Flashmelt oral dosage formulation

Details Flashmelt oral dosage formulation Flashmelt oral dosage formulation

A - Human Necessities

61

K

A61K 9/14 (2006.01) A61K 9/20 (2006.01) A61K 31/22 (2006.01) A61K 31/4184 (2006.01) A61K 31/496 (2006.01) A61K 31/522 (2006.01) A61K 31/554 (2006.01) A61K 47/02 (2006.01) A61K 47/04 (2006.01) A61K 47/10 (2006.01) A61K 47/26 (2006.01) A61K 47/32 (2006.01) A61K 47/36 (2006.01) A61K 47/38 (2006.01) A61P 9/12 (2006.01) A61P 25/18 (2006.01) A61P 31/04 (2006.01) A61P 31/12 (2006.01)

Patent

CA 2462886

There is provided granules for the production of improved flash-melt pharmaceutical oral dosage forms. In addition to one or more medicaments, the granules are composed of an excipient combination consisting of a superdisintegrant (of two or more agents selected from the group consisting of crospovidone, croscarmellose sodium, sodium, sodium starch glycolate, low- substituted hydroxypropyl cellulose or pregelatinized starch), a dispersing agent, a distributing agent, and a binder and may also include other conventional ingredients such as sweetening and flavoring agents. The subject granules are advantageous in that they are stable and can be prepared without the aid of solvents and without the need for special environments or handling. Dosage forms, especially tablets, prepared therefrom on conventional equipment disintegrate in the mouth in under about twenty five seconds.

L'invention porte sur des granules servant à la production par fusion-éclair de formes posologiques orales améliorées. En plus d'un ou plusieurs médicaments, les granules contiennent un excipient composé: d'un superdésintégrant (de deux ou plus de deux agents sélectionnés parmi la crospovidone, le croscarmellosesodium, le sodium, le glycolate de sodium amidon, l'hydroxypropylcellulose à faible substitution, ou l'amidon prégélifié), un agent disperseur, un agent distributeur, et un liant, ainsi que d'autres ingrédients usuels tels que des édulcorants ou aromatisants. Lesdits granules sont stables et peuvent être préparés sans l'aide de solvants et sans nécessiter une atmosphère ou des manipulations spéciales. Les formes posologiques, et spécialement les comprimés, en étant constitués, préparés avec des équipements classiques, se désintègrent dans la bouche en moins d'environ 25 secondes.

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