ECSP22022403A - Proceso industrial para la preparación de estetrol de alta pureza - Google Patents
Proceso industrial para la preparación de estetrol de alta purezaInfo
- Publication number
- ECSP22022403A ECSP22022403A ECSENADI202222403A ECDI202222403A ECSP22022403A EC SP22022403 A ECSP22022403 A EC SP22022403A EC SENADI202222403 A ECSENADI202222403 A EC SENADI202222403A EC DI202222403 A ECDI202222403 A EC DI202222403A EC SP22022403 A ECSP22022403 A EC SP22022403A
- Authority
- EC
- Ecuador
- Prior art keywords
- estetrol
- preparation
- high purity
- industrial process
- formula
- Prior art date
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07J—STEROIDS
- C07J1/00—Normal steroids containing carbon, hydrogen, halogen or oxygen, not substituted in position 17 beta by a carbon atom, e.g. estrane, androstane
- C07J1/0051—Estrane derivatives
- C07J1/0066—Estrane derivatives substituted in position 17 beta not substituted in position 17 alfa
- C07J1/007—Estrane derivatives substituted in position 17 beta not substituted in position 17 alfa the substituent being an OH group free esterified or etherified
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07J—STEROIDS
- C07J1/00—Normal steroids containing carbon, hydrogen, halogen or oxygen, not substituted in position 17 beta by a carbon atom, e.g. estrane, androstane
- C07J1/0051—Estrane derivatives
- C07J1/0066—Estrane derivatives substituted in position 17 beta not substituted in position 17 alfa
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/566—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol having an oxo group in position 17, e.g. estrone
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
- A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/30—Oestrogens
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07J—STEROIDS
- C07J1/00—Normal steroids containing carbon, hydrogen, halogen or oxygen, not substituted in position 17 beta by a carbon atom, e.g. estrane, androstane
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07J—STEROIDS
- C07J75/00—Processes for the preparation of steroids in general
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07J—STEROIDS
- C07J1/00—Normal steroids containing carbon, hydrogen, halogen or oxygen, not substituted in position 17 beta by a carbon atom, e.g. estrane, androstane
- C07J1/0051—Estrane derivatives
- C07J1/0066—Estrane derivatives substituted in position 17 beta not substituted in position 17 alfa
- C07J1/007—Estrane derivatives substituted in position 17 beta not substituted in position 17 alfa the substituent being an OH group free esterified or etherified
- C07J1/0074—Esters
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P20/00—Technologies relating to chemical industry
- Y02P20/50—Improvements relating to the production of bulk chemicals
- Y02P20/55—Design of synthesis routes, e.g. reducing the use of auxiliary or protecting groups
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Immunology (AREA)
- Gynecology & Obstetrics (AREA)
- Dermatology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Diabetes (AREA)
- Transplantation (AREA)
- Steroid Compounds (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
La invención se refiere a la preparación de estetrol de fórmula (I), derivados del mismo protegido en las posiciones 3,15α,16α,17β de fórmula general (III), y derivados 3-hidroxi del mismo protegido en las posiciones 15α,16α,17β de fórmula general (IV), y a los productos intermedios de fórmulas generales (III) y (IV) aplicados en el proceso. Otro aspecto de la invención es la aplicación de estetrol de fórmula (I) obtenido por el proceso de la invención para la preparación de una composición farmacéutica.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| HU1900315A HU231240B1 (hu) | 2019-09-03 | 2019-09-03 | Ipari eljárás nagytisztaságú ösztetrol hatóanyag előállítására |
| PCT/IB2020/058148 WO2021044302A1 (en) | 2019-09-03 | 2020-09-02 | Industrial process for the preparation of high purity estetrol |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ECSP22022403A true ECSP22022403A (es) | 2022-04-29 |
Family
ID=89992977
