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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 EP20160419.6A external-priority patent/EP3875077B1/en
Priority claimed from EP20160420.4A external-priority patent/EP3875079A1/en
Application filed by Gruenenthal Chemie filed Critical Gruenenthal Chemie
Publication of PE20230105A1 publication Critical patent/PE20230105A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; 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
    • A61K9/1676Agglomerates; 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
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • 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

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)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (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
EP20160419.6A EP3875077B1 (en) 2020-03-02 2020-03-02 Dosage form providing prolonged release of tapentadol phosphoric acid salt
EP20160420.4A EP3875079A1 (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
BR112022017700A2 (pt) 2020-03-02 2023-01-17 Gruenenthal Gmbh Forma de dosagem fornecendo liberação prolongada de sal de ácido fosfórico de tapentadol

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL88083A (en) * 1987-11-06 1992-11-15 Tanabe Seiyaku Co Controlled release pharmaceutical dosage form and its preparation
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
ES2429436T3 (es) * 2002-02-21 2013-11-14 Otsuka Pharmaceutical Co., Ltd. Preparaciones de liberación lenta y procedimiento para la producción de las mismas
PL1786403T3 (pl) 2004-07-01 2013-10-31 Gruenenthal Gmbh Doustna postać dawki zabezpieczona przed nadużywaniem zawierająca (1R, 2R)-3-(3-dimetyloamino-1-etylo0-2-metylo-propylo)fenol
CN101568329A (zh) 2006-10-27 2009-10-28 詹森药业有限公司 干燥颗粒药用组合物及其生产方法
AU2009207796B2 (en) 2008-01-25 2014-03-27 Grunenthal Gmbh Pharmaceutical dosage form
PE20190391A1 (es) 2008-10-30 2019-03-13 Gruenenthal Chemie Formas de dosificacion del tapentadol novedosas y potentes
DK3656765T3 (da) 2010-07-23 2021-06-14 Gruenenthal Gmbh Salte eller co-krystaller af 3-(3-dimethylamin-1-ethyl-2-methyl-propyl)-phenol
WO2012051246A1 (en) 2010-10-12 2012-04-19 Ratiopharm Gmbh Tapentadol hydrobromide and crystalline forms thereof
CN105682643B (zh) 2013-07-12 2019-12-13 格吕伦塔尔有限公司 含有乙烯-醋酸乙烯酯聚合物的防篡改剂型
US20160136112A1 (en) 2013-08-02 2016-05-19 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
ES2937740T3 (es) 2016-04-19 2023-03-30 Ratiopharm Gmbh Fosfato de tapentadol cristalino
EP3630074B1 (en) 2017-05-29 2023-10-25 Grünenthal GmbH Multiparticulate oral dosage form providing prolonged release of tapentadol
BR112022017700A2 (pt) 2020-03-02 2023-01-17 Gruenenthal Gmbh Forma de dosagem fornecendo liberação prolongada de sal de ácido fosfórico de tapentadol

Also Published As

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

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