Compositions and methods for treating anemia
Provided herein are specific doses of, and dosing regimens for, using a HIF prolyl hydroxylase inhibitor in treating or preventing anemia, such as anemia secondary to or associated with chronic kidney disease, anemia secondary to or associated with non-dialysis dependent chronic kidney disease anemia associated with or resulting from chemotherapy, or anemia associated with AIDS.
1. A tablet formulation comprising an intra-granular component, an extra-granular component, and a film coating component,
wherein the intra-granular component comprises
about 60% to about 70% by weight of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid,
or a pharmaceutically acceptable salt thereof,
about 20% to about 30% by weight of microcrystalline cellulose,
about 2.5% to about 3.5% by weight of sodium starch glycolate, and
about 2.3% to about 3.3% by weight of a hydroxypropyl methylcellulose;
wherein the extra-granular component comprises
about 2.5% to about 3.5% by weight of a sodium starch glycolate,
about 0.2% to about 0.3% by weight of colloidal silicon dioxide, and
about 0.55% to about 0.95% by weight of magnesium stearate; and
wherein the film coating component comprises about 1.0% to about 8% by weight of a tablet coating.
2. The tablet formulation of claim 1 ,
wherein the intra-granular component comprises
about 65% by weight of Compound 1,
about 25% by weight of microcrystalline cellulose,
about 3% by weight of sodium starch glycolate, and
about 2.8% by weight of a hydroxypropyl methylcellulose.
3. The tablet formulation of claim 1 , comprising about 150 mg Compound 1.
4. The tablet formulation of claim 1 , comprising about 300 mg Compound 1.
5. The tablet formulation of claim 1 , comprising about 450 mg Compound 1.
6. The tablet formulation of claim 1 , comprising about 600 mg Compound 1.
7. The tablet formulation of claim 1 , wherein the intra-granular component comprises:
about 150 mg Compound 1,
about 57.46 mg microcrystalline cellulose,
about 6.90 mg sodium starch glycolate, and
about 6.44 mg hydroxypropyl methylcellulose;
and
wherein the total weight of the intra-granular and extra-granular components is about 230 mg.
8. The tablet formulation of claim 7 , wherein the extra-granular component comprises:
about 6.9 mg sodium starch glycolate,
about 0.575 mg colloidal silicon dioxide, and
about 1.725 mg magnesium stearate.