Solid dose pharmaceutical composition
AssigneeSumitomo Pharma Oncology, Inc.
InventorsSteven L. WARNER, Jason Marc FOULKS, Paul FLYNN
Life of this patent
Estimating the term…
Abstract
The present disclosure provides pharmaceutical compositions comprising a compound having activity as an ACVR1 (ALK2) or ALK5 inhibitor.
Claims104
An oral solid pharmaceutical composition comprising:
- a) a compound of formula (I):
- or a pharmaceutically acceptable salt thereof,
- b) microcrystalline cellulose;
- c) lactose;
- d) croscarmellose;
- and
- e) magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) a compound of formula (I):
- or a pharmaceutically acceptable salt thereof,
- b) one or more diluent;
- c) one or more disintegrant;
- and
- d) one or more lubricant;
- wherein the compound of formula (I) or the pharmaceutically acceptable salt is in an amount from about 3 mg to about 350 mg based on free base weight.
An oral solid pharmaceutical composition comprising:
- a) about 5.4 mg of a compound of formula (I):
- or a pharmaceutically acceptable salt thereof;
- b) about 36.80 mg of microcrystalline cellulose;
- c) about 121.00 mg of lactose;
- d) about 5.10 mg of croscarmellose sodium;
- and
- e) about 1.70 mg of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) about 27.00 mg of a compound of formula (I):
- or a pharmaceutically acceptable salt thereof;
- b) about 31.50 mg of microcrystalline cellulose;
- c) about 104.70 mg of lactose;
- d) about 5.10 mg of croscarmellose sodium;
- and
- e) about 1.70 mg of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) about 135.00 mg of a compound of formula (I):
- or a pharmaceutically acceptable salt thereof,
- b) about 53.10 mg of microcrystalline cellulose;
- c) about 176.70 mg of lactose;
- d) about 11.40 mg of croscarmellose sodium;
- and
- e) about 3.80 mg of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) about 3.18% w/w of a compound of formula (I):
- or a pharmaceutically acceptable salt thereof,
- b) about 21.65% w/w of microcrystalline cellulose;
- c) about 71.18% w/w of lactose;
- d) about 3.00% w/w of croscarmellose sodium;
- and
- e) about 1.00% w/w of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) about 15.88% w/w of a compound of formula (I):
- or a pharmaceutically acceptable salt thereof,
- b) about 18.53% w/w of microcrystalline cellulose;
- c) about 61.59% w/w of lactose;
- d) about 3.00% w/w of croscarmellose sodium;
- and
- e) about 1.00% w/w of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) about 35.53% w/w of a compound of formula (I):
- or a pharmaceutically acceptable salt thereof,
- b) about 13.97% w/w of microcrystalline cellulose;
- c) about 46.50% w/w of lactose;
- d) about 3.00% w/w of croscarmellose sodium;
- and
- e) about 1.00% w/w of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) about 5.4 mg of hydrochloric acid salt of the compound of formula (I);
- b) about 36.80 mg of microcrystalline cellulose;
- c) about 121.00 mg of lactose;
- d) about 5.10 mg of croscarmellose sodium;
- and
- e) about 1.70 mg of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) about 27.00 mg of hydrochloric acid salt of the compound of formula (I);
- b) about 31.50 mg of microcrystalline cellulose;
- c) about 104.70 mg of lactose;
- d) about 5.10 mg of croscarmellose sodium;
- and
- e) about 1.70 mg of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) about 135.00 mg of hydrochloric acid salt of the compound of formula (I);
- b) about 53.10 mg of microcrystalline cellulose;
- c) about 176.70 mg of lactose;
- d) about 11.40 mg of croscarmellose sodium;
- and
- e) about 3.80 mg of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) about 3.18% w/w of hydrochloric acid salt of the compound of formula (I);
- b) about 21.65% w/w of microcrystalline cellulose;
- c) about 71.18% w/w of lactose;
- d) about 3.00% w/w of croscarmellose sodium;
- and
- e) about 1.00% w/w of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) about 15.88% w/w of hydrochloric acid salt of the compound of formula (I);
- b) about 18.53% w/w of microcrystalline cellulose;
- c) about 61.59% w/w of lactose;
- d) about 3.00% w/w of croscarmellose sodium;
- and
- e) about 1.00% w/w of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- a) about 35.53% w/w of hydrochloric acid salt of the compound of formula (I);
- b) about 13.97% w/w of microcrystalline cellulose;
- c) about 46.50% w/w of lactose;
- d) about 3.00% w/w of croscarmellose sodium;
- and
- e) about 1.00% w/w of magnesium stearate.
