PE20230105A1 - DOSAGE FORM PROVIDING SUPPORTED RELEASE OF TAPENTADOL PHOSPHORIC ACID SALT - Google Patents

DOSAGE FORM PROVIDING SUPPORTED RELEASE OF TAPENTADOL PHOSPHORIC ACID SALT

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
Spanish (es)
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/en

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

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.REFERRING TO A SUPPORTED RELEASE PHARMACEUTICAL DOSAGE FORM COMPRISING TAPENTADOL FOR TWICE DAILY ORAL ADMINISTRATION, WHEREIN TAPENTADOL IS PRESENT AS A PHOSPHORIC ACID SALT SUCH AS TAPENTADOL DIHYDROGEN PHOSPHATE, AND WHEREIN TAPENTADOL IS INCORPORATED INTO A MATRIX OF PROLONGED RELEASE CONSISTING OF HYDROXYPROPYL METHYLCELLULOSE (HPMC), HYDROXYPROPYL CELLULOSE (HPC), HYDROXYYTHYL CELLULOSE (HEC), MICROCRYSTALLINE CELLULOSE, AMONG OTHERS. THE EQUIVALENT DOSE BY WEIGHT OF TAPENTADOL CONTAINED IN THE PHARMACEUTICAL DOSAGE FORM IS WITHIN THE RANGE OF 10 TO 300 MG ON A TAPENTADOL FREE BASE BASIS.

PE2022001894A 2020-03-02 2021-03-01 DOSAGE FORM PROVIDING SUPPORTED RELEASE OF TAPENTADOL PHOSPHORIC ACID SALT PE20230105A1 (en)

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 (en) 2023-01-25

Family

ID=74701506

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2022001894A PE20230105A1 (en) 2020-03-02 2021-03-01 DOSAGE FORM PROVIDING SUPPORTED RELEASE OF TAPENTADOL PHOSPHORIC ACID SALT

Country Status (7)

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

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021175773A1 (en) 2020-03-02 2021-09-10 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 (en) 1994-07-23 1996-02-22 Gruenenthal Gmbh 1-phenyl-3-dimethylamino-propane compounds with pharmacological activity
PE20030527A1 (en) 2001-10-24 2003-07-26 Gruenenthal Chemie DELAYED-RELEASE PHARMACEUTICAL FORMULATION CONTAINING 3- (3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL) PHENOL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF THE SAME AND ORAL TABLETS CONTAINING IT
AR053304A1 (en) 2004-07-01 2007-05-02 Gruenenthal Gmbh PROTECTED ORAL PHARMACEUTICAL FORMS AGAINST ABUSE WITH CONTROLLED RELEASE OF (1R, 2R) -3- (3 DIMETHYLAMIN-1-ETIL-2METIL-PROPIL) PHENOL AND PROCEDURE FOR PRODUCTION.
CA2667925A1 (en) 2006-10-27 2008-05-02 Janssen Pharmaceutica N.V. Dry granulated pharmaceutical compositions and methods for producing same
NZ586792A (en) 2008-01-25 2012-09-28 Gruenenthal Chemie Tamper resistant controlled release pharmaceutical tablets form having convex and concave surfaces
DK2352494T3 (en) 2008-10-30 2019-10-28 Gruenenthal Gmbh NEW AND POTENTIAL TAPENT ADDRESS FORMS
EP3650439B1 (en) 2010-07-23 2021-02-24 Grünenthal GmbH Salts or co-crystals of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol
WO2012051246A1 (en) 2010-10-12 2012-04-19 Ratiopharm Gmbh Tapentadol hydrobromide and crystalline forms thereof
CN105682643B (en) 2013-07-12 2019-12-13 格吕伦塔尔有限公司 Tamper resistant dosage form containing ethylene-vinyl acetate polymer
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
PL3653599T3 (en) 2016-04-19 2023-03-20 Ratiopharm Gmbh Crystalline tapentadol phosphate
WO2018219897A1 (en) 2017-05-29 2018-12-06 Grünenthal GmbH Multiparticulate oral dosage form providing prolonged release of tapentadol
WO2021175773A1 (en) 2020-03-02 2021-09-10 Grünenthal GmbH Dosage form providing prolonged release of tapentadol phosphoric acid salt

Also Published As

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

Similar Documents

Publication Publication Date Title
CY1109910T1 (en) USE OF A MATRIX hydrophilize comprising a derivative of polyacrylic ACID, an ether CELLULOSE AND AN AGENT APOSATHROSIS FOR THE PRODUCTION OF A DRUG FOR THE TREATMENT OF DISEASES OF FEMALE GENITAL
AR059723A2 (en) COMPOSITION OF HIGH DOSE OF IBANDRONATO
ES2916649T1 (en) Compositions and uses for the treatment of multiple sclerosis
BR112015004244A2 (en) orally administered medical composition
KR20230145525A (en) Methods and compositions for treating excessive sleepiness
ECSP088974A (en) IMIDAZOL PYRIMIDINE DERIVATIVES FOR THE TREATMENT OF DISEASES RELATED TO THE SYNTHEOSE QUINASA GLYCOGEN (GSK3)
JP2019131588A5 (en) Antipruritic
RU2010133489A (en) USE OF GAMMA SECRETASE INHIBITORS FOR TREATMENT OF CANCER
ES2579857T3 (en) Platelet rich plasma compositions
PE20230105A1 (en) DOSAGE FORM PROVIDING SUPPORTED RELEASE OF TAPENTADOL PHOSPHORIC ACID SALT
US11925612B2 (en) Bactericidal and virucidal pharmaceutical composition
AR074739A1 (en) FAST DISGREGATION CAPECITABIN TABLETS
AR033671A1 (en) PHARMACEUTICAL COMPOSITION OF THE TYPE OF GEL FOR SUBCUTANEOUS ADMINISTRATION, PROCEDURE FOR THE PREPARATION AND USE OF THIS COMPOSITION FOR THE PREPARATION OF A MEDICINAL PRODUCT
AR061166A1 (en) PHARMACEUTICAL COMPOSITIONS FOR SUSTAINED RELEASE OF PHENYLPHERINE
BR112015010980A2 (en) composition of excipients and extended release pharmaceutical forms with increased bioavailability of antibacterial drugs, anticoccidial drugs and other medicinal products for poultry and commercial pigs
BR122021012549B8 (en) ORAL MELATONIN DISSOLUTION COMPOSITION WITH ACIDIFYING AGENT THAT MAKES MELATONIN SOLUBLE IN SALIVA
RU2006137329A (en) DISSOLVING TABLETS CONTAINING LICARBAZEPINE
AR108897A1 (en) A FAST ACTION ORAL DISINTEGRATION FILM FOR THE ADMINISTRATION OF LOCAL ANESTHESIA
KR101531030B1 (en) Orally disintegrating tablet containing mirtazapine
ES2923673T3 (en) Prolonged-release mucoadhesive vaginal tablet
CN110833540B (en) Salicorol, caffeine and chlorphenamine maleate tablet and preparation method thereof
PE20221446A1 (en) NEW FORMULATIONS OF FOSFOMICIN TABLET
CN103301063A (en) S (+) -flurbiprofen axetil emulsion for injection
CN101863876A (en) Fluoroquinolone comprising 7-(3-amino-4-oximido)-1-piperidyl substitutional group and application of composition thereof
PE20240113A1 (en) SUSTAINED RELEASE DOSAGE FORMS OF A SALT OF TAPENTADOL WITH L-(+)-TARTARIC ACID