MX361925B - Medicamento inhalable que comprende tiotropio. - Google Patents
Medicamento inhalable que comprende tiotropio.Info
- Publication number
- MX361925B MX361925B MX2014007357A MX2014007357A MX361925B MX 361925 B MX361925 B MX 361925B MX 2014007357 A MX2014007357 A MX 2014007357A MX 2014007357 A MX2014007357 A MX 2014007357A MX 361925 B MX361925 B MX 361925B
- Authority
- MX
- Mexico
- Prior art keywords
- tiotropium
- formulation
- inhalable medicament
- percentages
- mdi
- Prior art date
Links
- LERNTVKEWCAPOY-DZZGSBJMSA-N tiotropium Chemical compound O([C@H]1C[C@@H]2[N+]([C@H](C1)[C@@H]1[C@H]2O1)(C)C)C(=O)C(O)(C=1SC=CC=1)C1=CC=CS1 LERNTVKEWCAPOY-DZZGSBJMSA-N 0.000 title abstract 2
- 239000003814 drug Substances 0.000 title 1
- 229940110309 tiotropium Drugs 0.000 title 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 abstract 3
- 238000009472 formulation Methods 0.000 abstract 3
- 239000000203 mixture Substances 0.000 abstract 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract 2
- 150000007524 organic acids Chemical class 0.000 abstract 1
- 239000003380 propellant Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
-
- 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
- A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
-
- 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
- A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Otolaryngology (AREA)
- Emergency Medicine (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Abstract
Esta invención se refiere a una formulación para solución que comprende una sal de tiotropio, 12-20% de etanol, 0.1-1.5% de agua, 0.05-0.10% de ácido cítrico (u otro ácido orgánico) y un propelente de HFA, en donde los porcentajes son porcentajes en peso basados en el peso total de la formulación. La invención también provee un pMDI que comprende un envase que contiene la formulación.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161577315P | 2011-12-19 | 2011-12-19 | |
| GBGB1200525.2A GB201200525D0 (en) | 2011-12-19 | 2012-01-13 | An inhalable medicament |
| PCT/EP2012/074690 WO2013092237A1 (en) | 2011-12-19 | 2012-12-06 | An inhalable medicament comprising tiotropium |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2014007357A MX2014007357A (es) | 2014-08-21 |
| MX361925B true MX361925B (es) | 2018-12-19 |
Family
ID=45813952
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2014007357A MX361925B (es) | 2011-12-19 | 2012-12-06 | Medicamento inhalable que comprende tiotropio. |
Country Status (29)
| Country | Link |
|---|---|
| US (1) | US9655969B2 (es) |
| EP (3) | EP3143998B1 (es) |
| JP (1) | JP5791166B2 (es) |
| KR (2) | KR101670564B1 (es) |
| CN (1) | CN103998039A (es) |
| AR (1) | AR089302A1 (es) |
| AU (1) | AU2012358475B2 (es) |
| BR (1) | BR112014014535A2 (es) |
| CA (1) | CA2856047C (es) |
| CY (1) | CY1116142T1 (es) |
| DK (3) | DK3143998T3 (es) |
| EA (1) | EA028461B1 (es) |
| ES (3) | ES2728940T3 (es) |
| GB (1) | GB201200525D0 (es) |
| HK (2) | HK1198512A1 (es) |
| HR (1) | HRP20141176T1 (es) |
| HU (2) | HUE030983T2 (es) |
| IL (1) | IL232946A0 (es) |
| MX (1) | MX361925B (es) |
| PL (3) | PL2793886T3 (es) |
| PT (1) | PT2606891E (es) |
| RS (1) | RS53783B1 (es) |
| SI (1) | SI2606891T1 (es) |
| SM (1) | SMT201400192B (es) |
| TR (1) | TR201908429T4 (es) |
| TW (1) | TWI468187B (es) |
| UY (1) | UY34525A (es) |
| WO (1) | WO2013092237A1 (es) |
