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)-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 .- 24 . (canceled) 
     
     
         25 . A 10 mg dose unit capsule comprising:
 10 mg of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)phenylamino]-pyrimidin-4-yl}-1-methyl-urea, present at its mono-phosphate salt;   about 0.5-5% by weight of hydroxypropylmethylcellulose;   about 1-4% by weight crosslinked polyvinylpyrrolidone; and   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 content of the capsule. 
     
     
         26 . A 25 mg dose unit capsule comprising:
 25 mg of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)phenylamino]-pyrimidin-4-yl}-1-methyl-urea, present at its mono-phosphate salt;   about 0.5-5% by weight of hydroxypropylmethylcellulose;   about 1-4% by weight crosslinked polyvinylpyrrolidone; and   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 content of the capsule. 
     
     
         27 . The 25 mg dose unit capsule of  claim 26 , wherein the capsule comprises:
 about 2-4% by weight of hydroxypropylmethylcellulose; and   about 2-4% by weight of crosslinked polyvinylpyrrolidone.   
     
     
         28 . The 25 mg dose unit capsule of  claim 26 , wherein the filler comprises a combination of a cellulose and lactose. 
     
     
         29 . A 25 mg dose unit capsule comprising:
 25 mg of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)phenylamino]-pyrimidin-4-yl}-1-methyl-urea, present at its mono-phosphate salt;   about 2-4% by weight of hydroxypropylmethylcellulose;   about 2-4% by weight crosslinked polyvinylpyrrolidone; and   a cellulose,   
       wherein the weight percentages are based on the total weight of the content of the capsule. 
     
     
         30 . The 25 mg dose unit capsule of  claim 29 , wherein the capsule further comprises lactose. 
     
     
         31 . A 50 mg dose unit capsule comprising:
 50 mg of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)phenylamino]-pyrimidin-4-yl}-1-methyl-urea, present at its mono-phosphate salt;   about 0.5-5% by weight of hydroxypropylmethylcellulose;   about 1-4% by weight crosslinked polyvinylpyrrolidone; and   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 content of the capsule. 
     
     
         32 . A 75 mg dose unit capsule comprising:
 75 mg of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)phenylamino]-pyrimidin-4-yl}-1-methyl-urea, present at its mono-phosphate salt;   about 0.5-5% by weight of hydroxypropylmethylcellulose;   about 1-4% by weight crosslinked polyvinylpyrrolidone; and   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 content of the capsule. 
     
     
         33 . A 100 mg dose unit capsule comprising:
 100 mg of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)phenylamino]-pyrimidin-4-yl}-1-methyl-urea, present at its mono-phosphate salt;   about 0.5-5% by weight of hydroxypropylmethylcellulose;   about 1-4% by weight crosslinked polyvinylpyrrolidone; and   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 content of the capsule. 
     
     
         34 . The 100 mg dose unit capsule of  claim 33 , wherein the capsule comprises:
 about 2-4% by weight of hydroxypropylmethylcellulose; and   about 2-4% by weight of crosslinked polyvinylpyrrolidone.   
     
     
         35 . The 100 mg dose unit capsule of  claim 33 , wherein the filler comprises a combination of a cellulose and lactose. 
     
     
         36 . A 100 mg dose unit capsule comprising:
 100 mg of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)phenylamino]-pyrimidin-4-yl}-1-methyl-urea, present at its mono-phosphate salt;   about 2-4% by weight of hydroxypropylmethylcellulose;   about 2-4% by weight crosslinked polyvinylpyrrolidone; and   a cellulose,   
       wherein the weight percentages are based on the total weight of the content of the capsule. 
     
     
         37 . The 100 mg dose unit capsule of  claim 36 , wherein the capsule further comprises lactose. 
     
     
         38 . A 125 mg dose unit capsule comprising:
 125 mg of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)phenylamino]-pyrimidin-4-yl}-1-methyl-urea, present at its mono-phosphate salt;   about 0.5-5% by weight of hydroxypropylmethylcellulose;   about 1-4% by weight crosslinked polyvinylpyrrolidone; and   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 content of the capsule.