HRP20121045T1 - Farmaceutska smjesa za parenteralnu primjenu antagonista beta-adrenoreceptora ultrakratkog djelovanja - Google Patents

Farmaceutska smjesa za parenteralnu primjenu antagonista beta-adrenoreceptora ultrakratkog djelovanja Download PDF

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Publication number
HRP20121045T1
HRP20121045T1 HRP20121045AT HRP20121045T HRP20121045T1 HR P20121045 T1 HRP20121045 T1 HR P20121045T1 HR P20121045A T HRP20121045A T HR P20121045AT HR P20121045 T HRP20121045 T HR P20121045T HR P20121045 T1 HRP20121045 T1 HR P20121045T1
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Croatia
Prior art keywords
cyclodextrin
solution containing
salt
flestolol
landiolol
Prior art date
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HRP20121045AT
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English (en)
Inventor
Rudolf Stefan Widmann
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Aop Orphan Pharmaceuticals Ag
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Publication of HRP20121045T1 publication Critical patent/HRP20121045T1/hr

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    • 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
    • A61K47/40Cyclodextrins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/235Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
    • A61K31/24Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
    • 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
    • A61K31/535Heterocyclic 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
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • A61K31/53771,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/724Cyclodextrins
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P9/06Antiarrhythmics
    • 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B82NANOTECHNOLOGY
    • B82YSPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Nanotechnology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Emergency Medicine (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (10)