| ZA (2) | ZA201403041B (es) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GEP20166479B (en) | 2009-12-23 | 2016-05-25 | Chiesi Farma Spa | Aerosol formulation for copd |
| GB201200525D0 (en) | 2011-12-19 | 2012-02-29 | Teva Branded Pharmaceutical Prod R & D Inc | An inhalable medicament |
| WO2013127738A1 (de) | 2012-02-28 | 2013-09-06 | Boehringer Ingelheim International Gmbh | Neue treibgashaltige tiotropium-formulierung |
| EA201691068A1 (ru) * | 2013-11-22 | 2016-09-30 | Тева Брэндид Фармасьютикал Продактс Ар Энд Ди, Инк. | Ингалируемое лекарственное средство |
| JP2016539126A (ja) | 2013-11-22 | 2016-12-15 | テバ ブランデッド ファーマシューティカル プロダクツ アール アンド ディー インコーポレイテッド | 吸引可能薬剤 |
| US10034866B2 (en) | 2014-06-19 | 2018-07-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Inhalable medicament comprising tiotropium |
| EP3368083A1 (en) * | 2015-10-29 | 2018-09-05 | 3M Innovative Properties Company | Formulation and aerosol canisters, inhalers, and the like containing the formulation |
| WO2018051132A1 (en) * | 2016-09-19 | 2018-03-22 | Mexichem Fluor S.A. De C.V. | Pharmaceutical composition |
| EP3813797A4 (en) * | 2018-06-27 | 2022-03-30 | Kindeva Drug Delivery L.P. | TIOTROPIUM FORMULATION AND INHALER |
Family Cites Families (57)
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| GB8828477D0 (en) | 1988-12-06 | 1989-01-05 | Riker Laboratories Inc | Medical aerosol formulations |
| US5610163A (en) | 1989-09-16 | 1997-03-11 | Boehringer Ingelheim Gmbh | Esters of thienyl carboxylic acids and amino alcohols and their quaternization products |
| DE3931041C2 (de) | 1989-09-16 | 2000-04-06 | Boehringer Ingelheim Kg | Ester von Thienylcarbonsäuren mit Aminoalkoholen, ihre Quaternierungsprodukte, Verfahren zu ihrer Herstellung und diese enthaltende Arzneimittel |
| GB9026191D0 (en) * | 1990-12-01 | 1991-01-16 | Harris Pharma Ltd | Breath actuated dispensing device |
| IL104068A (en) | 1991-12-12 | 1998-10-30 | Glaxo Group Ltd | Surfactant-free pharmaceutical aerosol formulation comprising 1,1,1,2-tetrafluoroethane or 1,1,1,2,3,3,3-heptafluoro-n- propane as propellant |
| DK0616525T3 (da) | 1991-12-12 | 1996-01-08 | Glaxo Group Ltd | Medikamenter |
| GB2264238A (en) | 1992-05-29 | 1993-08-25 | Norton Healthcare Ltd | Medicament inhalor device |
| ES2129117T3 (es) | 1992-12-09 | 1999-06-01 | Boehringer Ingelheim Pharma | Formulaciones en disolucion en forma de aerosol medicinales estabilizadas. |
| US6309671B1 (en) | 1995-04-14 | 2001-10-30 | Inhale Therapeutic Systems | Stable glassy state powder formulations |
| US6258341B1 (en) | 1995-04-14 | 2001-07-10 | Inhale Therapeutic Systems, Inc. | Stable glassy state powder formulations |
| GB9616237D0 (en) | 1996-08-01 | 1996-09-11 | Norton Healthcare Ltd | Aerosol formulations |
| DK1131059T3 (da) | 1998-11-13 | 2003-06-30 | Jago Res Ag | Tørpulver til inhalation |
| DZ2947A1 (fr) | 1998-11-25 | 2004-03-15 | Chiesi Farma Spa | Inhalateur à compteur de dose sous pression. |
| CA2387212A1 (en) | 1999-10-12 | 2001-04-19 | Kaken Pharmaceutical Co., Ltd. | Dry powder inhalation and a method for the preparation thereof |
| UA73986C2 (uk) | 2000-05-22 | 2005-10-17 | К'Єзі Фармачеутічі С.П.А. | АЕРОЗОЛЬНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ <font face="Symbol">b</font>2-АДРЕНЕРГІЧНИЙ АГОНІСТ ТРИВАЛОЇ ДІЇ, ДОЗУЮЧИЙ ІНГАЛЯТОР ПІД ТИСКОМ ТА СПОСІБ ЙОГО ЗАПОВНЕННЯ |
