DK2486942T3 - Sammensætninger, der omfatter azelastin og fremgangsmåder til anvendelse deraf - Google Patents

Sammensætninger, der omfatter azelastin og fremgangsmåder til anvendelse deraf Download PDF

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Publication number
DK2486942T3
DK2486942T3 DK12167578.9T DK12167578T DK2486942T3 DK 2486942 T3 DK2486942 T3 DK 2486942T3 DK 12167578 T DK12167578 T DK 12167578T DK 2486942 T3 DK2486942 T3 DK 2486942T3
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Prior art keywords
azelastine
sucralose
steroid
fluticasone
triamcinolone
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DK12167578.9T
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English (en)
Inventor
Phuong Grace Dang
Brian D Lawrence
Gul Balwani
Alexander D D'addio
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Meda Pharmaceuticals Inc
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    • 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
    • A61K9/0043—Nose
    • 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
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • 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
    • A61P27/14—Decongestants or antiallergics
    • 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
    • A61P27/16—Otologicals
    • 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
    • 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
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • Y—GENERAL 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
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

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

Claims (17)

1. Farmaceutisk sammensætning, der omfatter azelastin, eller et farmaceutisk acceptabelt salt eller ester deraf, ved en koncentration på 0,005 til 5,0 vægt-%, og én eller flere farmaceutisk acceptable bærere eller excipienser, hvor mindst én af de farmaceutisk acceptable bærere eller excipienser er sucralose, der er til stede ved en koncentration på fra 0,001 til 1 % (vægt/volumen), hvor sucralosen maskerer smagen af azelastin eller et salt eller en ester deraf, således at patientens fornemmelse af en bitter smag forårsaget af administration af den farmaceutiske sammensætning til patienten reduceres eller elimineres.
2. Farmaceutisk sammensætning ifølge krav 1, hvor sucralose er til stede i en koncentration på fra 0,01 til 0,5 % (vægt/volumen).
3. Farmaceutisk sammensætning ifølge krav 1 eller 2, hvor sucralose er til stede i en koncentration på fra 0,05 til 0,15 % (vægt/volumen).
4. Farmaceutisk sammensætning ifølge krav 1, hvor sammensætningen er formuleret til okulær administration.
5. Farmaceutisk sammensætning ifølge krav 1, hvor sammensætningen omfatter mindst ét viskositetsøgende middel valgt fra gruppen bestående af et polyvinylpyrrolidon, et cellulosederivat valgt fra gruppen bestående af hydroxyethylcellulose, carboxymethylcellulose og hypromellose, carrageenan, guargummi, et alginat, en carbomer, en polyethylenglycol, en polyvinylalkohol og xanthangummi, der reducerer eller forebygger postnasale dryp af sammensætningen i svælget efter intranasal eller okulær administration af sammensætningen.
6. Farmaceutisk sammensætning ifølge krav 5, hvor det viskositetsøgende middel er hypromellose.
7. Farmaceutisk sammensætning ifølge krav 1, der endvidere omfatter én eller flere supplerende bestanddele valgt fra gruppen bestående af ét eller flere opløsningsmidler, ét eller flere konserveringsmidler, ét eller flere stabiliseringsmidler, ét eller flere opløsningsforbedrende midler, ét eller flere isotonicitetsmidler og én eller flere buffere.
8. Farmaceutisk sammensætning ifølge krav 1, der fortrinsvis omfatter azelastinhydrochlorid ved en koncentration på fra 0,05 til 0,15 % (vægt/volumen); og endvidere omfatter 0,001 til 5,00 % (vægt/volumen) af en vandopløselig polymer; 0,01 til 0,1% (vægt/volumen) dinatriumedetat; 0,001 til 0,5 % (vægt/volumen) benzalkoniumchlorid; en tilstrækkelig mængde af en farmaceutisk acceptabel buffer til at bevare sammensætningens pH inden for et interval på fra 4,5 til 7,4; en tilstrækkelig mængde af et isotonicitetsmiddel til at give en osmolalitet på 220 mosmol/kg til 350 msomol/kg; og vand i passende mængde.
9. Farmaceutisk sammensætning ifølge krav 8, hvor den vandopløselige polymer er hypromellose, der er til stede i sammensætningen ved en koncentration på fra 0,1 til 0,3 % (vægt/volumen).
10. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1, 4, 5 og 8 i en virksom mængde til anvendelse i behandling eller forebyggelse af en fysisk forstyrrelse valgt fra gruppen bestående af allergisk rhinitis, ikke-allergisk vasomotor rhinitis og allergisk conjunctivitis hos et dyr, fortrinsvis et pattedyr, mere fortrinsvis et menneske, der lider deraf eller er disponeret derfor.
11. Farmaceutisk sammensætning ifølge krav 1, hvor den farmaceutiske sammensætning er en flydende, farmaceutisk enhedsdosissammensætning, der omfatter en terapeutisk virksom dosis af azelastin, der er til stede ved en koncentration på fra 0,05 til 5,0 vægt-%, eller et farmaceutisk acceptabelt salt eller en ester deraf, sucralosen er til stede ved en koncentration på fra 0,05 til 0,15 vægt-%, hvor sammensætningen er fri, eller i alt væsentligt fri for konserveringsmidler, og hvor sammensætningen leveres i en enkeltstående enhedsdosisbeholder.
12. Farmaceutisk sammensætning ifølge krav 11, hvor azelastin er til stede i sammensætningen ved en koncentration på 0,1 vægt-% og sucralosen er til stede i sammensætningen ved en koncentration på 0,15 vægt-%.
13. Farmaceutisk sammensætning ifølge krav 11, hvor azelastin er til stede i sammensætningen ved en koncentration på fra 0,125 til 0,15 vægt-% og sucralosen er til stede i sammensætningen ved en koncentration på fra 0,05 til 0,15 vægt-%.
14. Farmaceutisk sammensætning ifølge krav 11, hvor azelastin er til stede i sammensætningen ved en koncentration på 0,15 vægt-% og sucralosen er til stede i sammensætningen ved en koncentration på 0,15 vægt-%.
15. Farmaceutisk sammensætning ifølge krav 11, hvor den enkeltstående enhedsdosisbeholder omfatter højdensitetspolyethylen.
16. Farmaceutisk sammensætning ifølge krav 11, hvor den enkeltstående enhedsdosisbeholder er en blow-fill-seal-højdensitetspolyethylenbeholder med en volumenkapacitet på 1,0 mL.
17. Farmaceutisk sammensætning ifølge krav 1, hvor sammensætningen er formuleret som en flydende formulering i form af næsespray eller næsedråber.
DK12167578.9T 2004-11-24 2005-11-22 Sammensætninger, der omfatter azelastin og fremgangsmåder til anvendelse deraf DK2486942T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US63027404P 2004-11-24 2004-11-24
EP05824835A EP1827499A4 (en) 2004-11-24 2005-11-22 COMPOSITIONS COMPRISING AZELASTIN AND METHODS OF USE

