ME02668B - Postupak za izdvajanje nalmefen hidrohlorida - Google Patents
Postupak za izdvajanje nalmefen hidrohloridaInfo
- Publication number
- ME02668B ME02668B MEP-2017-75A MEP201775A ME02668B ME 02668 B ME02668 B ME 02668B ME P201775 A MEP201775 A ME P201775A ME 02668 B ME02668 B ME 02668B
- Authority
- ME
- Montenegro
- Prior art keywords
- phase
- nalmefene hydrochloride
- aqueous composition
- process according
- aqueous
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 19
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 title 1
- GYWMRGWFQPSQLK-OPHZJPRHSA-N (4r,4as,7as,12bs)-3-(cyclopropylmethyl)-7-methylidene-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-4a,9-diol;hydron;chloride Chemical compound Cl.N1([C@@H]2CC3=CC=C(C=4O[C@@H]5[C@](C3=4)([C@]2(CCC5=C)O)CC1)O)CC1CC1 GYWMRGWFQPSQLK-OPHZJPRHSA-N 0.000 claims 10
- 239000000203 mixture Substances 0.000 claims 10
- 229960000677 nalmefene hydrochloride Drugs 0.000 claims 10
- 229960003086 naltrexone Drugs 0.000 claims 4
- DQCKKXVULJGBQN-XFWGSAIBSA-N naltrexone Chemical compound N1([C@@H]2CC3=CC=C(C=4O[C@@H]5[C@](C3=4)([C@]2(CCC5=O)O)CC1)O)CC1CC1 DQCKKXVULJGBQN-XFWGSAIBSA-N 0.000 claims 4
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims 3
- 239000003960 organic solvent Substances 0.000 claims 3
- 239000007787 solid Substances 0.000 claims 3
- LSNNMFCWUKXFEE-UHFFFAOYSA-N Sulfurous acid Chemical class OS(O)=O LSNNMFCWUKXFEE-UHFFFAOYSA-N 0.000 claims 2
- 239000012452 mother liquor Substances 0.000 claims 2
- 229950010675 nalmefene hydrochloride dihydrate Drugs 0.000 claims 2
- LSNNMFCWUKXFEE-UHFFFAOYSA-M Bisulfite Chemical compound OS([O-])=O LSNNMFCWUKXFEE-UHFFFAOYSA-M 0.000 claims 1
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 claims 1
- 239000012736 aqueous medium Substances 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 239000007900 aqueous suspension Substances 0.000 claims 1
- -1 bisulfite anion Chemical class 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- 238000002955 isolation Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 claims 1
- 238000005292 vacuum distillation Methods 0.000 claims 1
- 238000005406 washing Methods 0.000 claims 1
Classifications
-
- 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
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D489/00—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula:
- C07D489/06—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula: with a hetero atom directly attached in position 14
- C07D489/08—Oxygen atom
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Biomedical Technology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Emergency Medicine (AREA)
- Epidemiology (AREA)
- Psychiatry (AREA)
- Addiction (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (15)
1. Postupak za izdvajanje nalmefen hidrohlorida iz vodene kompozicije koja sadrži nalmefen hidrohlorid i naltrekson,pri čemu pomenutipostupak obuhvata fazu izolovanja nalmefen hidrohlorida iz neke vodene suspenzije koja obuhvata proizvod pripajanja naltrekson bisulfita ičvrstinalmefen hidrohlorid.
2. Postupak prema zahtevu 1,u kom je pomenuta vodena kompozicija nekivodeni rastvor.
3. Postupak prema bilo kom od zahteva 1-2,kojiobuhvata sledeće faze: (b) koncentrovanje vodene kompozicije; (e) mešanje vodene kompozicije sa bisulfitnom solju ili sa pogodnom solju stvarajući bisulfitni anjon u vodenoj sredini, pričemu se faze (b) i(e) mogu izvesti istovremeno i/ili sekvencijalno po bilo kom redosledu, (d) hlađenje mešavine dobijene iz faza (b) i (e), (e) izolovanje čvrste supstance iz mešavine dobijene u fazi (d), da bi se dobio nalmefen hidrohlorid.
4. Postupak prema zahtevu 3,u kom se faze (b) i (e) izvode istovremeno.
5.Postupak prema zahtevu 3,u kom se faze (b) i (e) izvode sekvencijalno počevšiod faze (e) praćeno fazom (b).
6. Postupak prema zahtevu 3,u kom se faze (b) i (e) izvode sekvencijalno počevšiod faze (b) praćeno fazom (e).
7. Postupak prema bilo kom od zahteva 3-6,kojiobuhvata početnu fazu (a) koja se izvodi pre faza (b) i (e); (a) ekstrahovanje vodene kompozicije nekim organskim rastvaračem praćeno izolovanjem vodenog sloja, gde vodena kompozicija faze (b) ili (e) obuhvata vodeni sloj izolovan iz faze (a). r 2
8. Postupak prema zahtevu 7,u kom je organskirastvarač u fazi (a) dihlorometan.
9. Postupak prema bilo kom od zahteva 3-8,u kom se koncentrovanje u fazi (b) izvodivakuumskom destilacijom.
10.Postupak prema bilo kom od zahteva 3-9,u kom je bisulfitna so u fazi (e) natrijum bisulfit.