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| US6553988B1 (en) | 2000-06-09 | 2003-04-29 | Norton Healthcare, Inc. | Medicament dispensing device with a multimaterial diaphragm bounding a pneumatic force chamber |
| AP1572A (en) | 2000-10-12 | 2006-02-13 | Boehringer Ingelheim Pharma | Crystalline monohydrate, method for producing the same and use thereof in the production of a medicament. |
| US6908928B2 (en) | 2000-10-12 | 2005-06-21 | Bi Pharma Kg. | Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions |
| CA2395653C (en) | 2000-10-12 | 2006-05-09 | Boehringer Ingelheim Pharma Kg | New inhalable powder containing tiotropium |
| EP1243263B1 (en) * | 2001-03-21 | 2002-11-27 | Schwarz Pharma Ag | Novel use of a peptide class of compound for treating allodynia or other different types of chronic or phantom pain |
| DE10126924A1 (de) | 2001-06-01 | 2002-12-05 | Boehringer Ingelheim Pharma | Inhalationskapseln |
| US20030070679A1 (en) | 2001-06-01 | 2003-04-17 | Boehringer Ingelheim Pharma Kg | Capsules containing inhalable tiotropium |
| PL208137B1 (pl) | 2001-06-22 | 2011-03-31 | Boehringer Ingelheim Pharma | Bezwodny krystaliczny bromek tiotropium, sposób jego wytwarzania i zastosowanie krystalicznego monohydratu bromku tiotropium do wytwarzania krystalicznego bezwodnego bromku tiotropium |
| US6608055B2 (en) | 2001-06-22 | 2003-08-19 | Boehringer Ingelheim Pharma Kg | Crystalline anticholinergic, processes for preparing it and its use for preparing a pharmaceutical composition |
| DE10130371A1 (de) * | 2001-06-23 | 2003-01-02 | Boehringer Ingelheim Pharma | Neue Arzneimittelkompositionen auf der Basis von Anticholinergika, Corticosteroiden und Betamimetika |
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| US7311894B2 (en) | 2002-03-28 | 2007-12-25 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | HFA suspension formulations containing an anticholinergic |
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| GB0219511D0 (en) | 2002-08-21 | 2002-10-02 | Norton Healthcare Ltd | Method of preparing dry powder inhalation compositions |
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| DE10339197A1 (de) | 2003-08-22 | 2005-03-24 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Sprühgetrocknete amorphe Pulver mit geringer Restfeuchte und guter Lagerstabilität |
| WO2005027875A1 (en) | 2003-09-18 | 2005-03-31 | Ivax Corporation | Particles |
| US7968717B2 (en) | 2003-11-03 | 2011-06-28 | Boehringer Ingelhein International Gmbh | Crystalline anhydrate with anticholinergic efficacy |
| JP4553902B2 (ja) | 2003-11-03 | 2010-09-29 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | 抗コリン作用を有する新規結晶性無水物 |
| SE0303570L (sv) | 2003-12-03 | 2005-06-04 | Microdrug Ag | Fukt-känslig medicinsk produkt |
| JP2007528409A (ja) | 2004-03-09 | 2007-10-11 | アリバ ファーマシューティカルズ， インコーポレイテッド | プロテアーゼインヒビターの低用量吸入による慢性閉塞性肺疾患の処置 |
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| SI1881980T1 (sl) | 2005-05-02 | 2012-12-31 | Boehringer Ingelheim International Gmbh | Nove kristalinične oblike tiotropijevega bromida |
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| GB0716026D0 (en) | 2007-08-16 | 2007-09-26 | Norton Healthcare Ltd | An inhalable medicament |
| EP2201934A1 (en) | 2008-12-23 | 2010-06-30 | CHIESI FARMACEUTICI S.p.A. | Tiotropium aerosol formulation products with improved chemical stability |
| KR20110104120A (ko) | 2009-01-26 | 2011-09-21 | 테바 파마슈티컬 인더스트리즈 리미티드 | 극미립자를 이용한 담체 코팅 방법 |
