Sugar-free oral transmucosal solid dosage forms and uses...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/20 (2006.01) A61K 9/00 (2006.01) A61K 31/4468 (2006.01)

Patent

CA 2515025

The present invention is directed to oral solid dosage forms. The solid dosage forms are sugar-free, and comprise a pharmaceutical agent and a suitable pharmaceutically acceptable excipient. Preferably, the solid dosage forms of the present invention are bioequivalent to a sugar-containing solid dosage form. Bioequivalence is preferably obtained by incorporating an ionizing agent, more preferably in the form of a buffer system, into the solid dosage forms, in an amount sufficient to maintain a portion of the pharmaceutical agent, upon dissolution of said composition in saliva, in an ionized state.

L'invention concerne des formes galéniques solides orales. Les formes galéniques solides sont exemptes de sucre et comprennent un agent pharmaceutique et un excipient acceptable sur le plan pharmaceutique approprié. Les formes galéniques solides selon l'invention sont, de préférence, bioéquivalentes à une forme galénique solide renfermant du sucre. La bioéquivalence est, de préférence, obtenue par incorporation d'un agent ionisant, idéalement présenté sous la forme d'un système tampon, dans les formes galéniques solides, en une quantité suffisante pour conserver une partie de l'agent pharmaceutique, au moment de la dissolution de la composition dans la salive, dans un état ionisé.

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