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DK2486942T3 true DK2486942T3 (da) 2019-01-28

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ID=36498307

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Application Number Title Priority Date Filing Date
DK12167578.9T DK2486942T3 (da) 2004-11-24 2005-11-22 Sammensætninger, der omfatter azelastin og fremgangsmåder til anvendelse deraf
DK12167579.7T DK2522365T3 (da) 2004-11-24 2005-11-22 Sammensætninger, der omfatter azelastin, og metoder til brug deraf
DK11173623.7T DK2377557T3 (da) 2004-11-24 2005-11-22 Sammensætninger, der omfatter azelastin, og metoder til brug deraf

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DK12167579.7T DK2522365T3 (da) 2004-11-24 2005-11-22 Sammensætninger, der omfatter azelastin, og metoder til brug deraf
DK11173623.7T DK2377557T3 (da) 2004-11-24 2005-11-22 Sammensætninger, der omfatter azelastin, og metoder til brug deraf

Country Status (24)

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US (3) US8071073B2 (da)
EP (4) EP2486942B1 (da)
JP (2) JP5607291B2 (da)
KR (3) KR20180030953A (da)
CN (1) CN101098714B (da)
AU (2) AU2005309657B2 (da)
BR (1) BRPI0517891A (da)
CA (1) CA2588338C (da)
CY (1) CY1121330T1 (da)
DK (3) DK2486942T3 (da)
ES (3) ES2704482T3 (da)
HR (1) HRP20182133T1 (da)
HU (2) HUE030388T2 (da)
IL (2) IL183372A (da)
LT (3) LT2377557T (da)
MX (2) MX344036B (da)
NZ (1) NZ555501A (da)
PL (3) PL2377557T3 (da)
PT (3) PT2486942T (da)
RS (1) RS58377B1 (da)
SI (3) SI2522365T1 (da)
TR (1) TR201820559T4 (da)
WO (1) WO2006058022A1 (da)
ZA (1) ZA200704902B (da)

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