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Claims for Patent: 6,821,975

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Claims for Patent: 6,821,975

Title: Beta-carboline drug products
Abstract:A compound of structural formula (I), and pharmaceutically acceptable salts and solvates thereof, wherein the compound is in free drug particulate form, is disclosed.
Inventor(s): Anderson; Neil R. (West Lafayette, IN), Hartauer; Kerry J. (Carmel, IN), Kral; Martha A. (Indianapolis, IN), Stephenson; Gregory A. (Fishers, IN)
Assignee: Lilly ICOS LLC (Wilmington, DE)
Application Number:10/031,463
Patent Claims: 1. A free drug particulate form of a compound having a formula ##STR3##

or pharmaceutically acceptable salts and solvates thereof, comprising particles of the compound wherein at least 90% of the particles have a particle size of less than about 40 microns.

2. The free drug particulate form of claim 1 wherein at least 90% of the particles have a particle size of less than about 25 microns.

3. The free drug particulate form of claim 1 wherein at least 90% of the particles have a particle size of less than about 15 microns.

4. The free drug particulate form of claim 1 wherein at least 90% of the particles have a particle size of less than about 10 microns.

5. A pharmaceutical solid composition comprising the free drug particulate form as in any one of claims 1-4 and one or more pharmaceutically-acceptable carriers, diluents, or excipients.

6. A method of treating sexual dysfunction in a patient in need thereof, which comprises administering to the patient a therapeutically effective amount of a solid composition comprising the free drug particulate form as in any one of claims 1-4 and one or more pharmaceutically-acceptable carriers, diluents, or excipients.

7. The method of claim 6 wherein the sexual dysfunction is male erectile dysfunction.

8. The method of claim 6 wherein the sexual dysfunction is female sexual arousal disorder.

9. A method of manufacturing the free drug particulate form of claim 1 comprising: (a) providing a solid, free form of the compound, and (b) comminuting the solid free form of the compound to provide particles of the compound wherein at least 90% of the particles have a particle size of less than about 40 microns.

10. The method of claim 9 further comprising the step of admixing the particles of step (b) with one or more pharmaceutically-acceptable carriers, diluents, or excipients.

11. A pharmaceutical solid composition prepared by admixing particles of a compound having a formula ##STR4##

or a pharmaceutically acceptable salt or solvate thereof, with one or more pharmaceutically acceptable carrier, diluent, or excipient, wherein the particles of the compound have a d90=40 or less.
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