Claims
- 1. A salt of topiramate, or a polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 2. The salt of claim 1 wherein the salt is topiramate sodium, topiramate lithium, or topiramate potassium.
- 3. Topiramate sodium, or a polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 4. Topiramate sodium trihydrate, or a polymorph thereof.
- 5. The topiramate sodium trihydrate of claim 4, or a polymorph thereof, which is a fine lathe-like crystalline solid.
- 6. A salt of topiramate which has unique powder X-ray diffraction peaks at approximately 4.5, 13.6, and 19.1 degrees 2-Theta.
- 7. A form of topiramate which has an aqueous solubility greater than about 10 mg/ml at 25° C.
- 8. The form of claim 7 which has an aqueous solubility greater than about 50 mg/ml at 25° C.
- 9. The form of claim 8 which has an aqueous solubility greater than about 100 mg/ml at 25° C.
- 10. The form of claim 7 wherein the form is a salt form.
- 11. A co-crystal or complex of topiramate.
- 12. The co-crystal or complex of claim 11, wherein said co-crystal or complex is a co-crystal or complex of caffeine and topiramate.
- 13. A pharmaceutical composition comprising a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof, and a pharmaceutically acceptable excipient or diluent.
- 14. The pharmaceutical composition of claim 13 wherein the pharmaceutically acceptable salt of topiramate is topiramate sodium, topiramate lithium, or topiramate potassium.
- 15. The pharmaceutical composition of claim 14 wherein the pharmaceutically acceptable salt is topiramate sodium.
- 16. The pharmaceutical composition of claim 15 in which the topiramate sodium is topiramate sodium trihydrate, or a polymorph thereof.
- 17. A pharmaceutical composition comprising a co-crystal or complex of topiramate and a pharmaceutically acceptable excipient or diluent.
- 18. The pharmaceutical composition of claim 17 wherein said co-crystal or complex is a co-crystal or complex of caffeine and topiramate.
- 19. A pharmaceutical unit dosage form comprising a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof, and an excipient.
- 20. The pharmaceutical unit dosage form of claim 19 wherein the pharmaceutically acceptable salt of topiramate is topiramate sodium, topiramate lithium, or topiramate potassium.
- 21. The pharmaceutical unit dosage form of claim 20 wherein the pharmaceutically acceptable salt is topiramate sodium.
- 22. The pharmaceutical unit dosage form of claim 21 in which the topiramate sodium is topiramate sodium trihydrate, or a polymorph thereof.
- 23. The pharmaceutical unit form of claim 19 which is suitable for oral, mucosal, parenteral, or transdermal administration to a patient.
- 24. The pharmaceutical unit dosage form of claim 23 formulated for controlled release of the pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 25. The pharmaceutical unit dosage form of claim 24, wherein the controlled release occurs by osmosis.
- 26. A capsule comprising a salt of topiramate.
- 27. The capsule of claim 26, wherein said capsule is a gelcap.
- 28. A pharmaceutical unit dosage form comprising a co-crystal or complex of topiramate.
- 29. The pharmaceutical unit dosage form of claim 28 wherein said co-crystal or complex is a co-crystal or complex of caffeine and topiramate.
- 30. The pharmaceutical unit form of claim 28 which is suitable for oral, mucosal, parenteral, or transdermal administration to a patient.
- 31. The pharmaceutical unit dosage form of claim 30 formulated for controlled release of the co-crystal.
- 32. The pharmaceutical unit dosage form of claim 31, wherein the dosage form is a matrix, erodible, coated, or osmotic controlled release dosage form.
- 33. The pharmaceutical unit dosage form of claim 32 wherein the controlled release occurs by osmosis.
- 34. A method of treating or preventing seizures in a patient which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate; dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 35. A method of treating or preventing seizures in a patient which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable co-crystal or complex of topiramate.
- 36. The method of claim 34 or 35 wherein the seizure is a partial seizure or a generalized seizure.
- 37. The method of claim 34 or 35 which further comprises the adjunctive administration of another anticonvulsant.
- 38. The method of claim 37 wherein the anticonvulsant is carbamazepine, phenytoin, ethotiagabine, valproic acid, ethosuximide, felbamate, gabapentin, lamotrigine, levetiracetam, or oxcarbazepine.
- 39. A method for treating or preventing tremors in a patient which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 40. A method for treating or preventing tremors in a patient which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable co-crystal or complex of topiramate.
- 41. A method of treating migraine in a human patient which comprises administering to a patient in need of such treatment a therapeutically effective amount of a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 42. A method of treating migraine in a human patient which comprises administering to a patient in need of such treatment a therapeutically effective amount of a pharmaceutically acceptable co-crystal or complex of topiramate.
- 43. A method of reducing the frequency or severity of migraine in a human patient which comprises administering to the patient in need thereof an effective amount of a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 44. A method of reducing the frequency or severity of migraine in a human patient which comprises administering to the patient in need thereof an effective amount of a pharmaceutically acceptable co-crystal or complex of topiramate.
- 45. A method of treating or preventing neuropathic pain in a patient which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 46. A method of treating or preventing neuropathic pain in a patient which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable co-crystal or complex of topiramate.
- 47. The method of claim 45 or 46 wherein the neuropathic pain is neuralgia.
- 48. A method treating or preventing a cerebral function disorder which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 49. A method treating or preventing a cerebral function disorder which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable co-crystal or complex of topiramate.
- 50. The method of claim 48 or 49 wherein the cerebral function disorder is Alzheimer's disease.
- 51. The method of claim 48 or 49 wherein the cerebral function disorder is Parkinson's disease.
