abstract |
The present invention relates to a pharmaceutical dosage form containing the active substance BIBW2992 as the dimaleate salt and providing an immediate release profile of the active substance, and the invention further relates to BIBW2992 dimaleate salt (BIBW2992MA 2 ). A compacted intermediate containing BIBW2992 dimaleate in powder form, prepared using a combined roller compaction and sieving step; an intermediate blend prepared from the compacted intermediate; and the compaction Solid oral formulations for immediate use / ingestion made from intermediates or from said intermediate blends that provide an immediate release profile of the active substance, eg capsules, and uncoated or film-coated tablets prepared by direct compression; The present invention also relates to a manufacturing method thereof. |