Delivery of multiple doses of medications

• US 7,431,944 B2
• Filed: 06/10/2003
• Issued: 10/07/2008
• Est. Priority Date: 12/04/1995
• Status: Expired due to Fees

• Current Assignee: Celgene Corporation (Bristol-Myers Squibb Company)
• Original Assignee: Celgene Corporation (Bristol-Myers Squibb Company)
• Inventors: Zeitlin, Andrew L., Dariani, Maghsoud M., Mehta, Atul M.
• Primary Examiner(s): Sheikh; Humera N.
• Application Number:
  US10/458,451
• Publication Number:
  US 20040091532A1
• Time in Patent Office: 1,946 Days
• Field of Search: 424/497, 424/458, 424/474, 424/468, 424/464, 424/490, 424/462, 424/494, 424/489, 424/480, 424/451
• US Class Current: 424/497
• 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 solid dosage form comprising d-threo methylphenidate or salt thereof providing a plasma concentration profile of said d-threo methylphenidate or salt thereof comprising two maxima temporally separated by from about two hours to about seven hours, said solid dosage form comprising:

(a) a first group of particles comprising from about 2% to about 99% by weight of d-threo methylphenidate or salt thereof; and

(b) a second group of particles comprising coated particles, said coated particles comprising from about 2% to about 75% by weight of d-threo methylphenidate or salt thereof in admixture with one or more binders and a coating comprising an ammonio methacrylate copolymer.

2. The solid dosage form of claim 1, wherein said solid dosage form is a tablet.

3. The solid dosage form of claim 1, wherein said solid dosage form is a capsule.

4. The solid dosage form of claim 1, wherein the d-threo methylphenidate or salt thereof is d-threo methylphenidate hydrochloride.

5. The solid dosage form of claim 1, wherein the first group of particles provides a substantially immediate dose of said d-threo methylphenidate upon ingestion by a mammal.

6. The solid dosage form of claim 1, wherein the magnitude of said plasma concentration profile maxima differ by no more than about 30%.