Toothpaste for delivery of allergens to oral mucosa
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.
1. A method of formulating a toothpaste suitable for oral mucosal therapy, the method comprising:
providing a first volume of solution comprising an allergen or allergen extract and a concentration of sugar alcohol;
formulating a second volume of pro-toothpaste comprising a concentration of vehicle and a concentration of thickener, the vehicle comprising a sugar alcohol corresponding to the sugar alcohol of the first volume in identity and in a concentration substantially corresponding to the concentration of sugar alcohol of the first volume, the first and second volumes being combinable in a ratio such that a concentration of sugar alcohol in the combined volume is between about 40% and 55% by volume, and mixing the first volume and second volume in the ratio.
2. The method according to claim 1 , wherein the sugar alcohol is glycerol.
3. The method according to claim 1 , wherein the thickener is selected from a carbomer and a silica-based thickener.
4. The method according to claim 1 , wherein the allergen is selected from a plant allergen, an animal allergen, a fungal/mold allergen, and combinations thereof.
5. The method according to claim 2 , wherein the concentration of glycerol in the combined volume is about 50% by volume.
6. The method according to claim 1 , wherein the allergen comprises an allergenic protein selected from a group of food products consisting of milk, egg, soy, wheat, peanut, tree nut, fish, shellfish, and combinations thereof.
7. The method according to claim 1 , wherein the allergen extract is a suspension comprising a sugar alcohol.
8. The method according to claim 7 , wherein the allergen extract suspension is a crude extract comprising source allergen material.
9. The method according to claim 8 , wherein the source allergen material is pulverized prior to inclusion in the allergen extract suspension.
10. The method according to claim 9 , wherein the source allergen material is peanut.
11. The method according to claim 8 , wherein the source allergen material is incubated in an aqueous medium to at least partially solubilize allergenic proteins.
12. The method according to claim 11 , wherein the source allergen material is peanut.
13. A method of formulating a toothpaste suitable for oral mucosal therapy, the method comprising:
pulverizing a source allergen material;
incubating the pulverized source allergen material in an aqueous medium to at least partially solubilize allergenic proteins, thereby providing a crude allergen extract;
suspending the crude allergen extract in a concentration of sugar alcohol to provide a first volume;
formulating a second volume of pro-toothpaste comprising a vehicle and a thickener, wherein the vehicle comprises a sugar alcohol corresponding to the sugar alcohol of the first volume in identity and in a concentration corresponding to the concentration of sugar alcohol of the first volume, the first and second volumes being combinable in a ratio such that a concentration of sugar alcohol in the combined volume is between about 40% and 60% by volume; and
mixing the first volume and second volume in the ratio,
wherein the sugar alcohol is glycerol.
14. The method according to claim 13 , wherein the source allergen material comprises an allergenic protein selected from a group of food products consisting of milk, egg, soy, wheat, peanut, tree nut, fish, shellfish, and combinations thereof.
15. The method according to claim 14 , wherein the source allergen material comprises peanut.
16. The method according to claim 14 , wherein the source allergen material comprises tree nuts.
17. The method according to claim 13 , wherein the thickener is selected from a carbomer and a silica-based thickener.
18. The method according to claim 13 , wherein the concentration of glycerol in the combined volume is about 50% by volume.