CA2306333A1 - Oral morphine multiparticulate formulation - Google Patents

Oral morphine multiparticulate formulation Download PDF

Info

Publication number
CA2306333A1
CA2306333A1 CA002306333A CA2306333A CA2306333A1 CA 2306333 A1 CA2306333 A1 CA 2306333A1 CA 002306333 A CA002306333 A CA 002306333A CA 2306333 A CA2306333 A CA 2306333A CA 2306333 A1 CA2306333 A1 CA 2306333A1
Authority
CA
Canada
Prior art keywords
morphine
multiparticulate formulation
patient
oral morphine
core
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
CA002306333A
Other languages
French (fr)
Other versions
CA2306333C (en
Inventor
Paul Stark
Sean Cunningham
Jagathesan Moodley
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.)
Alkermes Pharma Ireland Ltd
Original Assignee
Elan Corporation, Plc
Paul Stark
Sean Cunningham
Jagathesan Moodley
Elan Pharma International Limited
Edt Pharma Holdings Limited
Alkermes Pharma Ireland Limited
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26742378&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2306333(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Elan Corporation, Plc, Paul Stark, Sean Cunningham, Jagathesan Moodley, Elan Pharma International Limited, Edt Pharma Holdings Limited, Alkermes Pharma Ireland Limited filed Critical Elan Corporation, Plc
Priority to CA2558783A priority Critical patent/CA2558783C/en
Publication of CA2306333A1 publication Critical patent/CA2306333A1/en
Application granted granted Critical
Publication of CA2306333C publication Critical patent/CA2306333C/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
    • 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
    • A61K9/5084—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
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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 oral morphine multiparticulate formulation for once-daily administration to a patient, comprising sustained release particles each having a core containing water soluble morphine and an osmotic agent, the core being coated with a rate-controlling polymer coat comprised of ammonio methacrylate copolymers in an amount sufficient to achieve therapeutically effective plasma levels of morphine over at least 24 hours in the patient.
CA002306333A 1997-10-17 1997-12-05 Oral morphine multiparticulate formulation Expired - Lifetime CA2306333C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2558783A CA2558783C (en) 1997-10-17 1997-12-05 Oral morphine multiparticulate formulation

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US6252597P 1997-10-17 1997-10-17
US60/062,525 1997-10-17
US08/977,965 1997-11-25
US08/977,965 US6066339A (en) 1997-10-17 1997-11-25 Oral morphine multiparticulate formulation
PCT/IE1997/000082 WO1999020255A1 (en) 1997-10-17 1997-12-05 Oral morphine multiparticulate formulation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2558783A Division CA2558783C (en) 1997-10-17 1997-12-05 Oral morphine multiparticulate formulation

Publications (2)

Publication Number Publication Date
CA2306333A1 true CA2306333A1 (en) 1999-04-29
CA2306333C CA2306333C (en) 2006-10-10

Family

ID=26742378

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002306333A Expired - Lifetime CA2306333C (en) 1997-10-17 1997-12-05 Oral morphine multiparticulate formulation

Country Status (11)

Country Link
US (1) US6066339A (en)
EP (1) EP1023051B1 (en)
JP (1) JP4535613B2 (en)
AT (1) ATE239454T1 (en)
AU (1) AU5408098A (en)
CA (1) CA2306333C (en)
DE (1) DE69721845T2 (en)
DK (1) DK1023051T3 (en)
ES (1) ES2199378T3 (en)
PT (1) PT1023051E (en)
WO (1) WO1999020255A1 (en)

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Also Published As

Publication number Publication date
WO1999020255A1 (en) 1999-04-29
ATE239454T1 (en) 2003-05-15
JP2001520187A (en) 2001-10-30
EP1023051A1 (en) 2000-08-02
PT1023051E (en) 2003-09-30
CA2306333C (en) 2006-10-10
EP1023051B1 (en) 2003-05-07
DE69721845T2 (en) 2004-02-19
DE69721845D1 (en) 2003-06-12
DK1023051T3 (en) 2003-09-01
ES2199378T3 (en) 2004-02-16
AU5408098A (en) 1999-05-10
JP4535613B2 (en) 2010-09-01
US6066339A (en) 2000-05-23

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Effective date: 20171205