Highly porous, fast-disintegrating solid dosage form and its way of manufacturing comprising the preparation of a powder and a freezedrying step
AssigneePantec AG
InventorKurt Heinz Bauer
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Abstract
The invention relates to a method of manufacture of fast-disintegrating solid dosage forms, characterized in that one or more structure building components in mixed solid powder form are dosed into cavities of blister packs or moulds, the remaining components dissolved in water dosed and added to the powder to form a moistened, plasticized mass, frozen to below −20° C., and the water sublimed in high vacuum. In this way solid dosage forms are obtained with a similar porous structure as usually result from freeze drying processes, but the process requires much less water, which means considerably less time and less energy.
Claims13
A method of manufacture of a fast-disintegrating solid dosage form comprising steps (a)-(d), wherein:
- step (a) comprises dosing a mixed solid powder comprising one or more structure building components into cavities of blister packs or moulds,
- step (b) consists of dissolving a binder, and optionally a remaining component selected from the group consisting of an excipient, a solubilizer, a salt, a buffer, a wetting agent and an active ingredient, in water to form an aqueous solution, and then dosing the aqueous solution into the cavities with the powder to form a moistened, plasticized mass, wherein the amount of water in the aqueous solution is from 20% to 70% (w/w) of the total weight of all of the components of the fast-disintegrating solid dosage form,
- step (c) comprises freezing to below −20° C., and
- step (d) comprises subliming frozen water under high vacuum.
Dependencies are inferred from the claim text.