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ECSENADI202222403A ECSP22022403A (es) | 2019-09-03 | 2022-03-24 | Proceso industrial para la preparación de estetrol de alta pureza |
Country Status (32)
| Country | Link |
|---|---|
| US (1) | US11633406B2 (es) |
| EP (1) | EP3877395B1 (es) |
| JP (1) | JP7265087B2 (es) |
| KR (1) | KR102871606B1 (es) |
| CN (1) | CN114302889B (es) |
| AU (1) | AU2020343497B2 (es) |
| CA (1) | CA3147815C (es) |
| CL (1) | CL2022000492A1 (es) |
| CO (1) | CO2022003769A2 (es) |
| CU (1) | CU24692B1 (es) |
| DK (1) | DK3877395T3 (es) |
| EC (1) | ECSP22022403A (es) |
| ES (1) | ES2855923T3 (es) |
| FI (1) | FI3877395T3 (es) |
| GE (1) | GEP20247626B (es) |
| HR (1) | HRP20230230T1 (es) |
| HU (2) | HU231240B1 (es) |
| IL (1) | IL290973B2 (es) |
| JO (1) | JOP20220041A1 (es) |
| LT (1) | LT3877395T (es) |
| MA (1) | MA54200B1 (es) |
| MD (1) | MD3877395T2 (es) |
| MX (1) | MX2022002603A (es) |
| MY (1) | MY206905A (es) |
| PE (1) | PE20221418A1 (es) |
| PH (1) | PH12022550388A1 (es) |
| PL (1) | PL3877395T3 (es) |
| PT (1) | PT3877395T (es) |
| RS (1) | RS63966B1 (es) |
| SI (1) | SI3877395T1 (es) |
| WO (1) | WO2021044302A1 (es) |
| ZA (1) | ZA202203557B (es) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE112020004564T5 (de) * | 2019-09-27 | 2022-06-15 | Industriale Chimica S.R.L. | VERFAHREN ZUM HERSTELLEN VON (15α,16α,17β)-ESTRA-1,3,5(10)-TRIEN-3,15,16,17-TETROL (ESTETROL) UND ZWISCHENSTUFEN DES VERFAHRENS |
| HU231651B1 (hu) * | 2021-10-01 | 2025-05-28 | Industriale Chimica S.R.L. | Eljárás (15alfa,16alfa,17béta)-ösztra-1,3,5(10)-trién-3,15,16,17-tetrol (esztetrol) és esztetrol-monohidrát előállítására |
| JP2026503158A (ja) * | 2023-02-02 | 2026-01-27 | インダストリアーレ キミカ エッセ．エッレ．エッレ． | （１５α，１６α，１７β）－エストラ－１，３，５（１０）－トリエン－３，１５，１６，１７－テトロール（エステトロール）一水和物の調製方法 |
| CN117088928B (zh) * | 2023-08-16 | 2025-09-09 | 湖北共同甾体药物研究院有限公司 | 用于制备高纯度雌四醇的工艺 |
| CN119569803B (zh) * | 2023-09-05 | 2025-09-16 | 秦皇岛紫竹药业有限公司 | 一种制备高纯度雌四醇的方法 |
| HUP2400151A1 (hu) | 2024-02-28 | 2025-09-28 | Richter Gedeon Nyrt | Ösztetrol-monohidrát kristályosítási eljárás |
| CN119112905B (zh) * | 2024-09-10 | 2026-07-28 | 武汉九珑人福药业有限责任公司 | 含雌孕激素的药物组合物、药物制剂及其制备方法、应用 |
Family Cites Families (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE60217324T2 (de) | 2001-05-18 | 2007-04-26 | Pantarhei Bioscience B.V. | Pharmazeutische zusammensetzung für die hormonersatztherapie |
| EP1260225A1 (en) | 2001-05-18 | 2002-11-27 | Pantarhei Bioscience B.V. | A pharmaceutical composition for use in hormone replacement therapy |
| DK1390042T3 (da) | 2001-05-23 | 2008-03-31 | Pantarhei Bioscience Bv | System for administration af et lægemiddel omfattende tetrahydroxyleret östrogen til anvendelse i hormonal svangerskabsforebyggelse |
| DE60234515D1 (de) | 2001-05-23 | 2010-01-07 | Pantarhei Bioscience Bv | Tetrahydroxylierte estrogen enthaltendes arzneistoffverabreichungssystem zur verwendung in hormonalen kontrazeption |
| DE60216630T2 (de) | 2001-11-15 | 2007-09-20 | Pantarhei Bioscience B.V. | Verwendung von östrogen in kombination mit progestogen für die hormonsubstitutiionstherapie |
| SI1511496T1 (sl) | 2002-06-11 | 2007-04-30 | Pantarhei Bioscience Bv | Metoda zdravljenja ali prevencije imunsko mediiranih motenj in farmacevtska formulacija za njeno uporabo |
| ES2399423T3 (es) | 2002-06-11 | 2013-04-01 | Pantarhei Bioscience B.V. | Método para tratar la piel humana y una composición para el cuidado de la piel para su uso en tal método |
| EP1526856B1 (en) | 2002-07-12 | 2008-01-02 | Pantarhei Bioscience B.V. | Pharmaceutical composition comprising estetrol derivatives for use in cancer therapy |
| WO2004037269A1 (en) | 2002-10-23 | 2004-05-06 | Pantarhei Bioscience B.V. | Pharmaceutical compositions comprising estetrol derivatives for use in cancer therapy |
| CN100343269C (zh) * | 2002-11-08 | 2007-10-17 | 潘塔希生物科学股份有限公司 | 通过雌酮衍生的甾体化合物合成雌四醇 |
| US20090221540A1 (en) | 2006-01-09 | 2009-09-03 | Pantarhei Bioscience B.V. | Method of Treating An Acute Vascular Disorder |
| DE602008001783D1 (de) | 2007-01-08 | 2010-08-26 | Pantarhei Bioscience Bv | Verfahren zur behandlung oder prävention von unfruchtbarkeit bei weiblichen säugern und pharmazeutisches kit zur anwendung dieses verfahrens |
