Claims
- 1. A pulsatile release dosage form for oral administration of methylphenidate, comprising:
(a) a first dosage unit comprising a first methylphenidate dose that is released substantially immediately following oral administration of the dosage form to a patient; (b) a second dosage unit comprising a second methylphenidate dose and a means for delaying release of the second dose until approximately 3 to 5 hours following administration of the dosage form to a patient; and optionally (c) a third dosage unit comprising a third methylphenidate dose and a means for delaying release of the third dose until approximately 7 to 9 hours following oral administration of the dosage form to a patient.
- 2. The dosage form of claim 1, wherein the first, second and third dosage units are housed in a closed capsule.
- 3. The dosage form of claim 1, wherein the first, second and third dosage units represent integral and discrete segments of a single tablet.
- 4. The dosage form of claim 1, wherein the total of the first, second and third methylphenidate doses is in the range of approximately 2 mg to 100 mg.
- 5. The dosage form of claim 4, wherein said total of the first, second and third methylphenidate doses is in the range of approximately 2 mg to 50 mg.
- 6. The dosage form of claim 5, wherein the first and second methylphenidate doses are each in the range of approximately 1 mg to 20 mg.
- 7. The dosage form of claim 1, wherein the first and second methylphenidate doses are approximately equal.
- 8. The dosage form of claim 1, wherein the third dosage unit is present.
- 9. The dosage form of claim 8, wherein the third methylphenidate dose is approximately half that of the first methylphenidate dose.
- 10. The dosage form of claim 9, wherein the third dosage unit releases the third methylphenidate dose in the colon.
- 11. The dosage form of claim 2, wherein each dosage unit comprises a compressed tablet.
- 12. The dosage form of claim 2, wherein each dosage unit comprises a plurality of drug-containing beads or particles.
- 13. The dosage form of claim 1, wherein at least one of the first, second and third dosage units further comprises an additional drug.
- 14. The dosage form of claim 13, wherein the additional drug is a CNS stimulant.
- 15. The dosage form of claim 14, wherein the additional drug is an analeptic agent.
- 16. The dosage form of claim 13, wherein the first dosage unit contains the CNS stimulant, the second dosage unit optionally contains the CNS stimulant, and the third dosage unit does not contain the CNS stimulant.
- 17. The dosage form of claim 16, wherein the CNS stimulant is selected from the group consisting of amphetamine, d-amphetamine, amphetaminil, bemegride, benzphetamine, benzphetamine, brucine, chlorphentermine, clofenciclan, clortermine, deanol acetamidobenzoate, demanyl, dexoxadrol, diethpropion, doxapram, N-ethylamphetamine, ethamivan, etifelmin, etryptamine, fencamfamine, fenethylline, fenosolone, fenfluramine, flurothyl, hexacyclonate, homocamfin, mazindol, megexamide, methamphetamine, nicotinic agonists, nikethamide, pemoline, pentylenetetrazole, phenidimetrazine, phendimetrazine, phenmetrazine, phenmetrazine, phentermine, picrotoxin, pipradrol, prolintane, pyrovalerone, racephedrine, tetrahydrobenzothienopyridines, and pharmacologically acceptable salts thereof.
- 18. The dosage form of claim 17, wherein the CNS stimulant is selected from the group consisting of amphetamine, d-amphetamine, and pharmacologically acceptable salts thereof.
- 19. The dosage form of claim 18, wherein the CNS stimulant is selected from the group consisting of amphetamine, d-amphetamine, amphetamine phosphate, d-amphetamine phosphate, amphetamine sulfate, d-amphetamine sulfate, amphetamine hydrochloride, d-amphetamine hydrochloride, amphetamine saccharate, d-amphetamine saccharate, amphetamine aspartate, d-amphetamine aspartate, and combinations thereof.
- 20. The dosage form of claim 17, wherein the CNS stimulant is pemoline.
- 21. The dosage form of claim 13, wherein the additional drug is an antidepressant drug.
- 22. The dosage form of claim 21, wherein the antidepressant drug is a selective serotonin reuptake inhibitor.
- 23. The dosage form of claim 13, wherein the additional drug is an antianxiety agent.
- 24. The dosage form of claim 1, wherein the means for delaying release comprises a coating of a delayed release membrane material.
- 25. The dosage form of claim 24, wherein the delayed release membrane material is comprised of a bioerodible, hydrolyzable and/or gradually water-soluble polymer.
- 26. The dosage form of claim 25, wherein the delayed release membrane material is an acrylic resin.
- 27. The dosage form of claim 26, wherein the delayed release membrane material is a copolymer of acrylic acid, methacrylic acid, methyl acrylate, ethyl acrylate, methyl methacrylate, ethyl methacrylate, and/or derivatives thereof.
- 28. The dosage form of claim 26, wherein the delayed release membrane material is a terpolymer of ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate chloride.
- 29. The dosage form of claim 1, wherein at least one of the first, second and third dosage units further comprises a diluent.
- 30. The dosage form of claim 20, wherein the diluent is selected from the group consisting of dicalcium phosphate dihydrate, calcium sulfate, lactose, cellulose, kaolin, mannitol, dry starch, hydrolyzed starches, silicon dioxide, titanium oxide, alumina, talc, microcrystalline cellulose, powdered sugar, and mixtures thereof.
- 31. The dosage form of claim of claim 1, wherein at least one of the first, second and third dosage units further comprises a lubricant.
- 32. The dosage form of claim 31, wherein the lubricant is selected from the group consisting of magnesium stearate, calcium stearate, stearic acid, glyceryl behenate, polyethylene glycol, and mixtures thereof.
- 33. The dosage from of claim 32, wherein the lubricant is magnesium stearate.
- 34. The dosage form of claim 1, wherein at least one of the first, second and third dosage units further comprises a disintegrant.
- 35. The dosage form of claim 34, wherein the disintegrant is sodium starch glycolate.
- 36. The dosage form of claim 1, wherein each dosage unit has a different color.
- 37. A method for treating an individual suffering from ADD, comprising administering to the individual, once daily, the dosage form of claim 1.
- 38. A method for treating an individual suffering from ADHD, comprising administering to the individual, once daily, the dosage form of claim 1.
- 39. A method for treating an individual suffering from narcolepsy, comprising administering to the individual, once daily, the dosage form of claim 1.
- 40. A method for treating an individual suffering from acute depression, comprising administering to the individual, once daily, the dosage form of claim 1.
- 41. A method for treating an individual suffering from cognitive decline associated with Acquired Immunodeficiency Syndrome (“AIDS”) or AIDS-related conditions, comprising administering to the individual, once daily, the dosage form of claim 1.
- 42. A method for elevating the mood of a terminally ill patient, comprising administering to the patient, once daily, the dosage form of claim 1.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 60/127,984, filed Apr. 6, 1999.
Provisional Applications (1)
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Number |
Date |
Country |
|
60127984 |
Apr 1999 |
US |
Continuations (2)
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Number |
Date |
Country |
Parent |
09992353 |
Nov 2001 |
US |
Child |
10426138 |
Apr 2003 |
US |
Parent |
09544732 |
Apr 2000 |
US |
Child |
09992353 |
Nov 2001 |
US |