C-met modulator pharmaceutical compositions
Pharmaceutical compositions and unit dosage forms comprising Compound I are disclosed.
1. A tablet pharmaceutical composition comprising about:
Ingredient
(% w/w)
Compound I, L-malate salt
31.68
Microcrystalline Cellulose
38.85
Lactose anhydrous
19.42
Hydroxypropyl Cellulose
3.00
Croscarmellose Sodium
3.00
Total Intra-granular
95.95
Silicon dioxide, Colloidal
0.30
Croscarmellose Sodium
3.00
Magnesium Stearate
0.75
Total
100.00
wherein Compound I is:
Compound I.
2. A tablet pharmaceutical composition comprising:
30-32 percent by weight of Compound I, L-malate salt wherein Compound I is:
38-40 percent by weight of microcrystalline cellulose;
18-22 percent by weight of lactose;
2-4 percent by weight of hydroxypropyl cellulose;
4-8 percent by weight of croscarmellose sodium;
0.2-0.6 percent by weight of colloidal silicon dioxide; and
0.5-1 percent by weight of magnesium stearate.
3. The tablet pharmaceutical composition of claim 2 , further comprising a film coating containing hypromellose, titanium dioxide, triacetin, and iron oxide yellow.
4. The tablet pharmaceutical composition of claim 1 , further comprising a film coating containing hypromellose, titanium dioxide, triacetin, and iron oxide yellow.
5. The table pharmaceutical composition of claim 1 , containing 20 to 100 mg of Compound I.
6. The tablet pharmaceutical composition of claim 1 , containing 20, 25, 50, 60, 75, 80, or 100 mg of Compound I.
7. A tablet pharmaceutical composition comprising, based on 100 weight/weight percent:
30-32 percent by weight of Compound I, L-malate salt wherein Compound I is:
38-40 percent by weight of microcrystalline cellulose;
18-22 percent by weight of lactose
2-4 percent by weight of hydroxypropyl cellulose;
4-8 percent by weight of croscarmellose sodium;
0.2-0.6 percent by weight of colloidal silicon dioxide; and
0.5-1 percent by weight of magnesium stearate;
and further comprising a film coating containing hypromellose, titanium dioxide, triacetin, and iron oxide yellow.
8. The tablet pharmaceutical composition of claim 7 , containing 20 to 100 mg of Compound I.
9. The tablet pharmaceutical composition of claim 7 , containing 20, 25, 50, 60, 75, 80, or 100 mg of Compound I.
10. A tablet pharmaceutical composition comprising:
Ingredient
(% w/w)
Compound I, L-malate
31.68
salt
Microcrystalline Cellulose
38.85
Lactose anhydrous
19.42
Hydroxypropyl Cellulose
3.00
Croscarmellose Sodium
6.00
Silicon dioxide, Colloidal
0.30
Magnesium Stearate
0.75
Total
100.00.
wherein Compound I is:
11. The tablet pharmaceutical composition of claim 2 , containing 20 to 100 mg of Compound I.
12. The tablet pharmaceutical composition of claim 2 , containing 20, 25, 50, 60, 75, 80, or 100 mg of Compound I.