SK280496B6 - Spôsob výroby častíc s trvalým uvoľňovaním účinnej - Google Patents

Spôsob výroby častíc s trvalým uvoľňovaním účinnej Download PDF

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Publication number
SK280496B6
SK280496B6 SK1406-94A SK140694A SK280496B6 SK 280496 B6 SK280496 B6 SK 280496B6 SK 140694 A SK140694 A SK 140694A SK 280496 B6 SK280496 B6 SK 280496B6
Authority
SK
Slovakia
Prior art keywords
particles
diluent
carrier
soluble
tablet
Prior art date
Application number
SK1406-94A
Other languages
English (en)
Slovak (sk)
Other versions
SK140694A3 (en
Inventor
Ronald B. Miller
Stewart T. Leslie
Sandra T. A. Malkowska
Derek A. Prater
Trevor J. Knott
Joanne Heafield
Deborah Challis
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
Priority claimed from GB9324045A external-priority patent/GB2284760B/en
Priority claimed from GB9403922A external-priority patent/GB2288117A/en
Priority claimed from GB9404544A external-priority patent/GB9404544D0/en
Priority claimed from GB9404928A external-priority patent/GB2287880A/en
Priority claimed from EP94303128A external-priority patent/EP0624366B1/en
Priority claimed from EP94304144A external-priority patent/EP0636370B2/en
Priority claimed from GB9411842A external-priority patent/GB9411842D0/en
Application filed by Euro-Celtique S.A. filed Critical Euro-Celtique S.A.
Publication of SK140694A3 publication Critical patent/SK140694A3/sk
Publication of SK280496B6 publication Critical patent/SK280496B6/sk

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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
SK1406-94A 1993-11-23 1994-11-22 Spôsob výroby častíc s trvalým uvoľňovaním účinnej SK280496B6 (sk)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
GB9324045A GB2284760B (en) 1993-11-23 1993-11-23 A method of preparing pharmaceutical compositions by melt pelletisation
GB9403922A GB2288117A (en) 1994-03-01 1994-03-01 Sustained release morphine
GB9404544A GB9404544D0 (en) 1994-03-09 1994-03-09 Controlled release formulation
GB9404928A GB2287880A (en) 1994-03-14 1994-03-14 Production of sustained release compositions
EP94303128A EP0624366B1 (en) 1993-05-10 1994-04-29 Controlled release formulation containing tramadol
EP94304144A EP0636370B2 (en) 1993-07-01 1994-06-09 Sustained release compositions containing morphine
GB9411842A GB9411842D0 (en) 1994-06-14 1994-06-14 Pharmaceutical preparation

Publications (2)

Publication Number Publication Date
SK140694A3 SK140694A3 (en) 1995-07-11
SK280496B6 true SK280496B6 (sk) 2000-03-13

Family

ID=27562143

Family Applications (1)

Application Number Title Priority Date Filing Date
SK1406-94A SK280496B6 (sk) 1993-11-23 1994-11-22 Spôsob výroby častíc s trvalým uvoľňovaním účinnej

Country Status (17)

Country Link
EP (1) EP0654263B1 (zh)
JP (2) JP3411114B2 (zh)
CN (1) CN1121213C (zh)
AT (1) ATE212224T1 (zh)
AU (1) AU682223C (zh)
BG (1) BG62429B1 (zh)
CZ (1) CZ289650B6 (zh)
DE (1) DE69429710T2 (zh)
DK (1) DK0654263T3 (zh)
ES (1) ES2168290T3 (zh)
FI (1) FI113335B (zh)
HU (1) HU217205B (zh)
IL (1) IL111709A (zh)
NO (1) NO314124B1 (zh)
NZ (1) NZ264953A (zh)
PT (1) PT654263E (zh)
SK (1) SK280496B6 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
LT5033B (lt) 1999-12-28 2003-07-25 Slovakofarma, A. S. Kontroliuojamo išsiskyrimo farmacinė kompozicija, turinti tramadolo hidrochlorido, ir jos paruošimo būdas

