EP2566461A2 - Tapentadol solide sous forme non cristalline - Google Patents

Tapentadol solide sous forme non cristalline

Info

Publication number
EP2566461A2
EP2566461A2 EP11717513A EP11717513A EP2566461A2 EP 2566461 A2 EP2566461 A2 EP 2566461A2 EP 11717513 A EP11717513 A EP 11717513A EP 11717513 A EP11717513 A EP 11717513A EP 2566461 A2 EP2566461 A2 EP 2566461A2
Authority
EP
European Patent Office
Prior art keywords
tapentadol
crystalline
surface stabilizer
intermediate according
solvent
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP11717513A
Other languages
German (de)
English (en)
Inventor
Jana Paetz
Daniela Stumm
Wolfgang Albrecht
Alexandre Mathieu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ratiopharm GmbH
Original Assignee
Ratiopharm 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 Ratiopharm GmbH filed Critical Ratiopharm GmbH
Priority to EP11717513A priority Critical patent/EP2566461A2/fr
Publication of EP2566461A2 publication Critical patent/EP2566461A2/fr
Withdrawn legal-status Critical Current

Links

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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Abstract

L'invention concerne du tapentadol solide sous forme non cristalline, et un stabilisateur de surface sous la forme d'un intermédiaire stable. Dans l'intermédiaire selon l'invention, le tapentadol est présent sous forme amorphe ou sous la forme d'une solution solide. L'invention concerne un procédé de production de tapentadol sous forme non cristalline, solide et des formulations pharmaceutiques contenant du tapentadol non cristallin, solide.
EP11717513A 2010-05-05 2011-05-05 Tapentadol solide sous forme non cristalline Withdrawn EP2566461A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP11717513A EP2566461A2 (fr) 2010-05-05 2011-05-05 Tapentadol solide sous forme non cristalline

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP10004758 2010-05-05
EP11717513A EP2566461A2 (fr) 2010-05-05 2011-05-05 Tapentadol solide sous forme non cristalline
PCT/EP2011/002247 WO2011138037A2 (fr) 2010-05-05 2011-05-05 Tapentadol solide sous forme non cristalline

Publications (1)

Publication Number Publication Date
EP2566461A2 true EP2566461A2 (fr) 2013-03-13

Family

ID=43007230

Family Applications (1)

Application Number Title Priority Date Filing Date
EP11717513A Withdrawn EP2566461A2 (fr) 2010-05-05 2011-05-05 Tapentadol solide sous forme non cristalline

Country Status (3)

Country Link
US (1) US20130116333A1 (fr)
EP (1) EP2566461A2 (fr)
WO (1) WO2011138037A2 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013111161A2 (fr) * 2012-01-10 2013-08-01 Msn Laboratories Limited Procédé de préparation de dérivés de 3-aryl-2-méthyl-propanamine et de ses polymorphes
WO2014023652A1 (fr) * 2012-08-06 2014-02-13 Ratiopharm Gmbh Formulation pharmaceutique comprenant du tapentadol et de la cyclodextrine
EP2808319A1 (fr) 2013-05-31 2014-12-03 Arevipharma GmbH Complexe de résine 3-[3-(Diméthylamino)-1-éthyl-2-méthylpropyl]phénol
WO2015014980A1 (fr) * 2013-08-02 2015-02-05 Ratiopharm Gmbh Composition comprenant du tapentadol sous forme dissoute

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5145684A (en) * 1991-01-25 1992-09-08 Sterling Drug Inc. Surface modified drug nanoparticles
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
EP1612203B1 (fr) 2004-06-28 2007-08-01 Grünenthal GmbH Formes cristallines de chlorhydrate de (-)-(1R,2R)-3-(3-diméthylamino-1-ethyl-2-méthylpropyl)-phénol
EP1985292A1 (fr) * 2007-04-23 2008-10-29 Grünenthal GmbH Titrage de tapentadol
KR101972299B1 (ko) * 2007-11-23 2019-08-16 그뤼넨탈 게엠베하 타펜타돌 조성물
LT2240431T (lt) 2007-12-07 2017-04-10 Grünenthal GmbH (1r,2r)-3-(3-dimetilamino-1-etil-2-metilpropil) fenolio kristalinės modifikacijos
AU2009207796B2 (en) * 2008-01-25 2014-03-27 Grunenthal Gmbh Pharmaceutical dosage form
BRPI0921725A2 (pt) * 2008-10-30 2016-01-05 Grüenthal GmbH formas de dosagem potentes do tapentadol
US20100272815A1 (en) * 2009-04-28 2010-10-28 Actavis Group Ptc Ehf Amorphous form of tapentadol hydrochloride
WO2010141505A1 (fr) * 2009-06-01 2010-12-09 Protect Pharmaceutical Corporation Systèmes d'administration résistants aux abus
US8288592B2 (en) * 2009-09-22 2012-10-16 Actavis Group Ptc Ehf Solid state forms of tapentadol salts

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2011138037A2 *

Also Published As

Publication number Publication date
US20130116333A1 (en) 2013-05-09
WO2011138037A2 (fr) 2011-11-10
WO2011138037A3 (fr) 2012-03-15

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Legal Events

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PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

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Effective date: 20121128

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Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

RIN1 Information on inventor provided before grant (corrected)

Inventor name: MATHIEU, ALEXANDRE

Inventor name: PAETZ, JANA

Inventor name: STUMM, DANIELA

Inventor name: ALBRECHT, WOLFGANG

DAX Request for extension of the european patent (deleted)
17Q First examination report despatched

Effective date: 20131122

STAA Information on the status of an ep patent application or granted ep patent

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18D Application deemed to be withdrawn

Effective date: 20140403

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Owner name: RATIOPHARM GMBH