EA032932B1 - Лекарственная форма, содержащая натрий-1-[6-(морфолин-4-ил)пиримидин-4-ил]-4-(1h-1,2,3-триазол-1-ил)-1н-пиразол-5-олат, и способ ее получения - Google Patents

Лекарственная форма, содержащая натрий-1-[6-(морфолин-4-ил)пиримидин-4-ил]-4-(1h-1,2,3-триазол-1-ил)-1н-пиразол-5-олат, и способ ее получения

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Publication number
EA032932B1
EA032932B1 EA201690788A EA201690788A EA032932B1 EA 032932 B1 EA032932 B1 EA 032932B1 EA 201690788 A EA201690788 A EA 201690788A EA 201690788 A EA201690788 A EA 201690788A EA 032932 B1 EA032932 B1 EA 032932B1
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EA
Eurasian Patent Office
Prior art keywords
dosage form
sodium
pharmaceutical dosage
olate
morpholin
Prior art date
Application number
EA201690788A
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English (en)
Other versions
EA201690788A1 (ru
Inventor
Хайке Нойманн
Клаус Бенке
Михаель Формелль
Габриеле Винтер
Original Assignee
Байер Фарма Акциенгезельшафт
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49356354&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA032932(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Байер Фарма Акциенгезельшафт filed Critical Байер Фарма Акциенгезельшафт
Publication of EA201690788A1 publication Critical patent/EA201690788A1/ru
Publication of EA032932B1 publication Critical patent/EA032932B1/ru

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    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Hematology (AREA)
  • Hospice & Palliative Care (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Изобретение касается твердой пероральной лекарственной формы, содержащей натрий-1-[6-(морфолин-4-ил)пиримидин-4-ил]-4-(1H-1,2,3-триазол-1-ил)-1H-пиразол-5-олат (активное вещество (I)), причем (a) она содержит гидроксипропилметилцеллюлозу (ГПМЦ) в качестве гидрофильного связующего вещества, микрокристаллическую целлюлозу или маннитол или смесь из микрокристаллической целллозы и маннитола в качестве наполнителя и сухого связующего вещества, кроскармеллозу натрия в качестве активатора распада и стеарилфумарат натрия или глицеролдистеарат в качестве смазочного вещества, (b) концентрация активного вещества (I) составляет 10% или более из расчета на общую массу препаративной формы и (c) пленочная оболочка лекарственной формы свободна от полиэтиленгликоля. Также изобретение относится к способу получения пероральной лекарственной формы.
EA201690788A 2013-10-17 2014-10-13 Лекарственная форма, содержащая натрий-1-[6-(морфолин-4-ил)пиримидин-4-ил]-4-(1h-1,2,3-триазол-1-ил)-1н-пиразол-5-олат, и способ ее получения EA032932B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13189145 2013-10-17
PCT/EP2014/071855 WO2015055564A1 (de) 2013-10-17 2014-10-13 Pharmazeutische darreichungsformen enthaltend natrium-1-[6-(morpholin-4-yl)pyrimidin-4-yl]-4-(1h-1,2,3-triazol-1-yl)-1h-pyrazol-5-olat

Publications (2)

Publication Number Publication Date
EA201690788A1 EA201690788A1 (ru) 2016-09-30
EA032932B1 true EA032932B1 (ru) 2019-08-30

Family

ID=49356354

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201690788A EA032932B1 (ru) 2013-10-17 2014-10-13 Лекарственная форма, содержащая натрий-1-[6-(морфолин-4-ил)пиримидин-4-ил]-4-(1h-1,2,3-триазол-1-ил)-1н-пиразол-5-олат, и способ ее получения

Country Status (35)

