HRP20200067T1 - Medikamenti koji sadrže kristalne modifikacije (1r,2r)-3-(3-dimetilamino-1-etil-2-metilpropil)fenola - Google Patents
Medikamenti koji sadrže kristalne modifikacije (1r,2r)-3-(3-dimetilamino-1-etil-2-metilpropil)fenola Download PDFInfo
- Publication number
- HRP20200067T1 HRP20200067T1 HRP20200067TT HRP20200067T HRP20200067T1 HR P20200067 T1 HRP20200067 T1 HR P20200067T1 HR P20200067T T HRP20200067T T HR P20200067TT HR P20200067 T HRP20200067 T HR P20200067T HR P20200067 T1 HRP20200067 T1 HR P20200067T1
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- Prior art keywords
- ray diffraction
- group
- diffraction reflection
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- medicinal product
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Links
- 238000012986 modification Methods 0.000 title claims 11
- 230000004048 modification Effects 0.000 title claims 11
- KWTWDQCKEHXFFR-SMDDNHRTSA-N tapentadol Chemical compound CN(C)C[C@H](C)[C@@H](CC)C1=CC=CC(O)=C1 KWTWDQCKEHXFFR-SMDDNHRTSA-N 0.000 title claims 4
- 238000002441 X-ray diffraction Methods 0.000 claims 13
- 229940126601 medicinal product Drugs 0.000 claims 7
- 239000013078 crystal Substances 0.000 claims 6
- 239000003814 drug Substances 0.000 claims 4
- 229940079593 drug Drugs 0.000 claims 2
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C215/00—Compounds containing amino and hydroxy groups bound to the same carbon skeleton
- C07C215/46—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton
- C07C215/48—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton with amino groups linked to the six-membered aromatic ring, or to the condensed ring system containing that ring, by carbon chains not further substituted by hydroxy groups
- C07C215/54—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton with amino groups linked to the six-membered aromatic ring, or to the condensed ring system containing that ring, by carbon chains not further substituted by hydroxy groups linked by carbon chains having at least three carbon atoms between the amino groups and the six-membered aromatic ring or the condensed ring system containing that ring
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- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pain & Pain Management (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Rheumatology (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (11)
1. Medikament namijenjen oralnoj primjeni, naznačen time što sadrži kristalnu modifikaciju A (1R,2R)-3-(3-dimetilamino-1-etil-2-metilpropil)fenola, koja ima odraz difrakcije rendgenskih zraka na 15,58±0,20 (2Θ), dodatno najmanje jedan odraz difrakcije rendgenskih zraka kojeg se bira iz skupine koju čine 28,37±0,20 (2Θ) i 34,45±0,20 (2Θ) i dodatno najmanje jedan odraz difrakcije rendgenskih zraka kojeg se bira iz skupine koju čine 13,71±0,20 (2Θ), 14,80±0,20 (2Θ), 16,89±0,20 (2Θ), 17,79±0,20 (2Θ), 18,45±0,20 (2Θ), 20,20±0,20 (2Θ), 20,92±0,20 (2Θ), 22,50±0,20 (2Θ), 24,37±0,20 (2Θ) i 25,33±0,20 (2Θ).
2. Medikament u skladu s patentnim zahtjevom 1, naznačen time što kristalna modifikacija A dodatno sadrži najmanje jedan odraz difrakcije rendgenskih zraka kojeg se bira iz skupine koju čine 14,11±0,20 (2Θ), 19,07±0,20 (2Θ), 21,12±0,20 (2Θ), 21,90±0,20 (2Θ), 22,21 ±0,20 (2Θ), 24,75±0,20 (2Θ), 27,32±0,20 (2Θ), 27,55±0,20 (2Θ), 29,90±0,20 (2Θ) i 30,68±0,20 (2Θ).
3. Medikament u skladu s bilo kojim od patentnih zahtjeva 1 ili 2, naznačen time što kristalna modifikacija A ne sadrži najmanje jedan odraz difrakcije rendgenskih zraka kojeg se bira iz skupine koju čine 8,10±0,20 (2Θ), 10,93±0,20 (2Θ), 11,83±0,20 (2Θ), 12,41 ±0,20 (2Θ), 26,22±0,20 (2Θ), 26,54±0,20 (2Θ) i 26,72±0,20 (2Θ).
4. Medikament u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačen time što je kristalna modifikacija A endotermna u rasponu od 75 do 84 °C kod DSC.
