consisting essentially of about 0.1-10.0% of hydrogen peroxide;

about 0.05-5.0% of acrylic acid copolymer cross-linked with polyallyl sucrose;

about 2-80% of a polyol selected from the group consisting of glycerin, sorbitol, propylene glycol, polypropylene glycol, polyethylene glycol, an ethoxylated lower fatty alcohol, a propoxylated lower fatty alcohol and mixtures thereof; and

purified water;

(b) a paste component comprising;

(i) about 2-60% sodium bicarbonate;

(ii) about 0-6% of a salt selected from the group consisting of NaCl, KCl, MgCl₂, MgSO₄, Na₂ SO₄, and K₂ SO₄ ;

(iii) about 2-60% of a humectant selected from the group consisting of glycerin, sorbitol, polyethylene glycol, propylene glycol, polypropylene glycol, an ethoxylated lower fatty alcohol, a propoxylated lower fatty alcohol and mixture thereof;

(iv) about 0.1-5% of a thickener stabilizer selected from the group consisting of cellulose gum, magnesium aluminum silicate and mixtures thereof;

(v) about 1-30% of a stabilizing polishing agent selected from the group consisting of bentonite, titanium dioxide, silica, magnesium oxide and mixtures thereof;

(vi) a fluorine-containing compound selected from the group consisting of NaF, KF, sodium monofluorophosphate, potassium monofluorophosphate, sodium fluorosilicate, sodium fluorozirconate and mixtures thereof, in an amount sufficient to yield about 200-3000 ppm of fluorine; and

(vii) purified water;

said paste component being combined with said gel component immediately prior to use.

2. The composition of claim 1, wherein said gel component contains about 3.0-6.5% hydrogen peroxide;

and about 20-60% of said polyol, and

wherein said paste component comprises about 20-40% of said sodium bicarbonate;

about 2-4% of said salt;

about 15-25% of said humectant;

about 1.0-2.0% of said stabilizer;

about 1.5-20% of said stabilizing polishing agent; and

said fluorine-containing compound in an amount sufficient to yield about 1000-2000 ppm of fluorine,

said composition being effective against caries.

5. The composition of claim 1, said paste further comprising about 0.1-2.5% of a foaming agent selected from the group consisting of sodium lauryl sulfate, sodium lauroyl sarcosinate, sodium coconut monoglyceride sulfonate, sodium N-methyl-N-palmitoyl lauride, a polysorbate, a poloxamer and mixtures thereof.

6. The composition of claim 5, said paste further comprising about 1-30% of an additional cleansing agent selected from the group consisting of calcium sulfate, calcium phosphate, hydrated aluminum oxide, calcium carbonate, magnesium carbonate, magnesium silicate and mixtures thereof.

7. The composition of claim 6 wherein said paste component also comprises a preservative.

8. The composition of claim 7 wherein said paste component also comprises a coloring agent and a flavoring agent.

9. The composition of claim 2, said paste component further comprises about 0.2-0.5% of a foaming agent selected from the group consisting of sodium lauryl sulfate, sodium lauroyl sarcosinate, sodium coconut monoglyceride sulfonate, sodium N-methyl-N-palmitoyl lauride, a polysorbate, a poloxamer and mixtures thereof.

10. The composition of claim 9, said paste component further comprising about 1-20% of an additional polishing agent selected from the group consisting of calcium sulfate, agent selected from the group consisting of calcium sulfate, calcium phosphate, hydrated aluminum oxide, calcium carbonate, magnesium carbonate, magnesium silicate and mixtures thereof.

11. The composition of claim 10, said paste component further comprising a preservative.

12. The composition of claim 11, said paste component further comprising a coloring agent.

13. The composition of claim 12, said paste component further comprising a flavoring agent.

21. The composition of claim 11 wherein said gel copolymer is Carbopol 941, and polyol is glycerin;

said salt is NaCl, said paste humectant is glycerin, said stabilizing polishing agent is selected from the group consisting of TiO₂, silica, bentonite and mixtures thereof;

said fluorine containing compound is NaF, said foaming agent is sodium lauryl sulfate, and said preservative is selected from the group consisting of methyl and propyl paraben.

