CA2530385C - Melt extruded controlled release oxycodone multiparticulates - Google Patents

Melt extruded controlled release oxycodone multiparticulates Download PDF

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Publication number
CA2530385C
CA2530385C CA2530385A CA2530385A CA2530385C CA 2530385 C CA2530385 C CA 2530385C CA 2530385 A CA2530385 A CA 2530385A CA 2530385 A CA2530385 A CA 2530385A CA 2530385 C CA2530385 C CA 2530385C
Authority
CA
Canada
Prior art keywords
oxycodone
multiparticulates
pharmaceutical composition
release
composition according
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 - Fee Related
Application number
CA2530385A
Other languages
English (en)
French (fr)
Other versions
CA2530385A1 (en
Inventor
Malcolm Walden
Geoffrey Gerard Hayes
Hassan Mohammad
Harjit Tamber
Steve Whitelock
Vincenzo Martinelli
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.)
Euro Celtique SA
Original Assignee
Euro Celtique SA
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=33556051&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2530385(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from GB0315137A external-priority patent/GB0315137D0/en
Priority claimed from GB0403102A external-priority patent/GB0403102D0/en
Priority claimed from GB0413454A external-priority patent/GB0413454D0/en
Application filed by Euro Celtique SA filed Critical Euro Celtique SA
Publication of CA2530385A1 publication Critical patent/CA2530385A1/en
Application granted granted Critical
Publication of CA2530385C publication Critical patent/CA2530385C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/385—Heterocyclic compounds having sulfur as a ring hetero atom having two or more sulfur atoms in the same ring
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Rheumatology (AREA)
  • Emergency Medicine (AREA)
  • Neurology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Processes Of Treating Macromolecular Substances (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
CA2530385A 2003-06-27 2004-06-23 Melt extruded controlled release oxycodone multiparticulates Expired - Fee Related CA2530385C (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
GB0315137.0 2003-06-27
GB0315137A GB0315137D0 (en) 2003-06-27 2003-06-27 Multiparticulates
GB0403102A GB0403102D0 (en) 2004-02-12 2004-02-12 Multiparticulates
GB0403102.7 2004-02-12
GB0413454.0 2004-06-16
GB0413454A GB0413454D0 (en) 2004-06-16 2004-06-16 Multiparticulates
PCT/GB2004/002705 WO2005000310A1 (en) 2003-06-27 2004-06-23 Multiparticulates

Publications (2)

Publication Number Publication Date
CA2530385A1 CA2530385A1 (en) 2005-01-06
CA2530385C true CA2530385C (en) 2013-05-28

Family

ID=33556051

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2530385A Expired - Fee Related CA2530385C (en) 2003-06-27 2004-06-23 Melt extruded controlled release oxycodone multiparticulates

Country Status (25)

Country Link
EP (2) EP1644002B1 (enExample)
JP (2) JP5348841B2 (enExample)
KR (1) KR101116518B1 (enExample)
AR (1) AR044935A1 (enExample)
AT (1) ATE453394T1 (enExample)
AU (1) AU2004251481B2 (enExample)
BR (1) BRPI0411901B1 (enExample)
CA (1) CA2530385C (enExample)
CY (2) CY1109917T1 (enExample)
DE (1) DE602004024888D1 (enExample)
DK (2) DK1889621T3 (enExample)
EA (1) EA013424B1 (enExample)
ES (2) ES2337468T3 (enExample)
HR (2) HRP20100127T1 (enExample)
IL (1) IL172730A (enExample)
MX (1) MXPA05013799A (enExample)
MY (1) MY176831A (enExample)
NO (1) NO20060443L (enExample)
NZ (1) NZ544181A (enExample)
PE (1) PE20050286A1 (enExample)
PL (2) PL1644002T3 (enExample)
PT (2) PT1644002E (enExample)
SI (2) SI1889621T1 (enExample)
TW (1) TWI357815B (enExample)
WO (1) WO2005000310A1 (enExample)