| NZ600208A (en) * | 2009-11-17 | 2014-06-27 | Cipla Ltd | Inhalation solutions |
| EP2926855B1 (en) | 2010-10-12 | 2018-12-05 | Ivax Pharmaceuticals Ireland | Nasal spray device |
| GB201200504D0 (en) | 2011-12-19 | 2012-02-22 | Teva Branded Pharmaceutical Prod R & D Inc | An inhaler |
| GB201200525D0 (en) | 2011-12-19 | 2012-02-29 | Teva Branded Pharmaceutical Prod R & D Inc | An inhalable medicament |
| WO2013127738A1 (de) | 2012-02-28 | 2013-09-06 | Boehringer Ingelheim International Gmbh | Neue treibgashaltige tiotropium-formulierung |
-
2012
- 2012-01-13 GB GBGB1200525.2A patent/GB201200525D0/en not_active Ceased
- 2012-12-06 HU HUE12806382A patent/HUE030983T2/en unknown
- 2012-12-06 US US14/367,031 patent/US9655969B2/en active Active
- 2012-12-06 HU HUE16185402 patent/HUE044647T2/hu unknown
- 2012-12-06 ES ES16185402T patent/ES2728940T3/es active Active
- 2012-12-06 EP EP16185402.1A patent/EP3143998B1/en not_active Revoked
- 2012-12-06 JP JP2014543943A patent/JP5791166B2/ja not_active Expired - Fee Related
- 2012-12-06 MX MX2014007357A patent/MX361925B/es active IP Right Grant
- 2012-12-06 WO PCT/EP2012/074690 patent/WO2013092237A1/en not_active Ceased
- 2012-12-06 PL PL12806382T patent/PL2793886T3/pl unknown
- 2012-12-06 CA CA2856047A patent/CA2856047C/en not_active Expired - Fee Related
- 2012-12-06 AU AU2012358475A patent/AU2012358475B2/en not_active Ceased
- 2012-12-06 TR TR2019/08429T patent/TR201908429T4/tr unknown
- 2012-12-06 KR KR1020147017716A patent/KR101670564B1/ko not_active Expired - Fee Related
- 2012-12-06 EA EA201491206A patent/EA028461B1/ru not_active IP Right Cessation
- 2012-12-06 DK DK16185402.1T patent/DK3143998T3/da active
- 2012-12-06 KR KR1020167025194A patent/KR20160111539A/ko not_active Withdrawn
- 2012-12-06 PL PL16185402T patent/PL3143998T3/pl unknown
- 2012-12-06 BR BR112014014535A patent/BR112014014535A2/pt not_active Application Discontinuation
- 2012-12-06 HK HK14111996.5A patent/HK1198512A1/xx unknown
- 2012-12-06 ES ES12806382.3T patent/ES2602314T3/es active Active
- 2012-12-06 CN CN201280060763.4A patent/CN103998039A/zh active Pending
- 2012-12-06 DK DK12806382.3T patent/DK2793886T3/en active
- 2012-12-06 HK HK15100893.1A patent/HK1200343A1/xx unknown
- 2012-12-06 EP EP12806382.3A patent/EP2793886B1/en not_active Revoked
- 2012-12-12 DK DK12196725.1T patent/DK2606891T3/en active
- 2012-12-12 EP EP12196725.1A patent/EP2606891B1/en not_active Revoked
- 2012-12-12 PT PT121967251T patent/PT2606891E/pt unknown
- 2012-12-12 RS RS20140691A patent/RS53783B1/sr unknown
- 2012-12-12 PL PL12196725T patent/PL2606891T3/pl unknown
- 2012-12-12 ES ES12196725.1T patent/ES2526685T3/es active Active
- 2012-12-12 SI SI201230113T patent/SI2606891T1/sl unknown
- 2012-12-18 UY UY0001034525A patent/UY34525A/es not_active Application Discontinuation
- 2012-12-18 AR ARP120104795A patent/AR089302A1/es not_active Application Discontinuation
- 2012-12-19 TW TW101148516A patent/TWI468187B/zh not_active IP Right Cessation
-
2014
- 2014-04-25 ZA ZA2014/03041A patent/ZA201403041B/en unknown
- 2014-06-02 IL IL232946A patent/IL232946A0/en active IP Right Grant
- 2014-12-04 HR HRP20141176AT patent/HRP20141176T1/hr unknown
- 2014-12-19 CY CY20141101072T patent/CY1116142T1/el unknown
- 2014-12-22 SM SM201400192T patent/SMT201400192B/xx unknown
-
2015
- 2015-03-23 ZA ZA2015/01986A patent/ZA201501986B/en unknown
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