5. Medikament namijenjen oralnoj primjeni, naznačen time što sadrži kristalnu modifikaciju B (1R,2R)-3-(3-dimetilamino-1-etil-2-metilpropil)fenola, koja ima odraz difrakcije rendgenskih zraka na 29,06±0,20 (2Θ), dodatno najmanje jedan odraz difrakcije rendgenskih zraka kojeg se bira iz skupine koju čine 19,50±0,20 (2Θ), 35,49±0,20 (2Θ) i 40,01±0,20 (2Θ) i dodatno najmanje jedan odraz difrakcije rendgenskih zraka kojeg se bira iz skupine koju čine 14,11±0,20 (2Θ), 14,44±0,20 (2Θ), 16,08±0,20 (2Θ), 17,17±0,20 (2Θ), 17,43±0,20 (2Θ), 18,81±0,20 (2Θ), 20,24±0,20 (2Θ), 20,80±0,20 (2Θ), 22,00±0,20 (2Θ), 22,49±0,20 (2Θ), 23,40±0,20 (2Θ), 24,15±0,20 (2Θ), 24,51±0,20 (2Θ) i 29,89±0,20 (2Θ).
6. Medikament u skladu s patentnim zahtjevom 5, naznačen time što kristalna modifikacija B dodatno sadrži najmanje jedan odraz difrakcije rendgenskih zraka kojeg se bira iz skupine koju čine 18,67±0,20 (2Θ), 25,24±0,20 (2Θ), 25,36±0,20 (2Θ), 27,58±0,20 (2Θ), 27,79±0,20 (2Θ), 30,11±0,20 (2Θ) i 31,00±0,20 (2Θ).
7. Medikament u skladu s bilo kojim od patentnih zahtjeva 5 ili 6, naznačen time što kristalna modifikacija B ne sadrži najmanje jedan odraz difrakcije rendgenskih zraka kojeg se bira iz skupine koju čine 8,10±0,20 (2Θ), 10,93±0,20 (2Θ), 11,83±0,20 (2Θ), 12,41±0,20 (2Θ), 26,22±0,20 (2Θ), 26,54±0,20 (2Θ) i 26,72±0,20 (2Θ).
8. Medikament u skladu s bilo kojim od patentnih zahtjeva 5-7, naznačen time što je kristalna modifikacija B endotermna u rasponu od 87-93 °C kod DSC.
9. Medikament namijenjen oralnoj primjeni, naznačen time što sadrži kristalnu modifikaciju C (1R,2R)-3-(3-dimetilamino-1-etil-2-metilpropil)fenola, koja sadrži najmanje jedan odraz difrakcije rendgenskih zraka kojeg se bira iz skupine koju čine 10,93±0,20 (2Θ), 12,41±0,20 (2Θ) i 26,22±0,20 (2Θ), dodatno najmanje jedan odraz difrakcije rendgenskih zraka kojeg se bira iz skupine koju čine 8,10±0,20 (2Θ), 11,83±0,20 (2Θ), 26,54±0,20 (2Θ) i 26,72±0,20 (2Θ) i dodatno najmanje jedan odraz difrakcije rendgenskih zraka kojeg se bira iz skupine koju čine 13,71±0,20 (2Θ), 14,13±0,20 (2Θ), 14,82±0,20 (2Θ), 15,34±0,20 (2Θ), 15,59±0,20 (2Θ), 16,10±0,20 (2Θ), 16,43±0,20 (2Θ), 16,91±0,20 (2Θ), 17,32±0,20 (2Θ), 17,58±0,20 (2Θ), 17,82±0,20 (2Θ), 18,01±0,20 (2Θ), 18,46±0,20 (2Θ), 19,05±0,20 (2Θ), 20,23±0,20 (2Θ), 20,71 ±0,20 (2Θ), 20,94±0,20 (2Θ), 21,17±0,20 (2Θ), 21,90±0,20 (2Θ), 22,23±0,20 (2Θ), 22,52±0,20 (2Θ), 23,32±0,20 (2Θ), 24,12±0,20 (2Θ), 24,39±0,20 (2Θ), 24,92±0,20 (2Θ), 25,35±0,20 (2Θ), 27,33±0,20 (2Θ), 27,63±0,20 (2Θ), 27,84±0,20 (2Θ), 28,48±0,20 (2Θ), 29,64±0,20 (2Θ), 29,94±0,20 (2Θ), 30,54±0,20 (2Θ), 30,68±0,20 (2Θ), 31,03±0,20 (2Θ), 31,52±0,20 (2Θ), 32,29±0,20 (2Θ), 32,93±0,20 (2Θ), 33,66±0,20 (2Θ), 35,52±0,20 (2Θ), 36,05±0,20 (2Θ), 36,64±0,20 (2Θ), 37,54±0,20 (2Θ), 38,45±0,20 (2Θ), 39,15±0,20 (2Θ) i 40,05±0,20 (2Θ).
