Methods and devices for providing prolonged drug therapy

• US 8,629,179 B2
• Filed: 10/19/2009
• Issued: 01/14/2014
• 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:
  US12/581,699
• Publication Number:
  US 20100093796A1
• Time in Patent Office: 1,548 Days
• Field of Search: 514/532
• US Class Current: 514/532
• 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 tablet oral dosage form for effectively treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising:

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, third, fourth, fifth, and sixth sequential one-hour time intervals, and

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

2. The dosage form according to claim 1 wherein said dosage form releases said methylphenidate over a period comprising first, second, third, fourth, fifth, sixth, seventh, and eighth sequential one-hour time intervals,

and said sustained release portion releases more of said methylphenidate during said eighth interval than during said seventh interval.

3. The dosage form according to claim 1 wherein said sustained release portion releases more of said methylphenidate during said fifth interval than during said fourth interval.

4. The dosage form according to claim 1 wherein said sustained release portion releases more of said methylphenidate during said sixth interval than during said fifth interval.

5. The dosage form according to claim 4 wherein said sustained release portion releases less of said methylphenidate during a seventh one-hour time interval than during said sixth interval.

6. The dosage form according to claim 1 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.

7. The dosage form according to claim 1 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.

8. The dosage form according to claim 1 wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof up to about 5.5 hours following administration.

9. The dosage form according to claim 1 wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof up to about 6.5 hours following administration.

10. The dosage form according to claim 1 wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof up to about 8 hours following administration.

11. The dosage form according to claim 1 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.

12. The dosage form according to claim 1 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.

13. The dosage form according to claim 1 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.

14. The dosage form according to claim 1 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.

15. The dosage form according to claim 1 wherein said sustained release portion comprises methylphenidate hydrochloride.

16. The dosage form according to claim 1 wherein said dosage form is non-osmotic.

17. The dosage form according to claim 1 wherein said dosage form is osmotic.

18. The dosage form according to claim 1 wherein the methylphenidate hydrochloride in said immediate release coating is released primarily during said first interval.