HRP20191994T1 - Formulacije ketorolaka spremne za uporabu - Google Patents

Formulacije ketorolaka spremne za uporabu Download PDF

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Publication number
HRP20191994T1
HRP20191994T1 HRP20191994TT HRP20191994T HRP20191994T1 HR P20191994 T1 HRP20191994 T1 HR P20191994T1 HR P20191994T T HRP20191994T T HR P20191994TT HR P20191994 T HRP20191994 T HR P20191994T HR P20191994 T1 HRP20191994 T1 HR P20191994T1
Authority
HR
Croatia
Prior art keywords
ketorolac
pharmaceutically acceptable
pharmaceutical preparation
agent
acceptable salt
Prior art date
Application number
HRP20191994TT
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English (en)
Inventor
Joseph Pergolizzi
Alexander Mironov
Chad James Pickens
Douglas Giles Johnson
Original Assignee
Rtu Pharmaceuticals Llc
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 Rtu Pharmaceuticals Llc filed Critical Rtu Pharmaceuticals Llc
Publication of HRP20191994T1 publication Critical patent/HRP20191994T1/hr

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    • 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
    • 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
    • A61K31/407Heterocyclic 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 other heterocyclic ring systems, e.g. ketorolac, physostigmine
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (16)

1. Farmaceutski pripravak za parenteralnu primjenu koja sadrži: vodena otopina koji sadrži ketorolak ili njegovu farmaceutski prihvatljivu sol u količini od 0.1 mg/mL do 10 mg/mL; i farmaceutski prihvatljivi ekscipijent odabran iz skupine sastavljen od trehaloze, bezvodnog ili hidratnog oblika natrij klorida, dekstroze, saharoze, ksilitola, fruktoze, glicerola, sorbitola, kalij klorida, manoze, kalcij klorida i magnezij klorida; pri čemu pripravak ne sadrži alkohol; i pri čemu pripravak zadržava najmanje 90% količine ketorolaka ili njegove farmaceutski prihvatljive soli nakon skladištenja 6 mjeseci.
2. Farmaceutski pripravak sukladno patentnom zahtjevu 1, koja zadržava najmanje 95% količine ketorolaka ili njegove farmaceutski prihvatljive soli nakon skladištenja od 1 godine.
3. Farmaceutski pripravak sukladno patentnom zahtjevu 1 ili 2, koja ima pH od 4.5 do 8.5.
4. Farmaceutski pripravak sukladno bilo kojem patentnom zahtjevu, pri čemu je farmaceutski prihvatljiva sol ketorolak trometamin.
5. Farmaceutski pripravak sukladno bilo kojem patentnom zahtjevu, koja dalje sadrži kootapalo i/ili regulator pH odabran iz skupine sastavljene od kiseline ili baze
6. Farmaceutski pripravak sukladno bilo kojem patentnom zahtjevu, koja je sadržan u farmaceutski prihvatljivom spremniku odabranom iz skupine sastavljene od intravenskih vrećica i boca.
7. Farmaceutski pripravak sukladno bilo kojem patentnom zahtjevu, pri čemu ekscipijent nadalje obuhvaća sredstvo za pospješivanje otapanja, antioksidans, sredstvo za puferiranje, sredstvo za zakiseljavanje, sredstvo za pojačavanje kompleksa, fiziološka otopina, dekstrozu, pomoćno sredstvo za liofilizaciju, potpora, sredstvo za povećanje volumena, sredstva za stabiliziranje, elektrolita, drugi terapeutski agens, alkalizacijsko sredstvo, sredstvo protiv gljivica, ili njihove kombinacije.
8. Farmaceutski pripravak sukladno patentnom zahtjevu 1, pri čemu farmaceutski prihvatljivi ekscipijent nadalje obuhvaća sredstvo za toniziranje, trehalozu, površinski aktivno sredstvo, aminokiselinu, ili karboksilnu kiselinu.
9. Farmaceutski pripravak sukladno patentnom zahtjevu 1, pri čemu ekscipijens nadalje obuhvaća ciklodekstrin, pri čemu je ciklodekstrin betaciklodekstrin, pri čemu je ciklodekstrin sulfoalkilirani eter ciklodekstrin, pri čemu se formulacija razrjeđuje s farmaceutski prihvatljivim vodenim tekućim nosačem na sobnoj temperaturi s beznačajnim taloženje ketorolaka.
10. Farmaceutski pripravak sukladno bilo kojem patentnom zahtjevu, koji nadalje sadrži opioidni analgetik.
11. Farmaceutski pripravak sukladno patentnom zahtjevu 1 koja sadrži: od 0.1 mg/ml do 1 mg/ml ketorolaka ili njegove farmaceutski prihvatljive soli od 0.1 % do 3% dekstroze ili od 0.1% do 10% trehaloze; pri čemu se pripravak nalazi u fleksibilnoj intravenskoj vrećici; pri čemu formulacija sadrži pH od 6.0 do 7.5; i pri čemu formulacija zadržava najmanje 95% količine ketorolaka ili njegove farmaceutski prihvatljive soli nakon skladištenja godinu dana.
12. Farmaceutski pripravak sukladno bilo kojem prethodnom patentnom zahtjevu, naznačen time da se koristi u postupku liječenja ketorolakom kojim se može liječiti stanje kod pacijenta koji ima uvjete za liječenje ketorolakom sukladno bilo kojem od prethodnih zahtjeva.
13. Farmaceutski pripravak sukladno patentnom zahtjevu 12, pri čemu je postupak za pružanje analgezije, uz smanjenje količine opioida i/ili NSAIL-ova koji se daju pacijentu, pri čemu postupak sadrži parenteralno davanje pripravka sukladno bilo kojem od prethodnih zahtjeva kontinuiranom infuzijom pacijentu kome je to nužno.
14. Farmaceutski pripravak sukladno patentnom zahtjevu 12 ili 13, pri čemu je postupak za pružanje analgezije pacijentu kome je to nužno i uključuje primjenu bolusne doze ketorolaka da bi se postigla brza analgetička reakcija, praćena kontinuiranom infuzijom pripravka sukladno bilo kojem od prethodnih zahtjeva radi zadržavanja analgetičke reakcije.
15. Farmaceutski pripravak sukladno patentnom zahtjevu 12, pri čemu stanje koje se može tretirati keterolakom analgezija i postupak sadrži parenteralnu primjenu kompozicije kontinuiranom infuzijom pacijentu kome je to nužno.
16. Postupak pripreme farmaceutskog pripravka koji uključuje kombiniranje ketorolaka ili njegove farmaceutski prihvatljive soli s vodenom otopinom i ekscipijentom, čime se dobiva sastav bilo kojeg od prethodnih zahtjeva.
HRP20191994TT 2010-10-21 2019-11-05 Formulacije ketorolaka spremne za uporabu HRP20191994T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US40538410P 2010-10-21 2010-10-21
US201161481602P 2011-05-02 2011-05-02
PCT/US2011/057284 WO2012054831A2 (en) 2010-10-21 2011-10-21 Ready to use ketorolac formulations
EP11835216.0A EP2616064B1 (en) 2010-10-21 2011-10-21 Ready to use ketorolac formulations

