CO2022003769A2 - Proceso industrial para la preparación de estetrol de alta pureza - Google Patents
Proceso industrial para la preparación de estetrol de alta purezaInfo
- Publication number
- CO2022003769A2 CO2022003769A2 CONC2022/0003769A CO2022003769A CO2022003769A2 CO 2022003769 A2 CO2022003769 A2 CO 2022003769A2 CO 2022003769 A CO2022003769 A CO 2022003769A CO 2022003769 A2 CO2022003769 A2 CO 2022003769A2
- Authority
- CO
- Colombia
- Prior art keywords
- estetrol
- preparation
- high purity
- industrial process
- formula
- Prior art date
Links
- AJIPIJNNOJSSQC-NYLIRDPKSA-N estetrol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H]([C@H](O)[C@@H]4O)O)[C@@H]4[C@@H]3CCC2=C1 AJIPIJNNOJSSQC-NYLIRDPKSA-N 0.000 title abstract 3
- 229950009589 estetrol Drugs 0.000 title abstract 3
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 abstract 2
- 239000013067 intermediate product Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
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)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Immunology (AREA)
- Gynecology & Obstetrics (AREA)
- Dermatology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (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 protegidos en las posiciones 3,15α,16α,17β de fórmula general (III), y derivados 3-hidroxi del mismo protegidos 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 el uso 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 |
|---|---|
| CO2022003769A2 true CO2022003769A2 (es) | 2022-04-19 |
Family
ID=89992977
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CONC2022/0003769A CO2022003769A2 (es) | 2019-09-03 | 2022-03-29 | Proceso industrial para la preparación de estetrol de alta pureza |
Country Status (29)
| Country | Link |
|---|---|
| US (1) | US11633406B2 (es) |
| EP (1) | EP3877395B1 (es) |
| JP (1) | JP7265087B2 (es) |
| KR (1) | KR20220071206A (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) |
| 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) |
| PE (1) | PE20221418A1 (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 (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20220348607A1 (en) * | 2019-09-27 | 2022-11-03 | Industriale Chimica S.R.L. | Process for preparing (15alpha,16alpha,17beta)-estra-1,3,5(10)-triene- 3,15,16,17-tetrol (estetrol) and intermediates of said process |
| WO2023051937A1 (en) * | 2021-10-01 | 2023-04-06 | Industriale Chimica S.R.L. | Process for preparing (15alpha,16alpha,17 eta)-estra-1,3,5(10)-triene-3,15,16,17-tetrol (estetrol) monohydrate |
Family Cites Families (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1260225A1 (en) | 2001-05-18 | 2002-11-27 | Pantarhei Bioscience B.V. | A pharmaceutical composition for use in hormone replacement therapy |
| PT1390040E (pt) | 2001-05-18 | 2007-04-30 | Pantarhei Bioscience Bv | Composição farmacêutica para ser utilizado na terapia hormonal de substituição. |
| ATE449606T1 (de) | 2001-05-23 | 2009-12-15 | Pantarhei Bioscience Bv | Tetrahydroxylierte estrogen enthaltendes arzneistoffverabreichungssystem zur verwendung in hormonalen kontrazeption |
| US7732430B2 (en) | 2001-05-23 | 2010-06-08 | Pantarhei Bioscience B.V. | Drug delivery system comprising a tetrahydroxilated estrogen for use in hormonal contraception |
| WO2003041718A1 (en) | 2001-11-15 | 2003-05-22 | Pantarhei Bioscience B.V. | Use of estrogenic compounds in combination with progestogenic compounds in hormone-replacement therapy |
| WO2003103684A1 (en) | 2002-06-11 | 2003-12-18 | Pantarhei Bioscience B.V. | Method of treating or preventing immune mediated disorders and pharmaceutical formulation for use therein |
| EP1511498B1 (en) | 2002-06-11 | 2012-11-21 | Pantarhei Bioscience B.V. | A method of treating human skin and a skin care composition for use in such a method |
| EP1526856B1 (en) | 2002-07-12 | 2008-01-02 | Pantarhei Bioscience B.V. | Pharmaceutical composition comprising estetrol derivatives for use in cancer therapy |
