β-carboline pharmaceutical compositions
A soft capsule containing a solution or suspension of a PDE5 inhibitor, and use of the capsule in treating sexual dysfunction.
1. A soft capsule comprising:
(a) a shell comprising gelatin, wherein said shell encapsulates
(b) a suspension pharmaceutical formulation comprising about 1% to about 45% by weight of solid particles of an active compound having a structural formula
and a pharmaceutically acceptable carrier comprising (i) a pharmaceutically acceptable solvent selected from the group consisting of polyethylene glycol 400, propylene glycol, glycofurol, a C 8 -C 10 monoglyceride, and mixtures thereof, and (ii) a suspending agent comprising a saturated polyglycolyzed glyceride.
2. The capsules of claim 1 wherein the active compound is present as a free drug.
3. The capsules of claim 1 wherein the pharmaceutically acceptable carrier further comprises a polyvinylpyrrolidone.
4. The capsules of claim 1 wherein the pharmaceutical formulation comprises about 2% to about 2.8% by weight of the active compound, about 3% to about 8% by weight propylene glycol, and about 90% to about 95% by weight polyethylene glycol 400.
5. The capsules of claim 1 wherein the solvent further comprises C 8 -C 10 monoglycerides.
6. The capsules of claim 1 wherein the pharmaceutically acceptable carrier further comprises a surfactant.
7. The capsules of claim 5 wherein the pharmaceutical formulation comprises about 3% to about 8% by weight of the active compound, about 5% to about 8% by weight propylene glycol, about 10% to about 60% by weight of C 8 -C 10 monoglycerides, and about 30% to about 75% by weight of a saturated polyglycolyzed glyceride.
8. The capsules of claim 1 wherein the active compound is present in an amount of about 1 to about 20 mg per capsule.
9. The capsules of claim 1 wherein the active compound is present in an amount of about 2 to about 20 mg per capsule.
10. The capsules of claim 1 wherein the active compound is present in an amount of about 5 to about 15 mg per capsule.
11. The capsules of claim 1 wherein the active compound is present in an amount of about 10 mg per capsule.
12. A method of treating sexual dysfunction in a patient in need thereof comprising administering to the patient a capsule of claim 1 .
13. The method of claim 12 wherein the sexual dysfunction is male erectile dysfunction.
14. The method of claim 12 wherein the sexual dysfunction is female arousal disorder.