Methods and devices for providing prolonged drug therapy

• US 6,919,373 B1
• Filed: 02/19/1999
• Issued: 07/19/2005
• Est. Priority Date: 11/12/1996
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Ayer, Atul D., Gupta, Suneel K., Saks, Samuel R., Guinta, Diane R., Hamel, Lawrence G., Christopher, Carol A., Lam, Andrew C., Shivanand, Padmaja, Hatamkhany, Zahedeh, Wright, Jeri D., Weyers, Richard G.
• Primary Examiner(s): FAY, ZOHREH A
• Application Number:
  US09/253,317
• Time in Patent Office: 2,342 Days
• Field of Search: 514/532, 514/252
• 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 ADD or ADHD comprising administering a dosage form comprising methylphenidate that provides a release of methylphenidate at an ascending release rate over an extended period of time.

2. The method of claim 1 wherein said administration results in a substantially ascending methylphenidate plasma drug concentration over a time period of about 4 hours following said administration.

3. The method of claim 1 wherein said administration results in a substantially ascending methylphenidate plasma drug concentration over a time period of about 4 to about 5.5 hours following said administration.

4. The method of claim 1 wherein said administration results in a substantially ascending methylphenidate plasma drug concentration over a time period of about 4 to about 8 hours following said administration.

5. The method of claim 1 wherein said administration results in a substantially ascending methylphenidate plasma drug concentration over a time period of about 4 to about 9.5 hours following said administration.

6. The method of claim 1 wherein said administration results in a substantially ascending methylphenidate plasma drug concentration over a time period of about 5.5 hours following said administration.

7. The method of claim 1 wherein said administration results in a substantially ascending methylphenidate plasma drug concentration over a time period of about 8 hours following said administration.

8. The method of claim 1 wherein said administration results in a substantially ascending methylphenidate plasma drug concentration over a time period of about 9.5 hours following said administration.