BRPI0411901B1 - Multiparticulados extrudados de material fundido de liberação controlada, seu processo de preparação e composição farmacêutica na forma de dose unitária - Google Patents

Multiparticulados extrudados de material fundido de liberação controlada, seu processo de preparação e composição farmacêutica na forma de dose unitária Download PDF

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Publication number
BRPI0411901B1
BRPI0411901B1 BRPI0411901-0A BRPI0411901A BRPI0411901B1 BR PI0411901 B1 BRPI0411901 B1 BR PI0411901B1 BR PI0411901 A BRPI0411901 A BR PI0411901A BR PI0411901 B1 BRPI0411901 B1 BR PI0411901B1
Authority
BR
Brazil
Prior art keywords
oxycodone
multiparticulates
fact
ingredients
weight
Prior art date
Application number
BRPI0411901-0A
Other languages
English (en)
Portuguese (pt)
Inventor
Malcolm Walden
Geoffrey Gerard Hayes
Hassan Mohammad
Harjit Tamber
Steve Whitelock
Vincenzo Martinelli
Original Assignee
Euro-Celtique S.A
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=BRPI0411901(B1) "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 S.A filed Critical Euro-Celtique S.A
Publication of BRPI0411901A publication Critical patent/BRPI0411901A/pt
Publication of BRPI0411901B1 publication Critical patent/BRPI0411901B1/pt

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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pain & Pain Management (AREA)
  • Organic Chemistry (AREA)
  • Rheumatology (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Neurosurgery (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)
  • Manufacturing Of Micro-Capsules (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
BRPI0411901-0A 2003-06-27 2004-06-23 Multiparticulados extrudados de material fundido de liberação controlada, seu processo de preparação e composição farmacêutica na forma de dose unitária BRPI0411901B1 (pt)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
GB0315137A GB0315137D0 (en) 2003-06-27 2003-06-27 Multiparticulates
GB0315137.0 2003-06-27
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
BRPI0411901A BRPI0411901A (pt) 2006-08-08
BRPI0411901B1 true BRPI0411901B1 (pt) 2019-04-02

Family

ID=33556051

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0411901-0A BRPI0411901B1 (pt) 2003-06-27 2004-06-23 Multiparticulados extrudados de material fundido de liberação controlada, seu processo de preparação e composição farmacêutica na forma de dose unitária

Country Status (25)

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

Families Citing this family (38)

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US6375957B1 (en) 1997-12-22 2002-04-23 Euro-Celtique, S.A. Opioid agonist/opioid antagonist/acetaminophen combinations
EP1041987B1 (en) 1997-12-22 2006-04-19 Euro-Celtique S.A. Pharmaceutical oral dosage form comprising a combination of an opioid agonist and naltrexone
EP1387673B1 (en) 2001-05-11 2010-12-29 Endo Pharmaceuticals Inc. Abuse-resistant controlled-release opioid dosage form
EP1429744A1 (en) 2001-09-21 2004-06-23 Egalet A/S Morphine polymer release system
US20040234602A1 (en) 2001-09-21 2004-11-25 Gina Fischer Polymer release system
HUE032656T2 (en) 2002-04-05 2017-10-30 Euro Celtique Sa Pharmaceutical composition containing oxicodone and naloxone
WO2004084868A1 (en) 2003-03-26 2004-10-07 Egalet A/S 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
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
GEP20105052B (en) * 2005-01-28 2010-07-26 Euro Celtique Sa Alcohol resistant dosage forms
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
EP1991207A2 (en) * 2006-01-21 2008-11-19 Abbott GmbH & Co. KG Dosage form and method for the delivery of drugs of abuse
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
RU2465916C2 (ru) * 2007-10-19 2012-11-10 Оцука Фармасьютикал Ко., Лтд. Твердый фармацевтический препарат матричного типа
US9226907B2 (en) 2008-02-01 2016-01-05 Abbvie Inc. Extended release hydrocodone acetaminophen and related methods and uses thereof
BRPI0913724B8 (pt) * 2008-09-18 2021-05-25 Purdue Pharma Lp formas farmacêuticas de liberação prolongada compreendendo naltrexona e poli (e-caprolactona) e seu preparo
CA2751667C (en) 2009-02-06 2016-12-13 Egalet Ltd. Immediate release composition resistant to abuse by intake of alcohol
SG174286A1 (en) 2009-03-10 2011-10-28 Euro Celtique Sa Immediate release pharmaceutical compositions comprising oxycodone and naloxone
NZ597283A (en) 2009-06-24 2013-07-26 Egalet Ltd Controlled release formulations
JP2013519877A (ja) * 2010-02-11 2013-05-30 ハリー ライダー， 測定された薬物濃度の正規化方法、及び薬物治療レジメンのノンコンプライアンスを検査するための方法
GB2481017B (en) 2010-06-08 2015-01-07 Rb Pharmaceuticals Ltd Microparticle buprenorphine suspension
US9272044B2 (en) 2010-06-08 2016-03-01 Indivior Uk Limited Injectable flowable composition buprenorphine
AU2013285988A1 (en) 2012-07-06 2015-02-12 Egalet Ltd. Abuse deterrent pharmaceutical compositions for controlled release
JP2016525138A (ja) 2013-07-23 2016-08-22 ユーロ−セルティーク エス．エイ． 疼痛および腸内ディスバイオシスをもたらす疾患および／または腸内細菌移行に対するリスクを高める疾患に罹患している患者における痛みの治療への使用のためのオキシコドンおよびナロキソンの組み合わせ
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
US10172797B2 (en) 2013-12-17 2019-01-08 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
CA2955229C (en) 2014-07-17 2020-03-10 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
US9132096B1 (en) 2014-09-12 2015-09-15 Alkermes Pharma Ireland Limited Abuse resistant pharmaceutical compositions
WO2016064873A1 (en) 2014-10-20 2016-04-28 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form

