Delivery of multiple doses of medications

• US 20040091532A1
• Filed: 06/10/2003
• Published: 05/13/2004
• Est. Priority Date: 12/04/1995
• Status: Active Grant

• Current Assignee: Andrew L. Zeitlin, Atul M. Mehta, Maghsoud M. Dariani
• Original Assignee: Andrew L. Zeitlin, Atul M. Mehta, Maghsoud M. Dariani
• Inventors: Zeitlin, Andrew L., Dariani, Maghsoud M., Mehta, Atul M.
• Granted Patent: US 7,431,944 B2
• Time in Patent Office: Days
• US Class Current: 424/469
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 9/1676 having a drug-free core with discrete complete coating layer containing drug adsorbates of liquid drug formulations on inert powders without simultaneous granulation step A61K9/141; with further drug-free outer coating A61K9/5078; drug conjugated to non-active particles A61K47/6921
• CPC Class Codes: A61K 9/2081 with microcapsules or coated microparticles according to A61K9/50
• CPC Class Codes: A61K 9/2886 having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer of the type active core-drug layer-inactive layer A61K9/209
• CPC Class Codes: A61K 9/5026 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/5047 Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5078 with drug-free core
• 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: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 25/14 for treating abnormal movements, e.g. chorea, dyskinesia
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: C07D 211/34 with hydrocarbon radicals, substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
• CPC Class Codes: C12P 17/12 containing a six-membered hetero ring
• CPC Class Codes: C12P 41/006 by reactions involving C-N bonds, e.g. nitriles, amides, hydantoins, carbamates, lactames, transamination reactions, or keto group formation from racemic mixtures

Abstract

Dosage forms for oral administration of a methylphenidate drug are provided. The dosage forms provide a substantially immediate dose of methylphenidate upon ingestion, followed by one or more additional doses at predetermined times. By providing such a drug release profile, the dosage forms eliminate the need for a patient to carry an additional dose for ingestion during the day. The dosage forms and methods provided are useful in administering methylphenidate and pharmaceutically acceptable salts thereof, which generally require one or more doses throughout the day.

Claims

1. A method for treating disease in a patient in need of treatment comprising administering to the patient a dosage form providing once-daily oral administration of d-threo-methylphenidate hydrochloride, said dosage form comprising two groups of particles, each containing d-threo-methylphenidate, wherein:

a) said first group of particles comprises from about 2% to about 99% by weight of d-threo-methylphenidate hydrochloride and provides a substantially immediate dose of said d-threo methylphenidate upon ingestion by a mammal; and

b) said second group of particles comprises coated particles, said coated particles comprising from about 2% to about 75% by weight of d-threo-methylphenidate in admixture with one or more binders, and a coating consisting of an ammonio methacrylate copolymer in an amount sufficient to provide a dose of said d-threo-methylphenidate hydrochloride delayed by from about 4 hours to about 7 hours following said ingestion.

2. A dosage form of a pharmaceutically acceptable salt of a methylphenidate providing an in vitro release profile comprising two pulses of drug release, wherein said pulses are temporally separated by from about two hours to about seven hours.

3. A dosage form of a pharmaceutically acceptable salt of a methylphenidate providing a in vitro plasma concentration of said methylphenidate comprising two maxima, wherein said maxima are temporally separated by from about two hours to about seven hours and wherein the magnitude of said maxima differ by no more than about 30%.