HRP20140631T1 - Polimerni sustav za dostavu neviskozne otopine bez konzervansa zasnovane na prostaglandinu - Google Patents

Polimerni sustav za dostavu neviskozne otopine bez konzervansa zasnovane na prostaglandinu Download PDF

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Publication number
HRP20140631T1
HRP20140631T1 HRP20140631AT HRP20140631T HRP20140631T1 HR P20140631 T1 HRP20140631 T1 HR P20140631T1 HR P20140631A T HRP20140631A T HR P20140631AT HR P20140631 T HRP20140631 T HR P20140631T HR P20140631 T1 HRP20140631 T1 HR P20140631T1
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Croatia
Prior art keywords
solution according
solution
prostaglandin
agent
ethyl
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HRP20140631AT
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English (en)
Inventor
Fabrice Mercier
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Laboratoires Théa
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Publication of HRP20140631T1 publication Critical patent/HRP20140631T1/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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/557Eicosanoids, e.g. leukotrienes or prostaglandins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/557Eicosanoids, e.g. leukotrienes or prostaglandins
    • A61K31/5575Eicosanoids, e.g. leukotrienes or prostaglandins having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • A61P27/06Antiglaucoma agents or miotics

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (16)

1. Oftalmička otopina koja uključuje: - najmanje jedan prostaglandin; - otapajući agens; - gelirajući agens tipa karbomera; - agens za inhibiciju polimerizacije karbomera; - agens za ko-geliranje/ko-otapanje, Gdje: - otopina ima Brookfield viskoznost pri 25°C u rasponu od 8 mPa.s do 20 mPa.s; otopina ne sadrži antimikrobske konzervanse.
2. Otopina prema zahtjevu 1, naznačena time da ima Brookfield viskoznost u rasponu od 10 mPas.s do 14 mPa.s.
3. Otopina prema zahtjevu 1 ili 2, naznačena time da su antimikrobski konzervansi tipa kvarternog amonijaka, još poželjnije tip benzalkonij-klorida (BAK).
4. Otopina prema zahtjevu 1 ili 2, naznačena time da je koncentracija gelirajućeg agensa tipa karbomera u rasponu od 0,05% do 0,15% (w/v).
5. Otopina prema bilo kojem od zahtjeva 1 do 4, naznačena time da se prostaglandin bira iz skupine koja uključuje 17-fenil-13,14 dihidro trinor Prostaglandin F2α izopropil ester (latanoprost), 20-etil Prostaglandin F2a, (+)-Fluprostenol izopropil ester (travoprost), 17-fenil trinor Prostaglandin F2α amid, 7-fenil-13,14 dihidro trinor Prostaglandin F2α etil amid (bimatoprost), tafluprost Prostaglandin F2α etanolamid, bimatoprost (slobodna kiselina)-d4, bimatoprost-d4, latanoprost etil amid, 13,14 dihidro-15-keto-20-etil Prostaglandin F2α (unoproston), 13,14 dihidro-15-keto-20-etil Prostaglandin F2α izopropil ester (unoproston izopropil ester), poželjno latanoprost.
6. Otopina prema bilo kojem od zahtjeva 1 do 5, naznačena time da je koncentracija prostaglandina u otopini između 0,002% i 0,15% (w/v).
7. Otopina prema bilo kojem od zahtjeva 1 do 6, naznačena time da je inhibirajući agens za polimerizaciju karbomera izvor iona natrija, poželjno EDTA natrija, natrij-acetata ili natrij- klorida.
8. Otopina prema bilo kojem od zahtjeva 1 do 7, naznačena time da je otapajući agens hidroksistearat makroglicerola.
9. Otopina prema bilo kojem od zahtjeva 1 do 8, naznačena time da je ko-gelirajući/ ko-otapajući agens polimer izabran iz skupine koja uključuje polietilenglikol (PEG), polivinilski alkohol (PVA) ili polivinilpirolidon (PVP).
10. Otopina prema bilo kojem od zahtjeva 1 do 9, naznačena time da je otopina stabilna najmanje 18 mjeseci pri temperaturi okoline (25°C ili 30°C).
11. Otopina prema bilo kojem od zahtjeva 1 do 10, naznačena time da je otopina kompatibilna sa bočicama za jednokratnu ili multidoznu upotrebu napravljenim od LDPE bez aditiva.
12. Otopina prema bilo kojem od zahtjeva 1 do 11, naznačena time da također sadrži antiglaukomatski agens izabran iz skupine koja uključuje beta blokatore, inhibitore ugljične anhidraze i alfa-adrenergične agoniste.
13. Otopina prema bilo kojem od zahtjeva 1 do 12, naznačena time da također sadrži aditiv izabran iz skupine koja uključuje izotonične agense, antioksidanse i puferske sustave.
14. Otopina prema bilo kojem od zahtjeva 1 do 13 za upotrebu u tretiranju glaukome i/ili smanjenje intraokularnog pritiska.
15. Otopina prema zahtjevu 14 uključujući da se topički administrira jedna kap spomenute otopine po danu u svako oko ljudi ili životinja.
16. Bočica za jednokratnu ili multidoznu upotrebu napravljena od LDPE bez aditiva koja sadrži oftalmičku otopinu pokrivenu bilo kojim od zahtjeva 1 do 13.
HRP20140631AT 2010-06-29 2014-07-02 Polimerni sustav za dostavu neviskozne otopine bez konzervansa zasnovane na prostaglandinu HRP20140631T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US35969910P 2010-06-29 2010-06-29
FR1055236A FR2961694B1 (fr) 2010-06-29 2010-06-29 Systeme de delivrance polymerique d'une solution non visqueuse a base de prostaglandine sans conservateur
PCT/EP2011/060848 WO2012001009A1 (fr) 2010-06-29 2011-06-28 Systeme de delivrance polymerique d'une solution non visqueuse a base de prostaglandine sans conservateur

