Methods and devices for providing prolonged drug therapy

• US 9,000,038 B2
• Filed: 03/13/2013
• Issued: 04/07/2015
• Est. Priority Date: 11/12/1996
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Lam, Andrew C., Shivanand, Padmaja, Ayer, Atul D, Hatamkhany, Zahedeh, Weyers, Richard G, Gupta, Suneel K., Guinta, Diane R, Christopher, Carol A., Saks, Samuel R., Hamel, Lawrence G., Wright, Jeri D.
• Primary Examiner(s): FAY, ZOHREH A
• Application Number:
  US13/800,869
• Publication Number:
  US 20130209562A1
• Time in Patent Office: 755 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 method for treating Attention-Deficit Hyperactivity Disorder in a subject comprising:

administering to said subject an osmotic dosage form comprising

a capsule-shaped longitudinally compressed tablet core containing a plurality of layers wherein drug is contained in at least one layer and at least one other layer comprises a suitable fluid-expandable polymer, wherein said drug comprises methylphenidate hydrochloride;

a semipermeable wall that surrounds said longitudinally compressed tablet core to form a compartment that has an osmotic gradient that drives fluid from an external fluid environment contacting said semipermeable wall into said compartment; and

an orifice that is formed through said semipermeable wall at a location adjacent to the first layer that permits drug to be released from the compartment into said external fluid environment,

wherein the dosage form releases the drug over a period comprising a first, second, and third sequential time intervals of equal duration, and

wherein the dosage form releases more of said drug during said second interval than during said first interval and more of said drug during said third interval than during said second interval.

2. The method according to claim 1 wherein said period of release comprises a fourth sequential time interval, and wherein the dosage form releases more of said drug during said fourth interval than during said third interval.

3. The method according to claim 1 further comprising an outer surface and an immediate-release dosage of the drug applied as a coating onto the outer surface.

4. The method according to claim 3 wherein the dosage form releases more of said drug during said second interval than during said first interval, not including drug released from said coating during said first interval.

5. The method according to claim 4 wherein each of said time intervals is 30 minutes.

6. The method according to claim 4 wherein each of said time intervals is 1 hour.

7. The method according to claim 5 wherein the drug released during said first interval does not include any drug released from said first layer of said dosage form.

8. The method according to claim 6 wherein the drug released during said first interval does not include any drug released from said first layer of said dosage form.

9. The method according to claim 1 wherein said dosage form is administered orally.

10. The method according to claim 1 wherein said dosage form is administered one time per day for multiple days.

11. The method according to claim 1 wherein said dosage form is administered to a non-adult subject.

12. The method according to claim 1 wherein said dosage form further comprises a third layer comprising an additional portion of said drug, wherein said third layer is disposed between said other drug containing layer and said fluid-expandable polymer layer.