JP5635082B2 - 剤形 - Google Patents
剤形 Download PDFInfo
- Publication number
- JP5635082B2 JP5635082B2 JP2012513685A JP2012513685A JP5635082B2 JP 5635082 B2 JP5635082 B2 JP 5635082B2 JP 2012513685 A JP2012513685 A JP 2012513685A JP 2012513685 A JP2012513685 A JP 2012513685A JP 5635082 B2 JP5635082 B2 JP 5635082B2
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- JP
- Japan
- Prior art keywords
- dosage form
- microparticles
- melt
- present
- drug
- 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.)
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- 239000011159 matrix material Substances 0.000 claims description 61
- 238000000034 method Methods 0.000 claims description 46
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- 229960002085 oxycodone Drugs 0.000 claims description 40
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 36
- 239000003795 chemical substances by application Substances 0.000 claims description 36
- 150000003839 salts Chemical class 0.000 claims description 29
- WVLOADHCBXTIJK-YNHQPCIGSA-N hydromorphone Chemical compound O([C@H]1C(CC[C@H]23)=O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O WVLOADHCBXTIJK-YNHQPCIGSA-N 0.000 claims description 27
- 229960001410 hydromorphone Drugs 0.000 claims description 27
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- 239000003402 opiate agonist Substances 0.000 claims description 16
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- RMRJXGBAOAMLHD-IHFGGWKQSA-N buprenorphine Chemical compound C([C@]12[C@H]3OC=4C(O)=CC=C(C2=4)C[C@@H]2[C@]11CC[C@]3([C@H](C1)[C@](C)(O)C(C)(C)C)OC)CN2CC1CC1 RMRJXGBAOAMLHD-IHFGGWKQSA-N 0.000 claims description 2
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- 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
-
- 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
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
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- 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)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Emergency Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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| GBGB0909680.1A GB0909680D0 (en) | 2009-06-05 | 2009-06-05 | Dosage form |
| GB0909680.1 | 2009-06-05 | ||
| PCT/GB2010/050948 WO2010140007A2 (en) | 2009-06-05 | 2010-06-07 | Dosage form |
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| Publication Number | Publication Date |
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| JP2012528845A JP2012528845A (ja) | 2012-11-15 |
| JP2012528845A5 JP2012528845A5 (enExample) | 2013-07-25 |
| JP5635082B2 true JP5635082B2 (ja) | 2014-12-03 |
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| JP2012513685A Expired - Fee Related JP5635082B2 (ja) | 2009-06-05 | 2010-06-07 | 剤形 |
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| AU (1) | AU2010255502B2 (enExample) |
| BR (1) | BRPI1012004A2 (enExample) |
| CA (1) | CA2764517C (enExample) |
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| ES (1) | ES2713957T3 (enExample) |
| GB (1) | GB0909680D0 (enExample) |
| IL (1) | IL216748A0 (enExample) |
| MX (1) | MX2011012929A (enExample) |
| MY (1) | MY173629A (enExample) |
| NZ (1) | NZ596879A (enExample) |
| SG (2) | SG10201402810XA (enExample) |
| WO (1) | WO2010140007A2 (enExample) |
| ZA (1) | ZA201109221B (enExample) |
Families Citing this family (71)
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| EP1429739A1 (en) | 2001-09-21 | 2004-06-23 | Egalet A/S | Polymer release system |
| EP1429744A1 (en) | 2001-09-21 | 2004-06-23 | Egalet A/S | Morphine polymer release system |
| US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
| DE602004031096D1 (de) | 2003-03-26 | 2011-03-03 | Egalet As | Morphin-system mit kontrollierter freisetzung |
| DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
| DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| US8075872B2 (en) | 2003-08-06 | 2011-12-13 | Gruenenthal Gmbh | Abuse-proofed dosage form |
| DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
| 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 |
| DE102004032049A1 (de) | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Gegen Missbrauch gesicherte, orale Darreichungsform |
| DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| DE102007011485A1 (de) | 2007-03-07 | 2008-09-11 | Grünenthal GmbH | Darreichungsform mit erschwertem Missbrauch |
| CA2687192C (en) | 2007-06-04 | 2015-11-24 | Egalet A/S | Controlled release pharmaceutical compositions for prolonged effect |
| EP2187873B1 (en) * | 2007-08-13 | 2018-07-25 | Abuse Deterrent Pharmaceutical Llc | Abuse resistant drugs, method of use and method of making |
| US8383152B2 (en) | 2008-01-25 | 2013-02-26 | Gruenenthal Gmbh | Pharmaceutical dosage form |
| TWI524904B (zh) | 2008-05-09 | 2016-03-11 | 歌林達股份有限公司 | 製備醫藥用固體劑型,尤指錠劑之方法,及製備固體劑型,尤指錠劑之前驅物之方法 |
| NZ594207A (en) | 2009-02-06 | 2013-03-28 | Egalet Ltd | Immediate release composition resistant to abuse by intake of alcohol |
| NZ597283A (en) | 2009-06-24 | 2013-07-26 | Egalet Ltd | Controlled release formulations |
| JP5667183B2 (ja) | 2009-07-22 | 2015-02-12 | 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 | 加熱溶融押出成型した制御放出性投与剤型 |
| NZ596668A (en) | 2009-07-22 | 2013-09-27 | Gruenenthal Chemie | Oxidation-stabilized tamper-resistant dosage form |
| ES2642788T3 (es) | 2010-05-10 | 2017-11-20 | Euro-Celtique S.A. | Fabricación de gránulos sin principio activo y de comprimidos que comprenden los mismos |
| JP5840201B2 (ja) | 2010-05-10 | 2016-01-06 | ユーロ−セルティーク エス.エイ. | 活性剤を負荷した顆粒と追加の活性剤の組合せ |
| NZ700732A (en) | 2010-05-10 | 2015-08-28 | Euro Celtique Sa | Pharmaceutical compositions comprising hydromorphone and naloxone |
| MX2013002293A (es) | 2010-09-02 | 2013-05-09 | Gruenenthal Gmbh | Forma de dosificacion resistente a alteracion que comprende un polimero anionico. |
| ES2486791T3 (es) | 2010-09-02 | 2014-08-19 | Grünenthal GmbH | Forma de dosificación resistente a la manipulación que comprende una sal inorgánica |
| US9278052B2 (en) | 2010-11-04 | 2016-03-08 | Abbvie Inc. | Method for producing monolithic tablets |
| EP2635258A1 (en) * | 2010-11-04 | 2013-09-11 | AbbVie Inc. | Drug formulations |
| GB201020895D0 (en) * | 2010-12-09 | 2011-01-26 | Euro Celtique Sa | Dosage form |
| SG191208A1 (en) * | 2010-12-28 | 2013-07-31 | Euro Celtique Sa | A combination of an opioid agonist and an opioid antagonist in the treatment of parkinson's disease |
| PE20141650A1 (es) | 2011-07-29 | 2014-11-22 | Gruenenthal Chemie | Tableta a prueba de alteracion que proporciona liberacion inmediata del farmaco |
| EA201400172A1 (ru) | 2011-07-29 | 2014-06-30 | Грюненталь Гмбх | Устойчивая к разрушению таблетка, которая обеспечивает немедленное высвобождение лекарственного средства |
| ES2641437T3 (es) * | 2011-09-16 | 2017-11-10 | Purdue Pharma Lp | Formulaciones farmacéuticas resistentes a la manipulación indebida |
| WO2013050539A2 (en) * | 2011-10-06 | 2013-04-11 | Grünenthal GmbH | Tamper-resistant oral pharmaceutical dosage form comprising opioid agonist and opioid antagonist |
| AR088875A1 (es) * | 2011-11-17 | 2014-07-16 | Gruenenthal Gmbh | Forma de dosis farmaceutica oral a prueba de manipulacion |
| WO2013127831A1 (en) | 2012-02-28 | 2013-09-06 | Grünenthal GmbH | Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer |
| ES2692944T3 (es) * | 2012-04-18 | 2018-12-05 | Grünenthal GmbH | Forma de dosificación farmacéutica resistente a la manipulación y resistente a la descarga rápida de la dosis |
| US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
