DK1991201T3 - Forstøvet antibiotika til inhalationsterapi - Google Patents

Forstøvet antibiotika til inhalationsterapi Download PDF

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DK1991201T3
DK1991201T3 DK07703355.3T DK07703355T DK1991201T3 DK 1991201 T3 DK1991201 T3 DK 1991201T3 DK 07703355 T DK07703355 T DK 07703355T DK 1991201 T3 DK1991201 T3 DK 1991201T3
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aerosol
composition
excipient
active compound
group
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DK07703355.3T
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Manfred Keller
Aslihan Akkar
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Pari Pharma Gmbh
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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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays 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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4709—Non-condensed quinolines and 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/535—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 oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • 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
    • 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
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • 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
    • 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
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
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  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Nanotechnology (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Medical Informatics (AREA)
  • Dispersion Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Biophysics (AREA)
  • Oncology (AREA)
  • General Engineering & Computer Science (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Rheumatology (AREA)
  • Transplantation (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (15)

1. Farmaceutisk aerosol til nasal, sinunasal eller pulmonær administration omfattende en dispergeret væskefase og en kontinuerlig gasfase, hvor den dispergerede væskefase (a) består af vandige dråber omfattende 20 til 200 mg/ml af den aktive forbindelse levofloxacin eller den ækvivalente koncentration af et farmaceutisk acceptabelt salt, solvat eller isomer deraf, og mindst en excipiens valgt fra gruppen af calcium-, magnesium-, og aluminiumsalte; (b) har en massemediandiameter fra omkring 1,5 til omkring 6 μιτι; og (c) har en dråbestørrelsesdistribution, der udviser en geometrisk standardafvigelse fra omkring 1,2 til omkring 3,0.
2. Aerosolen ifølge krav 1, hvor den mindst ene excipiens er valgt fra gruppen af magnesiumsalte.
3. Aerosolen ifølge et hvilket som helst af kravene 1 til 2, som udsendes fra en aerosolgenerator med en hastighed på mindst omkring 0,1 ml dispergeret væskefase per minut.
4. Flydende farmaceutisk sammensætning til fremstilling af aerosolen ifølge et hvilket som helst af kravene 1 til 3, hvor sammensætningen omfatter 20 til 200 mg/ml af den aktive forbindelse levofloxacin eller den ækvivalente koncentration af et farmaceutisk acceptabelt salt, solvat eller isomer deraf, og mindst en excipiens valgt fra gruppen af calcium-, magnesium-, og aluminiumsalte, og hvor et volumen på ikke mere end omkring 10 ml og mere fortrinsvist mindre end omkring 5 ml af sammensætningen omfatter en effektiv dosis af den aktive forbindelse.
5. Den flydende farmaceutiske sammensætning ifølge krav 4, hvor den mindst ene excipiens er valgt fra gruppen af magnesiumsalte.
6. Sammensætningen ifølge et hvilket som helst af kravene 4 til 5, omfattende mindst en excipiens i stand til at påvirke den lokale biotilgængelighed, frigivelsen, og/eller den lokale opholdstid af den aktive forbindelse på stedet for aerosoldeponering, hvor excipiensen er valgt fra gruppen bestående af kompleksdannere, polymerer, og amfifile forbindelser.
7. Sammensætningen ifølge et hvilket som helst af kravene 4 til 6, omfattende mindst en smagsmodificerende excipiens, fortrinsvis valgt fra aromastoffer, sødemidler, kompleksdannere og smagsmaskeringsmidler, såsom en cyclodextrin, sukker, sukkeralkohol, natriumsaccharin, aspartam, eller arginin.
8. Kit til fremstillingen og leveringen af en farmaceutisk aerosol til nasal, sinunasal eller pulmonær administration omfattende en dispergeret væskefase og en kontinuerlig gasfase, hvor den dispergerede væskefase (a) består af vandige dråber omfattende 20 til 200 mg/ml af den aktive forbindelse levofloxacin eller den ækvivalente koncentration af et farmaceutisk acceptabelt salt, solvat eller isomer deraf og mindst en excipiens valgt fra gruppen af calcium-, magnesium-, og aluminiumsalte; (b) har en massemediandiameter fra omkring 1,5 til omkring 6 pm; og (c) har en dråbestørrelsesdistribution, der udviser en geometrisk standardafvigelse fra omkring 1,2 til omkring 3,0, hvor kittet omfatter en forstøver og en vandig væskesammensætning, hvor nævnte sammensætning omfatter 20 til 200 mg/ml af den aktive forbindelse levofloxacin eller den ækvivalente koncentration af et farmaceutisk acceptabelt salt, solvat eller isomer deraf, og mindst en excipiens valgt fra gruppen af calcium-, magnesium-, og aluminiumsalte, og omfattende en effektiv dosis af den aktive forbindelse inden for et volumen på ikke mere end omkring 10 ml og mere fortrinsvist mindre end 5 ml.
