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DK2488158T3 - Forbedrede medicinske aerosolformuleringer - Google Patents

Forbedrede medicinske aerosolformuleringer Download PDF

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Publication number
DK2488158T3
DK2488158T3 DK10768922T DK10768922T DK2488158T3 DK 2488158 T3 DK2488158 T3 DK 2488158T3 DK 10768922 T DK10768922 T DK 10768922T DK 10768922 T DK10768922 T DK 10768922T DK 2488158 T3 DK2488158 T3 DK 2488158T3
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weight
formulation
propellant
suspension formulation
fluticasone propionate
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DK10768922T
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English (en)
Inventor
Rudi Mueller-Walz
Lise-Marie Fueg
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Jagotec Ag
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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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • 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
    • A61K47/06—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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A61K9/124—Aerosols; Foams characterised by the propellant
    • 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
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • 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
    • A61P11/08—Bronchodilators
    • 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
    • A61P11/14—Antitussive agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pulmonology (AREA)
  • Pain & Pain Management (AREA)
  • Otolaryngology (AREA)
  • Dispersion Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Rheumatology (AREA)
  • Neurosurgery (AREA)
  • Neurology (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 (20)

1. Medicinsk aerosolsuspensionsformulering til MDI-indgivelse, omfattende: a) mikroniseret formoterolfumarat eller et farmaceutisk acceptabelt salt deraf; b) mikroniseret fluticasonpropionat eller et farmaceutisk acceptabelt salt deraf; c) en subterapeutisk mængde af en fugtighedsbindende excipiens omfattende natriumcromolyn; og d) et HFA-drivmiddel; hvor (a), (b) og (c) og deres respektive relative mængder er valgt således, at de associerer til dannelse af flokkulater med den samme middeldensitet som HFA-drivmidlets ± 0,2 g/cm3.
2. Medicinsk aerosolsuspensionsformulering ifølge krav 1, hvor flokkulat-ernes middeldensitet er den samme som drivmidlets densitet ± 0,1 g/cm3; fortrinsvis ± 0,05 g/cm3.
3. Medicinsk aerosolsuspensionsformulering ifølge krav 1 eller krav 2, hvor FIFA-drivmidlet er FIFA 227.
4. Medicinsk aerosolsuspensionsformulering ifølge et hvilket som helst af de foregående krav, hvor formoterolfumaratet eller et farmaceutisk acceptabelt salt eller derivat deraf foreligger i en mængde på 0,003-0,04 vægt-%; fortrinsvis 0,004-0,03 vægt-%; og mere fortrinsvis 0,005-0,02 vægt-%, baseret på formuleringens totalvægt.
5. Medicinsk aerosolsuspensionsformulering ifølge et hvilket som helst af de foregående krav, hvor fluticasonpropionatet eller et farmaceutisk acceptabelt salt eller derivat deraf foreligger i en mængde på 0,01-0,6 vægt-%; fortrinsvis mellem 0,02-0,5 vægt-%; og mere fortrinsvis 0,03-0,4 vægt-%, baseret på formuleringens totalvægt.
6. Medicinsk aerosolsuspensionsformulering ifølge et hvilket som helst af de foregående krav, hvor natriumcromolyn foreligger i en mængde på 0,01-0,1 vægt-%; fortrinsvis 0,016-0,09 vægt-%; og mere foretrukket 0,02-0,08 vægt- %, mere fortrinsvis 0,025-0,07 vægt-%, mere foretrukket 0,03-0,05 vægt-%, mere foretrukket 0,03-0,04 vægt-%, baseret på formuleringens totalvægt.
7. Medicinsk aerosolsuspensionsformulering ifølge et hvilket som helst af de foregående krav, yderligere omfattende et befugtningsmiddel, hvor befugtningsmidlet fortrinsvis er en dehydratiseret alkohol, mere fortrinsvis hvor befugtningsmidlet er ethanol, og fortrinsvis hvor alkoholen foreligger i en mængde på 0,01-3 vægt-%; fortrinsvis 0,05-2,5 vægt-%, og mere fortrinsvis 1,0-2,0 vægt-%, baseret på formuleringens totalvægt.
8. Farmaceutisk sammensætning omfattende a) 0,01-0,6 vægt-% mikroniseret fluticasonpropionat eller et farmaceutisk acceptabelt salt eller derivat deraf; b) 0,003-0,04 vægt-% mikroniseret formoterolfumaratdihydrat eller et farmaceutisk acceptabelt salt eller derivat deraf; c) 0,01-0,1 vægt-% natriumcromolyn; og d) hvor resten omfatter HFA-drivmiddel; hvor (a), (b) og (c) og deres respektive relative mængder er valgt således, at de associerer til dannelse af flokkulater med den samme middeldensitet som HFA-drivmidlets ± 0,2 g/cm3, fortrinsvis den samme ± 0,1 g/cm3; mere fortrinsvis den samme ± 0,05 g/cm3.
