PE20230105A1 - Forma de dosificacion que proporciona liberacion prolongada de sal de acido fosforico de tapentadol - Google Patents

Forma de dosificacion que proporciona liberacion prolongada de sal de acido fosforico de tapentadol

Info

Publication number
PE20230105A1
PE20230105A1 PE2022001894A PE2022001894A PE20230105A1 PE 20230105 A1 PE20230105 A1 PE 20230105A1 PE 2022001894 A PE2022001894 A PE 2022001894A PE 2022001894 A PE2022001894 A PE 2022001894A PE 20230105 A1 PE20230105 A1 PE 20230105A1
Authority
PE
Peru
Prior art keywords
tapentadol
dosage form
phosphoric acid
acid salt
form providing
Prior art date
Application number
PE2022001894A
Other languages
English (en)
Inventor
Ulrike Bertram
Ulrich Reinhold
Christian Grosse
Carmen Hartmann
Original Assignee
Gruenenthal Chemie
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=74701506&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20230105(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from EP20160420.4A external-priority patent/EP3875079A1/en
Priority claimed from EP20160419.6A external-priority patent/EP3875077B1/en
Application filed by Gruenenthal Chemie filed Critical Gruenenthal Chemie
Publication of PE20230105A1 publication Critical patent/PE20230105A1/es

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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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

Landscapes

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

Abstract

REFERIDO A UNA FORMA DE DOSIFICACION FARMACEUTICA DE LIBERACION PROLONGADA QUE COMPRENDE TAPENTADOL PARA SU ADMINISTRACION ORAL DOS VECES AL DIA, EN DONDE EL TAPENTADOL ESTA PRESENTE COMO UNA SAL CON ACIDO FOSFORICO TAL COMO DIHIDROGENOFOSFATO DE TAPENTADOL, Y EN DONDE EL TAPENTADOL SE INCORPORA A UNA MATRIZ DE LIBERACION PROLONGADA QUE CONSISTE EN HIDROXIPROPILMETILCELULOSA (HPMC), HIDROXIPROPILCELULOSA (HPC), HIDROXIETILCELULOSA (HEC), CELULOSA MICROCRISTALINA, ENTRE OTROS. LA DOSIS EQUIVALENTE EN PESO DE TAPENTADOL CONTENIDA EN LA FORMA DE DOSIFICACION FARMACEUTICA SE ENCUENTRA DENTRO DEL INTERVALO DE 10 A 300 MG EN BASE A LA BASE LIBRE DE TAPENTADOL.
PE2022001894A 2020-03-02 2021-03-01 Forma de dosificacion que proporciona liberacion prolongada de sal de acido fosforico de tapentadol PE20230105A1 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP20160420.4A EP3875079A1 (en) 2020-03-02 2020-03-02 Dosage form providing prolonged release of tapentadol phosphoric acid salt
EP20160419.6A EP3875077B1 (en) 2020-03-02 2020-03-02 Dosage form providing prolonged release of tapentadol phosphoric acid salt
PCT/EP2021/055025 WO2021175773A1 (en) 2020-03-02 2021-03-01 Dosage form providing prolonged release of tapentadol phosphoric acid salt

Publications (1)

Publication Number Publication Date
PE20230105A1 true PE20230105A1 (es) 2023-01-25

Family

ID=74701506

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2022001894A PE20230105A1 (es) 2020-03-02 2021-03-01 Forma de dosificacion que proporciona liberacion prolongada de sal de acido fosforico de tapentadol

Country Status (7)

Country Link
EP (1) EP4003318A1 (es)
BR (1) BR112022017700A2 (es)
CO (1) CO2022012567A2 (es)
DE (1) DE202021003994U1 (es)
MX (1) MX2022010780A (es)
PE (1) PE20230105A1 (es)
WO (1) WO2021175773A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4003318A1 (en) 2020-03-02 2022-06-01 Grünenthal GmbH Dosage form providing prolonged release of tapentadol phosphoric acid salt

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
AR053304A1 (es) 2004-07-01 2007-05-02 Gruenenthal Gmbh Formas farmaceuticas orales protegidas frente al abuso con liberacion controlada de (1r,2r)-3-(3 dimetilamino-1-etil-2metil-propil)fenol y procedimiento para su produccion.
BRPI0718320A2 (pt) 2006-10-27 2013-11-26 Janssen Pharmaceutica Nv Composições farmacêuticas secas granuladas e métodos para produzir as mesmas.
CA2713128C (en) 2008-01-25 2016-04-05 Gruenenthal Gmbh Pharmaceutical dosage form
RU2599846C2 (ru) 2008-10-30 2016-10-20 Грюненталь Гмбх Новые и эффективные лекарственые формы тапентадола
LT3650439T (lt) 2010-07-23 2021-03-25 Grünenthal GmbH 3-(3-dimetilamino-1-etil-2-metil-propil)-fenolio druskos arba bendri kristalai
WO2012051246A1 (en) 2010-10-12 2012-04-19 Ratiopharm Gmbh Tapentadol hydrobromide and crystalline forms thereof
JP6449871B2 (ja) 2013-07-12 2019-01-09 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング エチレン−酢酸ビニルポリマーを含有する改変防止剤形
EP3027214A1 (en) 2013-08-02 2016-06-08 ratiopharm GmbH Composition comprising tapentadol in a dissolved form
EP2942054A1 (en) 2014-05-09 2015-11-11 G.L. Pharma GmbH Slow-release pharmaceutical formulation
PL3445742T3 (pl) 2016-04-19 2020-05-18 Ratiopharm Gmbh Krystaliczny fosforan tapentadolu
WO2018219897A1 (en) 2017-05-29 2018-12-06 Grünenthal GmbH Multiparticulate oral dosage form providing prolonged release of tapentadol
EP4003318A1 (en) 2020-03-02 2022-06-01 Grünenthal GmbH Dosage form providing prolonged release of tapentadol phosphoric acid salt

Also Published As

Publication number Publication date
WO2021175773A1 (en) 2021-09-10
DE202021003994U1 (de) 2022-04-12
EP4003318A1 (en) 2022-06-01
CO2022012567A2 (es) 2022-09-09
MX2022010780A (es) 2022-09-26
BR112022017700A2 (pt) 2023-01-17

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