Country Link
US (1) US9827198B2 (ru)
EP (1) EP3057580B1 (ru)
JP (1) JP6525979B2 (ru)
KR (1) KR102330953B1 (ru)
CN (1) CN105636580B (ru)
AP (1) AP2016009135A0 (ru)
AR (1) AR098064A1 (ru)
AU (1) AU2014336389B2 (ru)
BR (1) BR112016007588A2 (ru)
CA (1) CA2927437C (ru)
CL (1) CL2016000857A1 (ru)
CU (1) CU24515B1 (ru)
DK (1) DK3057580T3 (ru)
DO (1) DOP2016000078A (ru)
EA (1) EA032932B1 (ru)
ES (1) ES2868228T3 (ru)
GT (1) GT201600072A (ru)
HR (1) HRP20210691T1 (ru)
HU (1) HUE054107T2 (ru)
IL (1) IL244933B (ru)
JO (1) JO3645B1 (ru)
LT (1) LT3057580T (ru)
MA (1) MA38974B2 (ru)
MX (1) MX2016004628A (ru)
MY (1) MY190202A (ru)
NI (1) NI201600054A (ru)
PE (1) PE20160669A1 (ru)
PH (1) PH12016500716A1 (ru)
SA (1) SA516370940B1 (ru)
SI (1) SI3057580T1 (ru)
TN (1) TN2016000135A1 (ru)
TW (1) TWI746418B (ru)
UA (1) UA119855C2 (ru)
UY (1) UY35784A (ru)
WO (1) WO2015055564A1 (ru)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3845230B1 (en) * 2018-08-31 2023-07-12 Astellas Pharma Inc. Pharmaceutical composition for oral administration

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012065967A1 (de) * 2010-11-18 2012-05-24 Bayer Pharma Aktiengesellschaft Substítuiertes natrium-1h-pyrazol-5-olat

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102006050516A1 (de) 2006-10-26 2008-04-30 Bayer Healthcare Ag Substituierte Dihydropyrazolone und ihre Verwendung
BRPI0808889A2 (pt) * 2007-03-13 2014-11-11 Dainippon Sumitomo Pharma Co Comprimido desintegrante oral

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012065967A1 (de) * 2010-11-18 2012-05-24 Bayer Pharma Aktiengesellschaft Substítuiertes natrium-1h-pyrazol-5-olat

Also Published As

Publication number Publication date
CU24515B1 (es) 2021-05-12
MY190202A (en) 2022-04-04
AU2014336389B2 (en) 2020-01-30
WO2015055564A1 (de) 2015-04-23
GT201600072A (es) 2018-12-19
JO3645B1 (ar) 2020-08-27
PH12016500716B1 (en) 2016-06-20
TN2016000135A1 (en) 2017-10-06
NI201600054A (es) 2016-09-21
LT3057580T (lt) 2021-04-12
PE20160669A1 (es) 2016-08-04
SI3057580T1 (sl) 2021-07-30
CA2927437A1 (en) 2015-04-23
SA516370940B1 (ar) 2019-11-20
UA119855C2 (uk) 2019-08-27
CU20160048A7 (es) 2016-10-28
EA201690788A1 (ru) 2016-09-30
TWI746418B (zh) 2021-11-21
ES2868228T3 (es) 2021-10-21
MX2016004628A (es) 2016-08-01
IL244933B (en) 2020-11-30
BR112016007588A2 (pt) 2017-09-12
JP6525979B2 (ja) 2019-06-05
JP2016538256A (ja) 2016-12-08
KR102330953B1 (ko) 2021-11-26
KR20160068784A (ko) 2016-06-15
CN105636580A (zh) 2016-06-01
AU2014336389A1 (en) 2016-05-12
AP2016009135A0 (en) 2016-04-30
AR098064A1 (es) 2016-04-27
HRP20210691T1 (hr) 2021-06-11
DK3057580T3 (da) 2021-05-10
EP3057580A1 (de) 2016-08-24
CA2927437C (en) 2022-06-28
CN105636580B (zh) 2020-03-31
IL244933A0 (en) 2016-05-31
US9827198B2 (en) 2017-11-28
UY35784A (es) 2015-05-29
NZ718063A (en) 2021-06-25
HUE054107T2 (hu) 2021-08-30
US20160256394A1 (en) 2016-09-08
PH12016500716A1 (en) 2016-06-20
TW201607568A (zh) 2016-03-01
DOP2016000078A (es) 2016-08-15
MA38974B2 (fr) 2020-11-30
MA38974A1 (fr) 2017-05-31
CL2016000857A1 (es) 2016-11-25
EP3057580B1 (de) 2021-02-24

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