HRP20130225T1 - Formulacija s odgođenim otpuštanjem koja sadrži 3-(2-dimetilaminometilcikloheksil) fenol - Google Patents

Formulacija s odgođenim otpuštanjem koja sadrži 3-(2-dimetilaminometilcikloheksil) fenol Download PDF

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Publication number
HRP20130225T1
HRP20130225T1 HRP20130225TT HRP20130225T HRP20130225T1 HR P20130225 T1 HRP20130225 T1 HR P20130225T1 HR P20130225T T HRP20130225T T HR P20130225TT HR P20130225 T HRP20130225 T HR P20130225T HR P20130225 T1 HRP20130225 T1 HR P20130225T1
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HR
Croatia
Prior art keywords
weight
hours
dosage form
active ingredient
phenol
Prior art date
Application number
HRP20130225TT
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English (en)
Inventor
Tobias Jung
Johannes Bartholomäus
Original Assignee
Grünenthal GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Grünenthal GmbH filed Critical Grünenthal GmbH
Publication of HRP20130225T1 publication Critical patent/HRP20130225T1/hr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/133Amines having hydroxy groups, e.g. sphingosine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pretreatment Of Seeds And Plants (AREA)

Claims (5)

1. Oblik doziranja za kontrolirano oslobađanje aktivnog sastojka 3-(2-dimetilamino-metilcikloheksil)fenola ili jedne od njegovih farmaceutski prihvatljivih soli, koji - in vitro, mjereno u skladu sa Europskom farmakopejom sa miješalicom sa lopaticom u puferu kod pH vrijednosti od 6.8, te temperature od 37°C i 75 okr/min, otpušta - nakon 0.5 sata od 9.0 do 31 % težinski, - nakon 1 sata od 20 do 48% težinski, - nakon 2 sata od 31 do 65% težinski, - nakon 3 sata od 42 do 76% težinski, - nakon 4 sata od 50 do 83% težinski, - nakon 6 sati od 60 do 94% težinski, - nakon 8 sati od 71 do 99% težinski, - nakon 12 sati više od 79% težinski aktivnog sastojka koji je izvorno sadržan u obliku doziranja, - sadrži polimerni matriks koji se temelji na celuloznom eteru ili celuloznom esteru koji kod koncentracije od 2.0% težinski u vodenoj otopini kao 20°C ima viskoznost u rasponu od 3 000 do 150 000 mPa·s, pri čemu je barem dio aktivnog sastojka sadržan u polimernom matriksu, pri čemu težinski udio polimernog matriksa iznosi od 5 do 85% težinski, u odnosu na ukupnu težinu oblika doziranja, te pri čemu je celulozni eter ili celulozni ester odabran iz skupine koja se sastoji od metilceluloze, etilceluloze, hidroksiceluloze, hidroksipropilceluloze, karboksimetilceluloze i hidroksipropilmetilceluloze.
2. Oblik doziranja prema zahtjevu 1, naznačena time da je aktivni sastojak (1R,2R)-3-(2-dimetilaminometilcikcloheksil)fenol ili jedna od njegovih farmaceutski prihvatljivih soli.
3. Oblik doziranja prema zahtjevu 1 ili 2, naznačen time da je predviđen u obliku tablete.
4. Uporaba aktivnog sastojka 3-(2-dimetilaminometilcikcloheksil)fenola ili jedne od njegovih farmaceutski prihvatljivih soli naznačena time da je za proizvodnju oblika doziranja prema jednom od zahtjeva 1 do 3 za suzbijanje boli.
5. Uporaba prema zahtjevu 4, naznačena time da se davanje odvija oralnim putem.
HRP20130225TT 2005-09-15 2013-03-15 Formulacija s odgođenim otpuštanjem koja sadrži 3-(2-dimetilaminometilcikloheksil) fenol HRP20130225T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005044212 2005-09-15
PCT/EP2006/008988 WO2007031326A2 (de) 2005-09-15 2006-09-15 Retardformulierung von 3-(2-dimethylaminomethyl-cyclohexyl)-phenol

Publications (1)

Publication Number Publication Date
HRP20130225T1 true HRP20130225T1 (hr) 2013-04-30

Family

ID=37744782

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20130225TT HRP20130225T1 (hr) 2005-09-15 2013-03-15 Formulacija s odgođenim otpuštanjem koja sadrži 3-(2-dimetilaminometilcikloheksil) fenol

Country Status (22)

