HRP20120262T1 - Farmaceutske formulacije i postupci za liječenje infekcija dišnih puteva - Google Patents

Farmaceutske formulacije i postupci za liječenje infekcija dišnih puteva Download PDF

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HRP20120262T1
HRP20120262T1 HR20120262T HRP20120262T HRP20120262T1 HR P20120262 T1 HRP20120262 T1 HR P20120262T1 HR 20120262 T HR20120262 T HR 20120262T HR P20120262 T HRP20120262 T HR P20120262T HR P20120262 T1 HRP20120262 T1 HR P20120262T1
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mol
sodium
calcium
pharmaceutical formulation
formulation according
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M. Lipp Michael
W. Clarke Robert
L. Hava David
Batycky Richard
Hanrahan John
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Pulmatrix
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    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/194Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/20Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/734Alginic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/04Sulfur, selenium or tellurium; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/10Carbonates; Bicarbonates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/14Alkali metal chlorides; Alkaline earth metal chlorides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/42Phosphorus; Compounds thereof
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
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    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/02Nasal agents, e.g. decongestants
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/08Bronchodilators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/16Antivirals for RNA viruses for influenza or rhinoviruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • AHUMAN NECESSITIES
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    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Farmaceutska formulacija koja sadrži kalcijevu sol i natrijevu sol, naznačena time da je omjer Ca+2 prema Na+ od 4:1 (mol:mol) do 16:1 (mol:mol). Patent sadrži još 23 patentna zahtjeva.

Claims (24)

