Dosage form having a saccharide matrix

A method of obtaining a fast dispersing non-compressed allergen dosage form suitable for oromucosal administration comprising

• 1) producing a fast dispersing, non-compressed solid allergen vaccine dosage form
• 2) measuring the friability of said dosage form in an assay comprising the steps of
• a) placing a solid dosage form contained in a sealed blister pack unit in an equipment suitable for friability measurements
• b) moving it for an appropriate time and at an appropriate velocity
• c) removing the sealed solid dosage form unit
• d) opening the scaled solid dosage form unit and emptying the unit in a container/placing the fast dispersing dosage form unit in a container
• e) removing the solid dosage form unit from the container leaving any loose residues in said container
• f) performing an immunochemical allergen specific assay on said residues detecting the amount of allergen content in said residues
• g) calculating the percentage of allergen content in said residues in comparison to total allergen content of the solid dosage form unit
• h) detecting whether the dosage form fulfills the requirements for low friability
• 3) repeating 1) and 2) until the requirements for the dosage form is fulfilled.

A freeze-dried non compressed fast-dispersing solid dosage form for oromucosal administration of an allergen comprising:

• (1) a matrix forming agent consisting of maltodextrin having a dextrose equivalent (DE) of between 1 and 20, sorbitol and mannitol, and
• (2) an allergen,
• wherein dosage form is prepared by freeze-drying of an aqueous dosing solution in which dosing solution maltodextrin is present in an amount of 3 to 33% (w/w) of the dosing solution;
• sorbitol is present in an amount of 0.01 to 0.1% (w/w) of the dosing solution, and mannitol is present in an amount of 1 to 10% (w/w) of the dosing solution;
• wherein the matrix is free of polymeric matrix forming agents;
• wherein said dosage form does not contain cellulose derivatives;
• wherein the allergen is not present in the form of microcapsules embedded in the matrix;
• and
• wherein the dosage form disintegrates in less than 90 seconds in the oral cavity.

A freeze-dried non-compressed fast-dispersing solid dosage form for oromucosal administration of an allergen comprising:

• (1) a matrix forming agent consisting of maltodextrin having a dextrose equivalent (DC) of between 1 and 20, sorbitol and mannitol, and
• (2) an allergen,
• wherein the dosage form is prepared by freeze-drying of an aqueous dosing solution in which dosing solution maltodextrin is present in an amount of 3 to 35% (w/w) of the dosing solution;
• sorbitol is present in an amount of 0.01 to 0.1% (w/w) of the dosing solution, and mannitol is present in an amount of 1 to 10% (w/w) of the dosing solution;
• wherein the matrix is free of gelatin, starch and gums;
• and
• wherein the dosage form disintegrates in less than 90 seconds in the oral cavity.

A freeze dried non-compressed fast-dispersing solid dosage form for oromucosal administration of an allergen composing:

• (1) a matrix forming agent consisting of maltodextrin having a dextrose equivalent (DE) of between 1 and 20, sorbitol and mannitol, and
• (2) an allergen,
• wherein the dosage form is prepared by freeze-drying of an aqueous dosing solution in which dosing solution maltodextrin is present in an amount of 3 to 35% (w/w) of the dosing solution;
• sorbitol is present in an amount of 0.01 to 0.1% (w/w) of the dosing solution, and mannitol is present in an amount of 1 to 10% (w/w) of the dosing solution;
• wherein the dosage form is free of gelatin, starch and gums;
• and
• wherein the dosage form disintegrates in less than 90 seconds in the oral cavity.