11.Postupak prema bilo kom od zahteva 3-10 praćen fazom: (f) ispiranje čvrste supstance dobijene u fazi (e) jednim ili više pogodnih organskih rastvarača.
12.Postupak prema bilo kom od zahteva 1-11,u kom pomenuta vodena kompozicija koja sadrži nalmefen hidrohlorid i naltrekson,obuhvata matični lug dobijen iz postupka pripremanja nalmefen hidrohlorid dihidrata.
13.Postupak prema bilo kom od zahteva 1-11,u kom pomenuta vodena kompozicija koja sadrži nalmefen hidrohlorid i naltrekson,obuhvata matični lug dobijen iz postupka pripremanja nalmefen hidrohlorid monohidrata.
14.Postupak za pripremanje nalmefen hidrohlorid dihidrata ili nalmefen hidrohlorid monohidrata,gde pomenuti postupak uključuje izdvajanje nalmefen hidrohlorida postupkom prema bilo kom od zahteva 1-13.
15.Jedinjenje predstavljeno formulom
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161567148P | 2011-12-06 | 2011-12-06 | |
| DKPA201100948 | 2011-12-06 | ||
| EP12797909.4A EP2788357B1 (en) | 2011-12-06 | 2012-12-06 | Process for recovery of nalmefene hydrochloride |
| PCT/EP2012/074623 WO2013083685A1 (en) | 2011-12-06 | 2012-12-06 | Process for recovery of nalmefene hydrochloride |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ME02668B true ME02668B (me) | 2017-06-20 |
Family
ID=48573602
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2017-75A ME02668B (me) | 2011-12-06 | 2012-12-06 | Postupak za izdvajanje nalmefen hidrohlorida |
Country Status (32)
| Country | Link |
|---|---|
| US (1) | US8841452B1 (me) |
| EP (1) | EP2788357B1 (me) |
| JP (1) | JP6086925B2 (me) |
| KR (1) | KR20140103288A (me) |
| CN (1) | CN104093721B (me) |
| AR (1) | AR089080A1 (me) |
| AU (1) | AU2012347261B2 (me) |
| BR (1) | BR112014013541B1 (me) |
| CA (1) | CA2857096C (me) |
| CL (1) | CL2014001454A1 (me) |
| CO (1) | CO6970605A2 (me) |
| CY (1) | CY1118785T1 (me) |
| DK (1) | DK2788357T3 (me) |
| ES (1) | ES2622156T3 (me) |
| HR (1) | HRP20170497T1 (me) |
| HU (1) | HUE033717T2 (me) |
| IL (1) | IL232826A (me) |
| IN (1) | IN2014KN01211A (me) |
| JO (1) | JO3251B1 (me) |
| LT (1) | LT2788357T (me) |
| ME (1) | ME02668B (me) |
| MX (1) | MX354331B (me) |
| PL (1) | PL2788357T3 (me) |
| PT (1) | PT2788357T (me) |
| RS (1) | RS55817B1 (me) |
| RU (1) | RU2631652C2 (me) |
| SG (1) | SG11201402956UA (me) |
| SI (1) | SI2788357T1 (me) |
| SM (1) | SMT201700200T1 (me) |
| TW (1) | TWI560170B (me) |
| WO (1) | WO2013083685A1 (me) |
| ZA (1) | ZA201404100B (me) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105646508B (zh) * | 2016-02-17 | 2018-02-27 | 南京卓康医药科技有限公司 | 一种盐酸纳美芬一水合物的制备方法 |
| US10927121B1 (en) | 2019-12-20 | 2021-02-23 | Southwest Research Institute | Technologies for removing residual solvent from nalmefene hydrochloride and producing crystalline nalmefene hydrochloride monohydrate, monosolvate, or crystalline nalmefene hydrochloride dihydrate |
| WO2022165040A1 (en) | 2021-01-28 | 2022-08-04 | Rhodes Technologies | Process for crystallizing nalmefene hydrochloride |
| CN117986261B (zh) * | 2024-04-02 | 2024-06-18 | 成都瑞尔医药科技有限公司 | 一种盐酸纳美芬母液的回收套用方法 |
| CN119080788A (zh) * | 2024-08-19 | 2024-12-06 | 南京海鲸药业股份有限公司 | 一种盐酸纳美芬杂质的去除监控系统及去除方法 |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2577947A (en) * | 1951-12-11 | Manufacture of dihydrocodeinone | ||
| US3814768A (en) * | 1971-11-26 | 1974-06-04 | Lewenstein E | 6-methylene-6-desoxy dihydro morphine and codeine derivatives and pharmaceutically acceptable salts |
