EA026238B9 - Стабильная комбинированная фармацевтическая композиция - Google Patents

Стабильная комбинированная фармацевтическая композиция

Info

Publication number
EA026238B9
EA026238B9 EA201100430A EA201100430A EA026238B9 EA 026238 B9 EA026238 B9 EA 026238B9 EA 201100430 A EA201100430 A EA 201100430A EA 201100430 A EA201100430 A EA 201100430A EA 026238 B9 EA026238 B9 EA 026238B9
Authority
EA
Eurasian Patent Office
Prior art keywords
bisoprolol fumarate
packaged
pharmaceutically acceptable
acceptable salt
dosage form
Prior art date
Application number
EA201100430A
Other languages
English (en)
Other versions
EA026238B1 (ru
EA201100430A1 (ru
Inventor
Ласло Вагнер
Жольт Жигмонд
Дьёрдь Уйфалушши
Хусар Магдольна Левентисне
Петер Тонка-Надь
Эржебет Барцаи
Ласлоне Гора
Эдит Селецки
Агнеш Фюлёп
Original Assignee
Эгиш Дьёдьсердьяр Ньильваношан Мюкеде Ресвеньтаршашаг
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 Эгиш Дьёдьсердьяр Ньильваношан Мюкеде Ресвеньтаршашаг filed Critical Эгиш Дьёдьсердьяр Ньильваношан Мюкеде Ресвеньтаршашаг
Publication of EA201100430A1 publication Critical patent/EA201100430A1/ru
Publication of EA026238B1 publication Critical patent/EA026238B1/ru
Publication of EA026238B9 publication Critical patent/EA026238B9/ru

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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
    • A61K31/138Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42Oxazoles
    • A61K31/422Oxazoles not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2095Tabletting 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
    • 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
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/08Vasodilators for multiple indications
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

Landscapes

  • 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)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Packages (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Hydrogenated Pyridines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Изобретение относится к способу изготовления стабильной твердой упакованной лекарственной формы, содержащей основание амлодипина или его фармацевтически приемлемую соль и бисопролол фумарат, в котором основание амлодипина или его фармацевтически приемлемую соль, бисопролол фумарат и эксципиенты, включающие, по меньшей мере, разрыхлитель и смазывающее вещество, гомогенизируют, затем добавляют антиадгезионный агент, гомогенизацию продолжают, затем: а) гомогенат прессуют в таблетки с использованием способа прямого прессования или б) заполняют в твердые желатиновые капсулы, затем полученные таблетки или капсулы упаковывают во влагонепроницаемую защитную упаковку, представляющую собой композитную фольгу OPA/AL/PVC, покрытую алюминиевой мембранной фольгой. Способ по изобретению не требует раздельной обработки активных ингредиентов во время процесса изготовления и позволяет получить упакованную лекарственную форму, обладающую повышенной стабильностью за счет предотвращения взаимодействия между амлодипином и бисопролола фумаратом.
EA201100430A 2008-09-30 2009-09-30 Стабильная комбинированная фармацевтическая композиция EA026238B9 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
HU0800591A HU230877B1 (hu) 2008-09-30 2008-09-30 Stabil kombinációs gyógyszerkészítmény
PCT/HU2009/000085 WO2010038091A2 (en) 2008-09-30 2009-09-30 Stable combination pharmaceutical composition

Publications (3)

Publication Number Publication Date
EA201100430A1 EA201100430A1 (ru) 2011-10-31
EA026238B1 EA026238B1 (ru) 2017-03-31
EA026238B9 true EA026238B9 (ru) 2017-05-31

Family

ID=89988527

Family Applications (2)

Application Number Title Priority Date Filing Date
EA201100430A EA026238B9 (ru) 2008-09-30 2009-09-30 Стабильная комбинированная фармацевтическая композиция
EA201691869A EA038392B1 (ru) 2008-09-30 2009-09-30 Стабильная комбинированная фармацевтическая композиция

Family Applications After (1)

Application Number Title Priority Date Filing Date
EA201691869A EA038392B1 (ru) 2008-09-30 2009-09-30 Стабильная комбинированная фармацевтическая композиция

Country Status (31)

