Claims
- 1. A pharmaceutical dosage form comprising (a) at least one agent effective in treatment of sexual dysfunction having a molecular weight, excluding counterions, not greater than 250, in a therapeutically or sexual-stimulatorily effective total amount, and (b) at least one pharmaceutically acceptable excipient; the dosage form being adapted for delivery by a route of administration that entails interaction with the organs of taste yet having acceptable organoleptic properties.
- 2. The dosage form of claim 1 wherein the at least one agent has a molecular weight, excluding counterions, not greater than 235.
- 3. The dosage form of claim 1 wherein the at least one agent has a molecular weight, excluding counterions, not greater than 220.
- 4. The dosage form of claim 1 wherein the at least one agent has a solubility in water at 20-25° C. of at least about 10 g/l.
- 5. The dosage form of claim 1 wherein the at least one agent is a compound having the formula
- 6. The dosage form of claim 1 wherein the total amount of the at least one agent per dose is lower than an amount causing significant side-effects.
- 7. The dosage form of claim 1 wherein the therapeutic agent is sumanirole or a salt thereof and is present in an amount of about 0.05 mg to about 5 mg per dose.
- 8. The dosage form of claim 1 wherein the therapeutic agent is (R)-5,6-dihydro-5-(methylamino)-4H-imidazo[4,5-ij]-quinoline-2(1H)-thione or a salt thereof and is present in an amount of about 0.05 mg to about 5 mg per dose.
- 9. The dosage form of claim 8 wherein the therapeutic agent is present in an amount of about 0.1 to about 3 mg per dose.
- 10. The dosage form of claim 1 that is adapted for a route of administration selected from oral, buccal, sublingual, nasal and tracheal routes.
- 11. The dosage form of claim 1 that is selected from
(a) buccal and sublingual tablets; (b) mucoadhesive films; (c) oral strips; (d) chewable tablets; (e) rapidly disintegrating oral dosage forms; (f) lozenges and pastilles; (g) breath-fresheners; (h) chewing gums; (i) lollipops and popsicles; (j) food adjuncts; (k) candies and chocolates; (l) periodontal gels; (m) mouthwashes; (n) oral and nasal drops and sprays; (o) dosage forms adapted for inhalation as an aerosol or vapor; (p) elixirs, solutions, suspensions and other orally administered liquid dosage forms; (q) powders, granules and tablets for dissolution or dispersion in water prior to oral administration; and (r) effervescent tablets and granules.
- 12. The dosage form of claim 1 that is adapted for discreet self-administration.
- 13. The dosage form of claim 1 that is adapted for nasal administration.
- 14. The dosage form of claim 13 that is formulated as a nasal spray solution.
- 15. The dosage form of claim 1 that is adapted for oral, buccal or sublingual administration.
- 16. The dosage form of claim 15 that dissolves in the mouth without need for drinking water or other fluid.
- 17. The dosage form of claim 15 that is a breath-freshening pastille.
- 18. The dosage form of claim 15 that is a chewing gum.
- 19. The dosage form of claim 15 that is a sublingual tablet.
- 20. The dosage form of claim 15 that is a mucoadhesive film.
- 21. The dosage form of claim 15 that is an oral strip.
- 22. The dosage form of claim 15 that is an oral fast-melt tablet.
- 23. A pharmaceutical dosage form comprising (a) a therapeutically or sexual-stimulatorily effective amount of about 0.1 mg to about 10 mg per dose of a therapeutic agent that comprises at least one compound of formula
- 24. The dosage form of claim 23 wherein the water-soluble compound or salt thereof has a solubility in water at 20-25° C. of at least about 10 g/l.
- 25. The dosage form of claim 23 wherein the water-soluble compound or salt thereof is disclosed generically or specifically in U.S. Pat. No. 5,273,975.
- 26. The dosage form of claim 23 that is adapted for a route of administration selected from oral, buccal, sublingual, nasal and tracheal routes.
- 27. The dosage form of claim 23 that is selected from
(a) buccal and sublingual tablets; (b) mucoadhesive films; (c) oral strips; (d) chewable tablets; (e) rapidly disintegrating oral dosage forms; (f) lozenges and pastilles; (g) breath-fresheners; (h) chewing gums; (i) lollipops and popsicles; (j) food adjuncts; (k) candies and chocolates; (l) periodontal gels; (m) mouthwashes; (n) oral and nasal drops and sprays; (o) dosage forms adapted for inhalation as an aerosol or vapor; (p) elixirs, solutions, suspensions and other orally administered liquid dosage forms; (q) powders, granules and tablets for dissolution or dispersion in water prior to oral administration; and (r) effervescent tablets and granules.
- 28. The dosage form of claim 23 that is adapted for discreet self-administration.
- 29. The dosage form of claim 23 that is adapted for nasal administration.
- 30. The dosage form of claim 29 that is formulated as a nasal spray solution.
- 31. The dosage form of claim 23 that is adapted for oral, buccal or sublingual administration.
- 32. The dosage form of claim 31 that dissolves in the mouth without need for drinking water or other fluid.
- 33. The dosage form of claim 31 that is a breath-freshening pastille.
- 34. The dosage form of claim 31 that is a chewing gum.
- 35. The dosage form of claim 31 that is a sublingual tablet.
- 36. The dosage form of claim 31 that is a mucoadhesive film.
- 37. The dosage form of claim 31 that is an oral strip.
- 38. The dosage form of claim 31 that is an oral fast-melt tablet.
- 39. A method of treating sexual dysfunction in a subject comprising intraoral administration of a dosage form of claim 1 to the subject, less than about 1 hour prior to sexual activity.
- 40. A method of treating sexual dysfunction in a subject comprising intraoral administration of a dosage form of claim 23 to the subject, less than about 1 hour prior to sexual activity.
- 41. A method of enhancing sexual desire, interest or performance in a subject comprising intraoral administration of a dosage form of claim 1 to the subject, less than about 1 hour prior to sexual activity.
- 42. A method of enhancing sexual desire, interest or performance in a subject comprising intraoral administration of a dosage form of claim 23 to the subject, less than about 1 hour prior to sexual activity.
Parent Case Info
[0001] This application claims priority of U.S. Provisional Application Serial No. 60/267,519, filed on Feb. 8, 2001.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60267519 |
Feb 2001 |
US |