| EP2383279A1 (en) * | 2011-07-19 | 2011-11-02 | Pantarhei Bioscience B.V. | Process for the preparation of estetrol |
| CA2843951C (en) | 2011-08-11 | 2019-08-06 | Wout WOUTERS | Use of estetrol as emergency contraceptive |
| AU2012320423C1 (en) * | 2011-10-07 | 2018-01-25 | Estetra Srl | Process for the production of estetrol |
| EP2653163A1 (en) | 2012-04-19 | 2013-10-23 | Université de Liège | Estrogenic components for use in the treatment of neurological disorders |
| WO2013034780A2 (en) * | 2012-12-20 | 2013-03-14 | Crystal Pharma, S.A.U. | Process for the preparation of estetrol and related compounds |
| ES2624667T3 (es) * | 2013-09-18 | 2017-07-17 | Crystal Pharma, S.A.U. | Procedimiento para la preparación de estetrol |
| DK3079671T3 (en) | 2013-12-12 | 2017-12-11 | Donesta Bioscience B V | Orally disintegrating solid dosage unit containing an estetrol component |
| EP3701944B1 (en) | 2015-06-18 | 2021-12-08 | Estetra SRL | Orodispersible dosage unit containing an estetrol component |
| LT3310345T (lt) | 2015-06-18 | 2021-06-25 | Estetra Sprl | Burnoje disperguojama tabletė, turinti estetrolio |
| MA44206B1 (fr) | 2015-06-18 | 2021-04-30 | Estetra Sprl | Comprimé orodispersible comprenant estetrol |
| CA3178291A1 (en) | 2016-08-05 | 2018-04-12 | Estetra Srl | Method for the management of dysmenorrhea and menstrual pain |
| KR102780201B1 (ko) | 2016-10-28 | 2025-03-12 | 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 | 월경통 및 생리통의 관리방법 |
| SG11202000881VA (en) | 2017-08-01 | 2020-02-27 | Fund Sa | Adjuvant therapy for use in prostate cancer treatment |
| IL276584B2 (en) | 2018-02-07 | 2024-10-01 | Estetra Srl | Contraceptive composition with reduced cardiovascular effects |
| DE112020004564T5 (de) | 2019-09-27 | 2022-06-15 | Industriale Chimica S.R.L. | VERFAHREN ZUM HERSTELLEN VON (15α,16α,17β)-ESTRA-1,3,5(10)-TRIEN-3,15,16,17-TETROL (ESTETROL) UND ZWISCHENSTUFEN DES VERFAHRENS |
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2019
- 2019-09-03 HU HU1900315A patent/HU231240B1/hu unknown
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2020
- 2020-09-02 ES ES20768398T patent/ES2855923T3/es active Active
- 2020-09-02 FI FIEP20768398.8T patent/FI3877395T3/fi active
- 2020-09-02 CN CN202080061521.1A patent/CN114302889B/zh active Active
- 2020-09-02 PT PT207683988T patent/PT3877395T/pt unknown
- 2020-09-02 RS RS20230112A patent/RS63966B1/sr unknown
- 2020-09-02 MD MDE20210894T patent/MD3877395T2/ro unknown
- 2020-09-02 IL IL290973A patent/IL290973B2/en unknown
- 2020-09-02 GE GEAP202015920A patent/GEP20247626B/en unknown
- 2020-09-02 CA CA3147815A patent/CA3147815C/en active Active
- 2020-09-02 KR KR1020227010919A patent/KR102871606B1/ko active Active
- 2020-09-02 MY MYPI2022000866A patent/MY206905A/en unknown
- 2020-09-02 LT LTEPPCT/IB2020/058148T patent/LT3877395T/lt unknown
- 2020-09-02 WO PCT/IB2020/058148 patent/WO2021044302A1/en not_active Ceased
- 2020-09-02 SI SI202030156T patent/SI3877395T1/sl unknown
- 2020-09-02 MA MA54200A patent/MA54200B1/fr unknown
- 2020-09-02 AU AU2020343497A patent/AU2020343497B2/en active Active
- 2020-09-02 HR HRP20230230TT patent/HRP20230230T1/hr unknown
- 2020-09-02 MX MX2022002603A patent/MX2022002603A/es unknown
- 2020-09-02 CU CU2022000013A patent/CU24692B1/es unknown
- 2020-09-02 JP JP2022511285A patent/JP7265087B2/ja active Active
- 2020-09-02 EP EP20768398.8A patent/EP3877395B1/en active Active
- 2020-09-02 PE PE2022000348A patent/PE20221418A1/es unknown
- 2020-09-02 HU HUE20768398A patent/HUE061427T2/hu unknown
- 2020-09-02 DK DK20768398.8T patent/DK3877395T3/da active
- 2020-09-02 PL PL20768398.8T patent/PL3877395T3/pl unknown
- 2020-09-02 US US17/639,206 patent/US11633406B2/en active Active
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2022
- 2022-02-21 JO JOP/2022/0041A patent/JOP20220041A1/ar unknown
- 2022-02-28 CL CL2022000492A patent/CL2022000492A1/es unknown
- 2022-03-24 EC ECSENADI202222403A patent/ECSP22022403A/es unknown
- 2022-03-28 ZA ZA2022/03557A patent/ZA202203557B/en unknown
- 2022-03-29 CO CONC2022/0003769A patent/CO2022003769A2/es unknown
- 2022-09-02 PH PH1/2022/550388A patent/PH12022550388A1/en unknown
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