Country Link
EP (2) EP2359815B1 (ru)
KR (1) KR101772619B1 (ru)
CN (1) CN102164585B (ru)
AT (2) AT510866A3 (ru)
BG (1) BG66274B1 (ru)
CH (1) CH702345B1 (ru)
CY (1) CY1122084T1 (ru)
CZ (2) CZ30825U1 (ru)
DE (1) DE202009019152U1 (ru)
DK (1) DK2344141T3 (ru)
EA (2) EA026238B9 (ru)
EE (1) EE05723B1 (ru)
ES (2) ES2739900T3 (ru)
GE (1) GEP20135859B (ru)
HK (1) HK1155976A1 (ru)
HR (3) HRP20110162B1 (ru)
HU (3) HU230877B1 (ru)
LT (3) LT2344141T (ru)
ME (1) ME03774B (ru)
MX (1) MX2011003407A (ru)
MY (1) MY175270A (ru)
PL (3) PL2359815T3 (ru)
PT (3) PT2359815T (ru)
RO (1) RO127490B1 (ru)
RS (3) RS60784B1 (ru)
RU (2) RU2549437C2 (ru)
SG (1) SG194392A1 (ru)
SI (2) SI2344141T1 (ru)
SK (2) SK288593B6 (ru)
UA (1) UA101407C2 (ru)
WO (1) WO2010038091A2 (ru)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HU230877B1 (hu) 2008-09-30 2018-11-29 EGIS Gyógyszergyár NyR Stabil kombinációs gyógyszerkészítmény
CN101766611B (zh) * 2010-02-09 2011-10-12 施慧达药业集团(吉林)有限公司 一种左旋氨氯地平或其可药用盐和β受体阻滞剂的药物组合物及其应用
US20150094345A1 (en) 2012-02-17 2015-04-02 Egis Gyogyszergyar Zrt. Pharmaceutical formulation having improved stability
CN114404414A (zh) * 2013-06-13 2022-04-29 阿克比治疗有限公司 用于治疗贫血症的组合物和方法
HUP1300496A2 (hu) 2013-08-16 2015-03-02 Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszvenytarsasag Stabil kombinációs gyógyszerkészítmény
FR3027803B1 (fr) * 2014-11-05 2018-02-09 Les Laboratoires Servier Composition pharmaceutique comprenant un betabloquant et un inhibiteur de l'enzyme de conversion
FR3050380B1 (fr) 2016-04-20 2020-07-10 Les Laboratoires Servier Composition pharmaceutique comprenant un betabloquant, un inhibiteur de l'enzyme de conversion et un antihypertenseur ou un ains.
WO2024052498A1 (en) 2022-09-07 2024-03-14 Kinast Lasse An immediate-release oral pharmaceutical form of amlodipine with increased api content
CN116687926B (zh) * 2023-07-27 2023-12-12 石家庄四药有限公司 一种比索洛尔氨氯地平复方片剂及其制备方法

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HU221810B1 (hu) * 1997-08-12 2003-01-28 EGIS Gyógyszergyár Rt. Eljárás amlodipin-bezilát előállítására és az eljárás intermedierjei
GB0001621D0 (en) * 2000-01-26 2000-03-15 Astrazeneca Ab Pharmaceutical compositions
AT5874U1 (de) * 2000-12-29 2003-01-27 Bioorg Bv Pharmazeutische zubereitungen enthaltend amlodipinmaleat
EP1309556B1 (en) 2000-12-29 2004-11-24 Pfizer Limited Amlodipine fumarate
AU2001100431A4 (en) * 2001-10-03 2001-11-01 Pfizer Limited Pharmaceutical compositions comprising amlodipine maleate
WO2003032954A1 (en) 2001-10-17 2003-04-24 Dr. Reddy's Laboratories Ltd. Stabilized pharmaceutical formulations containing amlodipine maleate
WO2004075825A2 (en) * 2003-02-28 2004-09-10 Ranbaxy Laboratories Limited Dosage forms of amlodipine and processes for their preparation
WO2005051350A2 (en) * 2003-10-28 2005-06-09 Torrent Pharmaceuticals Limited Water dispersible tablet
WO2005099699A1 (en) * 2004-04-07 2005-10-27 Sepracor Inc. Combination of (s)-amlodipine and a beta-blocker, and methods for reducing hypertension
IN224215B (ru) * 2004-08-05 2009-02-06
WO2006059217A1 (en) * 2004-12-01 2006-06-08 Ranbaxy Laboratories Limited Stable solid dosage forms of amlodipine besylate and processes for their preparation
CZ2005141A3 (cs) * 2005-03-07 2006-04-12 Lunaria, Spol. S. R. O. Lécivý prípravek na bázi amlodipin-besilátu se zvýsenou stabilitou
IES20070122A2 (en) * 2006-12-05 2008-05-28 Michael Hilary Burke A process for the preparation of an orally administered unit dose tablet
HU230877B1 (hu) 2008-09-30 2018-11-29 EGIS Gyógyszergyár NyR Stabil kombinációs gyógyszerkészítmény