9. Farmaceutisk sammensætning ifølge krav 8, yderligere omfattende et befugtningsmiddel, hvor befugtningsmidlet fortrinsvis er dehydratiseret alkohol, fortrinsvis ethanol, og fortrinsvis foreligger i en mængde på 0,01-3 vægt-%; fortrinsvis 0,05-2,5 vægt-%, og mere fortrinsvis 1,0-2,0 vægt-%, baseret på formuleringens totalvægt.
10. Farmaceutisk suspensionsformulering omfattende a) 0,003-0,04 vægt-% formoterolfumaratdihydrat; b) 0,01-0,6 vægt-% fluticasonpropionat; c) 0,01-0,1 vægt-% natriumcromolyn; d) 0,01-3 vægt-% dehydratiseret alkohol; og e) hvor resten omfatter HFA-drivmiddel; hvor (a), (b) og (c) og deres respektive relative mængder er valgt således, at de associerer til dannelse af flokkulater med den samme middeldensitet som HFA-drivmidlets ± 0,2 g/cm3, fortrinsvis ± 0,1 g/cm3; mere fortrinsvis ± 0,05 g/cm3.
11. Medicinsk aerosolsuspension ifølge krav 1 til 7, farmaceutisk sammensætning ifølge krav 8 og 9 eller farmaceutisk suspensionsformulering ifølge krav 10 til anvendelse ved behandling af inflammation og fortrinsvis til behandling af astma og allergisk rhinitis.
12. Anvendelse af natriumcromolyn til fremstilling af en farmaceutisk suspensionsformulering i HFA-drivmiddel omfattende formoterolfumarat-dihydrat- og fluticasonpropionat-mikropartikler til dannelse af flokkulater af formoterolfumaratdihydrat, fluticasonpropionat og natriumcromolyn med den samme middeldensitet som HFA-drivmidlets ± 0,2 g/cm3, fortrinsvis ± 0,1 g/cm3; mere fortrinsvis ± 0,05 g/cm3.
13. Anvendelse af 0,01 til 0,1 vægt-% natriumcromolyn til fremstilling af en farmaceutisk suspensionsformulering i HFA-drivmiddel omfattende 0,003 til 0,04 vægt-% formoterolfumaratdihydrat- og 0,01 til 0,6 vægt-% fluticason-propionat-mikropartikler til dannelse af flokkulater af formoterolfumaratdihydrat, fluticasonpropionat og natriumcromolyn med den samme middeldensitet som HFA-drivmidlets ± 0,2 g/cm3, fortrinsvis ± 0,1 g/cm3; mere fortrinsvis ± 0,05 g/cm3.
14. Anvendelse ifølge krav 12 eller 13, hvor den farmaceutiske suspensionsformulering yderligere omfatter et befugtningsmiddel, fortrinsvis en dehydratiseret alkohol, fortrinsvis ethanol.
15. Farmaceutisk sammensætning omfattende a) 0,0071 % v/v formoterolfumaratdihydrat; b) 0,0357 % v/v, 0,0714 % v/v, 0,1785 % v/v eller 0,3570 % v/v fluticasonpropionat; c) 0,0343 % v/v cromolynnatrium; og d) hvor resten omfatter HFA 227-drivmiddel; hvor (a), (b) og (c) og deres respektive relative mængder er valgt således, at de associerer til dannelse af flokkulater med den samme middeldensitet som HFA-drivmidlets ± 0,2 g/cm3, fortrinsvis ± 0,1 g/cm3; mere fortrinsvis ± 0,05 g/cm3.
16. Farmaceutisk sammensætning omfattende a) 0,0142 % v/v formoterolfumaratdihydrat; b) 0,357 % v/v fluticasonpropionat; c) 0,0343 % v/v eller 0,0686 % v/v cromolynnatrium; og d) hvor resten omfatter HFA 227-drivmiddel; hvor (a), (b) og (c) og deres respektive relative mængder er valgt således, at de associerer til dannelse af flokkulater med den samme middeldensitet som FIFA-drivmidlets ± 0,2 g/cm3, fortrinsvis ± 0,1 g/cm3; mere fortrinsvis ± 0,05 g/cm3.
17. Sammensætning ifølge krav 15 eller 16, yderligere omfattende 1,43 % v/v ethanol.
18. Fremgangsmåde til forøgelse af stabiliteten af en medicinsk aerosolsuspensionsformulering af mikroniseret formoterolfumaratdihydrat og mikroniseret fluticasonpropionat i HFA-drivmiddel over en længere opbevaringsperiode, omfattende tilsætning af en subterapeutisk mængde natrium-cromolyn, hvorved de respektive relative mængder af det mikroniserede formoterolfumaratdihydrat, det mikroniserede fluticasonpropionat og natriumcromolyn er valgt således, at de associerer til dannelse af flokkulater med den samme middeldensitet som HFA-drivmidlets ± 0,2 g/cm3, fortrinsvis ± 0,1 g/cm3; mere fortrinsvis ± 0,05 g/cm3.
19. Fremgangsmåde ifølge krav 18, hvorved den længere opbevaring er i 3, 6, 9, 12 eller 18 måneder.
20. Fremgangsmåde ifølge krav 18 eller 19, hvorved suspensionsformuleringens vandindhold efter længere opbevaring ligger i området fra 500 ppm til 800 ppm, fortrinsvis 600 ppm til 700 ppm.
DK10768922T 2009-10-16 2010-10-15 Forbedrede medicinske aerosolformuleringer DK2488158T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0918149.6A GB0918149D0 (en) 2009-10-16 2009-10-16 Improved medicinal aerosol formulation
PCT/EP2010/065573 WO2011045432A1 (en) 2009-10-16 2010-10-15 Improved medicinal aerosol formulations