| US9549899B2 (en) | 2012-07-06 | 2017-01-24 | Egalet Ltd. | Abuse deterrent pharmaceutical compositions for controlled release |
| ES2698611T3 (es) | 2012-07-12 | 2019-02-05 | SpecGx LLC | Composiciones farmacéuticas disuasorias del abuso y de liberación prolongada |
| CA2795324C (en) * | 2012-11-09 | 2015-07-14 | Purdue Pharma | Pharmaceutical compositions comprising hydromorphone and naloxone |
| US10751287B2 (en) | 2013-03-15 | 2020-08-25 | Purdue Pharma L.P. | Tamper resistant pharmaceutical formulations |
| US9737490B2 (en) | 2013-05-29 | 2017-08-22 | Grünenthal GmbH | Tamper resistant dosage form with bimodal release profile |
| BR112015026549A2 (pt) * | 2013-05-29 | 2017-07-25 | Gruenenthal Gmbh | forma de dosagem à prova de violação contendo uma ou mais partículas |
| AU2014289187B2 (en) | 2013-07-12 | 2019-07-11 | Grunenthal Gmbh | Tamper-resistant dosage form containing ethylene-vinyl acetate polymer |
| CA2919892C (en) | 2013-08-12 | 2019-06-18 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| EP3068397A1 (en) | 2013-11-13 | 2016-09-21 | Euro-Celtique S.A. | Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome |
| WO2015071248A1 (en) | 2013-11-15 | 2015-05-21 | Synthon B.V. | Abuse-proofed extended release pharmaceutical composition comprising tapentadol |
| AU2014356581C1 (en) | 2013-11-26 | 2020-05-28 | Grunenthal Gmbh | Preparation of a powdery pharmaceutical composition by means of cryo-milling |
| 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 |
| AU2014364800A1 (en) * | 2013-12-17 | 2016-07-07 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| WO2015089530A1 (de) * | 2013-12-20 | 2015-06-25 | G.L. PHARMA GmbH | Orale darreichungsform mit verzögerter freisetzung enthaltend morphin und naloxon |
| CA2847781C (en) * | 2014-03-28 | 2019-03-12 | Purdue Pharma | Reducing drug liking in a subject |
| MX2016014738A (es) | 2014-05-12 | 2017-03-06 | Gruenenthal Gmbh | Formulacion en capsula de liberacion inmediata resistente a alteraciones que comprende tapentadol. |
| CN106456550A (zh) | 2014-05-26 | 2017-02-22 | 格吕伦塔尔有限公司 | 避免乙醇剂量倾泻的多颗粒 |
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| DK3169315T3 (da) | 2014-07-17 | 2020-08-10 | Pharmaceutical Manufacturing Res Services In | Væskefyldt doseringsform til forhindring af misbrug med øjeblikkelig frigivelse |
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| CA2983648A1 (en) | 2015-04-24 | 2016-10-27 | Grunenthal Gmbh | Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix |
| BR112017021475A2 (pt) | 2015-04-24 | 2018-07-10 | Gruenenthal Gmbh | forma de dosagem resistente à adulteração (tamper) com liberação imediata e resistência contra extração de solvente |
| CA2983640A1 (en) | 2015-04-24 | 2016-10-27 | Grunenthal Gmbh | Tamper-resistant fixed dose combination providing fast release of two drugs from different particles |
| AU2016251851A1 (en) | 2015-04-24 | 2017-11-09 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from particles |
| JP2018520165A (ja) * | 2015-07-10 | 2018-07-26 | サン、ファーマ、アドバンスト、リサーチ、カンパニー、リミテッドSun Pharma Advanced Research Company Limited | ヒドロコドンの多数錠剤乱用抵抗性即時放出型固体投薬形態物 |
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| US11549878B2 (en) | 2018-08-09 | 2023-01-10 | Albireo Ab | In vitro method for determining the adsorbing capacity of an insoluble adsorbant |
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| DE19740983A1 (de) * | 1997-09-18 | 1999-04-08 | Warner Lambert Co N D Ges D St | Verfahren zur Erschwerung der Extraktion von Wirkstoffen aus Tabletten |
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| ES2289542T3 (es) | 2003-08-06 | 2008-02-01 | Grunenthal Gmbh | Forma farmaceutica protegida contra un posible abuso. |
