DK2722035T3 - Vandige farmaceutiske sammensætninger, som indeholder borat-polyol-komplekser - Google Patents

Vandige farmaceutiske sammensætninger, som indeholder borat-polyol-komplekser Download PDF

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DK2722035T3
DK2722035T3 DK14150805.1T DK14150805T DK2722035T3 DK 2722035 T3 DK2722035 T3 DK 2722035T3 DK 14150805 T DK14150805 T DK 14150805T DK 2722035 T3 DK2722035 T3 DK 2722035T3
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Bhagwati P Kabra
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Alcon Res Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/4965—Non-condensed pyrazines
    • A61K31/497—Non-condensed pyrazines containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/498—Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—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
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—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
    • 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
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/06—Antiglaucoma agents or miotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

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

Claims (21)

1. Multidosis ophthalmisk sammensætning, omfattende: brinzolamid, brimonidin eller en kombination deraf som terapeutisk middel; en første polyol, hvilken første polyol er valgt blandt mannitol, sorbitol eller en kombination deraf, idet koncentrationen af den første polyol er i det mindste 0,01 vægt/-volumen%, men ikke større end 0,5 vægt/volumen%; en anden polyol, hvilken anden polyol er valgt blandt propylenglycol, glycerin eller en kombination deraf, idet koncentrationen af den anden polyol er i det mindste 0,1 vægt/volumen%, men mindre end 5 vægt/volumen% af sammensætningen; en effektiv mængde af borat, idet den effektive mængde er i det mindste 0,05 vægt/volumen% og mindre end 0,5 vægt/volumen% af den samlede sammensætning; BAC som et antimikrobielt konserveringsmiddel, idet koncentrationen af BAC i sammensætningen er større end 0,00001 vægt/volumen% men mindre end 0,0035 vægt/volumen%; og vand.
2. Sammensætning ifølge krav 1, hvor sammensætningen opfylder Ph.Eur.A, Ph.Eur.B eller begge.
3. Sammensætning ifølge krav 1, hvor koncentrationen af den første polyol er mindre end 0,35 vægt/volumen%.
4. Sammensætning ifølge ethvert af de foregående krav, hvor koncentrationen af BAC er mindre end 0,0025 vægt/volumen% af sammensætningen.
5. Sammensætning ifølge ethvert af de foregående krav, hvor koncentrationen af BAC er mindre end 0,0015 vægt/volumen% af sammensætningen.
6. Sammensætning ifølge ethvert af de foregående krav, hvor den første polyol er mannitol.
7. Sammensætning ifølge ethvert af de foregående krav, hvor sammensætningen er fri for andre konserveringsmidler end benzalkoniumchlorid.
8. Sammensætning ifølge ethvert af de foregående krav, hvor modstanden, som tilvejebringes af sammensætningen imod normalisering af tåre pH efter indføring i øjet er mindre end 25 μΙ af 1 M NaOH/ml af sammensætningen.
9. Sammensætning ifølge ethvert af de foregående krav, hvor modstanden, som tilvejebringes af sammensætningen imod normalisering af tåre pH efter indføring i øjet er mindre end 5 μΙ af 1 M NaOH/ml af sammensætningen.
10. Sammensætning ifølge ethvert af de foregående krav, hvor pH for sammensætningen er fra 6,2 til 7,7.
11. Sammensætning ifølge ethvert af de foregående krav, som yderligere omfatter en anionisk polymer.
12. Sammensætning ifølge krav 11, hvor den anioniske polymer vælges blandt xanthan-gummi eller en carboxyvinylpolymer.
13. Sammensætning ifølge krav 11, hvor den anioniske polymer er en carboxyvinylpolymer.
14. Sammensætning ifølge ethvert af de foregående krav, hvor sammensætningen er en suspension med et terapeutisk middel suspenderet i en opløsning.
15. Sammensætning ifølge krav 14, hvor viskositeten af suspensionen er større end 0,02 Pas (20 cps), men mindre end 0,5 Pas (500 cps), hvor viskositeten af suspensionen måles ved en høj forskydningsrate på 120 see1 ved rumtemperatur.
16. Sammensætning ifølge ethvert af kravene 1 til 15, hvor sammensætningen er fri for terapeutiske antiinfektiva eller antibiotika.
17. Sammensætning ifølge krav 14 eller 15, hvor suspensionen gendispergeres med ikke mere end 15 sekunders kraftig rystning.
18. Sammensætning ifølge ethvert af de foregående krav, til anvendelse ved en fremgangsmåde til behandling af et øje på et pattedyr, hvilken fremgangsmåde omfatter: indgivelse af sammensætningen i øjet på pattedyret gentagende over en længere tidsperiode.
19. Sammensætning til anvendelse ved en fremgangsmåde ifølge krav 18, hvor sammensætningen indgives i det mindste én gang om dagen over en periode på i det mindste 1 måned.
20. Sammensætning til anvendelse ved en fremgangsmåde ifølge krav 18 eller 19, til anvendelse ved fremgangsmåden, som yderligere omfatter, før indgivelse, diagnos-tisering af øjet på pattedyret med en øjenlidelse, som er egnet til behandling med kronisk indgivelse af et terapeutisk middel.
21. Sammensætning til anvendelse ved en fremgangsmåde ifølge krav 20, hvor øjen-lidelsen er forøget intraokulært tryk.
DK14150805.1T 2009-06-19 2010-06-17 Vandige farmaceutiske sammensætninger, som indeholder borat-polyol-komplekser DK2722035T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US21847209P 2009-06-19 2009-06-19
EP10727317.9A EP2442790B1 (en) 2009-06-19 2010-06-17 Aqueous pharmaceutical compositions containing borate-polyol complexes

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DK2722035T3 true DK2722035T3 (da) 2016-08-01

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DK14150805.1T DK2722035T3 (da) 2009-06-19 2010-06-17 Vandige farmaceutiske sammensætninger, som indeholder borat-polyol-komplekser
DK16159225.8T DK3045164T3 (da) 2009-06-19 2010-06-17 Vandige farmaceutiske sammensætninger, der indeholder borat-polyol-komplekser
DK10727317.9T DK2442790T3 (da) 2009-06-19 2010-06-17 Vandige farmaceutiske sammensætninger, indeholdende borat-polyolkomplekser

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DK10727317.9T DK2442790T3 (da) 2009-06-19 2010-06-17 Vandige farmaceutiske sammensætninger, indeholdende borat-polyolkomplekser

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US (3) US9044484B2 (da)
EP (4) EP2442790B1 (da)
JP (3) JP6017956B2 (da)
KR (1) KR101738502B1 (da)
CN (2) CN104707145A (da)
AR (2) AR077126A1 (da)
AU (1) AU2010262898B2 (da)
BR (1) BRPI1015996B8 (da)
CA (1) CA2763778C (da)
CL (1) CL2010000634A1 (da)
CY (2) CY1117835T1 (da)
DK (3) DK2722035T3 (da)
ES (3) ES2584858T3 (da)
HR (2) HRP20160953T1 (da)
HU (2) HUE049477T2 (da)
LT (1) LT3045164T (da)
MX (1) MX2011013107A (da)
PL (3) PL2442790T3 (da)
PT (3) PT2442790E (da)
RU (1) RU2563125C2 (da)
SI (3) SI2442790T1 (da)
SM (1) SMT201600249B (da)
TW (1) TWI489997B (da)
UY (1) UY32709A (da)
WO (1) WO2010148190A1 (da)
ZA (1) ZA201108384B (da)

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