10. Medikament u skladu s patentnim zahtjevom 9, naznačen time što je kristalna modifikacija C endotermna s maksimalnom temperaturom od 75-84 °C i/ili endotermna s maksimalnom temperaturom od 87-93 °C u DSC ispitivanjima.
11. Medikament u skladu s bilo kojim od patentnih zahtjeva 1 do 10, namijenjen suzbijanju boli.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP07023728 | 2007-12-07 | ||
EP16203848.3A EP3173400B1 (de) | 2007-12-07 | 2008-12-05 | Arzneimittel enthaltend kristalline modifikationen von (1r,2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20200067T1 true HRP20200067T1 (hr) | 2020-04-03 |
Family
ID=39272207
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20170481TT HRP20170481T1 (hr) | 2007-12-07 | 2017-03-21 | Kristalne modifikacije (1r, 2r)-3-(3-dimentil amino-1-etil-2-metil-propil) fenola |
HRP20200067TT HRP20200067T1 (hr) | 2007-12-07 | 2020-01-16 | Medikamenti koji sadrže kristalne modifikacije (1r,2r)-3-(3-dimetilamino-1-etil-2-metilpropil)fenola |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20170481TT HRP20170481T1 (hr) | 2007-12-07 | 2017-03-21 | Kristalne modifikacije (1r, 2r)-3-(3-dimentil amino-1-etil-2-metil-propil) fenola |
Country Status (14)
Country | Link |
---|---|
US (1) | US8134032B2 (hr) |
EP (2) | EP2240431B1 (hr) |
CN (3) | CN101939287B (hr) |
CY (2) | CY1118976T1 (hr) |
DK (2) | DK3173400T3 (hr) |
ES (2) | ES2764451T3 (hr) |
HR (2) | HRP20170481T1 (hr) |
HU (2) | HUE047275T2 (hr) |
IL (2) | IL206197A (hr) |
LT (1) | LT2240431T (hr) |
PL (2) | PL2240431T3 (hr) |
PT (2) | PT3173400T (hr) |
SI (2) | SI2240431T1 (hr) |
WO (1) | WO2009071310A1 (hr) |
Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20100272815A1 (en) * | 2009-04-28 | 2010-10-28 | Actavis Group Ptc Ehf | Amorphous form of tapentadol hydrochloride |
US8288592B2 (en) | 2009-09-22 | 2012-10-16 | Actavis Group Ptc Ehf | Solid state forms of tapentadol salts |
EP2566461A2 (de) | 2010-05-05 | 2013-03-13 | Ratiopharm GmbH | Festes tapentadol in nicht-kristalliner form |
WO2012051246A1 (en) | 2010-10-12 | 2012-04-19 | Ratiopharm Gmbh | Tapentadol hydrobromide and crystalline forms thereof |
WO2013111161A2 (en) * | 2012-01-10 | 2013-08-01 | Msn Laboratories Limited | Process for the preparation of 3-aryl-2-methyl-propanamine derivatives and polymorphs thereof |
WO2014023652A1 (en) * | 2012-08-06 | 2014-02-13 | Ratiopharm Gmbh | Pharmaceutical formulation comprising tapentadol and cyclodextrin |
EP2808319A1 (en) | 2013-05-31 | 2014-12-03 | Arevipharma GmbH | 3-[3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol resin complex |
CZ307492B6 (cs) | 2014-02-04 | 2018-10-17 | Zentiva, K.S. | Pevná forma maleátu tapentadolu a způsob její přípravy |
GB2523089A (en) * | 2014-02-12 | 2015-08-19 | Azad Pharmaceutical Ingredients Ag | Stable polymorph form B of tapentadol hydrochloride |
ES2966219T3 (es) | 2016-04-19 | 2024-04-19 | Ratiopharm Gmbh | Fosfato de tapentadol amorfo |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1027666C (zh) * | 1993-02-20 | 1995-02-15 | 袁晓辉 | 高分子聚合物正温度系数热敏电阻材料 |
DE4426245A1 (de) * | 1994-07-23 | 1996-02-22 | Gruenenthal Gmbh | 1-Phenyl-3-dimethylamino-propanverbindungen mit pharmakologischer Wirkung |
PE20030527A1 (es) * | 2001-10-24 | 2003-07-26 | Gruenenthal Chemie | Formulacion farmaceutica con liberacion retardada que contiene 3-(3-dimetilamino-1-etil-2-metil-propil) fenol o una sal farmaceuticamente aceptable del mismo y tabletas para administracion oral que la contienen |