- 52. A method of treating or preventing obesity or weight gain in a patient which comprises administering to a patient in need of such treatment a therapeutically or prophylactically effective amount of a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 53. A method of treating or preventing obesity or weight gain in a patient which comprises administering to a patient in need of such treatment a therapeutically of prophylactically effective amount of a pharmaceutically acceptable co-crystal or complex of topiramate.
- 54. A method of treating or preventing affective disorders in a patient which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 55. A method of treating or preventing affective disorders in a patient which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable co-crystal or complex of topiramate.
- 56. The method of claim 54 or 55 wherein the affective disorder is a manic condition, an acute mania, manic rapid cycling, bipolar mood disorders or condition, manic-depressive bipolar disorder, mood stabilization, post-traumatic stress disorder, depression, an anxiety disorder, attention deficit disorder, attention deficit disorder with hyperactivity, compulsive or obsessive-compulsive disorder, narcolepsy, premenstrual syndrome, chronic fatigue syndrome, seasonal affective disorder, substance abuse or addiction, or nicotine addiction or craving.
- 57. A method of treating or preventing cluster headache in a patient which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 58. A method of treating or preventing cluster headache in a patient which comprises administering to a patient in need of such treatment or prevention a therapeutically or prophylactically effective amount of a pharmaceutically acceptable co-crystal or complex of topiramate.
- 59. A method of eliciting smoking cessation which comprises administering to a patient in need thereof a therapeutically effective amount of a pharmaceutically acceptable salt of topiramate, or a pharmaceutically acceptable polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 60. A method of eliciting smoking cessation which comprises administering to a patient in need thereof a therapeutically effective amount of a pharmaceutically acceptable co-crystal or complex of topiramate.
- 61. The method of claim 35, 40, 42, 44, 46, 49, 53, 55, 58, or 60 wherein said co-crystal or complex is a co-crystal or complex of topiramate and caffeine, N-methyl pyrrolidine, nicotine, or nicotinamide.
- 62. A pharmaceutical dosage form which comprises: a wall defining a cavity, the wall having an exit orifice formed or formable therein and at least a portion of the wall being semipermeable; an expandable layer located within the cavity remote from the exit orifice and in fluid communication with the semipermeable portion of the wall; a dry or substantially dry state drug layer located within the cavity adjacent the exit orifice and in direct or indirect contacting relationship with the expandable layer; and a flow-promoting layer interposed between the inner surface of the wall and at least the external surface of the drug layer located within the cavity, wherein the drug layer comprises a salt of topiramate, or a polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 63. A pharmaceutical dosage form which comprises: a wall defining a cavity, the wall having an exit orifice formed or formable therein and at least a portion of the wall being semipermeable; an expandable layer located within the cavity remote from the exit orifice and in fluid communication with the semipermeable portion of the wall; a drug layer located within the cavity adjacent the exit orifice and in direct or indirect contacting relationship with the expandable layer; the drug layer comprising a liquid, active agent formulation absorbed in porous particles, the porous particles being adapted to resist compaction forces sufficient to form a compacted drug layer without significant exudation of the liquid, active agent formulation, the dosage form optionally having a placebo layer between the exit orifice and the drug layer, wherein the active agent formulation comprises a salt of topiramate, or a polymorph, solvate, hydrate, dehydrate, co-crystal, anhydrous, or amorphous form thereof.
- 64. The dosage form of claim 62 or 63 wherein the salt of topiramate is a lithium potassium, or sodium salt.
- 65. The dosage form of claim 64 wherein the salt of topiramate is topiramate sodium trihydrate.
- 66. A pharmaceutical dosage form which comprises: a wall defining a cavity, the wall having an exit orifice formed or formable therein and at least a portion of the wall being semipermeable; an expandable layer located within the cavity remote from the exit orifice and in fluid communication with the semipermeable portion of the wall; a dry or substantially dry state drug layer located within the cavity adjacent the exit orifice and in direct or indirect contacting relationship with the expandable layer; and a flow-promoting layer interposed between the inner surface of the wall and at least the external surface of the drug layer located within the cavity, wherein the drug layer comprises a co-crystal or complex of topiramate.
- 67. A pharmaceutical dosage form which comprises: a wall defining a cavity, the wall having an exit orifice formed or formable therein and at least a portion of the wall being semipermeable; an expandable layer located within the cavity remote from the exit orifice and in fluid communication with the semipermeable portion of the wall; a drug layer located within the cavity adjacent the exit orifice and in direct or indirect contacting relationship with the expandable layer; the drug layer comprising a liquid, active agent formulation absorbed in porous particles, the porous particles being adapted to resist compaction forces sufficient to form a compacted drug layer without significant exudation of the liquid, active agent formulation, the dosage form optionally having a placebo layer between the exit orifice and the drug layer, wherein the active agent formulation comprises a co-crystal or complex of topiramate.
- 68. The dosage form of claim 66 or 67 wherein the co-crystal or complex is a co-crystal or complex of topiramate and caffeine, N-methyl pyrrolidine, nicotine, or nicotinamide.
Parent Case Info
[0001] This application is related to U.S. provisional patent application No. 60/356,764, filed Feb. 15, 2002, No. 60/380,288, filed May 15, 2002, and ______ filed Aug. 30, 2002, all of which are incorporated herein by reference in their entireties.
Provisional Applications (3)
|
Number |
Date |
Country |
|
60356764 |
Feb 2002 |
US |
|
60380288 |
May 2002 |
US |
|
60406974 |
Aug 2002 |
US |
Continuations (2)
|
Number |
Date |
Country |
Parent |
10295995 |
Nov 2002 |
US |
Child |
10637829 |
Aug 2003 |
US |
Parent |
10232589 |
Sep 2002 |
US |
Child |
10295995 |
Nov 2002 |
US |