Publications (1)

Publication Number Publication Date
HRP20140631T1 true HRP20140631T1 (hr) 2014-09-26

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ID=43064334

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HRP20140631AT HRP20140631T1 (hr) 2010-06-29 2014-07-02 Polimerni sustav za dostavu neviskozne otopine bez konzervansa zasnovane na prostaglandinu

Country Status (27)

Country Link
US (2) US20110319487A1 (hr)
EP (1) EP2588078B1 (hr)
JP (2) JP5657789B2 (hr)
KR (1) KR101809713B1 (hr)
CN (2) CN104274396B (hr)
AU (1) AU2011273549B2 (hr)
BR (1) BR112012033435B1 (hr)
CA (1) CA2802816C (hr)
CL (1) CL2012003684A1 (hr)
CO (1) CO6660508A2 (hr)
DK (1) DK2588078T3 (hr)
EA (1) EA025026B1 (hr)
ES (1) ES2486793T3 (hr)
FR (1) FR2961694B1 (hr)
HK (2) HK1178446A1 (hr)
HR (1) HRP20140631T1 (hr)
MA (1) MA34324B1 (hr)
MX (1) MX2012014503A (hr)
PL (1) PL2588078T3 (hr)
PT (1) PT2588078E (hr)
RS (1) RS53417B (hr)
SG (1) SG186361A1 (hr)
SI (1) SI2588078T1 (hr)
SM (1) SMT201400098B (hr)
TN (1) TN2012000588A1 (hr)
UA (1) UA107718C2 (hr)
WO (1) WO2012001009A1 (hr)

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Also Published As

Publication number Publication date
JP2013532159A (ja) 2013-08-15
SG186361A1 (en) 2013-01-30
JP5657789B2 (ja) 2015-01-21
SMT201400098B (it) 2014-09-08
EA025026B1 (ru) 2016-11-30
CN104274396B (zh) 2017-07-04
CA2802816A1 (fr) 2012-01-05
CN102958509B (zh) 2015-01-21
CN104274396A (zh) 2015-01-14
CO6660508A2 (es) 2013-04-30
CA2802816C (fr) 2015-05-12
EP2588078B1 (fr) 2014-05-14
EA201291307A1 (ru) 2013-05-30
US20120322871A1 (en) 2012-12-20
BR112012033435A2 (pt) 2016-11-22
HK1178446A1 (en) 2013-09-13
HK1201464A1 (en) 2015-09-04
TN2012000588A1 (fr) 2014-04-01
AU2011273549B2 (en) 2013-06-27
UA107718C2 (en) 2015-02-10
RS53417B (en) 2014-12-31
DK2588078T3 (da) 2014-08-18
US20110319487A1 (en) 2011-12-29
FR2961694B1 (fr) 2013-01-25
ES2486793T3 (es) 2014-08-19
KR20130112728A (ko) 2013-10-14
CL2012003684A1 (es) 2013-03-08
JP5877885B2 (ja) 2016-03-08
EP2588078A1 (fr) 2013-05-08
MX2012014503A (es) 2013-01-29
FR2961694A1 (fr) 2011-12-30
BR112012033435B1 (pt) 2022-03-29
US8637054B2 (en) 2014-01-28
JP2015038099A (ja) 2015-02-26
PT2588078E (pt) 2014-07-16
MA34324B1 (fr) 2013-06-01
KR101809713B1 (ko) 2017-12-15
SI2588078T1 (sl) 2014-09-30
PL2588078T3 (pl) 2014-09-30
WO2012001009A1 (fr) 2012-01-05
CN102958509A (zh) 2013-03-06
AU2011273549A1 (en) 2013-01-10

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