DK2915529T3 - Terapeutisk regenerering og berigelse af okulær overfladesmøring - Google Patents

Terapeutisk regenerering og berigelse af okulær overfladesmøring Download PDF

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DK2915529T3
DK2915529T3 DK15151634.1T DK15151634T DK2915529T3 DK 2915529 T3 DK2915529 T3 DK 2915529T3 DK 15151634 T DK15151634 T DK 15151634T DK 2915529 T3 DK2915529 T3 DK 2915529T3
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prg4
pharmaceutical composition
thr
pro
lys
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DK15151634.1T
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Benjamin Sullivan
Tannin A Schmidt
David A Sullivan
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Univ California
Schepens Eye Res Inst
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1841—Transforming growth factor [TGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/14—Peptides containing saccharide radicals; Derivatives thereof, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/688—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols both hydroxy compounds having nitrogen atoms, e.g. sphingomyelins
    • 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
    • A61K31/70—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
    • 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
    • A61K31/70—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
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13—Cyclosporins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/24—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
    • 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
    • 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
    • A61K9/0051—Ocular inserts or implants
    • 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
    • A61P27/04—Artificial tears; Irrigation solutions
    • 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
    • A61P27/14—Decongestants or antiallergics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents

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  • Health & Medical Sciences (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
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  • Ophthalmology & Optometry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Dermatology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Pulmonology (AREA)
  • Rheumatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Eyeglasses (AREA)
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Claims (16)

