SI1991201T1 - Nebulizirani antibiotiki za inhalacijsko terapijo - Google Patents

Nebulizirani antibiotiki za inhalacijsko terapijo Download PDF

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SI1991201T1
SI1991201T1 SI200732031T SI200732031T SI1991201T1 SI 1991201 T1 SI1991201 T1 SI 1991201T1 SI 200732031 T SI200732031 T SI 200732031T SI 200732031 T SI200732031 T SI 200732031T SI 1991201 T1 SI1991201 T1 SI 1991201T1
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excipient
aerosol
group
active compound
magnesium
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SI200732031T
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Manfred Keller
Aslihan Akkar
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Pari Pharma Gmbh
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • 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
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    • 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
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    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • 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
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    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • 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
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    • 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
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    • 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
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    • A61K9/0043—Nose
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    • 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
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    • 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
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    • 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
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    • 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
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    • 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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Claims (16)

  1. NEBULIZIRANI ANTIBIOTIKI ZA INHALACIJSKO TERAPIJO PATENTNI ZAHTEVKI
    1. Farmacevtski aerosol za nazalno, sinunazalno ali pljučno dajanje, ki obsega dispergirano tekočo fazo in kontinuirno plinsko fazo, pri čemer dispergirana tekoča faza (a) sestoji iz vodnih kapljic, ki obsegajo 20 do 200 mg/ml aktivne spojine levofloksacina ali ekvivalentno koncentracijo farmacevtsko sprejemljive soli, solvata ali izomera le-tega in vsaj en ekscipient izbran iz skupine kalcijevih-, magnezijevih- in aluminijevih- soli; (b) ima masni srednji premer od okoli 1,5 do okoli 6 pm; in (c) ima razporeditev velikosti kapljic, ki kaže geometrijsko standardno odstopanje od okoli 1,2 do okoli 3,0.
  2. 2. Aerosol po zahtevku 1, kjer je vsaj en ekscipient izbran iz skupine magnezijevih soli.
  3. 3. Aerosol po katerem koli od zahtevkov 1 do 2, ki ga oddaja generator aerosola s hitrostjo vsaj okoli 0,1 ml razpršene tekoče faze na minuto.
  4. 4. Tekoči farmacevtski sestavek za pripravo aerosola po katerem koli od zahtevkov 1 do 3, kjer sestavek obsega obsega 20 do 200 mg/ml aktivne spojine levofloksacin ali ekvivalentno koncentracijo farmacevtsko sprejemljive soli, solvata ali izomera le-tega ter vsaj en ekscipient, izbran iz skupine kalcijevih-, magnezijevih-, in aluminijevih- soli in kjer volumen ne več kot okoli 10 ml in bolj prednostno manj kot okoli 5 ml sestavka vsebuje učinkovito dozo aktivne spojine.
  5. 5. Tekoči farmacevtski sestavek po zahtevku 4, kjer je vsaj en ekscipient izbran iz skupine magnezijevih soli.
  6. 6. Sestavek po katerem koli od zahtevkov 4 do 5, ki obsega vsaj en ekscipient, ki lahko vpliva na lokalno biološko razpoložljivost, sproščanje in/ali lokalni čas zadrževanja aktivne spojine na mestu nanosa aerosola, kjer je ekscipient izbran iz skupine, ki jo sestavljajo kompleksirna sredstva, polimeri in amfifilne spojine.
  7. 7. Sestavek po katerem koli od zahtevkov 4 do 6, ki obsega vsaj en okus-modificirajoč ekscipient, prednostno izbrano iz okusov, sladil, kompleksirnih sredstev in sredstev za maskiranje okusa, kot je ciklodekstrin, sladkor, sladkorni alkohol, natrijev saharin, aspartam ali arginin.