3. A composition useful for combatting gum disease comprising:

(a) a gel component comprising;

(i) about 2-25% urea peroxide;

(ii) about zero-5.0% of an acrylic acid copolymer crosslinked with polyallyl sucrose;

the balance being glycerin; and

(b) a paste component comprising;

(i) about 2-60% sodium bicarbonate;

(ii) about 0-6% of a salt selected from the group consisting of NaCl, KCl, MgCl₂, MgSO₄, Na₂ SO₄, and K₂ SO₄ ;

(iii) about 2-60% of a humectant selected from the group consisting of glycerin, sorbitol, polyethylene glycol, propylene glycol, polypropylene glycol, an ethoxylated lower fatty alcohol, a propoxylated lower fatty alcohol and mixtures thereof;

(iv) about 0.1-5% of a thickener stabilizer selected from the group consisting of cellulose gum, magnesium aluminum silicate and mixtures thereof;

(v) about 1-30% of a stabilizing polishing agent selected from the group consisting of bentonite, titanium dioxide, silica, magnesium oxide and mixtures thereof;

(vi) a fluorine-containing compound selected from the group consisting of NaF, KF, sodium monofluorophosphate, potassium monofluorophosphate, sodium fluorosilicate, sodium fluorozirconate and mixtures thereof in an amount sufficient to yield about 200-3000 ppm of fluorine; and

(vii) purified water, said paste and said gel component being combined immediately prior to use.

4. The composition of claim 3 wherein said gel component contains about 8-12% of urea peroxide;

about 1-3% of said acrylic acid copolymer; and

glycerin, and

wherein said paste component comprises about 20-40% of said sodium bicarbonate;

about 2-4% of said salt;

about 15-25% of said humectant;

about 1.0-2.0% of said stabilizer;

about 1.5-20% of said stabilizing polishing agent; and

said fluorine-containing compound in an amount sufficient to yield about 1000-2000 ppm of fluorine.

14. The composition of claim 3, said paste further comprising about 0.1-2.5% of a foaming agent selected from the group consisting of sodium lauryl sulfate, sodium lauroyl sarcosinate, sodium coconut monoglyceride sulfonate, sodium N-methyl-N-palmitoyl lauride, a polysorbate, a poloxamer and mixtures thereof.

15. The composition of claim 14, said paste further comprising about 1-30% of an additional cleansing agent selected from the group consisting of calcium sulfate, calcium phosphate, hydrated aluminum oxide, calcium carbonate, magnesium carbonate, magnesium silicate and mixtures thereof.

16. The composition of claim 15 wherein said paste component also comprises a preservative.

17. The composition of claim 4, said paste component further comprising about 0.2-0.5% of a foaming agent selected from the group consisting of sodium lauryl sulfate, sodium lauroyl sarcosinate, sodium coconut monoglyceride sulfonate, sodium N-methyl-N-palmitoyl lauride, a polysorbate, a poloxamer and mixtures thereof.

18. The composition of claim 17, said paste component further comprising about 1-30% of an additional polishing agent selected from the group consisting of calcium sulfate, calcium phosphate, hydrated aluminum oxide, calcium carbonate, magnesium carbonate, magnesium silicate and mixtures thereof.

19. The composition of claim 18, said paste component further comprising a preservative.

20. The composition of claim 19, said paste component further comprising a coloring agent and a flavoring agent.

22. The composition of claim 19 wherein said polymer is Carbopol 941, said salt is NaCl, said paste humectant is glycerin, said stabilizing polishing agent is selected from the group consisting of TiO₂, silica, bentonite and mixtures thereof;

said fluorinated compound is NaF, said foaming agent is sodium lauryl sulfate, and said preservative is selected from the group consisting of methyl and propyl paraben.