1. Uporaba ciklodekstrina i/ili funkcionalnog derivata ciklodekstrina izabranog iz grupe koja obuhvaća α-ciklodekstrin, β-ciklodekstrin, γ-ciklodekstrin, (2-hidroksipropil)-β-ciklodekstrin i (sulfobutileter)-7β-ciklodekstrin i njihove smjese, za povećanje stabilnosti antagonista β-adrenoreceptora ultrakratkog djelovanja izabranog iz grupe koja obuhvaća esmolol, landiolol, flestolol ili njegovu farmaceutski prihvatljivu sol, u vodenoj otopini stabilnoj za čuvanje za parenteralnu primjenu.
2. Farmaceutska smjesa za parenteralnu primjenu antagonista β-adrenoreceptora ultrakratkog djelovanja u obliku otopine stabilne za čuvanje, koja u biti sadrži a) antagonist β-adrenoreceptora ultrakratkog djelovanja izabran iz grupe koja obuhvaća esmolol, landiolol, flestolol ili njegovu farmaceutski prihvatljivu sol, b) vodu, c) ciklodekstrina i/ili funkcionalni derivat ciklodekstrina izabran iz grupe koja obuhvaća α-ciklodekstrin, β-ciklodekstrin, γ-ciklodekstrin, (2-hidroksipropil)-β-ciklodekstrin i (sulfobutileter)-7β-ciklodekstrin.
3. Farmaceutska smjesa prema zahtjevu 2, sadrži druge pomoćne tvari izabrane između pufera, konzervansa, otapala koja se miješaju s vodom, soli, šećernih alkohola i/ili šećera.
4. Uporaba smjese prema bilo kojem od zahtjeva 1 do 3, naznačeno time što je pH vrijednost te otopine 3 do 7.5, poželjno 5 do 7.
5. Uporaba smjese prema bilo kojem od zahtjeva 1 do 4, naznačeno time što je koncentracija ciklodekstrina, odnosno njegovog funkcionalnog derivata, 0.1% do 20% (w/v), poželjno 0.25% do 7% (w/v), posebno poželjno 0.5% do 4%.
6. Uporaba ili smjesa prema bilo kojem od prethodnih zahtjeva, naznačeno time što je koncentracija antagonista β-adrenoreceptora ultrakratkog djelovanja, odnosno njegove soli, 0.1% do 30%.
7. Uporaba ili smjesa prema bilo kojem od prethodnih zahtjeva, naznačeno time što je osmolalnost otopine 270 mosmol/l do 310 mosmol/l, poželjno 280 mosmol/l do 300 mosmol/l.
8. Uporaba ili smjesa prema bilo kojem od prethodnih zahtjeva, gdje je ta smjesa prisutna u obliku prodajne jedinice izabrane iz grupe koja obuhvaća- 1 ml otopine koja sadrži 10-20 mg esmolola ili njegove soli - 2 ml otopine koja sadrži 10-100 mg esmolola ili njegove soli - 5 ml otopine koja sadrži 50-500 mg esmolola ili njegove soli - 10 ml otopine koja sadrži 50-5000 mg, posebno 2500 mg esmolola ili njegove soli - 50 ml otopine koja sadrži 50-5000 mg esmolola ili njegove soli - 100 ml otopine koja sadrži 50-5000 mg esmolola ili njegove soli - 250 ml otopine koja sadrži 50-5000 mg esmolola ili njegove soli.
9. Uporaba ili smjesa prema bilo kojem od zahtjeva 1 do 8, gdje je ta smjesa prisutna u obliku prodajne jedinice izabrane iz grupe koja obuhvaća- 1 ml otopine koja sadrži 5-20 mg landialola ili flestolola ili njegove soli - 2 ml otopine koja sadrži 5-100 mg landiolola ili flestolola ili njegove soli- 5 ml otopine koja sadrži 10-500 mg landiolola ili flestolola ili njegove soli - 10 ml otopine koja sadrži 10-5000 mg landiolola ili flestolola ili njegove soli - 25 ml otopine koja sadrži 25-2500 mg landiolola ili flestolola ili njegove soli- 50 ml otopine koja sadrži 50-5000 mg landiolola ili flestolola ili njegove soli - 100 ml otopine koja sadrži 50-5000 mg landiolola ili flestolola ili njegove soli - 250 ml otopine koja sadrži 50-5000 mg landiolola ili flestolola ili njegove soli.
10. Uporaba smjese prema bilo kojem od prethodnih zahtjeva za proizvodnju lijeka za snižavanje frekvencije srčanih klijetki u bolesnika s atrijskom fibrilacijom, atrijskom undulacijom i sinusnom tahikardijom, s atrioventrikularnom tahikardijom i tahikardijom AV čvora, s tahikardijalnim supra i ventrikularnim aritmijama, s tahikardijom i/ili hipertenzijom prije, tijekom i nakon operacija kao i u drugim hitnim slučajevima, za profilaksu i liječenje perioperativnih ishemija, za liječenje nestabilne angine pektoris i akutnog infarkta miokarda.
HRP20121045AT 2007-12-21 2012-12-18 Farmaceutska smjesa za parenteralnu primjenu antagonista beta-adrenoreceptora ultrakratkog djelovanja HRP20121045T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AT21072007 2007-12-21
PCT/AT2008/000470 WO2009079679A2 (de) 2007-12-21 2008-12-22 Pharmazeutische zusammensetzung

Publications (1)

Publication Number Publication Date
HRP20121045T1 true HRP20121045T1 (hr) 2013-01-31

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US (5) US20100311738A1 (hr)
EP (1) EP2234614B1 (hr)
JP (1) JP5623288B2 (hr)
CN (1) CN101903024A (hr)
AU (1) AU2008340179B2 (hr)
CA (1) CA2712414C (hr)
CY (1) CY1114951T1 (hr)
DK (1) DK2234614T3 (hr)
ES (1) ES2397126T3 (hr)
HR (1) HRP20121045T1 (hr)
NZ (1) NZ586200A (hr)
PL (1) PL2234614T3 (hr)
PT (1) PT2234614E (hr)
SI (1) SI2234614T1 (hr)
WO (1) WO2009079679A2 (hr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2872953C (en) 2012-05-10 2020-04-07 Aop Orphan Pharmaceuticals Ag Parenteral esmolol formulation
EP2796139A1 (en) * 2013-04-26 2014-10-29 AOP Orphan Pharmaceuticals AG Use of landiolol hydrochloride in the long-term treatment of tachyarrhythmias