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AU660290B2 (en) * 1990-08-09 1995-06-22 Endocon, Inc. Multiple drug delivery system
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
CA2219995C (en) * 1995-05-01 2004-04-13 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
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EP2092936B1 (en) * 2000-02-08 2013-03-20 Euro-Celtique S.A. Tamper-resistant oral opioid agonist formulations
FR2818552B1 (fr) * 2000-12-26 2003-02-07 Servier Lab Compositions pharmaceutique solide thermoformable pour la liberation controlee d'ivabradine
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CN1741792A (zh) * 2003-01-24 2006-03-01 控制递送系统有限公司 经眼部递送肾上腺素能剂的持续释放系统和方法
TWI357815B (en) * 2003-06-27 2012-02-11 Euro Celtique Sa Multiparticulates

Also Published As

Publication number Publication date
MY176831A (en) 2020-08-24
TW200510000A (en) 2005-03-16
KR101116518B1 (ko) 2012-03-13
ES2490598T3 (es) 2014-09-04
KR20060026892A (ko) 2006-03-24
IL172730A (en) 2010-12-30
JP5348841B2 (ja) 2013-11-20
CY1109917T1 (el) 2014-09-10
PL1644002T3 (pl) 2010-05-31
EA013424B1 (ru) 2010-04-30
CA2530385C (en) 2013-05-28
JP2013209387A (ja) 2013-10-10
JP2007520429A (ja) 2007-07-26
MXPA05013799A (es) 2006-03-13
PL1889621T3 (pl) 2014-10-31
NZ544181A (en) 2008-12-24
TWI357815B (en) 2012-02-11
AR044935A1 (es) 2005-10-12
WO2005000310A1 (en) 2005-01-06
CA2530385A1 (en) 2005-01-06
ATE453394T1 (de) 2010-01-15
EP1644002A1 (en) 2006-04-12
HRP20140635T1 (hr) 2014-09-26
DK1889621T3 (da) 2014-08-11
JP5960089B2 (ja) 2016-08-02
BRPI0411901A (pt) 2006-08-08
PE20050286A1 (es) 2005-06-13
DK1644002T3 (da) 2010-04-19
SI1644002T1 (sl) 2010-03-31
PT1644002E (pt) 2010-03-03
EP1644002B1 (en) 2009-12-30
NO333779B1 (https=) 2013-09-16
IL172730A0 (en) 2006-04-10
ES2337468T3 (es) 2010-04-26
PT1889621E (pt) 2014-08-27
EP1889621A1 (en) 2008-02-20
EP1889621B1 (en) 2014-05-21
EA200600111A1 (ru) 2006-06-30
AU2004251481A1 (en) 2005-01-06
HRP20100127T1 (hr) 2010-04-30
NO20060443L (no) 2006-01-27
AU2004251481B2 (en) 2010-01-28
SI1889621T1 (sl) 2014-09-30
DE602004024888D1 (de) 2010-02-11
CY1115415T1 (el) 2017-01-04

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B07B Technical examination (opinion): publication cancelled [chapter 7.2 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]
B12B Appeal against refusal [chapter 12.2 patent gazette]
B25G Requested change of headquarter approved

Owner name: EURO-CELTIQUE S.A (LU)

B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 02/04/2019, OBSERVADAS AS CONDICOES LEGAIS. (CO) 10 (DEZ) ANOS CONTADOS A PARTIR DE 02/04/2019, OBSERVADAS AS CONDICOES LEGAIS

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 16A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2594 DE 24-09-2020 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.