| US3896226A (en) * | 1971-11-26 | 1975-07-22 | Lewinstein Evalina | 6-methylene-6-desoxy dihydro morphine and codeine derivatives and pharmaceutically acceptable salts thereof, and use of the same as a narcotic antagonist |
| US4535157A (en) | 1983-11-01 | 1985-08-13 | Key Pharmaceuticals, Inc. | Process for making 6-desoxy-6-methylenenaloxone and 6-desoxy-6-methylenenaltrexone |
| US4751307A (en) | 1985-01-17 | 1988-06-14 | Mallinckrodt, Inc. | Wittig-reaction processes |
| US5869669A (en) * | 1996-07-26 | 1999-02-09 | Penick Corporation | Preparation of 14-hydroxynormorphinones from normorphinone dienol acylates |
| EP2003134B1 (en) * | 1999-11-09 | 2011-03-02 | Abbott Laboratories | Hydromorphinone compositions |
| JP4683842B2 (ja) * | 2002-03-14 | 2011-05-18 | ユーロ−セルティーク エス．エイ． | 塩酸ナルトレキソン組成物 |
| CN101395159A (zh) * | 2006-03-02 | 2009-03-25 | 马林克罗特公司 | 制备含有低含量α,β-不饱和酮化合物的吗啡烷-6-酮产物的方法 |
| CA2671518C (en) * | 2006-12-04 | 2016-06-07 | Noramco, Inc. | Process for preparing oxycodone having reduced levels of 14-hydroxycodeinone |
| EP2121669A2 (en) | 2007-01-30 | 2009-11-25 | Biogen Idec MA, Inc. | Furanone compounds and methods of making and using the same |
| UA102128C2 (en) | 2008-12-05 | 2013-06-10 | Х. Луннбек А/С | Nalmefene hydrochloride dihydrate |
| ME02622B (me) | 2009-05-25 | 2017-06-20 | H Lundbeck As | Pripremanje nalmefen hidrohlorida od naltreksona |
| CN101768164B (zh) * | 2010-01-25 | 2011-09-14 | 海南数尔药物研究有限公司 | 一种高纯度的盐酸纳洛酮化合物 |
-
2012
- 2012-11-22 TW TW101143647A patent/TWI560170B/zh not_active IP Right Cessation
- 2012-12-04 AR ARP120104552A patent/AR089080A1/es unknown
- 2012-12-04 JO JOP/2012/0364A patent/JO3251B1/ar active
- 2012-12-06 US US14/294,707 patent/US8841452B1/en active Active
- 2012-12-06 JP JP2014545252A patent/JP6086925B2/ja active Active
- 2012-12-06 LT LTEP12797909.4T patent/LT2788357T/lt unknown
- 2012-12-06 ES ES12797909.4T patent/ES2622156T3/es active Active
- 2012-12-06 AU AU2012347261A patent/AU2012347261B2/en not_active Ceased
- 2012-12-06 SM SM20170200T patent/SMT201700200T1/it unknown
- 2012-12-06 PT PT127979094T patent/PT2788357T/pt unknown
- 2012-12-06 WO PCT/EP2012/074623 patent/WO2013083685A1/en not_active Ceased
- 2012-12-06 DK DK12797909.4T patent/DK2788357T3/en active
- 2012-12-06 KR KR1020147016975A patent/KR20140103288A/ko not_active Ceased
- 2012-12-06 HU HUE12797909A patent/HUE033717T2/en unknown
- 2012-12-06 CN CN201280067483.6A patent/CN104093721B/zh not_active Expired - Fee Related
- 2012-12-06 ME MEP-2017-75A patent/ME02668B/me unknown
- 2012-12-06 HR HRP20170497TT patent/HRP20170497T1/hr unknown
- 2012-12-06 IN IN1211KON2014 patent/IN2014KN01211A/en unknown
- 2012-12-06 CA CA2857096A patent/CA2857096C/en active Active
- 2012-12-06 SI SI201230923A patent/SI2788357T1/sl unknown
- 2012-12-06 PL PL12797909T patent/PL2788357T3/pl unknown
- 2012-12-06 SG SG11201402956UA patent/SG11201402956UA/en unknown
- 2012-12-06 EP EP12797909.4A patent/EP2788357B1/en active Active
- 2012-12-06 RU RU2014126489A patent/RU2631652C2/ru active
- 2012-12-06 MX MX2014006705A patent/MX354331B/es active IP Right Grant
- 2012-12-06 BR BR112014013541-0A patent/BR112014013541B1/pt not_active IP Right Cessation
- 2012-12-06 RS RS20170349A patent/RS55817B1/sr unknown
-
2014
- 2014-05-27 IL IL232826A patent/IL232826A/en active IP Right Grant
- 2014-06-03 CL CL2014001454A patent/CL2014001454A1/es unknown
- 2014-06-05 ZA ZA2014/04100A patent/ZA201404100B/en unknown
- 2014-06-06 CO CO14122226A patent/CO6970605A2/es active IP Right Grant
-
2017
- 2017-03-31 CY CY20171100389T patent/CY1118785T1/el unknown
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