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| DE102004062475A1 (de) | 2004-12-24 | 2006-07-06 | Bayer Healthcare Ag | Feste, oral applizierbare pharmazeutische Darreichungsformen mit modifizierter Freisetzung |
| EP1771160A2 (en) * | 2005-01-28 | 2007-04-11 | Euroceltique S.A. | Alcohol resistant dosage forms |
| US20070026025A1 (en) | 2005-04-12 | 2007-02-01 | Aquegel Cosmetics, Llc | Topical ointment and method for making and using same |
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| DE102005047561A1 (de) | 2005-10-04 | 2007-04-05 | Bayer Healthcare Ag | Feste, oral applizierbare pharmazeutische Darreichungsformen mit schneller Wirkstofffreisetzung |
| ATE482690T1 (de) | 2005-12-14 | 2010-10-15 | Hoffmann La Roche | Hcv-prodrug-formulierung |
| EP1813276A1 (en) * | 2006-01-27 | 2007-08-01 | Euro-Celtique S.A. | Tamper resistant dosage forms |
| US7799790B2 (en) | 2006-07-20 | 2010-09-21 | Helm Ag | Amorphous aripiprazole and process for the preparation thereof |
| EP1935405A1 (en) | 2006-12-22 | 2008-06-25 | LEK Pharmaceuticals D.D. | Orally disintegrating tablets |
| DE102007011485A1 (de) | 2007-03-07 | 2008-09-11 | Grünenthal GmbH | Darreichungsform mit erschwertem Missbrauch |
| GB2447898B (en) | 2007-03-24 | 2011-08-17 | Reckitt Benckiser Healthcare | A tablet having improved stability with at least two actives |
| MX2011004972A (es) * | 2008-11-12 | 2011-07-29 | Akzo Nobel Coatings Int Bv | Dispersiones polimericas de distribucion estrecha de tamaño de particula. |
| DE102009015702A1 (de) | 2009-03-31 | 2010-10-07 | Ratiopharm Gmbh | Tabletten enthaltend Dapoxetin und Trockenverarbeitungsverfahren zu deren Herstellung |
| GB201020895D0 (en) | 2010-12-09 | 2011-01-26 | Euro Celtique Sa | Dosage form |
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2009
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2010
- 2010-06-07 US US13/376,113 patent/US9814679B2/en active Active
- 2010-06-07 JP JP2012513685A patent/JP5635082B2/ja not_active Expired - Fee Related
- 2010-06-07 BR BRPI1012004A patent/BRPI1012004A2/pt not_active Application Discontinuation
- 2010-06-07 WO PCT/GB2010/050948 patent/WO2010140007A2/en not_active Ceased
- 2010-06-07 SG SG10201402810XA patent/SG10201402810XA/en unknown
- 2010-06-07 CN CN201610970584.4A patent/CN106667919A/zh active Pending
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- 2010-06-07 MY MYPI2011005869A patent/MY173629A/en unknown
- 2010-06-07 SG SG2011089273A patent/SG176304A1/en unknown
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- 2010-06-07 EP EP10725263.7A patent/EP2437729B1/en active Active
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2011
- 2011-12-04 IL IL216748A patent/IL216748A0/en unknown
- 2011-12-14 ZA ZA2011/09221A patent/ZA201109221B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| GB0909680D0 (en) | 2009-07-22 |
| CN102481260A (zh) | 2012-05-30 |
| EA201171389A1 (ru) | 2012-05-30 |
| EA022801B1 (ru) | 2016-03-31 |
| WO2010140007A2 (en) | 2010-12-09 |
| ZA201109221B (en) | 2012-08-29 |
| SG176304A1 (en) | 2012-01-30 |
| MY173629A (en) | 2020-02-12 |
| AU2010255502A1 (en) | 2012-01-12 |
| MX2011012929A (es) | 2012-04-20 |
| JP2012528845A (ja) | 2012-11-15 |
| ES2713957T3 (es) | 2019-05-24 |
| US20120135075A1 (en) | 2012-05-31 |
| NZ596879A (en) | 2013-06-28 |
| KR101816130B1 (ko) | 2018-01-08 |
| CA2764517A1 (en) | 2010-12-09 |
| EP2437729B1 (en) | 2019-01-23 |
| AU2010255502B2 (en) | 2016-09-22 |
| BRPI1012004A2 (pt) | 2016-05-10 |
| US9814679B2 (en) | 2017-11-14 |
| CN106667919A (zh) | 2017-05-17 |
| IL216748A0 (en) | 2012-02-29 |
| WO2010140007A9 (en) | 2012-01-19 |
| EP2437729A2 (en) | 2012-04-11 |
| SG10201402810XA (en) | 2014-08-28 |
| WO2010140007A3 (en) | 2011-11-17 |
| KR20120026595A (ko) | 2012-03-19 |
| CA2764517C (en) | 2017-07-04 |
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