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US6548084B2 (en) 1995-07-20 2003-04-15 Smithkline Beecham Plc Controlled release compositions
GB9514842D0 (en) * 1995-07-20 1995-09-20 Smithkline Beecham Plc Novel formulation
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GB9713549D0 (en) * 1996-10-18 1997-09-03 Euro Celtique Sa Pharmaceutical combination formulation
BE1010803A3 (fr) * 1996-12-16 1999-02-02 Therabel Research Sa Comprimes pharmaceutiques a liberation prolongee a base de tramadol et leur preparation.
DE19729487A1 (de) * 1997-07-10 1999-01-14 Dresden Arzneimittel Verfahren zur Herstellung von Wirkstoff-Zubereitungen mit kontrollierter Freisetzung aus einer Matrix
RS49982B (sr) 1997-09-17 2008-09-29 Euro-Celtique S.A., Sinergistička analgetička kombinacija analgetičkog opijata i inhibitora ciklooksigenaze-2
PT1041987E (pt) 1997-12-22 2006-07-31 Euro Celtique Sa Forma farmaceutica de dosagem oral, compreendendo uma combinacao de um agonista de opioide e naltrexona
US6375957B1 (en) 1997-12-22 2002-04-23 Euro-Celtique, S.A. Opioid agonist/opioid antagonist/acetaminophen combinations
DE19901687B4 (de) * 1999-01-18 2006-06-01 Grünenthal GmbH Opioide Analgetika mit kontrollierter Wirkstofffreisetzung
DE19901683B4 (de) * 1999-01-18 2005-07-21 Grünenthal GmbH Analgetikum mit kontrollierter Wirkstofffreisetzung
DE19923551A1 (de) * 1999-05-21 2000-11-30 Lohmann Therapie Syst Lts Pharmazeutisches Präparat mit dem Wirkstoff Diamorphin und seine Verwendung in einem Verfahren zur Behandlung der Opiatsucht
EP1387673B1 (en) 2001-05-11 2010-12-29 Endo Pharmaceuticals Inc. Abuse-resistant controlled-release opioid dosage form
ES2733051T1 (es) 2002-04-05 2019-11-27 Euro Celtique Sa Matriz para liberación sostenida, invariable e independiente de compuestos activos
US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
TWI319713B (en) 2002-10-25 2010-01-21 Sustained-release tramadol formulations with 24-hour efficacy
US8487002B2 (en) 2002-10-25 2013-07-16 Paladin Labs Inc. Controlled-release compositions
DE10300325A1 (de) 2003-01-09 2004-07-22 Hexal Ag Granulat mit öliger Substanz, Herstellungsverfahren und Tablette
DE102004032051A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten, festen Darreichungsform
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
EP1604666A1 (en) 2004-06-08 2005-12-14 Euro-Celtique S.A. Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD)
DE102004032049A1 (de) * 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
PE20060652A1 (es) * 2004-08-27 2006-08-11 Novartis Ag Composiciones farmaceuticas de liberacion inmediata que comprenden granulos de fusion
GB2418854B (en) 2004-08-31 2009-12-23 Euro Celtique Sa Multiparticulates
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
EP1702558A1 (en) 2005-02-28 2006-09-20 Euro-Celtique S.A. Method and device for the assessment of bowel function
RU2008113439A (ru) 2005-09-09 2009-10-20 Лабофарм Инк. (CA) Композиции с замедленным высвобождением лекарственного средства
RS53624B1 (en) 2006-03-16 2015-04-30 Euro-Celtique S.A. PHARMACEUTICAL SFEROIDS
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
DE102007011485A1 (de) 2007-03-07 2008-09-11 Grünenthal GmbH Darreichungsform mit erschwertem Missbrauch
JP5774853B2 (ja) 2008-01-25 2015-09-09 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング 医薬投薬形
CA2723438C (en) 2008-05-09 2016-10-11 Gruenenthal Gmbh Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
MY152279A (en) 2009-03-10 2014-09-15 Euro Celtique Sa Immediate release pharmaceutical compositions comprising oxycodone and naloxone
DE102009019268A1 (de) * 2009-04-28 2010-11-11 Lts Lohmann Therapie-Systeme Ag Arzneimittel mit poröser Matrix
MX2012000317A (es) 2009-07-22 2012-02-08 Gruenenthal Gmbh Forma de dosificacion de liberacion controlada extruida por fusion en caliente.
MX2012000369A (es) 2009-07-22 2012-02-01 Gruenenthal Gmbh Forma de dosificacion resistente a la manipulacion para opioides sensibles a la oxidacion.
RU2604676C2 (ru) 2010-09-02 2016-12-10 Грюненталь Гмбх Устойчивая к разрушению лекарственная форма, содержащая неорганическую соль
ES2487244T3 (es) 2010-09-02 2014-08-20 Grünenthal GmbH Forma de dosificación resistente a la manipulación que comprende un polímero aniónico
US20130028972A1 (en) 2011-07-29 2013-01-31 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
PT2736495T (pt) 2011-07-29 2017-11-30 Gruenenthal Gmbh Comprimido resistente à adulteração proporcionando libertação imediata de fármaco
BR112014019988A8 (pt) 2012-02-28 2017-07-11 Gruenenthal Gmbh Forma de dosagem resistente a socamento compreendendo um composto farmacologicamente ativo e um polímero aniônico
JP6282261B2 (ja) 2012-04-18 2018-02-21 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング 不正使用防止および過量放出防止医薬剤形
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
CA2907950A1 (en) 2013-05-29 2014-12-04 Grunenthal Gmbh Tamper-resistant dosage form containing one or more particles
BR112015029616A2 (pt) 2013-05-29 2017-07-25 Gruenenthal Gmbh forma de dosagem resistente à adulteração com perfil de liberação bimodal
KR20160031526A (ko) 2013-07-12 2016-03-22 그뤼넨탈 게엠베하 에틸렌-비닐 아세테이트 중합체를 함유하는 템퍼 내성 투여형
MY183489A (en) 2013-07-23 2021-02-22 Euro Celtique Sa A combination of oxycodone and naloxone for use in treating pain in patients suffering from pain and a disease resulting in intestinal dysbiosis and/or increasing the risk for intestinal bacterial translocation
MX371372B (es) 2013-11-26 2020-01-28 Gruenenthal Gmbh Preparacion de una composicion farmaceutica en polvo por medio de criomolienda.
CA2947786A1 (en) 2014-05-12 2015-11-19 Grunenthal Gmbh Tamper resistant immediate release capsule formulation comprising tapentadol
WO2015181059A1 (en) 2014-05-26 2015-12-03 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
CN107889459A (zh) 2015-04-24 2018-04-06 格吕伦塔尔有限公司 具有立即释放和对溶剂萃取的抗性的抗篡改剂型
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US4132753A (en) * 1965-02-12 1979-01-02 American Cyanamid Company Process for preparing oral sustained release granules
SE9003296L (sv) * 1990-10-16 1992-04-17 Kabi Pharmacia Ab Foerfarande foer att formulera laekemedel
SE9200858L (sv) * 1992-03-20 1993-09-21 Kabi Pharmacia Ab Metod för framställning av pellets med fördröjd frisättning
CN1230154C (zh) * 1993-07-01 2005-12-07 欧洲凯尔特公司 缓释组合物及制备药用组合物的方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
LT5033B (lt) 1999-12-28 2003-07-25 Slovakofarma, A. S. Kontroliuojamo išsiskyrimo farmacinė kompozicija, turinti tramadolo hidrochlorido, ir jos paruošimo būdas

