Allergen dosage form

A method of producing a fast-dispersing, non-compressed solid and stable dosage form having low friability, comprising at least one matrix forming agent and being suitable for oromucosal administration comprising an effective dose for desensitizing an individual to at least one allergen, comprising the steps of

• (a) preparing an aqueous solution comprising said at least one allergen and said at least one matrix forming agent,
• (b) introducing the solution into one or more depressions in a mould
• (c) subjecting the loaded mould to freezing and freeze-drying using standard conditions of shelf temperature and chamber pressure to obtain said solid dosage form in each depression.

A pharmaceutical product suitable for oromucosal administration to a mammal, said product being a fast-dispersing solid dosage form comprising:

• a matrix suitable for fast-dispersion upon oromucosal administration;
• and
• an allergen in an amount sufficient to induce an allergen specific immune response to said allergen in said mammal.

A method for inducing an allergen specific immune response in a mammal, comprising oromucosal administration of a fast-dispersing solid pharmaceutical product that comprises

• a matrix suitable for fast-dispersion upon oromucosal administration;
• and
• an allergen in an amount sufficient to induce an allergen specific immune response to said allergen in said mammal, wherein said pharmaceutical product is provided in its own separate container or compartment.

A method for desensitizing a mammal to a major allergen or major allergens, comprising administering oromucosally to a mammal in need thereof a plurality of fast dispersing pharmaceutical products, each pharmaceutical product comprising substantially the same amount of at least one major allergen, wherein said amount is sufficient to induce an allergen specific immune response to said major allergen(s) in said mammal, and wherein each pharmaceutical product in the plurality is administered according to a schedule of treatment.

A method for desensitizing a mammal to an allergen or allergens, comprising administering oromucosally to a mammal in need thereof a plurality of fast dispersing pharmaceutical products, each pharmaceutical product comprising substantially the same amount of an allergen extract, which is sufficient to induce an allergen specific immune response to at least one major allergen in said allergen extract in said mammal, and wherein each pharmaceutical product in the plurality is administered according to a schedule of treatment.

A pharmaceutical product for desensitizing a mammal to a major allergen or major allergens, comprising a fast-dispersing solid dosage form suitable for oromucosal administration, the dosage form comprising a matrix suitable for fast-dispersion and further comprising an effective dose of at least one major allergen, the product inducing an allergen specific immune response to said major allergen(s) in the absence of an added adjuvant.

A method for treating grass pollen allergy in a mammal which comprises:

• orally administering to said mammal an oral dosage form containing a predetermined effective dose of a major grass pollen allergen for desensitization of said mammal to grass pollen and
• repeating the administration of the same predetermined effective dose at least once daily.

A method for treatment of an allergy which comprises:

• orally administering to a mammal in need of such treatment an oral dosage form containing a predetermined effective dose of an allergen for desensitization to said allergy, and
• repeatedly administering the same predetermined effective dose to said mammal.

A kit for use in treating an allergy in a mammal which comprises:

• a solid support,
• a plurality of solid oral dosage forms, each of said solid oral dosage forms being held in a sealed enclosure on said support and each containing essentially the same effective dose of a major allergen for desensitizing said mammal to said major allergen.

The kit of claim 77 wherein the grass pollen allergen comprises from about 0.25 μg to about 375 μg of a member selected from the group consisting of grass group 1 allergen, grass group 5 allergen and grass group 6 allergen.