  8. 8. Komplet za pripravo in dostavo farmacevtskega aerosola za nosno, sinunazalno ali pljučno dajanje, ki obsega dispergirano tekočo fazo in kontinuirno plinsko fazo, kjer razpršena tekoča faza (a) sestoji iz vodnih kapljic, ki obsegajo 20 do 200 mg/ml aktivne spojine levofloksacin ali ekvivalenta koncentracijo farmacevtsko sprejemljive soli, solvata ali izomera le-tega in vsaj enega ekscipienta izbranega iz skupine kalcijevih-, magnezijevih- in aluminijevih soli; (b) ima masni srednji premer od okoli 1,5 do okoli 6 pm; in (c) ima razporeditev velikosti kapljic, ki kaže geometrično standardno deviacijo od okoli 1,2 do okoli 3,0, pri čemer komplet obsega nebulator in vodni tekoči sestavek, pri čemer omenjeni sestavek obsega od 20 do 200 mg/ml aktivne spojine levofloksacina ali ekvivalentno koncentracijo farmacevtsko sprejemljive soli, solvata ali izomera le-tega in vsaj en ekscipient, izbran iz skupine kalcijevih-, magnezijevih- in aluminievih soli in vsebuje učinkovito dozo aktivne spojine v prostornini ne več kot okoli 10 ml in bolj prednostno manj kot 5 ml.
  9. 9. Komplet po zahtevku 8, kjer je vsaj en ekscipient izbran iz skupine magnezijevih soli.
  10. 10. Komplet po katerem koli od zahtevkov od 8 do 9, kjer je vsaj okoli 40 mas.% napolnjene doze zaobseženo v kapljicah, ki imajo premer ne več kot približno 5 pm.
  11. 11. Metoda za pripravo aerosola za dostavo osebi, ki potrebuje nosno, sinunazalno ali pljučno antibiotično zdravljenje ali profilakso, omenjena metoda obsega korake: (a) zagotavljanje tekočega farmacevtskega sestavka, ki obsega 20 do 200 mg/ml aktivne spojine levofloksacina ali ekvivalentno koncentracijo farmacevtsko sprejemljive soli, solvata ali izomera le-tega in vsaj enega ekscipienta, izbranega iz skupine kalcijevih-, magnezijevih- in aluminijevih soli, in obsega učinkovito dozo aktivne spojine v prostornini, ne več od okoli 10 ml in bolj prednostno manj kot 5 ml; (b) zagotavljanje nebulatorja, ki je sposoben aerosoliziranja omenjenega tekočega farmacevtskega sestavka pri skupni izhodni hitrosti najmanj 0,1 ml/min, nebulator je nadalje prirejen za oddajanje aerosola, ki obsega dispergirano fazo ki ima masni srednji premer od okoli 1,5 do okoli 6 pm in geometrično standardno odstopanje od okoli 1,2 do okoli 3; in (c) delovanje nebulatorja za aerosoliziranje tekočega sestavka.
  12. 12. Metoda po zahtevku 11, kjer je vsaj en ekscipient izbran iz skupine magnezijevih soli.
  13. 13. Uporaba aerosola po zahtevku 1 ali tekočega sestavka po zahtevku 4 ali kompleta po zahtevku 8 za pripravo zdravila za profilakso ali zdravljenje akutnega ali kroničnega sinusitisa ali rinosinusitisa, bronhitisa, pljučnice, kronične obstruktivne pljučne bolezni, profilaksa za preprečevanje zavrnitve presadka po presaditvi pljuč, parenhimatska in/ali fibrotičnih bolezni ali motenj, vključno s cistično fibrozo z ali brez akutnih poslabšanj, po izbiri zaradi Streptococcus pneumoniae, Haemophilus influenza ali Moraxella catarrhalis; akutnega bakterijskega poslabšanja pri kroničnem bronhitisu ali pri kronični obstruktivni pljučni bolezni, po možnosti zaradi Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenza, Haemophilus parainfluenza ali Moraxella catarrhalis; nosokomialne pljučnice, po možnosti zaradi Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Burkholderia cepacia, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenza ali Streptococcus pneumoniae; ali zunajbolnišnične pljučnice (CAP) ali bolnišnično pridobljene pljučnice (HAP) ali pljučnice, povezane z ventilatorjem (VAP), po izbiri zaradi Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenza, Haemophilus parainfluenza, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila ali Mycoplasma pneumoniae.
  14. 14. Uporaba po zahtevku 13, kjer je zdravilo dano pulmonalno.
  15. 15. Uporaba po katerem koli izmed zahtevkov od 13 do 14, kjer je zdravilo prilagojeno za dajanje dvakrat ali enkrat na dan.
  16. 16. Uporaba polimerne spojine kot ekscipienta v farmacevtskem sestavku za pripravo aerosola, kjer sestavek obsega od 20 do 200 mg/ml aktivne spojine levofloksacina ali ekvivalentno koncentracijo farmacevtsko sprejemljive soli, solvata ali izomera le-tega ter vsaj en ekscipient, izbran iz skupine kalcijevih-, magnezijevih- in aluminijevih soli in kjer je polimerna spojina izbrana izmed hitozana.
SI200732031T 2006-02-10 2007-02-08 Nebulizirani antibiotiki za inhalacijsko terapijo SI1991201T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP06002734 2006-02-10
EP07703355.3A EP1991201B1 (en) 2006-02-10 2007-02-08 Nebulised antibiotics for inhalation therapy
PCT/EP2007/001080 WO2007090646A1 (en) 2006-02-10 2007-02-08 Nebulised antibiotics for inhalation therapy

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SI1991201T1 true SI1991201T1 (sl) 2018-08-31

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

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