Allergen dosage form
View Patent ↗The invention provides allergen containing pharmaceutical products and in particular fast-dispersing solid allergen dosage forms. In particular, fast-dispersing, non-compressed solid dosage forms suitable for oromucosal administration comprising a matrix and at least one allergen are provided. Suitable matrices are gelatine, starch and mannitol. Methods for the dosage forms are also provided.
1. A fast-dispersing, solid, non-compressed oromucosal dosage form suitable for sublingual administration for alleviating symptoms to allergen induced allergy in an individual comprising:
a lyophilized network formed from a solution comprising 1-10% W/W mannitol, 2-10% W/W fish gelatin,
wherein said dosage form is packaged in a blister pack and comprises an allergen extract content of 2.5 μg-3.75 mg, wherein said allergen is selected from the group consisting of grass pollen allergen, house dust mite allergen, and ragweed pollen allergen and wherein the allergen extract content is effective for inducing an immune response in said individual
wherein the loss of the allergen content in said dosage form is less than 50% of the initial allergen content after being held for 3 months at 25° C. and 60% relative humidity, and the loss of allergen content from said solid dosage form is less than 0.5 μg allergen extract or less than 0.05 μg major allergen when subjected to a friability test after being held for 3 months at 25° C. and 60% relative humidity, and
wherein the water content of the dry matter does not exceed 8% by weight.
2. The dosage form of claim 1 , wherein said dosage form has a major allergen content of about 0.05 μg to about 500 μg.
3. The dosage form of claim 1 , wherein said allergen is a house dust mite allergen.
4. The dosage form of claim 1 wherein said allergen is a ragweed pollen allergen.
5. The dosage form of claim 1 , wherein said allergen is a grass pollen allergen.
6. The dosage form of claim 5 , wherein said grass pollen allergen is selected from the group consisting of grass group 1, grass group 2/3, grass group 5 and grass group 6 allergens.
7. The dosage form of claim 5 , wherein the amount of allergen extract is about 25 μg to about 1.25 mg of an allergen extract comprising said grass pollen allergen.
8. The dosage form of claim 1 , wherein the amount of allergen extract is about 25 μg to about 1.25 mg.
9. The dosage form of claim 1 , wherein the amount of major allergen is about 2.5 μg to about 125 μg.
10. The dosage form of claim 1 , that is in a non-coated form.
11. The dosage form of claim 1 , wherein the potency of said dosage form is between about 650 and about 6000 Biological Allergen Units (BAU).
12. The dosage form of claim 11 , wherein the potency of said dosage form is between about 650 and about 4700 Biological Allergen Units (BAU).
13. The dosage form of claim 11 , wherein the potency of said dosage form is between about 650 and about 3500 Biological Allergen Units (BAU).
14. The dosage form of claim 1 , wherein the mannitol concentration of said solution is 3-5.5% W/W mannitol.
15. The dosage form of claim 1 , wherein the fish gelatin concentration of said solution is 3-6.5% W/W fish gelatin.
16. The dosage form of claim 1 , wherein said solution comprises 5.08% W/W mannitol and 6.0% W/W fish gelatin.
17. The dosage form of claim 1 , which disintegrates within about 30 seconds of being administered to said individual.
18. A fast-dispersing, solid, non-compressed oromucosal dosage form suitable for sublingual administration for alleviating symptoms to allergen induced allergy in an individual comprising:
a lyophilized network formed from a solution comprising 3-5.5% W/W mannitol, and 3-6.5% W/W fish gelatin,
wherein said dosage form is packaged in a blister pack and comprises a grass pollen allergen extract content of 2.5 μg-3.75 mg, wherein the grass pollen allergen extract content is effective for inducing an immune response in said individual,
wherein the loss of the allergen content in said dosage form is less than 50% of the initial allergen content after being held for 3 months at 25° C. and 60% relative humidity, and the loss of allergen content from said solid dosage form is less than 0.5 μg allergen extract or less than 0.05 μg major allergen when subjected to a friability test after being held for 3 months at 25° C. and 60% relative humidity, wherein the potency of said dosage form is between about 650 and about 3500 Biological Allergen Units (BAU) and
wherein the water content of the dry matter does not exceed 8% by weight.