Multiparticle pharmaceutical dosage form containing a...

A - Human Necessities – 61 – K

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A61K 9/26 (2006.01)

Patent

CA 2532487

The invention relates to an oral, multiparticle pharmaceutical dosage form containing pellets, the size of which ranges from 50 to 2500 ~m and which essentially consist of: a) an inner matrix layer containing an active substance which is a peptide or a protein, including the derivatives or conjugates thereof, and which is embedded in a matrix consisting of a polymer with mucoadhesive effect, and b) an outer film coating essentially consisting of an anionic polymer or copolymer, which can be optionally formulated with pharmaceutically conventional adjuvants, more particularly softening agents.

L'invention concerne une forme galénique multiparticulaire orale, contenant des granules dont les dimensions sont comprises dans la plage allant de 50 à 2500 ?m et qui sont essentiellement constitués des éléments suivants : a) une couche matricielle interne contenant un principe actif qui se présente sous la forme d'un peptide ou d'une protéine et de ses dérivés ou conjugués et qui est intégré dans une matrice constituée d'un polymère présentant une action mucoadhésive, et ; b) un revêtement externe pelliculaire constitué essentiellement d'un polymère ou copolymère anionique qui peut éventuellement être formulé avec des excipients pharmaceutiquement courants, en particulier des plastifiants.

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