1. Farmaceutska formulacija koja sadrži kalcijevu sol i natrijevu sol, naznačena time da je omjer Ca+2 prema Na+ od 4:1 (mol:mol) do 16:1 (mol:mol).
2. Farmaceutska formulacija prema zahtjevu 1, naznačena time da omjer Ca+2 prema Na+ je od 4:1 (mol:mol) do 12:1 (mol:mol), 4:1 (mol:mol) do 10:1 (mol:mol), ili 4: 1 (mol:mol) do 8:1 (mol:mol).
3. Farmaceutska formulacija prema zahtjevu 1, naznačena time da omjer Ca+2 prema Na- je od 4:1 (mol:mol) do 7:1 (mol:mol), ili 4:1 (mol:mol) do 6:1 (mol:mol).
4. Farmaceutska formulacija prema zahtjevu 1, naznačena time da omjer Ca+2 prema Na+ je 4:1 (mol:mol), ili 4.5:1 (mol:mol), ili 5:1 (mol:mol), ili 5.5:1 (mol:mol) ili 6:1 (mol:mol).
5. Farmaceutska formulacija prema zahtjevu 1, naznačena time da omjer Ca+2 prema Na+ je 7:1 (mol:mol), 8:1 (mol:mol), 9:1(mol:mol); 10:1 (mol:mol), 11:1 (mol:mol) ili 12:1 (mol:mol).
6. Farmaceutska formulacija prema zahtjevu 1, naznačena time da omjer Ca+2 prema Na+ je 13:1 (mol:mol), 14:1 (mol:mol), 15:1 (mol:mol) ili 16:1 (mol:mol).
7. Farmaceutska formulacija prema bilo kojem od zahtjeva 1-6, naznačena time da farmaceutska formulacija je tekuća formulacija, pri čemu proizvoljno je Ca2+ ion prisutan u koncentraciji od 0.115 M do 1.15 M, ili pri čemu je Ca2+ ion prisutan u koncentraciji od 0.575 M do 1.15 M.
8. Farmaceutska formulacija prema zahtjevu 7, naznačena time da je Na+ ion prisutan u koncentraciji od 0.053 M do 0.3 M, ili pri čemu je Na+ ion prisutan u koncentraciji od 0.075 M do 0.3 M.
9. Farmaceutska formulacija prema zahtjevu 7 ili 8, naznačena time da je kalcijeva sol odabrana iz skupine koja sadrži kalcijev klorid, kalcijev karbonat, kalcijev acetat, kalcijev fosfat, kalcijev alginat; kalcijev stearat, kalcijev sorbat, kalcijev sulfat, kalcijev glukonat, kalcijev laktat i kalcijev citrat, pri čemu proizvoljno kalcijeva sol je kalcijev laktat, kalcijev citrat, ili kalcijev sulfat, ili pri čemu kalcijeva sol je kalcijev klorid ili kalcijev laktat.
10. Farmaceutska formulacija prema bilo kojem od zahtjeva 7-9, naznačena time da natrijeva sol je odabrana iz skupine koja sadrži natrijev klorid, natrijev acetat, natrijev bikarbonat, natrijev karbonat, natrijev sulfat, natrijev stearat, natrijev askorbat, natrijev benzoat, natrijev bifosfat, natrijev fosfat, natrijev bisulfit, natrijev citrat, natrijev borat, natrijev glukonat, natrijev metasilikat, te natrijev laktat, pri čemu proizvoljno natrijeva sol je natrijev klorid, ili pri čemu natrijeva sol je natrijev laktat, natrijev citrat, ili natrijev sulfat.
11. Farmaceutska formulacija prema zahtjevu 1-6, naznačena time da farmaceutska formulacija je suha praškasta formulacija.
12. Farmaceutska formulacija prema zahtjevu 11, naznačena time da kalcijeva sol je prisutna u količini od 19.5% do 90% (tež./tež.).
13. Farmaceutska formulacija prema zahtjevu 11 ili 12, naznačena time da kalcijeva sol je odabrana iz skupine koja sadrži kalcijev klorid, kalcijev karbonat, kalcijev acetat, kalcijev fosfat, kalcijev alginat, kalcijev stearat, kalcijev sorbat, kalcijev sulfat, kalcijev glukonat, kalcijev laktat i kalcijev citrat, pri čemu proizvoljno kalcijeva sol je kalcijev laktat, kalcijev citrat, kalcijev sulfat ili kalcijev klorid.
14. Farmaceutska formulacija prema bilo kojem od zahtjeva 11-13, naznačena time da natrijeva sol je odabrana iz skupine koja sadrži natrijev klorid, natrijev acetat, natrijev bikarbonat, natrijev karbonat, natrijev sulfat, natrijev stearat, natrijev askorbat, natrijev benzoat, natrijev bifosfat, natrijev fosfat, natrijev bisulfit, natrijev citrat, natrijev borat, natrijev glukonat, natrijev metasilikat, te natrijev laktat, pri čemu proizvoljno natrijeva sol je natrijev klorid, ili pri čemu natrijeva sol je natrijev laktat, natrijev citrat, ili natrijev sulfat.
15. Farmaceutska formulacija prema bilo kojem od zahtjeva 1-14, naznačena time da farmaceutska formulacija je formulirana da donosi Ca+2 dozu od 0.001 mg/kg tjelesne težine/dozi do 10 mg/kg tjelesne težine/dozi u dišni sustav, i/ili nadalje sadrži pomoćnu tvar, pri čemu je proizvoljno pomoćna tvar odabrana iz skupine koja sadrži laktozu, glicin, alanin, leucin, izoleucin, trehalozu, dipalmitoilfosfosfatidilkolin (DPPC), difosfatidil glicerol (DPPG), 1,2-Dipalmitoil-sn-glicero-3-fosfo-L-serin (DPPS), 1,2-Dipalmitoil-sn-glicero-3-fosfokolin (DSPC), 1,2-Distearoil-sn-glicero-3-fosfoetanolamin (DSPE), 1-palmitoil-2-oleoilfosfatidilkolin (POPC), polioksietilen-9-lauril eter, sorbitan trioleat (Span 85), glikokolat, surfaktin, tiloksapol, natrijev fosfat, dekstran, dekstrin, manitol, maltodekstrin, humani serumski albumin, rekombinantni humani serumski albumin, i biorazgradive polimere, pri čemu proizvoljno pomoćna tvar je leucin, maltodekstrin, ili manitol.
