Methods, Articles and Kits for Allergic Desensitization via the Oral Mucosa

Abstract

Compositions and methods of use for desensitizing a subject to an allergen via regions of the oral mucosa are provided.

1 . A flexible porous pouch for insertion by a subject into an oral cavity of the subject and capable of fixedly conforming to a vestibular mucosal surface of the oral cavity, the pouch comprising a composition formulated for extended release, the composition comprising at least one allergen. 
     
     
         2 . The flexible porous pouch according to  claim 1 , wherein the allergen is selected from the group consisting of pollen, dust mite, mold and animal dander. 
     
     
         3 . The flexible porous pouch according to  claim 1 , wherein the subject exhibits clinical symptoms of an allergy and the one or more allergens are selected based on association with the allergy. 
     
     
         4 . The flexible porous pouch according to  claim 2 , wherein the pollen is ragweed pollen and the allergen consists of ragweed pollen and dust mite. 
     
     
         5 . The flexible porous pouch according to  claim 1 , wherein the extended release formulation comprises a matrix incorporating the one or more allergens, said matrix being capable of dissolving in saliva thereby releasing the one or more allergens into the saliva, wherein the matrix optionally comprises a physiologically acceptable excipient, wherein the physiologically acceptable excipient optionally comprises starch or other physiologically acceptable polymer. 
     
     
         6 . The flexible porous pouch according to  claim 1  comprising a disposable single-use pouch. 
     
     
         7 . A flexible porous pouch adapted for receiving and containing a dose of a composition, wherein once the pouch contains the dose it is suitable for insertion by a subject into an oral cavity of the subject and is capable of conforming to a vestibular mucosal surface of the oral cavity. 
     
     
         8 . A method for decreasing sensitivity to one or more allergens and reducing symptoms of allergy in a subject, the method comprising providing sustained exposure to one or more allergens associated with the allergy in a vestibular mucosal region of the oral mucosa by inserting a flexible porous pouch into an oral cavity of the subject, said flexible porous pouch being capable of fixedly conforming to a vestibular mucosal surface of the oral cavity, the pouch comprising a composition formulated for extended release, the composition comprising at least one allergen. 
     
     
         9 . The method according to  claim 8 , wherein the at least one allergen is selected from pollen, dust mite, mold and animal dander. 
     
     
         10 . The method according to  claim 9 , wherein the pollen is ragweed pollen and the at least one allergen consists of ragweed pollen and dust mite. 
     
     
         11 . A kit comprising a plurality of flexible porous pouches according to  claim 3  and instructions comprising a dosing schedule effective for desensitizing the subject to the at least one allergen thereby reducing the severity of at the clinical symptoms. 
     
     
         12 . A kit comprising: a plurality of flexible porous pouches according to  claim 7 ; a plurality of individually contained extracts of a set of common environmental allergens; an amount of organic non-toxic filler material; and instructions for mixing extract with the filler material and for filling the flexible porous pouch. 
     
     
         13 . The flexible porous pouch of  claim 1 , wherein the allergen comprises a  Cryptomeria japonica  pollen allergen or an allergen that is immunologically cross-reactive therewith. 
     
     
         14 . The method of  claim 8  wherein the allergen comprises a  Cryptomeria japonica  pollen allergen or an allergen that is immunologically cross-reactive therewith. 
     
     
         15 . The flexible porous pouch of  claim 1 , wherein the allergen comprises a grass pollen allergen or an allergen that is immunologically cross-reactive therewith. 
     
     
         16 . The method of  claim 8  wherein the allergen comprises a grass pollen allergen or an allergen that is immunologically cross-reactive therewith.