Also Published As

Publication number Publication date
CZ308237B6 (cs) 2020-03-18
EP2359815A1 (en) 2011-08-24
RS60686B1 (sr) 2020-09-30
PT2344141T (pt) 2019-08-06
MY175270A (en) 2020-06-17
HUE045326T2 (hu) 2019-12-30
EE05723B1 (et) 2014-10-15
EA026238B1 (ru) 2017-03-31
WO2010038091A3 (en) 2010-09-23
PT2010038091Y (pt) 2020-02-10
EP2359815B1 (en) 2020-01-08
HU230877B1 (hu) 2018-11-29
EP2344141B1 (en) 2019-05-01
ME03774B (me) 2021-04-20
HUE049948T2 (hu) 2020-11-30
RS60784B1 (sr) 2020-10-30
LT5815B (lt) 2012-02-27
HU0800591D0 (en) 2008-11-28
SK7997Y1 (sk) 2018-02-05
HRP20110162A2 (hr) 2011-06-30
GEP20135859B (en) 2013-06-25
RO127490A2 (ro) 2012-06-29
AT510866A3 (de) 2014-06-15
ES2385988B2 (es) 2013-12-11
RU2687282C2 (ru) 2019-05-13
EA038392B1 (ru) 2021-08-20
RU2549437C2 (ru) 2015-04-27
AT14769U1 (de) 2016-05-15
LT2011012A (lt) 2011-10-25
EP2344141A2 (en) 2011-07-20
AT510866A2 (de) 2012-07-15
DK2344141T3 (da) 2019-08-05
CN102164585A (zh) 2011-08-24
EA201100430A1 (ru) 2011-10-31
RU2014139476A (ru) 2015-06-20
SK50232011A3 (sk) 2011-08-04
DE202009019152U1 (de) 2017-03-06
KR101772619B1 (ko) 2017-08-29
HRP20110162A8 (hr) 2019-03-22
CZ30825U1 (cs) 2017-07-11
HUP0800591A2 (en) 2010-10-28
LT2359815T (lt) 2020-04-27
CY1122084T1 (el) 2020-11-25
EA201691869A1 (ru) 2017-04-28
KR20110063563A (ko) 2011-06-10
SK288593B6 (sk) 2018-09-03
EE201100029A (et) 2011-06-15
RS59201B1 (sr) 2019-10-31
RO127490B1 (ro) 2022-01-28
UA101407C2 (ru) 2013-03-25
BG66274B1 (bg) 2012-12-28
BG110927A (bg) 2011-09-30
WO2010038091A2 (en) 2010-04-08
LT2344141T (lt) 2019-08-26
PL394605A1 (pl) 2011-09-26
HRP20110162B1 (hr) 2019-09-20
PL2359815T3 (pl) 2020-11-30
PL2344141T3 (pl) 2019-10-31
RU2011112047A (ru) 2012-11-10
WO2010038091A9 (en) 2011-04-07
SK72017U1 (sk) 2017-08-02
HK1155976A1 (zh) 2012-06-01
MX2011003407A (es) 2011-06-20
HRP20200614T1 (hr) 2020-10-02
ES2739900T3 (es) 2020-02-04
ES2385988A1 (es) 2012-08-06
RS20110136A1 (en) 2012-08-31
SG194392A1 (en) 2013-11-29
SI2344141T1 (sl) 2019-09-30
HRP20191373T1 (hr) 2019-11-01
CZ2011252A3 (cs) 2011-07-07
PT2359815T (pt) 2020-04-16
SI2359815T1 (sl) 2020-10-30
CH702345B1 (de) 2014-05-15
CN102164585B (zh) 2016-04-27

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