Method of treating conditions of teeth and their supporting tissue with sucralfate

• US 5,240,710 A
• Filed: 09/04/1992
• Issued: 08/31/1993
• Est. Priority Date: 02/26/1988
• Status: Expired due to Fees

• Current Assignee: Niels Bukh, Tandlaegeselskabet Jesper Hamberger APS
• Original Assignee: Niels Bukh, Tandlaegeselskabet Jesper Hamberger APS
• Inventors: Bukh, Niels, Bar-Shalom, Daniel K., Hamburger, Jesper
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Levy, Neil S.
• Application Number:
  US07/939,969
• Time in Patent Office: 361 Days
• Field of Search: 464/53, 464/54, 464/56, 464/422
• US Class Current: 424/422
• CPC Class Codes: A61K 31/7024 Esters of saccharides
• CPC Class Codes: A61K 8/22 Peroxides; Oxygen; Ozone
• CPC Class Codes: A61K 8/60 Sugars; Derivatives thereof
• CPC Class Codes: A61K 8/65 Collagen; Gelatin; Keratin; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/73 Polysaccharides
• CPC Class Codes: A61K 8/731 Cellulose; Quaternized cellulose derivatives
• CPC Class Codes: A61K 8/735 Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• 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

Abstract

The use of a sulphated saccharide or a salt or a complex thereof as an ingredient in a topical preparation for the prophylaxis or treatment of diseases or conditions of the tooth or tooth-supporting tissue, in particular for the prophylaxis or treatment of inflammatory and plaque-related conditions, a method of preventing or treating such diseases or conditions by topically applying the sulphated saccharide or salt or complex thereof, and a topical preparation containing the sulphated saccharide or salt or complex thereof for the prophylaxis or treatment of such diseases or conditions. The sulphated saccharide is especially a polysulphated or persulphated saccharide. e.g. sucralfate (sucrose octakis(hydrogen sulphate) aluminum complex) or a sodium and/or potassium salt of sucrose octakis(hydrogen sulphate). The preparation may be in the form of a solution, suspension, salve, paste, powder, gel, cream, dental fixative, periodontal implant, chewing gum, chewable tablet, effervescent tablet or lozenge.

Claims

1. A method of preventing, diminishing or treating dental disease in a human, which comprises topically administering into the oral cavity a salve, paste, gel or cream preparation comprising a prophylactically or therapeutically effective amount of an aluminum salt or complex of a sulfated saccharide, said preparation being suitable for dental use.

2. The method of claim 1, wherein the saccharide is an oligosaccharide.

3. The method of claim 2, wherein the oligosaccharide is selected from the group consisting of sucrose, lactose, maltose, and cellobiose.

4. The method of claim 1, wherein the saccharide is polysulphated.

5. The method of claim 4, wherein the saccharide is persulfated.

6. The method of claim 1, wherein the aluminum is in the form of aluminum hydroxide.

7. A method of claim 1, wherein the sulphated saccharide is an aluminum disaccharide polysulphate.

8. The method of claim 7, wherein the sulphated saccharide is sucralfate.

9. The method of claim 1, wherein the sulphated saccharide is formulated as a topical preparation.

10. The method of claim 9, wherein the topical preparation additionally contains a non-sulphated polysaccharide.

11. The method of claim 9, wherein the preparation comprises an adhesive which is capable of adhering to the teeth or tooth-supporting tissue.

12. The method of claim 9, wherein the topical preparation is biodegradable.

13. The method of claim 1, wherein the disease is selected from the group consisting of dental caries, dental plaque, gingivitis, periodontitis, alveolitis, pulpitis, osteomyelitis, post-extractive or post-surgical wounds, tooth eruption, bone resorption, prosthetic irritation, cysts or neoplasms originating is the tooth-supporting tissue, and bacterial, mycotic, and viral oral infections.

14. The method of claim 9, wherein the topical preparation has a form selected from the group consisting of a salve, a paste, a gel, a cream.

15. The method of claim 9, wherein the topical preparation is administered together with one or more other active agents selected from the group consisting of an antibiotic, and antibacterial or antimicrobial agent, an antiviral agent, an antimycotic agent, a bacteriostatic agent, an antiseptic agent, a disinfectant, a local anesthetic or analgesic, an anti-inflammatory agent, an antineoplastic agent, and an anticarious agent.