Also Published As

Publication number Publication date
ES2168290T3 (es) 2002-06-16
DE69429710T2 (de) 2002-08-08
SK140694A3 (en) 1995-07-11
NO944473L (no) 1995-05-24
BG62429B1 (bg) 1999-11-30
BG99198A (en) 1995-08-28
EP0654263A1 (en) 1995-05-24
JPH07196475A (ja) 1995-08-01
CN1121213C (zh) 2003-09-17
DK0654263T3 (da) 2002-04-29
JP3411114B2 (ja) 2003-05-26
FI113335B (fi) 2004-04-15
NO944473D0 (no) 1994-11-22
IL111709A (en) 2002-12-01
ATE212224T1 (de) 2002-02-15
FI945476A0 (fi) 1994-11-22
DE69429710D1 (de) 2002-03-14
HU9403353D0 (en) 1995-02-28
CN1116521A (zh) 1996-02-14
NZ264953A (en) 1996-11-26
EP0654263B1 (en) 2002-01-23
PT654263E (pt) 2002-06-28
CZ289650B6 (cs) 2002-03-13
HUT74910A (en) 1997-03-28
JP2003113075A (ja) 2003-04-18
IL111709A0 (en) 1995-01-24
AU682223C (en) 2005-03-24
HU217205B (hu) 1999-12-28
NO314124B1 (no) 2003-02-03
CZ286694A3 (en) 1995-06-14
AU682223B2 (en) 1997-09-25
AU7901594A (en) 1995-06-01
FI945476A (fi) 1995-05-24

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