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DK2488158T3 true DK2488158T3 (da) 2015-03-23

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DK10768922T DK2488158T3 (da) 2009-10-16 2010-10-15 Forbedrede medicinske aerosolformuleringer
DK14199881.5T DK2881108T3 (da) 2009-10-16 2010-10-15 Forbedrede medicinske aerosolformuleringer

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Country Status (26)

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US (3) US20120282189A1 (da)
EP (3) EP2881108B1 (da)
JP (6) JP2013507430A (da)
CN (1) CN102665675B (da)
AU (1) AU2010305698C9 (da)
BR (1) BR112012008983A2 (da)
CA (1) CA2776359C (da)
CL (1) CL2012000947A1 (da)
CY (1) CY1116109T1 (da)
DK (2) DK2488158T3 (da)
ES (2) ES2533372T3 (da)
FI (1) FI2881108T3 (da)
GB (1) GB0918149D0 (da)
HR (2) HRP20150174T1 (da)
HU (1) HUE065583T2 (da)
IL (1) IL219161B (da)
LT (1) LT2881108T (da)
MX (1) MX2012004337A (da)
NZ (1) NZ599901A (da)
PL (2) PL2881108T3 (da)
PT (2) PT2488158E (da)
RS (2) RS65391B1 (da)
SI (2) SI2488158T1 (da)
SM (2) SMT202400119T1 (da)
WO (1) WO2011045432A1 (da)
ZA (1) ZA201202452B (da)

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