A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 47/32 (2006.01) A61K 9/28 (2006.01) A61K 9/32 (2006.01)
Patent
CA 2489064
The invention relates to a method for producing a coated dosage form or a dosage form in the form of a matrix containing an active substance. The dosage form is produced by processing a copolymer that contains a pharmaceutical active substance, an optional core and/or pharmaceutically conventional aggregates in a manner known per se by melting, injection-molding, extrusion, wet granulation, casting, dipping, spreading, spraying or compaction to give a coated dosage form and/or to give a matrix containing an active substance. The method is characterized in that a copolymer is used that is composed of 20 to 33 % by weight of methacrylic acid, 5 to 30 % by weight of methyl acrylate, 20 to 40 % by weight of ethyl acrylate, and more than 10 to 30 % by weight of butyl methacrylate and optionally 0 to 10 % by weight of additional vinylically copolymerizable monomers, with the proviso that the glass temperature of the copolymer is 55 to 70 ~C according to ISO 11357-2, item 3.3.3. The invention also relates to the dosage form produced according to the invention, to the copolymer and to the use thereof.
L'invention concerne un proc~d~ servant ~ produire une forme gal~nique enrob~e ou une forme gal~nique sous forme de matrice ~ principe actif. Selon l'invention, on transforme un copolymre, un principe actif pharmaceutique, un noyau ~ventuellement pr~sent et/ou des additifs pharmaceutiques habituels, de manire connue en soi par fusion, moulage par injection, extrusion, granulation humide, coul~e, immersion, application, pulv~risation ou compression, en une forme gal~nique enrob~e et/ou en une matrice ~ principe actif. Le proc~d~ selon l'invention est caract~ris~ en ce qu'on utilise un copolymre qui comprend 20 ~ 33 % en poids d'acide m~thacrylique, 5 ~ 30 % en poids de m~thylacrylate, 20 ~ 40 % en poids d'~thylacrylate, ainsi que plus de 10 ~ 30 % en poids de butylm~thacrylate et, ~ventuellement, 0 ~ 10 % en poids d'un autre monomre vinyliquement copolym~risable, la temp~rature de transition vitreuse du copolymre selon ISO 11357-2, point 3.3.3, ~tant comprise entre 55 et 70 ~C. L'invention concerne ~galement la forme gal~nique produite selon le proc~d~ de l'invention, le copolymre correspondant et son utilisation.
Meier Christian
Petereit Hans-Ulrich
Schultes Klaus
Evonik Roehm Gmbh
Norton Rose Or S.e.n.c.r.l.,s.r.l./llp
Roehm Gmbh & Co. Kg
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