Composition for transmucosal delivery of polypeptides

A - Human Necessities – 61 – K

Patent

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Details

A61K 38/11 (2006.01) A61K 9/08 (2006.01) A61K 9/14 (2006.01) A61K 9/46 (2006.01) A61K 31/575 (2006.01) A61K 38/21 (2006.01) A61K 38/22 (2006.01) A61K 38/23 (2006.01) A61K 38/26 (2006.01) A61K 38/28 (2006.01) A61K 38/29 (2006.01)

Patent

CA 2685853

The invention described herein provides an oral solid transmucosal dosage form that enhances transmucosal permeation of biologically active polypeptides across oral mucosal tissue and provides relatively rapid efficacious therapeutic onset thereof. Dosage forms prepared according to the invention can enhance transmucosal absorption of polypeptides in therapeutic serum concentrations to the recipient. The invention provides a solid dosage form for oral transmucosal absorption of a biologically active polypeptide, wherein the dosage form comprises a pharmaceutical composition comprising: a therapeutically active polypeptide; a bile salt; and an effervescent excipient component, which can comprise an effervescent couple and optionally a pH adjusting substance. The invention includes a method of administering a biologically active polypeptide, as well as a method of enhancing transmucosal absorption of a biologically active polypeptide.

L'invention concerne une forme pharmaceutique solide transmuqueuse buccale qui accroît la perméation transmuqueuse de polypeptides biologiquement actifs à travers le tissu muqueux buccal et assure un déclenchement thérapeutique efficace relativement rapide de ceux-ci. Les formes pharmaceutiques préparées selon l'invention permettent d'accroître l'absorption transmuqueuse des polypeptides selon des concentrations sériques thérapeutiques chez l'utilisateur. Elle constitue une forme pharmaceutique solide pour l'absorption transmuqueuse buccale d'un polypeptide biologiquement actif, cette forme pharmaceutique comprenant une composition pharmaceutique qui renferme: un polypeptide thérapeutiquement actif; un sel biliaire; et un composant d'excipient effervescent qui peut comprendre un couple effervescent et éventuellement une matière de réglage du pH. L'invention comprend un procédé d'administration d'un polypeptide biologiquement actif, ainsi qu'un procédé pour accroître l'absorption transmuqueuse d'un polypeptide biologiquement actif.

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