Toothpaste for Delivery of Allergens to Oral Mucosa

20240252626

18/633053

April 11, 2024

Pro-toothpaste compositions formulated to receive a volume of allergen solution to provide toothpastes that exhibit efficacy for oral mucosal immunotherapy (OMIT) and acceptable consumer and product stability properties, along with kits of pro-toothpaste, allergen/extracts of allergens, and optionally compounding means and/or specialized toothbrushes are provided. Toothpastes suitable and effective for OMIT and methods for managing allergic symptoms and for reducing risk of allergy in people without symptoms employing the pro-toothpastes, toothpastes, and kits of the invention are also disclosed.

Allovate, LLC (Brooklyn, NY, US)

1-30. (canceled)

31. An oral mucosal therapy kit comprising: at least one vial of pro-toothpaste comprising: from about 40% to about 60% by volume glycerol; from about 12% to about 30% by weight of a silica-based viscosity modifier; and from about 0.2% to about 0.5% by weight of sodium fluoride; and at least one separate vial comprising at least one allergen or allergen extract suspended in a solution comprising glycerol; wherein a concentration of glycerol in the allergen or allergen extract solution corresponds to a concentration of glycerol in the pro-toothpaste.

32. The oral mucosal therapy kit according to claim 31, wherein the at least one allergen or allergen extract is selected from the group consisting of animal dander, mites, white oak, maple, birch, ragweed, timothy grass, Bermuda grass, weeds, mold, fungi, and combinations thereof.

33. The oral mucosal therapy kit according to claim 31, wherein the at least one allergen or allergen extract is selected from the group consisting of milk, egg, soy, wheat, peanut, tree nut, fish, shellfish, and combinations thereof.

34. The oral mucosal therapy kit according to claim 31, wherein the pro-toothpaste further comprises one or more of a binder, a surface-active agent, an abrasive, water, a sweetener, a preservative, a flavoring agent, a coloring agent, and an opacifier.

35. The oral mucosal therapy kit according to claim 34, wherein the pro-toothpaste comprises one or more of: from about 10% to about 22% by weight of the binder; from about 5% to about 10% by weight of the abrasive; from about 0.2% to about 0.4% by weight of the sweetener; from about 1.5% to about 3% by weight of the preservative; from about 0.5% to about 1.5% of the flavoring agent; and from about 0.1% to about 0.2% of the opacifier.

36. A method for formulating a toothpaste suitable for oral mucosal therapy, the method comprising: providing a first volume of a solution comprising an allergen or allergen extract and a concentration of glycerol; formulating a second volume of a pro-toothpaste comprising: a concentration of glycerol substantially corresponding to the concentration of glycerol of the first volume; and sodium fluoride; and mixing the first and second volumes together to provide the toothpaste composition suitable for oral mucosal therapy, wherein the combined volume of glycerol in the toothpaste composition is from about 40% to about 55% by volume.

37. The method according to claim 36, wherein the allergen or allergen extract is selected from the group consisting of animal dander, mites, white oak, maple, birch, ragweed, timothy grass, Bermuda grass, weeds, mold, fungi, and combinations thereof.

38. The method according to claim 36, wherein the allergen or allergen extract is selected from the group consisting of milk, egg, soy, wheat, peanut, tree nut, fish, shellfish, and combinations thereof.

39. The method according to claim 36, wherein the second volume of pro-toothpaste further comprises one or more of a binder, a surface-active agent, an abrasive, water, a sweetener, a preservative, a flavoring agent, a coloring agent, and an opacifier.

40. The method according to claim 39, wherein the pro-toothpaste comprises one or more of: from about 10% to about 22% by weight of the binder; from about 5% to about 10% by weight of the abrasive; from about 0.2% to about 0.4% by weight of the sweetener; from about 1.5% to about 3% by weight of the preservative; from about 0.5% to about 1.5% of the flavoring agent; and from about 0.1% to about 0.2% of the opacifier.

41. The method according to claim 36, wherein the combined volume of glycerol in the toothpaste composition is about 50% by volume

42. A toothpaste composition formulated by combining the pro-toothpaste with the at least one allergen or allergen extract suspended in a solution comprising glycerol according to claim 31, further wherein the total silica content of the toothpaste composition equals the silica content of the pro-toothpaste.

43. The toothpaste composition according to claim 42 comprising about 50% glycerol by volume.

44. A method for reducing an immune response to an allergen in a subject, the method comprising delivering an amount of at least one allergen to a target area of the oral mucosa of the subject by contacting the target area of the oral mucosa with a toothpaste formulation according to claim 42 at least daily.

45. The method according to claim 44, wherein the target area of the oral mucosa comprises a vestibular buccal area.

46. The method according to claim 44, wherein the daily oral care regimen comprises brushing teeth with the toothpaste composition at least twice daily.

47. The method according to claim 44, wherein the at least one allergen or allergen extract is selected from the group consisting of animal dander, mites, white oak, maple, birch, ragweed, timothy grass, Bermuda grass, weeds, mold, fungi, and combinations thereof.

48. The method according to claim 44, wherein the at least one allergen or allergen extract is selected from the group consisting of milk, egg, soy, wheat, peanut, tree nut, fish, shellfish, and combinations thereof.

49. The method according to claim 48 comprising a food introduction technology regimen, wherein the subject is a human between the ages of 4 months and 6 years.

50. The method according to claim 44, where the subject is a non-human animal.

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edspap.20240252626