An oral solid pharmaceutical composition comprising
- about 3 mg to about 350 mg of a compound of formula (I) or a pharmaceutically acceptable salt thereof,
- one or more diluent;
- one or more disintegrant;
- and
- one or more lubricant.
An oral solid pharmaceutical composition comprising
- about 3 mg to about 150 mg of a compound of formula (I) or a pharmaceutically acceptable salt thereof,
- about 30 mg to 260 mg of one or more diluent;
- about 3 mg to about 13 mg of one or more disintegrant;
- and
- about 1 mg to about 5 mg of one or more lubricant.
An oral solid pharmaceutical composition comprising
- about 1-50% w/w of a compound of formula (I) or a pharmaceutically acceptable salt thereof,
- about 10-95% w/w of one or more diluent;
- about 0.1-6.0% w/w of one or more disintegrant;
- and
- about 0.1-3.0% w/w of one or more lubricant.
An oral solid pharmaceutical composition comprising
- about 2-38% w/w of a compound of formula (I) or a pharmaceutically acceptable salt thereof,
- about 10-80% w/w of one or more diluent;
- about 24% w/w of one or more disintegrant;
- and
- about 0.7-1.3% w/w of one or more lubricant.
An oral solid pharmaceutical composition comprising:
- about 3 mg to about 30 mg of a compound of formula (I), or a pharmaceutically acceptable salt thereof,
- about 30 mg to about 60 mg of microcrystalline cellulose;
- about 100 mg to about 200 mg of lactose;
- about 3 mg to about 13 mg of croscarmellose sodium;
- and
- about 1 mg to about 5 mg of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- about 5 mg to 6 mg of a compound of formula (I), or a pharmaceutically acceptable salt thereof,
- about 33 mg to 39 mg microcrystalline cellulose;
- about 115 mg to 125 mg lactose;
- about 4 mg to 6 mg croscarmellose sodium;
- and
- about 1.4 mg to 2 mg magnesium stearate.
An oral solid pharmaceutical composition comprising:
- about 25.00 mg to 30 mg of a compound of formula (I), or a pharmaceutically acceptable salt thereof,
- about 28 mg to 35 mg of microcrystalline cellulose;
- about 100 mg to 110 mg of lactose;
- about 4 mg to 6 mg of croscarmellose sodium;
- and
- about 1.4 mg to 2 mg of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- about 125.00 mg to 140 mg of a compound of formula (I), or a pharmaceutically acceptable salt thereof,
- about 48 mg to 58 mg of microcrystalline cellulose;
- about 170 mg to 180 mg of lactose;
- about 8 mg to 14 mg of croscarmellose sodium;
- and
- about 3.3 mg to 4.3 mg of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- about 2-38% w/w of a compound of formula (I) or a pharmaceutically acceptable salt thereof,
- about 12-25% w/w of microcrystalline cellulose;
- about 45-75% w/w of lactose;
- about 24% w/w of croscarmellose sodium;
- and
- about 0.7-1.3% w/w of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- about 2-38% w/w of a compound of formula (I) or a pharmaceutically acceptable salt thereof,
- about 12-25% w/w of microcrystalline cellulose;
- about 45-75% w/w of lactose;
- about 3% w/w of croscarmellose sodium;
- and
- about 1% w/w of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- about 3-3.3% w/w of hydrochloric acid salt of the compound of formula (I);
- about 20-23% w/w of microcrystalline cellulose;
- about 70-73% w/w of lactose;
- about 3.00% w/w of croscarmellose sodium;
- and
- about 1.00% w/w of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- about 14-17% w/w of hydrochloric acid salt of the compound of formula (I);
- about 17-20% w/w of microcrystalline cellulose;
- about 60-64% w/w of lactose;
- about 3.00% w/w of croscarmellose sodium;
- and
- about 1.00% w/w of magnesium stearate.
An oral solid pharmaceutical composition comprising:
- about 34-37% w/w of hydrochloric acid salt of the compound of formula (I);
- about 12-15% w/w of microcrystalline cellulose;
- about 45-48% w/w of lactose;
- about 3.00% w/w of croscarmellose sodium;
- and
- about 1.00% w/w of magnesium stearate.
Dependencies are inferred from the claim text.