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|Title:||.beta.-carboline pharmaceutical compositions|
|Abstract:||A soft capsule containing a solution or suspension of a PDE5 inhibitor, and use of the capsule in treating sexual dysfunction.|
|Inventor(s):||Anderson; Neil R. (West Lafayette, IN), Gullapalli; Rampurna P. (Elmsford, NY)|
|Assignee:||Lilly Icos LLC. (Wilmington, DE)|
|Filing Date:||Apr 15, 2002|
|Claims:||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 ##STR2## |
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.sub.8 -C.sub.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.sub.8 -C.sub.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.sub.8 -C.sub.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.
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