CA2198630A1 - Acetaminophen sustained-release formulation - Google Patents

Acetaminophen sustained-release formulation

Info

Publication number
CA2198630A1
CA2198630A1 CA002198630A CA2198630A CA2198630A1 CA 2198630 A1 CA2198630 A1 CA 2198630A1 CA 002198630 A CA002198630 A CA 002198630A CA 2198630 A CA2198630 A CA 2198630A CA 2198630 A1 CA2198630 A1 CA 2198630A1
Authority
CA
Canada
Prior art keywords
release
sustained
dosage form
particles
coated
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002198630A
Other languages
French (fr)
Other versions
CA2198630C (en
Inventor
Shirish A. Shah
Chris Y. Ho
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
L Perrigo Co
Original Assignee
L Perrigo Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by L Perrigo Co filed Critical L Perrigo Co
Publication of CA2198630A1 publication Critical patent/CA2198630A1/en
Application granted granted Critical
Publication of CA2198630C publication Critical patent/CA2198630C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids

Abstract

An orally administrable sustained-release dosage form includes particles of an active pharmaceutical ingredient which is coated with a polymeric material that is water-insoluble, but water-permeable and water-swellable, so that the sustained-release dosage form provides controlled release which is independent of certain variable physiological factors such as pH. In accordance with one aspect of the invention, the active pharmaceutical ingredient is acetaminophen and the coated acetaminophen particles are combined with uncoated acetaminophen particles to provide a combination immediate-release/sustained-release dosage form. In accordance with another aspect of the invention, the active pharmaceutical ingredient is coated with a methacrylate ester copolymer, and the coated particles are combined with uncoated particles of an active pharmaceutical ingredient to provide a combination immediate-release/sustained-release dosage form, wherein the sustained-release component provides a release rate which is substantially independent of physiological factors such as pH. The final orally administrable dosage form can appear as compressed tablets, capsules or pouches.
CA002198630A 1996-02-27 1997-02-26 Acetaminophen sustained-release formulation Expired - Lifetime CA2198630C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/608,839 1996-02-27
US08/608,839 US5773031A (en) 1996-02-27 1996-02-27 Acetaminophen sustained-release formulation

Publications (2)

Publication Number Publication Date
CA2198630A1 true CA2198630A1 (en) 1997-08-27
CA2198630C CA2198630C (en) 2006-01-10

Family

ID=24438247

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002198630A Expired - Lifetime CA2198630C (en) 1996-02-27 1997-02-26 Acetaminophen sustained-release formulation

Country Status (5)

Country Link
US (2) US5773031A (en)
JP (1) JPH1029936A (en)
CA (1) CA2198630C (en)
GB (1) GB2310601B (en)
MX (1) MX9701465A (en)

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MX9701465A (en) 1998-04-30
CA2198630C (en) 2006-01-10
US5773031A (en) 1998-06-30
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US6126969A (en) 2000-10-03
GB2310601B (en) 1999-12-22
GB9704069D0 (en) 1997-04-16

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