Families Citing this family (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6375957B1 (en) 1997-12-22 2002-04-23 Euro-Celtique, S.A. Opioid agonist/opioid antagonist/acetaminophen combinations
TR200001942T2 (tr) 1997-12-22 2000-11-21 Euro-Celtique, S.A. Opioid agonist/antagonist kombinasyonlar
EP1387673B1 (en) 2001-05-11 2010-12-29 Endo Pharmaceuticals Inc. Abuse-resistant controlled-release opioid dosage form
WO2003024429A1 (en) 2001-09-21 2003-03-27 Egalet A/S Polymer release system
US20040253310A1 (en) 2001-09-21 2004-12-16 Gina Fischer Morphine polymer release system
LT2425821T (lt) 2002-04-05 2017-07-25 Euro-Celtique S.A. Farmacinis preparatas, turintis oksikodono ir naloksono
US8877241B2 (en) 2003-03-26 2014-11-04 Egalet Ltd. Morphine controlled release system
TWI357815B (en) * 2003-06-27 2012-02-11 Euro Celtique Sa Multiparticulates
GB0403098D0 (en) 2004-02-12 2004-03-17 Euro Celtique Sa Extrusion
TWI350762B (en) * 2004-02-12 2011-10-21 Euro Celtique Sa Particulates
GB0501638D0 (en) * 2005-01-28 2005-03-02 Euro Celtique Sa Particulates
EP1604666A1 (en) 2004-06-08 2005-12-14 Euro-Celtique S.A. Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD)
GB2418854B (en) * 2004-08-31 2009-12-23 Euro Celtique Sa Multiparticulates
EP1702558A1 (en) 2005-02-28 2006-09-20 Euro-Celtique S.A. Method and device for the assessment of bowel function
US8852638B2 (en) 2005-09-30 2014-10-07 Durect Corporation Sustained release small molecule drug formulation
RU2433817C2 (ru) * 2006-01-21 2011-11-20 Эбботт Гмбх Унд Ко.Кг Лекарственная форма и способ для доставки вызывающих зависимость лекарственных веществ
SA07280459B1 (ar) 2006-08-25 2011-07-20 بيورديو فارما إل. بي. أشكال جرعة صيدلانية للتناول عن طريق الفم مقاومة للعبث تشتمل على مسكن شبه أفيوني
CA2678367C (en) * 2007-03-02 2014-07-08 Farnam Companies, Inc. Sustained release compositions using wax-like materials
EP2152315B1 (en) 2007-05-25 2016-01-06 Indivior UK Limited Sustained delivery formulations of risperidone compounds
US8821928B2 (en) 2007-06-04 2014-09-02 Egalet Ltd. Controlled release pharmaceutical compositions for prolonged effect
JP4879351B2 (ja) 2007-10-19 2012-02-22 大塚製薬株式会社 医薬固形製剤
JP2011511782A (ja) 2008-02-12 2011-04-14 アボット・ラボラトリーズ 長期放出性ヒドロコドンアセトアミノフェンならびにその関連方法および用途
CN102159193B (zh) * 2008-09-18 2015-09-16 普渡制药公司 包含聚(ε-己内酯)的药物剂型
NZ594207A (en) 2009-02-06 2013-03-28 Egalet Ltd Immediate release composition resistant to abuse by intake of alcohol
PL2405915T3 (pl) 2009-03-10 2019-05-31 Euro Celtique Sa Kompozycje farmaceutyczne o natychmiastowym uwalnianiu zawierające oksykodon i nalokson
AU2010265213B2 (en) 2009-06-24 2012-08-23 Egalet Ltd. Controlled release formulations
WO2011099984A1 (en) * 2010-02-11 2011-08-18 Harry Leider Methods of normalizing measured drug concentrations and testing for non-compliance with a drug treatment regimen
US9272044B2 (en) 2010-06-08 2016-03-01 Indivior Uk Limited Injectable flowable composition buprenorphine
GB2513060B (en) 2010-06-08 2015-01-07 Rb Pharmaceuticals Ltd Microparticle buprenorphine suspension
JP2015521988A (ja) 2012-07-06 2015-08-03 イガレット・リミテッド 制御放出用乱用防止性医薬組成物
KR20160034352A (ko) 2013-07-23 2016-03-29 유로-셀티큐 에스.에이. 장내 세균총이상을 초래하고/하거나 장내 박테리아 전위에 대한 위험을 증가시키는 질환과 통증으로 인해 고통받고 있는 환자에서 통증을 치료하는데 사용하기 위한 옥시코돈과 날록손의 조합물
CA3042642A1 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
WO2015095391A1 (en) 2013-12-17 2015-06-25 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
GB201404139D0 (en) 2014-03-10 2014-04-23 Rb Pharmaceuticals Ltd Sustained release buprenorphine solution formulations
DK3169315T3 (da) 2014-07-17 2020-08-10 Pharmaceutical Manufacturing Res Services In Væskefyldt doseringsform til forhindring af misbrug med øjeblikkelig frigivelse
US9132096B1 (en) 2014-09-12 2015-09-15 Alkermes Pharma Ireland Limited Abuse resistant pharmaceutical compositions
AU2015336065A1 (en) 2014-10-20 2017-05-04 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4861598A (en) * 1986-07-18 1989-08-29 Euroceltique, S.A. Controlled release bases for pharmaceuticals
JPH11508224A (ja) * 1990-08-09 1999-07-21 エンドコン・インコーポレーテッド 多重ドラッグデリバリーシステム
US5266331A (en) * 1991-11-27 1993-11-30 Euroceltique, S.A. Controlled release oxycodone compositions
US5286493A (en) * 1992-01-27 1994-02-15 Euroceltique, S.A. Stabilized controlled release formulations having acrylic polymer coating
DE69530973T2 (de) * 1994-02-16 2004-05-19 Abbott Laboratories, Abbott Park Verfahren zur herstellung feinteiliger pharmazeutischer formulierungen
US5965161A (en) * 1994-11-04 1999-10-12 Euro-Celtique, S.A. Extruded multi-particulates
WO1996034634A1 (en) * 1995-05-01 1996-11-07 Sam Yang Co. Ltd. Implantable bioresorbable membrane and method for the preparation thereof
SE505146C2 (sv) * 1995-10-19 1997-06-30 Biogram Ab Partiklar för fördröjd frisättning
WO1997045091A2 (en) * 1996-05-31 1997-12-04 Euro-Celtique, S.A. Sustained release oxycodone formulations with no fed/fast effect
US6022554A (en) * 1997-12-15 2000-02-08 American Home Products Corporation Polymeric microporous film coated subcutaneous implant
IT1304152B1 (it) * 1998-12-10 2001-03-08 Mediolanum Farmaceutici Srl Composizioni comprendenti un peptide ed acido polilattico-glicolicoatte alla preparazione di impianti sottocutanei aventi un prolungato
FR2795326B1 (fr) * 1999-06-28 2001-08-31 Adir Composition pharmaceutique solide thermoformable a liberation controlee
EP2295043A1 (en) * 1999-10-29 2011-03-16 Euro-Celtique S.A. Controlled release hydrocodone formulations
SI2283842T1 (sl) * 2000-02-08 2015-07-31 Euro-Celtique S.A. Oralne formulacije opioidnih agonistov, varne pred zlorabo
FR2818552B1 (fr) * 2000-12-26 2003-02-07 Servier Lab Compositions pharmaceutique solide thermoformable pour la liberation controlee d'ivabradine
BR0309844A (pt) * 2002-05-07 2005-02-15 Control Delivery Sys Inc Processos para formação de um dispositivo para a distribuição de droga
BRPI0406858A (pt) * 2003-01-24 2006-01-03 Control Delivery Sys Inc Liberação controlada de agentes altamente solúveis
TWI357815B (en) * 2003-06-27 2012-02-11 Euro Celtique Sa Multiparticulates

