Methods and devices for providing prolonged drug therapy

• US 9,144,549 B2
• Filed: 03/13/2013
• Issued: 09/29/2015
• Est. Priority Date: 11/12/1996
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Gupta, Suneel K., Guinta, Diane R, Christopher, Carol A., Saks, Samuel R., Hamel, Lawrence G.
• Primary Examiner(s): FAY, ZOHREH A
• Application Number:
  US13/801,000
• Publication Number:
  US 20130195934A1
• Time in Patent Office: 930 Days
• Field of Search: 514/532
• US Class Current: 1/1
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/421 1,3-Oxazoles, e.g. pemoline, trimethadione
• CPC Class Codes: A61K 31/4422 1,4-Dihydropyridines, e.g. nifedipine, nicardipine
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 9/0002 Galenical forms characterised by the drug release technique; Application systems commanded by energy
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61K 9/5084 Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs tablets containing such a mixture A61K9/2077
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092

Abstract

Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended time period are provided. The dosage forms may additionally comprise an immediate-release dose of drug.

Claims

1. A method for treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject that comprises administering a pharmaceutically acceptable composition comprising methylphenidate or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier to a patient in a manner that achieves an ascending release rate of said methylphenidate beginning with a first periodic interval that begins at time t=0 and continuing through about 5.5 hours following said administration.

2. A method for treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising orally administering a dosage form to said subject, wherein said dosage form comprises

an immediate release coating comprising methylphenidate hydrochloride;

and

a sustained release portion comprising methylphenidate hydrochloride and a pharmaceutically acceptable carrier,

wherein;

said dosage form provides release of said methylphenidate hydrochloride over a period comprising first, second, third, and fourth sequential, one-hour time intervals; and

said sustained release portion releases more of said methylphenidate hydrochloride during said second interval than during said first interval, more of said methylphenidate hydrochloride during said third interval than during said second interval, and more of said methylphenidate hydrochloride during said fourth interval than during said third interval.

3. The method according to claim 2 wherein said dosage form is administered one time per day for multiple days.

4. The method according to claim 2 wherein said dosage form is administered to a non-adult subject.

5. The method according to claim 2 wherein said dosage form is a non-osmotic dosage form.

6. The method according to claim 2 wherein said dosage form is an osmotic dosage form.

7. The method according to claim 2 wherein the methylphenidate hydrochloride in said immediate release coating is released primarily during said first interval.

8. A method for treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising orally administering a dosage form to said subject, wherein said dosage form comprises

an immediate release portion comprising methylphenidate or a pharmaceutically effective salt thereof;

and

a sustained release portion comprising methylphenidate or a pharmaceutically effective salt thereof and a pharmaceutically acceptable carrier,

wherein;

said dosage form releases said methylphenidate over a period comprising first, second, and third sequential one-hour time intervals, and

said sustained release portion releases more of said methylphenidate during said second interval than during said first interval, and more of said methylphenidate during said third interval than during said second interval.

9. The method according to claim 8 wherein said period of release comprises a fourth sequential time interval, and wherein the sustained release portion releases more of said methylphenidate during said fourth interval than during said third interval.

10. The method according to claim 8 wherein the methylphenidate released during said first interval only includes methylphenidate released from said immediate release portion.

11. The method according to claim 10 wherein said immediate release portion is applied as a coating on an outer surface of the dosage form.

12. The method according to claim 11 wherein the dosage form releases more of said methylphenidate during said second interval than during said first interval, not including methylphenidate released from said coating during said first interval.

13. The method according to claim 12 wherein the methylphenidate released during said first interval only includes methylphenidate released from said coating.

14. The method according to claim 8 wherein said immediate release portion and said sustained release portion comprise methylphenidate hydrochloride.

15. The method according to claim 8 wherein said dosage form is a non-osmotic dosage form.

16. The method according to claim 8 wherein said dosage form is an osmotic dosage form.

17. The method according to claim 8 wherein the methylphenidate hydrochloride in said immediate release coating is released primarily during said first interval.

18. A method for treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising orally administering a dosage form to said subject, wherein said dosage form comprises:

an immediate release portion comprising methylphenidate or a pharmaceutically effective salt thereof; and

a sustained release portion comprising methylphenidate or a pharmaceutically effective salt thereof and a pharmaceutically acceptable carrier,

wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof from 2.5 hours following administration to 5.5 hours following administration.

19. The method according to claim 18 wherein said immediate release portion and said sustained release portion each comprise D-methylphenidate.

20. The method according to claim 18 wherein said immediate release portion and said sustained release portion each comprise methylphenidate hydrochloride.

21. The method according to claim 18 wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof from 1.5 to 5.5 hours following administration.

22. The method according to claim 18 wherein said dosage form provides a blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof that is greater at about 8 hours following administration than at 4 hours following administration.

23. The method according to claim 18 wherein said blood plasma at a time up to 4 hours following administration comprises said methylphenidate or pharmaceutically effective salt thereof from said immediate release portion.

24. The method according to claim 18 wherein said blood plasma at a time after 4 hours following administration does not comprise methylphenidate or pharmaceutically effective salt thereof from said immediate release portion.

25. The method according to claim 18 wherein said dosage form is a non-osmotic dosage form.

26. The method according to claim 18 wherein said dosage form is an osmotic dosage form.

27. The method according to claim 18 wherein the methylphenidate hydrochloride in said immediate release coating is released primarily during said first interval.

28. The method according to claim 18 wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof from 2.5 hours following administration to 6.5 hours following administration.

29. The method according to claim 18 wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof from 2.5 hours following administration to 8 hours following administration.

30. The method according to claim 18 wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof from 1.5 hours following administration to 8 hours following administration.

31. The method according to claim 18 wherein said dosage form provides a blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof that is greater at about 8 hours following administration than at 2.5 hours following administration.

32. A method for treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising orally administering a dosage form to said subject, wherein said dosage form comprises:

an immediate release portion comprising methylphenidate or a pharmaceutically effective salt thereof; and

a sustained release portion comprising methylphenidate or a pharmaceutically effective salt thereof and a pharmaceutically acceptable carrier,

wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof from 2.5 hours following administration to 5.5 hours following administration

and wherein;

said dosage form releases said methylphenidate over a period comprising at least a first and a second sequential time intervals, and

said sustained release portion releases more of said methylphenidate during said first interval than during said second interval.