A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/00 (2006.01) A61K 31/517 (2006.01) A61P 35/00 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01)
Patent
CA 2726472
The present invention relates to a pharmaceutical dosage form containing the active substance BIBW 2992 as the dimaleate salt, providing an immediate release profile of the active substance, further, the invention relates to compacted intermediates comprising BIBW 2992 dimaleate salt (BIBW 2992 MA2) in form of a powder prepared using a combined roller compaction and sieving step from BIBW 2992 MA2, intermediate blends prepared from said compacted intermediate as well as solid oral formulations providing an immediate release profile of the active substance, made from said compacted intermediate or from said intermediate blends ready for use/ingestion, e.g. capsule and tablet formulations such as uncoated or film-coated tablets prepared by direct-compression, and methods for their production.
La présente invention concerne une forme de dosage pharmaceutique qui contient la substance active BIBW 2992 sous forme dun sel de dimaléate, permettant dobtenir un profil de libération immédiate de la substance active. Linvention concerne en outre des intermédiaires compactés qui comprennent un sel de dimaléate de BIBW 2992 (BIBW 2992 MA2) sous la forme dune poudre préparée en utilisant une étape combinée de compactage à rouleaux et de tamisage du BIBW 2992 MA2, des mélanges intermédiaires préparés à partir dudit intermédiaire compacté, ainsi que des formulations orales solides permettant dobtenir un profil de libération immédiate de la substance active, préparées à partir dudit intermédiaire compacté ou desdits mélanges dintermédiaires prêts pour utilisation/ingestion, par ex., des formulations en capsules ou en comprimés telles que des comprimés nus ou pelliculés préparés par compression directe, et des procédés pour leur production.
Friedl Thomas
Messerschmid Roman
Boehringer Ingelheim International Gmbh
Fetherstonhaugh & Co.
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