Country Link
US (2) US20090104266A1 (hr)
EP (1) EP1928441B1 (hr)
JP (1) JP2009507875A (hr)
KR (1) KR20080059212A (hr)
CN (1) CN101262857A (hr)
AU (1) AU2006291422B2 (hr)
BR (1) BRPI0621466A2 (hr)
CA (1) CA2621270A1 (hr)
CY (1) CY1113943T1 (hr)
DK (1) DK1928441T3 (hr)
EC (1) ECSP088285A (hr)
ES (1) ES2402206T3 (hr)
HR (1) HRP20130225T1 (hr)
IL (1) IL189820A0 (hr)
NO (1) NO20081785L (hr)
NZ (1) NZ566473A (hr)
PL (1) PL1928441T3 (hr)
PT (1) PT1928441E (hr)
RU (1) RU2445081C2 (hr)
SI (1) SI1928441T1 (hr)
WO (1) WO2007031326A2 (hr)
ZA (1) ZA200802269B (hr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10356362A1 (de) 2003-11-28 2005-06-23 Grünenthal GmbH Verwendung von 1-Phenyl-3-dimethylamino-propanverbindungen zur Therapie von Angststörungen
EP2085081A1 (de) * 2008-02-04 2009-08-05 Grünenthal GmbH 3-(2-Dimethylaminomethyl-cyclohexyl)-phenol gegen polyneuropathischen Schmerz
MX2018006903A (es) * 2015-12-08 2018-11-09 Ardea Biosciences Inc Composicion farmaceutica.
WO2019156074A1 (ja) 2018-02-06 2019-08-15 第一三共株式会社 アミノアルキル化合物
CN112566668A (zh) * 2018-06-22 2021-03-26 快力胶囊股份有限公司 肠溶性硬胶囊

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4329794C2 (de) * 1993-09-03 1997-09-18 Gruenenthal Gmbh Tramadolsalz enthaltende Arzneimittel mit verzögerter Wirkstofffreisetzung
DE4426245A1 (de) * 1994-07-23 1996-02-22 Gruenenthal Gmbh 1-Phenyl-3-dimethylamino-propanverbindungen mit pharmakologischer Wirkung
DE19525137C2 (de) * 1995-07-11 2003-02-27 Gruenenthal Gmbh 6-Dimethylaminomethyl-1-phenyl-cyclohexanverbin -dungen als Zwischenprodukte zur Herstellung pharmazeutischer Wirkstoffe
DE10059411A1 (de) * 2000-11-30 2002-06-13 Gruenenthal Gmbh Verwendung von 6-Dimethylaminomethyl-1-phenyl-cyclohexanverbindungen zur Therapie der Harninkontinenz
DE10109763A1 (de) * 2001-02-28 2002-09-05 Gruenenthal Gmbh Pharmazeutische Salze
US20050176790A1 (en) * 2001-02-28 2005-08-11 Johannes Bartholomaus Pharmaceutical salts
JP4207651B2 (ja) * 2003-05-07 2009-01-14 ソニー株式会社 充電器
DE10333835A1 (de) * 2003-07-24 2005-03-10 Gruenenthal Gmbh 6-Dimethylaminomethyl-1-(3-methoxy-phenyl)-cyclohexane-1,3-diol enthaltendes Arzneimittel mit verzögerter Wirkstofffreisetzung

Also Published As

Publication number Publication date
SI1928441T1 (sl) 2013-04-30
WO2007031326A3 (de) 2007-06-07
US20120039963A1 (en) 2012-02-16
ES2402206T3 (es) 2013-04-29
DK1928441T3 (da) 2013-04-08
ECSP088285A (es) 2008-04-28
AU2006291422B2 (en) 2012-07-05
RU2445081C2 (ru) 2012-03-20
WO2007031326A2 (de) 2007-03-22
EP1928441B1 (de) 2013-02-27
CA2621270A1 (en) 2007-03-22
CN101262857A (zh) 2008-09-10
NZ566473A (en) 2011-05-27
US20090104266A1 (en) 2009-04-23
CY1113943T1 (el) 2016-07-27
NO20081785L (no) 2008-06-02
PT1928441E (pt) 2013-03-18
PL1928441T3 (pl) 2013-05-31
JP2009507875A (ja) 2009-02-26
RU2008114051A (ru) 2010-01-20
KR20080059212A (ko) 2008-06-26
ZA200802269B (en) 2008-12-31
EP1928441A2 (de) 2008-06-11
IL189820A0 (en) 2008-11-03
AU2006291422A1 (en) 2007-03-22
BRPI0621466A2 (pt) 2012-09-11

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