| CA2503549C (en) | 2002-10-23 | 2012-07-10 | Pantarhei Bioscience B.V. | Pharmaceutical compositions comprising estetrol derivatives for use in cancer therapy |
| DE60332754D1 (de) * | 2002-11-08 | 2010-07-08 | Pantarhei Bioscience Bv | Synthese von oestetrol aus von oestron abgeleiteten steroiden |
| US20090221540A1 (en) | 2006-01-09 | 2009-09-03 | Pantarhei Bioscience B.V. | Method of Treating An Acute Vascular Disorder |
| EP2114412B1 (en) | 2007-01-08 | 2010-07-14 | Pantarhei Bioscience B.V. | Method of treating or preventing infertility in a female mammal and pharmaceutical kit for use in such method |
| EP2383279A1 (en) * | 2011-07-19 | 2011-11-02 | Pantarhei Bioscience B.V. | Process for the preparation of estetrol |
| HUE033590T2 (hu) | 2011-08-11 | 2017-12-28 | Estetra Sprl | Esztetrol alkalmazása sürgõsségi fogamzásgátlóként |
| JP6196625B2 (ja) | 2011-10-07 | 2017-09-13 | エステトラ エス．ペ．エール．エル． | エステトロールを製造するための方法 |
| 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 |
| US9988417B2 (en) * | 2013-09-18 | 2018-06-05 | Crystal Pharma, S.A.U. | Process for the preparation of estetrol |
| MX369035B (es) | 2013-12-12 | 2019-10-25 | Donesta Bioscience B V | Unidad de dosificacion solida de disolucion oral que contiene un componente de estetrol. |
| SI3310345T1 (sl) | 2015-06-18 | 2021-05-31 | Estetra Sprl | Orodisperzibilna tableta, ki vsebuje estetrol |
| RS61777B1 (sr) | 2015-06-18 | 2021-06-30 | Estetra Sprl | Oralno-disperzibilna tableta koja sadrži estetrol |
| ME03728B (me) | 2015-06-18 | 2021-01-20 | Estetra Sprl | Orodisperzibilna dozna jedinica koja sadrži komponentu estetrola |
| KR20220144885A (ko) | 2016-08-05 | 2022-10-27 | 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 | 월경통 및 생리통의 관리방법 |
| CA3041016C (en) | 2016-10-28 | 2023-09-05 | Estetra Sprl | Method for the management of dysmenorrhea and menstrual pain |
| CA3071660A1 (en) | 2017-08-01 | 2019-02-07 | Fund Sa | Adjuvant therapy for use in prostate cancer treatment |
| SG11202007163WA (en) | 2018-02-07 | 2020-08-28 | Estetra Sprl | Contraceptive composition with reduced cardiovascular effects |
| US20220348607A1 (en) | 2019-09-27 | 2022-11-03 | Industriale Chimica S.R.L. | Process for preparing (15alpha,16alpha,17beta)-estra-1,3,5(10)-triene- 3,15,16,17-tetrol (estetrol) and intermediates of said process |
-
2019
- 2019-09-03 HU HU1900315A patent/HU231240B1/hu unknown
-
2020
- 2020-09-02 CA CA3147815A patent/CA3147815C/en active Active
- 2020-09-02 PL PL20768398.8T patent/PL3877395T3/pl unknown
- 2020-09-02 CN CN202080061521.1A patent/CN114302889B/zh active Active
- 2020-09-02 EP EP20768398.8A patent/EP3877395B1/en active Active
- 2020-09-02 MA MA54200A patent/MA54200B1/fr unknown
- 2020-09-02 MX MX2022002603A patent/MX2022002603A/es unknown
- 2020-09-02 CU CU2022000013A patent/CU24692B1/es unknown
- 2020-09-02 SI SI202030156T patent/SI3877395T1/sl unknown
- 2020-09-02 DK DK20768398.8T patent/DK3877395T3/da active
- 2020-09-02 IL IL290973A patent/IL290973B2/en unknown
- 2020-09-02 RS RS20230112A patent/RS63966B1/sr unknown
- 2020-09-02 AU AU2020343497A patent/AU2020343497B2/en active Active
- 2020-09-02 PE PE2022000348A patent/PE20221418A1/es unknown
- 2020-09-02 HR HRP20230230TT patent/HRP20230230T1/hr unknown
- 2020-09-02 HU HUE20768398A patent/HUE061427T2/hu unknown
- 2020-09-02 JP JP2022511285A patent/JP7265087B2/ja active Active
- 2020-09-02 FI FIEP20768398.8T patent/FI3877395T3/fi active
- 2020-09-02 JO JOP/2022/0041A patent/JOP20220041A1/ar unknown
- 2020-09-02 LT LTEPPCT/IB2020/058148T patent/LT3877395T/lt unknown
- 2020-09-02 MD MDE20210894T patent/MD3877395T2/ro unknown
- 2020-09-02 KR KR1020227010919A patent/KR20220071206A/ko unknown
- 2020-09-02 US US17/639,206 patent/US11633406B2/en active Active
- 2020-09-02 ES ES20768398T patent/ES2855923T3/es active Active
- 2020-09-02 PT PT207683988T patent/PT3877395T/pt unknown
- 2020-09-02 WO PCT/IB2020/058148 patent/WO2021044302A1/en active Application Filing
-
2022
- 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
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