1. Farmaceutisk sammensætning omfattende PRG4, eller et smørefragment deraf, til anvendelse i behandlingen, med topikal anvendelse på den okulære overflade, af en mangel på okulær smøring eller symptomer associeret dermed.
2. Farmaceutisk sammensætning til anvendelse ifølge krav 1, hvor den farmaceutiske sammensætning omfattende PRG4, eller et smørefragment deraf, er administreret i kombination med en for øjnene acceptabel formulering omfattende et eller flere for øjnene acceptable stoffer valgt fra gruppen bestående af et for øjnene acceptabelt lindrende middel, en for øjnene acceptabel excipiens, et for øjnene acceptabelt sammensnerpende middel, et for øjnene acceptabelt karforsnævrende middel, et for øjnene acceptabelt blødgøringsmiddel, og en for øjnene acceptabel elektrolyt.
3. Farmaceutisk sammensætning til anvendelse ifølge krav 1, hvor den farmaceutiske sammensætning omfattende PRG4, eller et smørefragment deraf, er administreret i kombination med en for øjnene acceptabel opløsning omfattende en terapeutisk effektiv koncentration af natriumhyaluronat eller hyaluronsyre.
4. Farmaceutisk sammensætning til anvendelse ifølge krav 3, hvor den for øjnene acceptable opløsning omfatter natriumhyaluronat eller hyaluronsyre i den terapeutisk effektive koncentration på 10-100.000 pg/mL.
5. Farmaceutisk sammensætning til anvendelse ifølge krav 3, hvor den for øjnene acceptable opløsning omfatter natriumhyaluronat eller hyaluronsyre i den terapeutisk effektive koncentration på 500-5.000 pg/mL.
6. Farmaceutisk sammensætning til anvendelse ifølge krav 1, hvor den farmaceutiske sammensætning omfattende PRG4, eller et smørefragment deraf, er administreret i kombination med en for øjnene acceptabel opløsning omfattende en terapeutisk effektiv koncentration af et overfladeaktivt phospholipid valgt fra gruppen bestående af L-a-dipalmitoylphosphatidylcholin, phosphatidylcholin, phosphatidylethanolamin og sphingomyelin.
7. Farmaceutisk sammensætning til anvendelse ifølge krav 6, hvor den for øjnene acceptable opløsning omfatter det overfladeaktive phospholipid i den terapeutisk effektive koncentration på 10-10.000 pg/mL.
8. Farmaceutisk sammensætning til anvendelse ifølge krav 1, hvor den farmaceutiske sammensætning omfattende PRG4, eller et smørefragment deraf, er administreret i kombination med en phosphat-bufferet saltopløsning omfattende mindst natriumphosphat og natriumchlorid.
9. Farmaceutisk sammensætning til anvendelse ifølge krav 1, hvor den farmaceutiske sammensætning omfattende PRG4, eller et smørefragment deraf, er administreret i kombination med en for øjnene acceptabel balanceret saltopløsning omfattende en eller flere elektrolytter valgt fra gruppen bestående af kaliumchlorid, natriumbicarbonat, kaliumbicarbonat, calciumchlorid, magnesiumchlorid, trinatriumcitrat, saltsyre og natriumhydroxid.
10. Farmaceutisk sammensætning til anvendelse ifølge krav 1, hvor PRG4, eller smørefragmentet deraf er et rekombinant PRG4-protein, eller smørefragment deraf.
11. Farmaceutisk sammensætning til anvendelse ifølge krav 1, hvor PRG4 er et oprenset naturligt forekommende PRG4-protein.
12. Farmaceutisk sammensætning til anvendelse ifølge krav 1, hvor den farmaceutiske sammensætning omfattende PRG4, eller et smørefragment deraf, er administreret i kombination med en for øjnene acceptabel opløsning omfattende en terapeutisk effektiv koncentration af natriumhyaluronat eller hyaluronsyre, og et overfladeaktivt phospholipid valgt fra gruppen bestående af L-α-dipalmitoylphosphatidylcholin, phosphatidylcholin, phosphatidylethanolamin og sphingomyelin.
13. Farmaceutisk sammensætning til anvendelse ifølge krav 1, hvor manglen på okulær smøring er forårsaget af vandig eller fordampende tørre øjne sygdom, Sjogrens syndrom, keratoconjunctivitis sicca, androgenmangel, meibomsk kirtelsygdom, østrogenerstatningsterapi, kontaktlinseslid, refraktionskirurgi, allergi, reduceret tårefilms brudtid, kompromitteret tårefilm, allergi, okulær overfladelidelser, øgede proteaseniveauer i tårefilmen og ved den okulære overflade, kronisk inflammation, hyperosmolaritet, aldring, eller kombinationer deraf.
14. Farmaceutisk sammensætning egnet til topikal påføring til en okulær overflade omfattende en terapeutisk effektiv koncentration af PRG4, eller et smørefragment deraf, opslæmmet i en for øjnene acceptabel balanceret saltopløsning.
15. Farmaceutisk sammensætning, til anvendelse ifølge krav 1, eller den farmaceutiske sammensætning ifølge krav 14, hvor smørefragmentet af PRG4 omfatter færre gentagelser inden for det centrale mucin-lignende KEPAPTT-gentagelsesdomæne (SEQ ID N0:4).
16. Farmaceutisk sammensætning til anvendelse ifølge krav 1, hvor den farmaceutiske sammensætning omfatter PRG4, eller et smørefragment deraf, i en koncentration på 50-500 pg/mL.
DK15151634.1T 2008-05-07 2009-04-08 Terapeutisk regenerering og berigelse af okulær overfladesmøring DK2915529T3 (da)

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Application Number Priority Date Filing Date Title
US5111208P 2008-05-07 2008-05-07
EP09743204.1A EP2285364B1 (en) 2008-05-07 2009-04-08 Therapeutic replenishment and enrichment of ocular surface lubrication

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DK09743204.1T DK2285364T3 (da) 2008-05-07 2009-04-08 Terapeutisk regenerering og berigelse af okulær overfladesmøring
DK15151634.1T DK2915529T3 (da) 2008-05-07 2009-04-08 Terapeutisk regenerering og berigelse af okulær overfladesmøring
DK09743588.7T DK2276496T3 (da) 2008-05-07 2009-05-06 Terapeutisk modulering af øjenoverfladebefugtning

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US (9) US9138457B2 (da)
EP (4) EP2915529B1 (da)
JP (3) JP5508398B2 (da)
CN (2) CN102164593B (da)
CA (3) CA2722913C (da)
CY (2) CY1119122T1 (da)
DK (3) DK2285364T3 (da)
ES (3) ES2633792T3 (da)
HR (3) HRP20150097T1 (da)
HU (2) HUE024146T2 (da)
LT (2) LT2915529T (da)
PL (3) PL2915529T3 (da)
PT (2) PT2285364E (da)
RU (1) RU2510274C2 (da)
SI (3) SI2915529T1 (da)
WO (3) WO2009137217A2 (da)

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