16. The method of claim 10 wherein the non-sulfated polysaccharide is hyaluronic acid.

17. The method of claim 1 wherein the concentration of sulfated saccharide in the preparation is at least about 1% by weight of the preparation.

18. The method of claim 9 wherein the preparation contains a high molecular weight material selected from the group consisting of pectin, gelatine and methylcellulose, and a triglyceride comprising acid moieties of a length of 14-18 carbon atoms.

19. The method of claim 1 in which the preparation is a dental paste.

47. The method of claim 1 wherein the dental disease is gingivitis.

20. A topical salve, paste, gel or cream preparation useful in preventing or treating dental disease in a human which comprises a prophylactically or therapeutically effective amount of an aluminum salt or complex of a sulfated saccharide, said preparation being suitable for dental use.

21. The preparation of claim 20, which additionally contains a pharmaceutical excipient.

22. The preparation of claim 20, wherein the saccharide is an oligosaccharide.

23. The preparation of claim 20, wherein the oligosaccharide is selected from the group consisting of sucrose, lactose, maltose and cellobiose.

24. The preparation of claim 20, wherein the saccharide is polysulphated.

25. The preparation of claim 24, wherein the saccharide is persulfated.

26. The preparation of claim 20, wherein the aluminum is in the form of aluminum hydroxide.

27. The preparation of claim 20, wherein the sulphated saccharide is an aluminum disaccharide polysulphate.

28. The preparation of claim 27, wherein the sulphated saccharide is sucralfate.

29. A preparation of claim 20, wherein the topical preparation additionally contains a non-sulphated polysaccharide.

30. The preparation of claim 20, wherein the preparation comprises an adhesive which is capable of adhering to the teeth or tooth-supporting tissue.

31. The preparation of claim 20, wherein the topical preparation is biodegradable.

32. The preparation of claim 20, wherein the disease is selected from the group consisting of dental caries, dental plaque, gingivitis, periodontitis, alveolitis, pulpitis, osteomyelitis, post-extractive or post-surgical wounds, tooth eruption, bone resorption, prosthetic irritation, cysts or neoplasms originating in the tooth-supporting tissue, and bacterial, mycotic, and viral oral infections.

33. The preparation of claim 20, wherein the topical preparation has a form selected from the group consisting of a salve, a paste, a gel, a cream.

34. The preparation of claim 20, wherein the concentration of sulphated saccharide is from about 0.01 to about 75% by weight of the preparation.

35. The preparation of claim 29 wherein the non-sulfated polysaccharide is hyaluronic acid.

36. The preparation of claim 20 wherein the concentration of sulfated saccharide in the preparation is at least about 1% by weight of the preparation.

37. The preparation of claim 20 which contains a high molecular weight material selected from the group consisting of pectin, gelatine and methyl-cellulose, and a triglyceride comprising acid moieties of a length of 12-18 carbon atoms.

38. The preparation of claim 20 which is further characterized as a dental paste.

39. A method of inhibiting the formation of dental plaque which comprises introducing into the oral cavity of a patient a preparation comprising a prophylactically effective amount of a sulfated saccharide, or a salt or complex thereof, said preparation being suitable for dental use.

40. The method of claim 39 wherein the saccharide is an oligosaccharide.

41. The method of claim 39 wherein the preparation comprises a prophylactically effective amount of an aluminum salt or complex of a sulfate saccharide.

42. The method of claim 41 wherein the preparation comprises a prophylactically effective amount of sucralfate.

43. The method of claim 39 wherein the preparation is a dental salve, paste, gel or cream.

44. The method of claim 39 wherein the concentration of sulfated saccharide in the preparation comprises at least about 1% by weight of the preparation.

45. The method of claim 39 wherein the preparation further comprises an adhesive and is applied to and adheres to the gingiva, periodontal sulcus/pocket, tooth enamel, dentine, root cement or tooth-supporting tissue.

46. The method of claim 45 wherein the preparation is biodegradable.

48. A toothpaste useful in preventing or treating dental disease in a human which comprises a therapeutically effective amount of sucralfate, which is from about 0.1 to about 20% by weight, solubilized in about 0.05 to about 10% by weight of a water-soluble non-soap synthetic organic detergent preparation.