Methods and devices for providing prolonged drug therapy

• US 8,163,798 B2
• Filed: 08/12/2003
• Issued: 04/24/2012
• Est. Priority Date: 11/12/1996
• Status: Expired due to Term

• 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:
  US10/639,355
• Publication Number:
  US 20050025832A1
• Time in Patent Office: 3,178 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. An oral tablet dosage form for the treatment of 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, 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.

2. The dosage form according to claim 1 wherein the methylphenidate released during said first interval only includes methylphenidate released from said immediate release portion.

3. The dosage form according to claim 1 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.

4. The dosage form according to claim 1 wherein said immediate release portion is applied as a coating on an outer surface of the dosage form.

5. The dosage form according to claim 1 wherein said immediate release portion and said sustained release portion comprise methylphenidate hydrochloride.

6. The dosage form according to claim 5 wherein said methylphenidate hydrochloride in said immediate release portion constitutes about 25% of said methylphenidate hydrochloride in said dosage form.

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

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

7. An oral tablet dosage form for the treatment of Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising:

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;

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;

the methylphenidate hydrochloride released during said first interval only includes methylphenidate hydrochloride released from said immediate release coating.

10. The dosage form according to claim 7 wherein said dosage form is osmotic.

11. The dosage form according to claim 7 wherein said dosage form is non-osmotic.