CA2446738C - Abuse-resistant opioid dosage form - Google Patents

Abuse-resistant opioid dosage form Download PDF

Info

Publication number
CA2446738C
CA2446738C CA2446738A CA2446738A CA2446738C CA 2446738 C CA2446738 C CA 2446738C CA 2446738 A CA2446738 A CA 2446738A CA 2446738 A CA2446738 A CA 2446738A CA 2446738 C CA2446738 C CA 2446738C
Authority
CA
Canada
Prior art keywords
opioid
antagonist
tablet
release
matrix
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.)
Expired - Lifetime
Application number
CA2446738A
Other languages
English (en)
French (fr)
Other versions
CA2446738A1 (en
Inventor
Huai-Hung Kao
Yadi Zeng
Michelle Howard-Sparks
Fai Jim
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.)
Endo Pharmaceuticals Inc
Original Assignee
Endo Pharmaceuticals Inc
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 Endo Pharmaceuticals Inc filed Critical Endo Pharmaceuticals Inc
Priority to CA2778114A priority Critical patent/CA2778114A1/en
Publication of CA2446738A1 publication Critical patent/CA2446738A1/en
Application granted granted Critical
Publication of CA2446738C publication Critical patent/CA2446738C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36Opioid-abuse
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Addiction (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Investigating Or Analyzing Materials By The Use Of Fluid Adsorption Or Reactions (AREA)
  • Air Bags (AREA)
CA2446738A 2001-05-11 2002-05-10 Abuse-resistant opioid dosage form Expired - Lifetime CA2446738C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2778114A CA2778114A1 (en) 2001-05-11 2002-05-10 Abuse-resistant opioid dosage form

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US29043801P 2001-05-11 2001-05-11
US60/290,438 2001-05-11
PCT/US2002/015021 WO2002092059A1 (en) 2001-05-11 2002-05-10 Abuse-resistant opioid dosage form

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2778114A Division CA2778114A1 (en) 2001-05-11 2002-05-10 Abuse-resistant opioid dosage form

Publications (2)

Publication Number Publication Date
CA2446738A1 CA2446738A1 (en) 2002-11-21
CA2446738C true CA2446738C (en) 2012-05-29

Family

ID=23115998

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2778114A Abandoned CA2778114A1 (en) 2001-05-11 2002-05-10 Abuse-resistant opioid dosage form
CA2446738A Expired - Lifetime CA2446738C (en) 2001-05-11 2002-05-10 Abuse-resistant opioid dosage form

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2778114A Abandoned CA2778114A1 (en) 2001-05-11 2002-05-10 Abuse-resistant opioid dosage form

Country Status (10)

Country Link
US (6) US20030004177A1 (enExample)
EP (1) EP1389092B1 (enExample)
JP (3) JP2005515960A (enExample)
CN (2) CN101439024A (enExample)
AT (1) ATE345112T1 (enExample)
AU (1) AU2002303718B2 (enExample)
CA (2) CA2778114A1 (enExample)
DE (1) DE60216078T2 (enExample)
ES (1) ES2275868T3 (enExample)
WO (1) WO2002092059A1 (enExample)

Families Citing this family (134)

* Cited by examiner, † Cited by third party
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CA2446738A1 (en) 2002-11-21
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DE60216078T2 (de) 2007-07-05
ATE345112T1 (de) 2006-12-15
CA2778114A1 (en) 2002-11-21
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