Claims for Patent: 10,278,969

Summary for Patent: 10,278,969

Title:	Pharmaceutical dosage forms
Abstract:	The present invention relates to solid pharmaceutical dosage forms comprising the drug substance 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)-ph- enylamino]-pyrimidin-4-yl}-1-methyl-urea or any pharmaceutically acceptable salt thereof. It further relates to processes of making said solid pharmaceutical dosage forms.
Inventor(s):	Ribeiro; Suzie (Basel, CH)
Assignee:	Novartis AG (Basel, CH)
Application Number:	15/102,378
Patent Claims:	1. A capsule for oral administration that encapsulates a pharmaceutical blend comprising (a) 20-60% by weight of the drug substance 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)-ph- enylamino]-pyrimidin-4-yl}-1-methyl-urea in its free base form, present as mono-phosphate salt, (b) 0.5-5% by weight of hydroxypropylmethylcellulose, (c) 1-4% by weight of crosslinked polyvinylpyrrolidone, and (d) a filler selected from the group consisting of a cellulose, lactose, mannitol, and combinations thereof; wherein the weight percentages are based on the total weight of the pharmaceutical blend content of the capsule. 2. The capsule of claim 1, wherein the pharmaceutical blend has a poured bulk density of at least 0.4 g/mL. 3. The capsule of claim 1, wherein the pharmaceutical blend comprises 30-45% of the drug substance. 4. The capsule of claim 3, wherein the pharmaceutical blend comprises: 2-4% by weight of hydroxypropylmethylcellulose, and 2-4% by weight of crosslinked polyvinylpyrrolidone.