PL2814465T3 - Preparat farmaceutyczny o poprawionej stabilności - Google Patents

Preparat farmaceutyczny o poprawionej stabilności

Info

Publication number
PL2814465T3
PL2814465T3 PL12711438T PL12711438T PL2814465T3 PL 2814465 T3 PL2814465 T3 PL 2814465T3 PL 12711438 T PL12711438 T PL 12711438T PL 12711438 T PL12711438 T PL 12711438T PL 2814465 T3 PL2814465 T3 PL 2814465T3
Authority
PL
Poland
Prior art keywords
pharmaceutical formulation
improved stability
stability
improved
formulation
Prior art date
Application number
PL12711438T
Other languages
English (en)
Inventor
András FEHÉR
Zsolt Zsigmond
György ÚJFALUSSY
Péter TONKA-NAGY
György MOROVJÁN
Original Assignee
Egis Gyógyszergyár Zrt.
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 Egis Gyógyszergyár Zrt. filed Critical Egis Gyógyszergyár Zrt.
Publication of PL2814465T3 publication Critical patent/PL2814465T3/pl

Links

Classifications

    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; 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
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • 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
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404Indoles, e.g. pindolol
    • 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
    • A61K31/435Heterocyclic 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
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/05Dipeptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
PL12711438T 2012-02-17 2012-02-17 Preparat farmaceutyczny o poprawionej stabilności PL2814465T3 (pl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/HU2012/000013 WO2013121233A1 (en) 2012-02-17 2012-02-17 Pharmaceutical formulation having improved stability
EP12711438.7A EP2814465B1 (en) 2012-02-17 2012-02-17 Pharmaceutical formulation having improved stability

Publications (1)

Publication Number Publication Date
PL2814465T3 true PL2814465T3 (pl) 2020-01-31

Family

ID=45922707

Family Applications (1)

Application Number Title Priority Date Filing Date
PL12711438T PL2814465T3 (pl) 2012-02-17 2012-02-17 Preparat farmaceutyczny o poprawionej stabilności

Country Status (16)

Country Link
US (1) US20150094345A1 (pl)
EP (2) EP2814465B1 (pl)
CN (2) CN107441495A (pl)
AU (2) AU2012369903A1 (pl)
BR (1) BR112014020184B1 (pl)
CA (1) CA2864456A1 (pl)
EA (1) EA030466B1 (pl)
HK (1) HK1205683A1 (pl)
HU (1) HUE046229T2 (pl)
IL (1) IL233972A0 (pl)
MX (1) MX370647B (pl)
PH (1) PH12014501840A1 (pl)
PL (1) PL2814465T3 (pl)
UA (1) UA113977C2 (pl)
WO (1) WO2013121233A1 (pl)
ZA (1) ZA201405925B (pl)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012011118A2 (en) * 2010-05-13 2012-01-26 Purshotama Sagi Reddy Babu Reddy Development of a fixed dose combination dosage form containing ramipril and carvedilol
CN107441495A (zh) 2012-02-17 2017-12-08 埃吉斯药物私人有限公司 稳定性提高的药物制剂
HUP1300496A2 (hu) 2013-08-16 2015-03-02 Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszvenytarsasag Stabil kombinációs gyógyszerkészítmény
EP3886817A1 (en) 2018-11-27 2021-10-06 Zaklady Farmaceutyczne Polpharma S.A. Pharmaceutical composition comprising ramipril and indapamide
CN114748436B (zh) * 2022-05-30 2023-05-16 迪沙药业集团有限公司 一种硝苯地平组合物及其制备方法
EP4710920A1 (en) 2024-09-16 2026-03-18 Adamed Pharma S.A. Pharmaceutical composition comprising combination of amlodipine, ramipril and rosuvastatin