Also Published As

Publication number Publication date
HRP20140635T1 (hr) 2014-09-26
SI1889621T1 (sl) 2014-09-30
TWI357815B (en) 2012-02-11
JP5348841B2 (ja) 2013-11-20
JP5960089B2 (ja) 2016-08-02
PE20050286A1 (es) 2005-06-13
WO2005000310A1 (en) 2005-01-06
MXPA05013799A (es) 2006-03-13
BRPI0411901A (pt) 2006-08-08
EP1644002A1 (en) 2006-04-12
JP2007520429A (ja) 2007-07-26
IL172730A0 (en) 2006-04-10
PT1644002E (pt) 2010-03-03
NZ544181A (en) 2008-12-24
DK1889621T3 (da) 2014-08-11
MY176831A (en) 2020-08-24
AU2004251481A1 (en) 2005-01-06
NO333779B1 (enExample) 2013-09-16
ATE453394T1 (de) 2010-01-15
PL1644002T3 (pl) 2010-05-31
TW200510000A (en) 2005-03-16
PL1889621T3 (pl) 2014-10-31
IL172730A (en) 2010-12-30
CY1109917T1 (el) 2014-09-10
DE602004024888D1 (de) 2010-02-11
EP1889621A1 (en) 2008-02-20
ES2337468T3 (es) 2010-04-26
EP1889621B1 (en) 2014-05-21
SI1644002T1 (sl) 2010-03-31
DK1644002T3 (da) 2010-04-19
BRPI0411901B1 (pt) 2019-04-02
KR101116518B1 (ko) 2012-03-13
PT1889621E (pt) 2014-08-27
CY1115415T1 (el) 2017-01-04
CA2530385A1 (en) 2005-01-06
EA200600111A1 (ru) 2006-06-30
NO20060443L (no) 2006-01-27
JP2013209387A (ja) 2013-10-10
KR20060026892A (ko) 2006-03-24
EP1644002B1 (en) 2009-12-30
ES2490598T3 (es) 2014-09-04
AU2004251481B2 (en) 2010-01-28
HRP20100127T1 (hr) 2010-04-30
AR044935A1 (es) 2005-10-12
EA013424B1 (ru) 2010-04-30

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