16. Farmaceutska formulacija prema bilo kojem od zahtjeva 1-15, naznačena time da farmaceutska formulacija je formulacija sa jediničnim doziranjem.
17. Učinkovita količina farmaceutske formulacije prema bilo kojem od zahtjeva 1-16 naznačena time da je za uporabu za liječenje infekcije dišnih puteva kod pojedinca koji ima infekciju dišnih puteva, pokazuje simptome infekcije dišnih puteva, ili ima rizik za dobivanje infekcije dišnih puteva.
18. Učinkovita količina farmaceutske formulacije prema bilo kojem od zahtjeva 1-16 naznačena time da je za uporabu za smanjivanje širenja infekcije dišnih puteva kod pojedinca koji ima infekciju dišnih puteva, pokazuje simptome infekcije dišnih puteva, ili ima rizik za dobivanje infekcije dišnih puteva.
19. Farmaceutska formulacija prema zahtjevu 17 ili 18, naznačena time da infekcija dišnih puteva je gripa, proizvoljno (i) gdje je gripa uzrokovana sa virusom gripe A ili virusom gripe B, ili (ii) gdje je infekcija dišnih puteva uzrokovana sa humani parainfluenza virusom, pri čemu proizvoljno humani parainfluenza virus je humani parainfluenza virus 3 (hPIV-3), ili (iii) gdje je infekcija dišnih puteva uzrokovana sa rinovirusom, ili (iv) gdje je infekcija dišnih puteva uzrokovana sa respiratornim sincitijalnim virusom (RSV), ili (v) gdje je infekcija dišnih puteva je upala pluća, pri čemu proizvoljno upala pluća je bakterijska upala pluća, pri čemu proizvoljno bakterijska upala pluća je uzrokovana sa S. pneumoniae, ili (vi) gdje je infekcija dišnih puteva je bakterijska infekcija, pri čemu proizvoljno bakterijska infekcija je uzrokovana sa bakterijom odabranom iz skupine koja sadrži Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pyogenes, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Moraxella catarrhalis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila, Serratia marcescens, Burkholderia cepacia, Burkholderia pseudomallei, Bacillus anthracis, Bacillus cereus, Bordatella pertussis, Stenotrophomonas maltophilia, bakterija iz obitelji citrobacter, bakterija iz obitelji ecinetobacter, te Mycobacterium tuberculosis.
20. Učinkovita količina farmaceutske formulacije prema bilo kojem od zahtjeva 1-16 naznačena time da je za uporabu za liječenje plućne bolesti kod pojedinca koji ima plućnu bolest, pokazuje simptome plućne bolesti, ili je podložan dobivanju plućne bolesti.
21. Učinkovita količina farmaceutske formulacije prema bilo kojem od zahtjeva 1-16 naznačena time da je za uporabu kod liječenja akutne egzacerbacije plućne bolesti kod pojedinca koji ima akutnu egzacerbaciju plućne bolesti, pokazuje simptome akutne egzacerbacije plućne bolesti, ili je podložan dobivanju akutne egzacerbacije plućne bolesti.
22. Farmaceutska formulacija prema zahtjevima 20 ili 21, naznačena time da plućna bolest je astma, preosjetljivost dišnih putova, alergijski rinitis, sezonska alergija, bronhiektazija, kronični bronhitis, emfizem, kronična opstruktivna plućna bolest ili cistična fibroza.
23. Farmaceutska formulacija prema zahtjevu 21, naznačena time da je akutna egzacerbacija kronične plućne bolesti uzrokovana sa virusnom infekcijom, bakterijskom infekcijom, gljivičnom infekcijom, parazitskom infekcijom, alergenom iz okoliša ili iritirajućim sredstvom iz okoliša.
24. Farmaceutska formulacija prema bilo kojem od zahtjeva 1-23, naznačena time da nadalje sadrži dodatno ljekovito sredstvo.
HR20120262T 2009-03-26 2012-03-22 Farmaceutske formulacije i postupci za liječenje infekcija dišnih puteva HRP20120262T1 (hr)

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US16376709P 2009-03-26 2009-03-26
US16376309P 2009-03-26 2009-03-26
US16377209P 2009-03-26 2009-03-26
US25576409P 2009-10-28 2009-10-28
US29809210P 2010-01-25 2010-01-25
US30581910P 2010-02-18 2010-02-18
PCT/US2010/028906 WO2010111644A1 (en) 2009-03-26 2010-03-26 Pharmaceutical formulations and methods for treating respiratory tract infections

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EP (1) EP2315580B1 (hr)
JP (1) JP2012522011A (hr)
KR (1) KR20120002981A (hr)
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AT (1) ATE538774T1 (hr)
AU (1) AU2010229724B2 (hr)
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CA2702094C (en) 2007-10-10 2018-05-01 Parion Sciences, Inc. Delivering osmolytes by nasal cannula
US20120083531A1 (en) * 2009-03-26 2012-04-05 Clarke Robert W Calcium citrate and calcium lactate formulations for alteration of biophysical properties of mucosal lining
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