9. Kittet ifølge krav 8, hvor den mindst ene excipiens er valgt fra gruppen af magnesiumsalte.
10. Kittet ifølge et hvilket som helst af kravene 8 til 9, hvor mindst omkring 40 vægtprocent af den påfyldte dosis er omfattet af dråber med en diameter på ikke mere end omkring 5 prn.
11. Fremgangsmåde til fremstilling af en aerosol til levering til en person med behov for nasal, sinunasal eller pulmonær antibiotikabehandling eller -profylakse, hvilken fremgangsmåde omfatter trinnene: (a) at tilvejebringe en flydende farmaceutisk sammensætning omfattende 20 til 200 mg/ml af den aktive forbindelse levofloxacin eller den ækvivalente koncentration af et farmaceutisk acceptabelt salt, solvat eller isomer deraf og mindst en excipiens valgt fra gruppen af calcium-, magnesium-, og aluminiumsalte, og omfattende en effektiv dosis af den aktive forbindelse i et volumen på ikke mere end omkring 10 ml og mere fortrinsvist mindre end 5 ml; (b) at tilvejebringe en forstøver i stand til at aerosolisere nævnte flydende farmaceutisk sammensætning med en samlet outputhastighed på mindst 0,1 ml/min, hvilken forstøver endvidere er indrettet til at udsende en aerosol omfattende en dispergeret fase med en massemediandiameter fra omkring 1,5 til omkring 6 pm og en geometrisk standardafvigelse fra omkring 1,2 til omkring 3; og (c) at betjene forstøveren til at aerosolisere den flydende sammensætning.
2. Fremgangsmåden ifølge krav 11, hvor den mindst ene excipiens er valgt fra gruppen af magnesiumsalte.
13. Anvendelse af aerosolen ifølge krav 1 eller af den flydende sammensætning ifølge krav 4 eller af kittet ifølge krav 8 til fremstillingen af et medikament til profylaksen eller behandlingen af akut eller kronisk sinusitis eller rhinosinusitis, bronkitis, lungebetændelse, kronisk obstruktiv lungesygdom, profylakse til at forhindre transplantatafstødning efter lungetransplantation, parenkymatiske og/eller fibrotiske sygdomme eller lidelser, der inkluderer cystisk fibrose med eller uden akut forværringer, eventuelt på grund af Streptococcus pneumoniae. Flaemophilus influenza eller Moraxella catarrhalis; akut bakterieforværringer i kronisk bronkitis eller i kronisk obstruktiv lungesygdom, eventuelt på grund af Staphylococcus aureus, Streptococcus pneumoniae. Haemophilus influenza, Haemophilus parainfluenza eller Moraxella catarrhalis; nosocomial lungebetændelse, eventuelt på grund af Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Burkholderia cepacia, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenza eller Streptococcus pneumoniae: eller samfundserhvervet lungebetændelse (CAP), eller hospitalserhvervet lungebetændelse (HAP), eller ventilator-associeret lungebetændelse (VAP), eventuelt på grund af Staphylococcus aureus, Streptococcus pneumoniae. Haemophilus influenza, Haemophilus parainfluenza, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, eller Mycoplasma pneumoniae.
14. Anvendelsen ifølge krav 13, hvor medikamentet administreres pulmonalt.
15. Anvendelsen ifølge et hvilket som helst af kravene 13 til 14, hvor medikamentet er indrettet til administration to gange eller en gang dagligt.
16. Anvendelsen af en polymerforbindelse som excipiens i en farmaceutisk sammensætning til fremstillingen af en aerosol, hvor sammensætningen omfatter 20 til 200 mg/ml af den aktive forbindelse levofloxacin eller den ækvivalente koncentration af et farmaceutisk acceptabelt salt, solvat eller isomer deraf, og mindst en excipiens valgt fra gruppen af calcium-, magnesium-, og aluminiumsalte, og hvor polymerforbindelsen er valgt fra chitosan.
DK07703355.3T 2006-02-10 2007-02-08 Forstøvet antibiotika til inhalationsterapi DK1991201T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP06002734 2006-02-10
PCT/EP2007/001080 WO2007090646A1 (en) 2006-02-10 2007-02-08 Nebulised antibiotics for inhalation therapy

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DK1991201T3 true DK1991201T3 (da) 2018-06-14

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US (1) US20090025713A1 (da)
EP (1) EP1991201B1 (da)
JP (1) JP2009526003A (da)
CN (1) CN101389313A (da)
AU (1) AU2007213983B2 (da)
BR (1) BRPI0707641A2 (da)
CA (1) CA2641827A1 (da)
CY (1) CY1120284T1 (da)
DK (1) DK1991201T3 (da)
ES (1) ES2671342T3 (da)
HU (1) HUE037773T2 (da)
LT (1) LT1991201T (da)
MX (1) MX2008010222A (da)
PL (1) PL1991201T3 (da)
PT (1) PT1991201T (da)
RU (1) RU2008136460A (da)
SI (1) SI1991201T1 (da)
TR (1) TR201807714T4 (da)
WO (1) WO2007090646A1 (da)

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ES2671342T3 (es) 2018-06-06
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AU2007213983A1 (en) 2007-08-16
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