HRP20140873T1 - Tekuä†i pripravak koji sadrži kompleks pimobendana i ciklodekstrina - Google Patents

Tekuä†i pripravak koji sadrži kompleks pimobendana i ciklodekstrina Download PDF

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Publication number
HRP20140873T1
HRP20140873T1 HRP20140873TT HRP20140873T HRP20140873T1 HR P20140873 T1 HRP20140873 T1 HR P20140873T1 HR P20140873T T HRP20140873T T HR P20140873TT HR P20140873 T HRP20140873 T HR P20140873T HR P20140873 T1 HRP20140873 T1 HR P20140873T1
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liquid preparation
preparation according
cyclodextrin
pimobendan
mass
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HRP20140873TT
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English (en)
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Martin A. Folger
Stefan Lehner
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Boehringer Ingelheim Vetmedica Gmbh
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Publication of HRP20140873T1 publication Critical patent/HRP20140873T1/hr

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    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/50Pyridazines; Hydrogenated pyridazines
    • A61K31/501Pyridazines; Hydrogenated pyridazines not condensed and containing further heterocyclic rings
    • 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
    • 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
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • A61P21/04Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
    • 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
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/08Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
    • 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
    • A61P9/04Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • 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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nanotechnology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Urology & Nephrology (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Claims (14)

1. Tekući pripravak, naznačen time, da obuhvaća derivat eterificiranog ciklodekstrina i pimobendan ili njegovu farmaceutski prihvatljivu sol, pri čemu je derivat eterificiranog ciklodekstrina odabran iz skupine koju čine: alfa-ciklodekstrin-eter, beta-ciklodekstrin-eter i gama-ciklodekstrin-eter, te pritom tekući pripravak ima pH vrijednost od 5,5 do 8,5.
2. Tekući pripravak prema zahtjevu 1, naznačen time, da derivat etirificiranog ciklodekstrina je hidroksipropil-beta-ciklodekstrin.
3. Tekući pripravak prema bilo kojem od zahtjeva 1 do 2, naznačen time, da udio derivata etirificiranog ciklodekstrina iznosi 15 do 40% (masa/volumen).
4. Tekući pripravak prema zahtjevu 3, naznačen time, da udio derivata eterificiranog ciklodekstrina iznosi 20 do 30% (masa/volumen).
5. Tekući pripravak prema bilo kojem od zahtjeva 1 do 4, naznačen time, da udio pimobendana ili njegove farmaceutski prihvatljive soli iznosi 0,005 do 0,15% (masa/volumen).
6. Tekući pripravak prema bilo kojem od zahtjeva 1 do 5, naznačen time, da pripravak ima pH vrijednost od 6,5 do 7,5 i osmolalnost od 280 do 300 mOsm/kg.
7. Tekući pripravak prema bilo kojem od zahtjeva 1 do 6, naznačen time, da pripravak obuhvaća sljedeće: a) hidroksipropil-beta-ciklodekstrin od 20 do 30% (masa/volumen); b) pimobendan ili njegova farmaceutski prihvatljiva sol od 0,005 do 0,15% (masa/volumen); te pri čemu je pH vrijednost tekućine namještena na 6,5 do 7,5, a osmolalnost je 280 do 300 mOsm/kg.
8. Postupak proizvodnje tekućeg pripravka prema bilo kojem od zahtjeva 1 do 5, naznačen time, da obuhvaća sljedeće korake: a) otapanje derivata eterificiranog ciklodekstrina u otapalu; b) dodavanje pimobendana ili njegove farmaceutski prihvatljive soli u otopinu koja je dobivena u koraku a); i c) miješanje dobivene smjese iz koraka b) za dobivanje tekućeg pripravka u obliku vodene otopine koja ima pH vrijednost od 5,5 do 8,5.
9. Postupak prema zahtjevu 8, naznačen time, da otapalo je voda.
10. Tekući pripravak prema bilo kojem od zahtjeva 1 do 7, naznačen time, da se upotrebljava kao lijek.
11. Tekući pripravak prema bilo kojem od zahtjeva 1 do 7, naznačen time, da se upotrebljava u liječenju ili prevenciji bolesti kod subjekta kojem je to liječenje potrebno, dok je ono odabrano od sljedećih indikacija: kongestivni srčani zastoj (CHF), akutni CHF, dekompenzirana endokardioza (DCE), dilatacijska kardiomiopatija (DCM), asimptomatični (okultni) CHF, asimptomatična DCM, održavanje kardiovaskularne funkcije i/ili renalne perfuzije za vrijeme anestezije, šoka, gastričke dilatacije, volvulusa, miokardijske i renalne ishemije.
12. Tekući pripravak prema zahtjevu 11, naznačen time, da subjekt kojem je potrebno takvo liječenje je konj, pas ili mačka.
13. Tekući pripravak prema zahtjevu 11 ili 12, naznačen time, da se farmaceutski sastav primjenjuje pomoću injekcije ili infuzije.
14. Garnitura, naznačena time, da obuhvaća sljedeće: a) tekući pripravak prema bilo kojem od zahtjeva 1 do 7; i b) pakirani listić koji sadrži uputu kako se tekući pripravak treba koristiti za prevenciju i/ili liječenje kongestivnog srčanog zastoja kod subjekta kojem je potrebna takva prevencija ili takvo liječenje.
HRP20140873TT 2006-11-07 2014-09-12 Tekuä†i pripravak koji sadrži kompleks pimobendana i ciklodekstrina HRP20140873T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP06123567A EP1920785A1 (en) 2006-11-07 2006-11-07 Liquid preparation comprising a complex of pimobendan and cyclodextrin
PCT/EP2007/061879 WO2008055871A1 (en) 2006-11-07 2007-11-05 Liquid preparation comprising a complex of pimobendan and cyclodextrin

Publications (1)

Publication Number Publication Date
HRP20140873T1 true HRP20140873T1 (hr) 2014-12-05

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ID=37735786

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20140873TT HRP20140873T1 (hr) 2006-11-07 2014-09-12 Tekuä†i pripravak koji sadrži kompleks pimobendana i ciklodekstrina

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Country Link
US (3) US9107952B2 (hr)
EP (3) EP1920785A1 (hr)
JP (1) JP5565794B2 (hr)
KR (1) KR101434324B1 (hr)
CN (3) CN101534864A (hr)
AR (1) AR063587A1 (hr)
AU (1) AU2007316712B2 (hr)
BR (1) BRPI0718541B8 (hr)
CA (1) CA2668733C (hr)
CL (1) CL2007003201A1 (hr)
CY (1) CY1115710T1 (hr)
DK (2) DK2789349T3 (hr)
ES (2) ES2649718T3 (hr)
HR (1) HRP20140873T1 (hr)
HU (1) HUE035821T2 (hr)
MX (1) MX2009004767A (hr)
NZ (1) NZ577067A (hr)
PL (2) PL2089060T3 (hr)
PT (1) PT2089060E (hr)
SI (1) SI2089060T1 (hr)
TW (1) TWI432425B (hr)
WO (1) WO2008055871A1 (hr)
ZA (1) ZA200902085B (hr)

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