Publications (1)

Publication Number Publication Date
HRP20191994T1 true HRP20191994T1 (hr) 2020-02-07

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Application Number Title Priority Date Filing Date
HRP20191994TT HRP20191994T1 (hr) 2010-10-21 2019-11-05 Formulacije ketorolaka spremne za uporabu

Country Status (18)

Country Link
US (5) US9421191B2 (hr)
EP (3) EP3632432B1 (hr)
JP (1) JP6013346B2 (hr)
KR (4) KR102114568B1 (hr)
CN (2) CN108703948A (hr)
CA (1) CA2814805C (hr)
CY (1) CY1122516T1 (hr)
DK (1) DK2616064T3 (hr)
ES (2) ES2753981T3 (hr)
HR (1) HRP20191994T1 (hr)
HU (1) HUE045889T2 (hr)
LT (1) LT2616064T (hr)
MX (1) MX346879B (hr)
PL (1) PL2616064T3 (hr)
PT (1) PT2616064T (hr)
RS (1) RS59526B1 (hr)
SI (1) SI2616064T1 (hr)
WO (1) WO2012054831A2 (hr)

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Publication number Publication date
CN108703948A (zh) 2018-10-26
MX346879B (es) 2017-04-03
EP3632432B1 (en) 2022-09-14
US9962371B2 (en) 2018-05-08
US9421191B2 (en) 2016-08-23
KR20200078541A (ko) 2020-07-01
CA2814805A1 (en) 2012-04-26
US20170007575A1 (en) 2017-01-12
DK2616064T3 (da) 2019-11-11
CY1122516T1 (el) 2021-01-27
JP2013543843A (ja) 2013-12-09
EP3632432A1 (en) 2020-04-08
PL2616064T3 (pl) 2020-02-28
EP4190327A1 (en) 2023-06-07
KR20180119610A (ko) 2018-11-02
WO2012054831A3 (en) 2012-06-07
KR102307601B1 (ko) 2021-09-30
EP2616064A2 (en) 2013-07-24
PT2616064T (pt) 2019-11-06
US20120101142A1 (en) 2012-04-26
US20220023260A1 (en) 2022-01-27
WO2012054831A2 (en) 2012-04-26
US10278959B2 (en) 2019-05-07
KR20140012029A (ko) 2014-01-29
MX2013004393A (es) 2014-09-12
LT2616064T (lt) 2019-11-25
EP2616064B1 (en) 2019-08-07
HUE045889T2 (hu) 2020-01-28
EP2616064A4 (en) 2016-07-20
US20190105301A1 (en) 2019-04-11
CA2814805C (en) 2021-11-02
ES2753981T3 (es) 2020-04-15
CN103167800A (zh) 2013-06-19
SI2616064T1 (sl) 2019-12-31
KR20190085561A (ko) 2019-07-18
JP6013346B2 (ja) 2016-10-25
KR102114568B1 (ko) 2020-05-22
ES2933198T3 (es) 2023-02-02
US20180280351A1 (en) 2018-10-04
US11116750B2 (en) 2021-09-14
RS59526B1 (sr) 2019-12-31

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