Family Cites Families (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19575012I2 (de) 1980-10-23 2002-01-24 Schering Corp Carboxyalkyl-Dipeptide Verfahren zu ihrer Herstellung und diese enthaltende Arzneimittel
DE3226768A1 (de) 1981-11-05 1983-05-26 Hoechst Ag, 6230 Frankfurt Derivate der cis, endo-2-azabicyclo-(3.3.0)-octan-3-carbonsaeure, verfahren zu ihrer herstellung, diese enthaltende mittel und deren verwendung
DE3739690A1 (de) 1987-11-24 1989-06-08 Hoechst Ag Stabilisierte arzneistoffe, verfahren zu ihrer herstellung sowie stabile arzneizubereitungen
FR2824477B1 (fr) * 2001-05-09 2005-09-09 Ethypharm Lab Prod Ethiques Granules enrobes a base d'inhibiteur de l'enzyme de conversion de l'anfiotensine, leur procede de preparation et comprimes orodispersibles contenant les granules enrobes
HU226642B1 (en) 2001-12-17 2009-05-28 Egis Gyogyszergyar Nyilvanosan Amlodipine bezylate tablets having extended stability and process for producing the same
US20030215526A1 (en) 2002-03-08 2003-11-20 Scott Stofik Stable formulations of angiotensin converting enzyme (ACE) inhibitors
ES2322854T3 (es) * 2003-06-26 2009-06-30 Teva Pharmaceutical Industries Limited Composiciones farmaceuticas estables de derivados del acido 2-aza-biciclo(3.3.0)-octano-3-carboxilico.
EP1694308A1 (en) 2003-10-30 2006-08-30 Lupin Ltd. Stable formulations of ace inhibitors and methods for preparation thereof
GB2394660A (en) 2003-12-17 2004-05-05 Niche Generics Ltd Stabilisation of pharmaceutical compositions comprising ACE inhibitor by absence of acidic excipients having large specific surface area, eg silicon dioxide
US20080234353A1 (en) 2004-03-24 2008-09-25 Reynir Eyjolfsson Formulations of Ramipril
CA2586760A1 (en) * 2004-11-05 2006-05-18 Edward S. Wilson Stabilized ramipril compositions and methods of making
CN100374462C (zh) 2005-11-21 2008-03-12 大连帝恩生物工程有限公司 截短胰高血糖素样肽1(sGLP-1)、制法及其应用
US20070232680A1 (en) * 2006-04-04 2007-10-04 Vijayabhaskar Bolugoddu Preparation of ramipril and stable pharmaceutical compositions
CN101489550A (zh) * 2006-04-19 2009-07-22 特瓦制药工业有限公司 2-氮杂-二环[3.3.0]-辛烷-3-羧酸衍生物的稳定药物组合物
KR20080112387A (ko) 2006-04-19 2008-12-24 테바 파마슈티컬 인더스트리즈 리미티드 2-아자-비사이클로[3.3.0]-옥탄-3-카르복실산 유도체의 안정한 약학 조성물
CA2652620A1 (en) * 2006-06-02 2007-12-13 Teva Pharmaceutical Industries Ltd. Stable formulation comprising moisture sensitive drug/s and manufacturing procedure thereof
US20070281000A1 (en) * 2006-06-02 2007-12-06 Michael Fox Stable formulation comprising moisture sensitive drug/s and manufacturing procedure thereof
US20100035955A1 (en) 2006-06-30 2010-02-11 Panagiotis Keramidas Stabilised Composition Comprising ACE Inhibitors
EP2049089A4 (en) 2006-08-08 2012-07-04 Accu Break Technologies Inc PHARMACEUTICAL TABLETS WITH SEVERAL ACTIVE SEGMENTS
WO2008065485A2 (en) 2006-10-19 2008-06-05 Torrent Pharmaceuticals Limited Stable pharmaceutical compositions of a calcium channel blocker and an ace inhibitor
GB0624087D0 (en) * 2006-12-01 2007-01-10 Selamine Ltd Ramipril combination salt
WO2008068217A2 (en) * 2006-12-04 2008-06-12 Boehringer Ingelheim International Gmbh Pharmaceutical composition comprising a coated hmg-coa reductase inhibitor and an inhibitor of the renin-angiotensin system
CA2677623C (en) 2007-02-09 2015-04-07 Alphapharm Pty Ltd A dosage form containing two or more active pharmaceutical ingredients in different physical forms
WO2008132756A1 (en) 2007-05-01 2008-11-06 Lupin Limited Stable pharmaceutical compositions of ramipril
HU230877B1 (hu) 2008-09-30 2018-11-29 EGIS Gyógyszergyár NyR Stabil kombinációs gyógyszerkészítmény
SI2538924T1 (sl) * 2010-02-24 2014-09-30 Sanofi-Aventis Deutschland Gmbh Trdne farmacevtske formulacije ramiprila in amlodipin bezilata in njihova priprava
CN107441495A (zh) 2012-02-17 2017-12-08 埃吉斯药物私人有限公司 稳定性提高的药物制剂

Also Published As

Publication number Publication date
EP2814465B1 (en) 2019-07-03
HUE046229T2 (hu) 2020-02-28
EP3501501A1 (en) 2019-06-26
CN107441495A (zh) 2017-12-08
MX370647B (es) 2019-12-19
HK1205683A1 (en) 2015-12-24
UA113977C2 (xx) 2017-04-10
BR112014020184A8 (pt) 2017-07-11
BR112014020184A2 (pl) 2017-06-20
AU2012369903A1 (en) 2014-09-04
MX2014009871A (es) 2015-03-19
IL233972A0 (en) 2014-09-30
CA2864456A1 (en) 2013-08-22
EA201491510A1 (ru) 2014-11-28
ZA201405925B (en) 2015-11-25
WO2013121233A1 (en) 2013-08-22
EA030466B1 (ru) 2018-08-31
BR112014020184B1 (pt) 2021-11-30
CN104254321A (zh) 2014-12-31
EP2814465A1 (en) 2014-12-24
US20150094345A1 (en) 2015-04-02
PH12014501840A1 (en) 2014-11-10
AU2016203463A1 (en) 2016-07-07

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