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1985004580A1 (en) * 1984-04-09 1985-10-24 American Hospital Supply Corporation Pharmaceutical composition and method for treatment or prophylaxis of cardiac disorders
US4727064A (en) 1984-04-25 1988-02-23 The United States Of America As Represented By The Department Of Health And Human Services Pharmaceutical preparations containing cyclodextrin derivatives
US4857552A (en) 1988-06-08 1989-08-15 E. I. Du Pont De Nemours And Co. Stable pharmaceutical composition
DE4207922A1 (de) 1992-03-13 1993-09-23 Pharmatech Gmbh Wasserloesliche einschlussverbindungen und verfahren zu deren herstellung
CA2150554A1 (en) * 1992-12-02 1994-06-09 Sheng-Wan Tsao Cyclodextrin and polymer based drug delivery system
EP1239864A1 (en) 1999-11-23 2002-09-18 Aderis Pharmaceuticals, Inc. Treatment of heart rhythm disturbances with n6 -substituted-5'-(n-substituted) carboxamidoadenosines
TWI277414B (en) * 2001-01-12 2007-04-01 Baxter Int Esmolol formulation
WO2003028718A1 (en) * 2001-10-01 2003-04-10 Smithkline Beecham Corporation Novel formulations of carvedilol
WO2003033025A2 (en) 2001-10-18 2003-04-24 Decode Genetics Ehf Cyclodextrin complexes
JP2005530736A (ja) * 2002-04-18 2005-10-13 シーブイ・セラピューティクス・インコーポレイテッド ベーターブロッカー、カルシウムチャネルブロッカー、または心臓のグリコシドと共にa1アデノシンアゴニストを投与することを含む不整脈の処置方法
US7148211B2 (en) * 2002-09-18 2006-12-12 Genzyme Corporation Formulation for lipophilic agents
EP1417962A1 (de) 2002-11-06 2004-05-12 AOP Orphan Pharmaceuticals AG Verfahren zur Herstellung eines Arzneimittels enthaltend Esmolol
US7893040B2 (en) * 2005-07-22 2011-02-22 Oculis Ehf Cyclodextrin nanotechnology for ophthalmic drug delivery
CN1827109A (zh) * 2006-04-14 2006-09-06 北京润德康医药技术有限公司 一种以兰洛地尔及其盐为活性成分的冻干粉针制剂及其制备工艺
US8722736B2 (en) * 2007-05-22 2014-05-13 Baxter International Inc. Multi-dose concentrate esmolol with benzyl alcohol

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Publication number Publication date
US20230277674A1 (en) 2023-09-07
WO2009079679A2 (de) 2009-07-02
US11517624B2 (en) 2022-12-06
ES2397126T3 (es) 2013-03-04
AU2008340179A1 (en) 2009-07-02
CA2712414A1 (en) 2009-07-02
US20200323988A1 (en) 2020-10-15
PL2234614T3 (pl) 2013-03-29
SI2234614T1 (sl) 2013-01-31
US20160361422A1 (en) 2016-12-15
US10660964B2 (en) 2020-05-26
CN101903024A (zh) 2010-12-01
US20190046646A1 (en) 2019-02-14
US20100311738A1 (en) 2010-12-09
CY1114951T1 (el) 2016-12-14
JP2011506486A (ja) 2011-03-03
AU2008340179B2 (en) 2014-10-23
EP2234614A2 (de) 2010-10-06
CA2712414C (en) 2016-07-12
JP5623288B2 (ja) 2014-11-12
DK2234614T3 (da) 2013-02-11
EP2234614B1 (de) 2012-10-17
NZ586200A (en) 2012-06-29
PT2234614E (pt) 2013-01-25
WO2009079679A3 (de) 2009-11-26

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