Pharmaceutical dosage forms
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)-phenylamino]-pyrimidin-4-yl}-1-methyl-urea or any pharmaceutically acceptable salt thereof. It further relates to processes of making said solid pharmaceutical dosage forms.
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)-phenylamino]-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.