# US 9,000,038 B2 · Methods and devices for providing prolonged drug therapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,000,038 B2 - Document ID: US9000038B2 - Status: Granted - Kind: B2 - Application number: 13/800,869 - Filed: 2013-03-13 - Published: 2013-08-15 - Granted: 2015-04-07 - Earliest claimed: 1996-11-12 - Assignees: Alza Corporation - Applicants: ALZA Corporation - Inventors: Andrew C. Lam; Padmaja Shivanand; Atul D Ayer; Zahedeh Hatamkhany; Richard G Weyers; Suneel K. Gupta; Diane R Guinta; Carol A. Christopher; Samuel R. Saks; Lawrence G. Hamel; Jeri D. Wright - Web page: https://patentgrep.com/patent/US9000038B2 ## CPC - 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)} - A61K 9/0002: {Galenical forms characterised by the drug release technique; Application systems commanded by energy} - A61K 9/0004: {Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas} - 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)} - A61K 9/209: {containing drug in at least two layers or in the core and in at least one outer layer} - 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)} - A61K 9/70: Web, sheet or filament bases {; Films; Fibres of the matrix type containing drug (hollow drug-filled fibres A61K9/0092)} - A61K 31/00: Medicinal preparations containing organic active ingredients - A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} - A61K 31/421: 1,3-Oxazoles, e.g. pemoline, trimethadione - A61K 31/4422: 1,4-Dihydropyridines, e.g. nifedipine, nicardipine - A61K 31/4458: only substituted in position 2, e.g. methylphenidate - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## 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 ### Claim 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. ### Claim 2 (depends on 1) 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. ### Claim 3 (depends on 1) 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. ### Claim 4 (depends on 3) 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. ### Claim 5 (depends on 4) The method according to claim 4 wherein each of said time intervals is 30 minutes. ### Claim 6 (depends on 4) The method according to claim 4 wherein each of said time intervals is 1 hour. ### Claim 7 (depends on 5) 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. ### Claim 8 (depends on 6) 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. ### Claim 9 (depends on 1) The method according to claim 1 wherein said dosage form is administered orally. ### Claim 10 (depends on 1) The method according to claim 1 wherein said dosage form is administered one time per day for multiple days. ### Claim 11 (depends on 1) The method according to claim 1 wherein said dosage form is administered to a non-adult subject. ### Claim 12 (depends on 1) 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.