ALLERGEN DOSAGE FORM

摘要

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.

主权项

1. A pharmaceutical product suitable for administration of allergen comprising
a fast-dispersing, non-compressed solid dosage form suitable for oromucosal administration including:
(a) a matrix formed from at least one matrix-forming agent, and(b) an effective dose of an allergen for desensitizing an individual to said allergen, wherein
(c) 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(d) the loss of allergen content from said solid dosage form is less than about 0.5 μg allergen extract or less than about 0.05 μg major allergen when subjected to a friability test.