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 PDF

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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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Croatia
Prior art keywords
ray diffraction
group
diffraction reflection
additionally
medicinal product
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HRP20200067TT
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English (en)
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Michael Gruss
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Grünenthal GmbH
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Publication of HRP20200067T1 publication Critical patent/HRP20200067T1/hr

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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
    • 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.
HRP20200067TT 2007-12-07 2020-01-16 Medikamenti koji sadrže kristalne modifikacije (1r,2r)-3-(3-dimetilamino-1-etil-2-metilpropil)fenola HRP20200067T1 (hr)

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

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HRP20200067T1 true HRP20200067T1 (hr) 2020-04-03

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HRP20170481TT HRP20170481T1 (hr) 2007-12-07 2008-12-05 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

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Country Status (14)

Country Link
US (1) US8134032B2 (hr)
EP (2) EP3173400B1 (hr)
CN (3) CN104447361B (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 (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE602004007905T2 (de) * 2004-06-28 2008-05-08 Grünenthal GmbH Kristalline Formen von (-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochlorid
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
PT3445742T (pt) 2016-04-19 2020-02-19 Ratiopharm Gmbh Fosfato de tapentadol cristalino

Family Cites Families (7)

* Cited by examiner, † Cited by third party
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
DE602004007905T2 (de) * 2004-06-28 2008-05-08 Grünenthal 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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Publication number Publication date
PT3173400T (pt) 2019-12-13
DK3173400T3 (da) 2019-11-25
CY1118976T1 (el) 2018-01-10
US20090149534A1 (en) 2009-06-11
IL206197A (en) 2015-03-31
CN104447361A (zh) 2015-03-25
PT2240431T (pt) 2017-05-03
SI2240431T1 (sl) 2017-05-31
US8134032B2 (en) 2012-03-13
CN104447361B (zh) 2017-04-12
CN104447360B (zh) 2017-04-12
SI3173400T1 (sl) 2020-01-31
HUE031126T2 (en) 2017-07-28
EP2240431A1 (de) 2010-10-20
IL206197A0 (en) 2010-12-30
HRP20170481T1 (hr) 2017-05-19
PL3173400T3 (pl) 2020-05-18
CN104447360A (zh) 2015-03-25
ES2623413T3 (es) 2017-07-11
WO2009071310A1 (de) 2009-06-11
IL237478A0 (en) 2015-04-30
DK2240431T3 (en) 2017-04-10
CY1122416T1 (el) 2021-01-27
CN101939287A (zh) 2011-01-05
LT2240431T (lt) 2017-04-10
CN101939287B (zh) 2014-10-22
EP3173400A1 (de) 2017-05-31
EP2240431B1 (de) 2017-01-25
EP3173400B1 (de) 2019-11-06
PL2240431T3 (pl) 2017-07-31
HUE047275T2 (hu) 2020-04-28
ES2764451T3 (es) 2020-06-03

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