Formulations of triphenyl calcilytic compounds
The present disclosure provides tablet formulations including a triphenyl calcilytic compound for the treatment of autosomal dominant hypocalcemia (ADH), where the compound is represented by formula (I): a solvate, a hydrate, a pharmaceutically acceptable salt, or a combination thereof.
1. A tablet formulation comprising:
a compound represented by formula (I):
a solvate, a hydrate, or a pharmaceutically acceptable salt thereof, or a combination thereof;
mannitol and microcrystalline cellulose in a combined amount of from about 50% to about 70% by weight of the tablet formulation;
colloidal silicon dioxide in an amount of from about 1% to about 4% by weight of the tablet formulation;
croscarmellose sodium in an amount of from about 10% to about 30% by weight of the tablet formulation;
hydroxypropyl methylcellulose in an amount of from about 2% to about 5% by weight of the tablet formulation; and
magnesium stearate in an amount of from about 1% to about 2% by weight of the tablet formulation.
2. The tablet formulation of claim 1 , wherein the compound of formula (I) is present in an amount of from about 12% to about 32% by weight of the tablet formulation, on a salt-free and anhydrous basis.
3. The tablet formulation of claim 1 , wherein the compound of formula (I) is present in an amount of from about 12% to about 15% by weight of the tablet formulation, on a salt-free and anhydrous basis.
4. The tablet formulation of claim 1 , wherein the compound of formula (I) is a hemihydrate hemisulfate salt.
5. The tablet formulation of claim 4 , wherein the hemihydrate hemisulfate salt of the compound of formula (I) is present in an amount of from about 13% to about 35% by weight of the tablet formulation.
6. The tablet formulation of claim 4 , wherein the hemihydrate hemisulfate salt of the compound of formula (I) is present in an amount of about 14.3% by weight of the tablet formulation.
7. The tablet formulation of claim 1 , wherein at least about 75% of the compound of formula (I) is released from the tablet formulation after about 60 minutes in a buffered solution of pH 6.8 containing sodium lauryl sulfate.
8. The tablet formulation of claim 1 , wherein at least about 80% of the compound of formula (I) is released from the tablet formulation after about 60 minutes in a buffered solution of pH 6.8 containing sodium lauryl sulfate.
9. The tablet formulation of claim 1 , wherein at least about 85% of the compound of formula (I) is released from the tablet formulation after about 60 minutes in a buffered solution of pH 6.8 containing sodium lauryl sulfate.
10. The tablet formulation of claim 1 , wherein at least about 90% of the compound of formula (I) is released from the tablet formulation after about 60 minutes in a buffered solution of pH 6.8 containing sodium lauryl sulfate.
11. The tablet formulation of claim 1 , wherein at least about 95% of the compound of formula (I) is released from the tablet formulation after about 60 minutes in a buffered solution of pH 6.8 containing sodium lauryl sulfate.