HRP20191667T1 - Vodenasta oftalmološka otopina i postupak tretmana sindroma suhog oka - Google Patents

Vodenasta oftalmološka otopina i postupak tretmana sindroma suhog oka Download PDF

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HRP20191667T1
HRP20191667T1 HRP20191667T HRP20191667T1 HR P20191667 T1 HRP20191667 T1 HR P20191667T1 HR P20191667 T HRP20191667 T HR P20191667T HR P20191667 T1 HRP20191667 T1 HR P20191667T1
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ophthalmic solution
container
μmol
polymer
acetylcysteinyl
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Martin Prinz
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Croma Pharma Ges M B H
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/722—Chitin, chitosan
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/50—Medicinal 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
    • A61K47/51—Medicinal 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 non-active ingredient being a modifying agent
    • A61K47/56—Medicinal 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 non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/61—Medicinal 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 non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P27/02—Ophthalmic agents
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    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D65/00—Wrappers or flexible covers; Packaging materials of special type or form
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Claims (20)

1. Sterilna vodenasta oftalmološka otopina obuhvaćajući 0,05% do 0,5% (w/w) N-(N-acetilcisteinil-)kitozan ili farmaceutski prihvatljivu sol istog u otopini nositelju, naznačena time da N-(N- acetilcisteinil-)kitozan ima sadržaj slobodnih tiol grupa u iznosu od 80 µmol/g polimera do 280 µmol/g polimera.
2. Oftalmološka otopina prema zahtjevu 1, naznačena time da je koncentracija N-(N-acetilcisteinil-)kitozana ili navedene farmaceutski prihvatljive sol istog u navedenoj otopini od 0,05 do 0,3% (w/w), poželjno od 0,05 do 0,2% (w/w), još poželjnije 0,08 – 0,16% (w/w).
3. Oftalmološka otopina prema zahtjevu 1 ili 2, naznačena time da je navedena farmaceutski prihvatljiva sol odabrana od grupe koja se sastoji od soli organskih kiselina poput octene, limunske, mravlje i vinske kiseline, i soli mineralnih kiselina poput HCl i H2SO4.
4. Oftalmološka otopina prema bilo kojem od prethodnih zahtjeva, naznačena time da N-(N-acetilcisteinil-)kitozan ima sadržaj slobodnih tiol grupa u količini od 105 µmol/g polimera do 250 µmol/g polimera, poželjno od 110 µmol/g polimera do 250 µmol/g polimera, najpoželjnije od poželjno 140 do 250 µmol/g polimera.
5. Oftalmološka otopina prema bilo kojem od prethodnih zahtjeva, naznačena time da je količina umreženih tiol grupa u N-(N-acetilcisteinil-)kitozanu 30% ili manje od ukupnih sadržanih tiol grupa, poželjno 25% ili manje, najpoželjnije 15% ili manje.
6. Oftalmološka otopina prema bilo kojem od prethodnih zahtjeva, dalje obuhvaćajući barem jednu pomoćnu tvar odabranu iz grupe koja se sastoji od borne kiseline i njezinih soli, soli limunske kiseline, soli octene kiseline, polietilen glikola, Na2-EDTA, manitola, sorbitola, glicerola, natijevog klorida, natrijevog metabisulfita, hidroksipropil metilceluloze, polivinilpirolidona, polivinilalkohola, lubricina, hijaluronske kiseline i njihovih farmaceutski prihvatljivih soli ili mješavina istih.
7. Oftalmološka otopina prema zahtjevu 6, obuhvaćajući: 0,05% do 0,5% (w/w), poželjno 0,05% do 0,3% (w/w) N-(N-acetilcisteinil-)kitozana ili farmaceutski prihvatljive soli istog; Bornu kiselinu u količini od 1,0 do 16,0 mg/ml, poželjno 8 do 16 mg/ml; Polietilenglikol 400 u količini od 0,01 do 5,0 mg/ml, poželjno 1 do 5 mg/ml; Na2-EDTA u količini od 0,01 do 0,5 mg/ml; Manitol u količini od 0,01 do 5,5 mg/ml, poželjno 0,1 do 4 mg/ml; Natrijev klorid u količini od 0,01 do 9 mg/ml, poželjno 1 do 3 mg/ml; i Hidroksipropil metilceluloza u količini od 0,01 do 20 mg/ml, poželjno 1 do 3 mg/ml.
8. Oftalmološka otopina prema bilo kojem od prethodnih zahtjeva, naznačena time da N-(N-acetilcisteinil-)kitozan korišten za pripremu otopine ima pri koncentraciji od 0,5% u vodi na 25 ºC kinematski viskozitet unutar raspona od 1 do 15 mm2/s, poželjno 2 do 10 mm2/s.