DE10326097A1 (de) * | 2003-06-06 | 2005-01-05 | Grünenthal GmbH | Verfahren zur Herstellung von Dimethyl-(3-aryl-butyl)-aminverbindungen |
ATE368639T1 (de) * | 2004-06-28 | 2007-08-15 | Gruenenthal Gmbh | Kristalline formen von (-)-(1r,2r)-3-(3- dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochlorid |
DE102005034974A1 (de) * | 2005-07-22 | 2007-04-19 | Grünenthal GmbH | Salz von Dimethylaminomethyl-phenyl-cyclohexan und dessen kristalline Formen |
US20070254960A1 (en) * | 2006-04-28 | 2007-11-01 | Gruenenthal Gmbh | Pharmaceutical combination |
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2008
- 2008-12-05 HU HUE16203848A patent/HUE047275T2/hu unknown
- 2008-12-05 DK DK16203848T patent/DK3173400T3/da active
- 2008-12-05 US US12/329,111 patent/US8134032B2/en active Active
- 2008-12-05 ES ES16203848T patent/ES2764451T3/es active Active
- 2008-12-05 DK DK08857298.7T patent/DK2240431T3/en active
- 2008-12-05 SI SI200831791A patent/SI2240431T1/sl unknown
- 2008-12-05 LT LTEP08857298.7T patent/LT2240431T/lt unknown
- 2008-12-05 PT PT162038483T patent/PT3173400T/pt unknown
- 2008-12-05 ES ES08857298.7T patent/ES2623413T3/es active Active
- 2008-12-05 EP EP08857298.7A patent/EP2240431B1/de active Active
- 2008-12-05 PT PT88572987T patent/PT2240431T/pt unknown
- 2008-12-05 PL PL08857298T patent/PL2240431T3/pl unknown
- 2008-12-05 PL PL16203848T patent/PL3173400T3/pl unknown
- 2008-12-05 CN CN200880126383.XA patent/CN101939287B/zh active Active
- 2008-12-05 WO PCT/EP2008/010330 patent/WO2009071310A1/de active Application Filing
- 2008-12-05 HU HUE08857298A patent/HUE031126T2/en unknown
- 2008-12-05 SI SI200832101T patent/SI3173400T1/sl unknown
- 2008-12-05 EP EP16203848.3A patent/EP3173400B1/de active Active
- 2008-12-05 CN CN201410468681.4A patent/CN104447361B/zh active Active
- 2008-12-05 CN CN201410468436.3A patent/CN104447360B/zh active Active
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2010
- 2010-06-06 IL IL206197A patent/IL206197A/en active IP Right Grant
-
2015
- 2015-03-01 IL IL237478A patent/IL237478A0/en unknown
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2017
- 2017-03-21 HR HRP20170481TT patent/HRP20170481T1/hr unknown
- 2017-04-07 CY CY20171100414T patent/CY1118976T1/el unknown
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2019
- 2019-12-04 CY CY20191101278T patent/CY1122416T1/el unknown
-
2020
- 2020-01-16 HR HRP20200067TT patent/HRP20200067T1/hr unknown
Also Published As
Publication number | Publication date |
---|---|
DK2240431T3 (en) | 2017-04-10 |
EP3173400A1 (de) | 2017-05-31 |
CN104447360B (zh) | 2017-04-12 |
CN101939287A (zh) | 2011-01-05 |
EP3173400B1 (de) | 2019-11-06 |
CY1118976T1 (el) | 2018-01-10 |
HUE031126T2 (en) | 2017-07-28 |
HRP20170481T1 (hr) | 2017-05-19 |
PL2240431T3 (pl) | 2017-07-31 |
CN104447360A (zh) | 2015-03-25 |
EP2240431B1 (de) | 2017-01-25 |
IL206197A0 (en) | 2010-12-30 |
HUE047275T2 (hu) | 2020-04-28 |
PL3173400T3 (pl) | 2020-05-18 |
ES2764451T3 (es) | 2020-06-03 |
LT2240431T (lt) | 2017-04-10 |
SI3173400T1 (sl) | 2020-01-31 |
EP2240431A1 (de) | 2010-10-20 |
WO2009071310A1 (de) | 2009-06-11 |
IL237478A0 (en) | 2015-04-30 |
CN104447361A (zh) | 2015-03-25 |
CY1122416T1 (el) | 2021-01-27 |
PT3173400T (pt) | 2019-12-13 |
CN104447361B (zh) | 2017-04-12 |
ES2623413T3 (es) | 2017-07-11 |
US20090149534A1 (en) | 2009-06-11 |
CN101939287B (zh) | 2014-10-22 |
IL206197A (en) | 2015-03-31 |
SI2240431T1 (sl) | 2017-05-31 |
US8134032B2 (en) | 2012-03-13 |
DK3173400T3 (da) | 2019-11-25 |
PT2240431T (pt) | 2017-05-03 |
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