EA026238B9 - Стабильная комбинированная фармацевтическая композиция - Google Patents

Стабильная комбинированная фармацевтическая композиция

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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
EA201100430A1 (ru
EA026238B1 (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

    • 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
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • 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
    • A61K31/41—Heterocyclic 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
    • A61K31/42—Oxazoles
    • A61K31/422—Oxazoles not condensed and containing further heterocyclic rings
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61P9/08—Vasodilators for multiple indications
    • 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
    • A61P9/12—Antihypertensives

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)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (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)
  • Peptides Or Proteins (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Hydrogenated Pyridines (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) CZ308237B6 (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) LT2359815T (ru)
ME (1) ME03774B (ru)
MX (1) MX2011003407A (ru)
MY (1) MY175270A (ru)
PL (3) PL2359815T3 (ru)
PT (3) PT2010038091Y (ru)
RO (1) RO127490B1 (ru)
RS (3) RS60784B1 (ru)
RU (2) RU2687282C2 (ru)
SG (1) SG194392A1 (ru)
SI (2) SI2344141T1 (ru)
SK (2) SK7997Y1 (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
WO2013121233A1 (en) 2012-02-17 2013-08-22 Egis Gyógyszergyár Nyilvánosan Működö Részvénytársaság Pharmaceutical formulation having improved stability
NZ753904A (en) * 2013-06-13 2020-07-31 Akebia Therapeutics Inc Compositions and methods for treating anemia
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
GB2444904B (en) * 2006-12-05 2008-11-05 Michael Hilary Burke A Process For The Preparation of an Orally Administrable Unit Dose Tablet
HU230877B1 (hu) 2008-09-30 2018-11-29 EGIS Gyógyszergyár NyR Stabil kombinációs gyógyszerkészítmény

Also Published As

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

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