9. Oftalmološka otopina prema bilo kojem od prethodnih zahtjeva, naznačena time da otopina ima osmotski tlak od 150 do 400 mOsM, poželjno 200 do 330 mOsM, najpoželjnije od 250 do 330 mOsM.
10. Oftalmološka otopina prema bilo kojem od prethodnih zahtjeva, naznačena time da otopina ima pH-vrijednost od 5,8 do 6,8, poželjno 6,0 do 6,6.
11. Spremnik obuhvaćajući oftalmološku otopinu prema bilo kojem od prethodnih zahtjeva u atmosferi koja je esencijalno bez kisika.
12. Spremnik prema zahtjevu 11, obuhvaćajući prvi spremnik koji sadrži oftalmološku otopinu i drugi spremnik koji obuhvaća navedeni prvi spremnik.
13. Spremnik prema zahtjevima 11 do 12, naznačen time da navedeni spremnik i/ili navedeni prvi spremnik i/ili navedeni drugi spremnik je/su u obliku plinonepropusne vrećice, posebno vrećice izrađene od aluminija ili aluminijevog laminata ili aluminijskog sastava.
14. Spremnik prema zahtjevu 13, naznačen time da navedena plinonepropusna vrećica sadrži jednu ili više pojedinačnih doza pod-spremnika koji sadrže navedenu oftalmološku otopinu.
15. Spremnik prema bilo kojem od zahtjeva 11 do 14, naznačen time da navedeni spremnik i/ili navedeni prvi spremnik i/ili navedeni drugi spremnik obuhvaća materijal koji upija kisik.
16. Spremnik prema bilo kojem od zahtjeva 11 do 15, naznačen time da naveden N-(N-acetilcisteinil-)kitozan sadržan u istome ima sadržaj slobodnih tiol grupa od 80 µmol/g polimera do 250 µmol/g polimera, poželjno 105 µmol/g polimera do 250 µmol/g polimera, nakon što je pohranjen barem 12 mjeseci na sobnoj temperaturi.
17. Spremnik prema bilo kojem od zahtjeva 11 do 16, naznačen time da je količina umreženih tiol grupa u N-(N-acetilcisteinil-)kitozanu 30% ili manje od ukupnih sadržanih tiol grupa, poželjno 25% ili manje, najpoželjnije 20% ili manje nakon što je pohranjen barem 12 mjeseci na sobnoj temperaturi.
18. Sterilna vodenasta oftalmološka otopina prema bilo kojem od zahtjeva 1 do 10 za specifično korištenje u prevenciji ili tretmanu sindroma suhog oka ili znakova suhog oka i/ili simptoma.
19. Sterilna vodenasta oftalmološka otopina za specifično korištenje prema zahtjevu 18, naznačena time da su navedeni znakovi suhog oka i/ili simptomi uzrokovani od ili povezani sa sindromom suhog oka (KCS), suhim okom povezanim sa starošću, Stevens – Johnson sindromom, Sjogrenovim sindromom, očnim ožiljnim pemfigoidom, oštećenjem rožnice, infekcijom, Riley – Day sindromom, urođenom alakrimijom, PRK, LASEK i/ili LASIK tretmanom, alergijskim konjunktivitisom, blefaritisom i disfunkcijom Meibomovih žlijezda, poremećajima ili nedostacima u prehrani (uključujući vitamine), farmakološkim nuspojavama, uništenjem žlijezda ili tkiva, autoimunim poremećajima i drugim poremećajima imunodeficijencije, intolerancijom na kontaktne leće, izloženosti lebdećim česticama u okolišu, izloženosti dimu u okolišu, izloženosti smogu u okolišu, i izloženosti pretjerano suhom zraku u okolišu, nemogućnošću treptanja kod pacijenata u komi, ili očnim stresom uzrokovanim radom na računalu ili računalnim igrama.
20. Sterilna vodenasta oftalmološka otopina za specifično korištenje prema zahtjevu 18 ili 19, naznačena time da se primjenjuje ne više od dva puta dnevno, poželjno jednom dnevno.
HRP20191667 2014-05-07 2019-09-16 Vodenasta oftalmološka otopina i postupak tretmana sindroma suhog oka HRP20191667T1 (hr)

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EP14167381 2014-05-07
EP15718956.4A EP3139903B1 (en) 2014-05-07 2015-05-04 Aqueous ophthalmic solution and method for treating dry eye syndrome
PCT/EP2015/059674 WO2015169728A1 (en) 2014-05-07 2015-05-04 Aqueous ophthalmic solution and method for treating dry eye syndrome

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US (2) US10342759B2 (hr)
EP (1) EP3139903B1 (hr)
JP (1) JP6639480B2 (hr)
KR (1) KR102378391B1 (hr)
CN (1) CN106456536B (hr)
AR (1) AR100334A1 (hr)
AU (1) AU2015257874B2 (hr)
BR (1) BR112016024454B1 (hr)
CA (1) CA2947065C (hr)
CL (1) CL2016002815A1 (hr)
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IL248804B (en) 2020-05-31
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US10653620B2 (en) 2020-05-19
SI3139903T1 (sl) 2019-10-30
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