SI1991201T1 - Nebulizirani antibiotiki za inhalacijsko terapijo - Google Patents
Nebulizirani antibiotiki za inhalacijsko terapijo Download PDFInfo
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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
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- 239000003242 anti bacterial agent Substances 0.000 title claims abstract 3
- 229940088710 antibiotic agent Drugs 0.000 title claims abstract 3
- 238000002664 inhalation therapy Methods 0.000 title claims 2
- 239000000203 mixture Substances 0.000 claims abstract 12
- 239000000443 aerosol Substances 0.000 claims abstract 10
- 239000007788 liquid Substances 0.000 claims abstract 7
- 210000004072 lung Anatomy 0.000 claims abstract 3
- 239000008249 pharmaceutical aerosol Substances 0.000 claims abstract 3
- 238000011282 treatment Methods 0.000 claims abstract 3
- 239000000546 pharmaceutical excipient Substances 0.000 claims 14
- 150000001875 compounds Chemical class 0.000 claims 13
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims 6
- GSDSWSVVBLHKDQ-JTQLQIEISA-N Levofloxacin Chemical compound C([C@@H](N1C2=C(C(C(C(O)=O)=C1)=O)C=C1F)C)OC2=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-JTQLQIEISA-N 0.000 claims 6
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims 6
- 229960003376 levofloxacin Drugs 0.000 claims 6
- 150000003839 salts Chemical class 0.000 claims 6
- 239000012453 solvate Substances 0.000 claims 6
- AZDRQVAHHNSJOQ-UHFFFAOYSA-N alumane Chemical class [AlH3] AZDRQVAHHNSJOQ-UHFFFAOYSA-N 0.000 claims 5
- 239000007791 liquid phase Substances 0.000 claims 5
- 239000011777 magnesium Substances 0.000 claims 5
- 229910052749 magnesium Inorganic materials 0.000 claims 5
- 241000606768 Haemophilus influenzae Species 0.000 claims 4
- 241000193998 Streptococcus pneumoniae Species 0.000 claims 4
- 239000011575 calcium Substances 0.000 claims 4
- 229910052791 calcium Inorganic materials 0.000 claims 4
- 159000000003 magnesium salts Chemical class 0.000 claims 4
- 239000008194 pharmaceutical composition Substances 0.000 claims 4
- 229940031000 streptococcus pneumoniae Drugs 0.000 claims 4
- 241000588655 Moraxella catarrhalis Species 0.000 claims 3
- 206010035664 Pneumonia Diseases 0.000 claims 3
- 241000191967 Staphylococcus aureus Species 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 239000012071 phase Substances 0.000 claims 3
- 229920000642 polymer Polymers 0.000 claims 3
- 238000011321 prophylaxis Methods 0.000 claims 3
- 230000002685 pulmonary effect Effects 0.000 claims 3
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 claims 2
- 241000606766 Haemophilus parainfluenzae Species 0.000 claims 2
- 241000588747 Klebsiella pneumoniae Species 0.000 claims 2
- 230000001154 acute effect Effects 0.000 claims 2
- 206010006451 bronchitis Diseases 0.000 claims 2
- 239000008139 complexing agent Substances 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 239000000796 flavoring agent Substances 0.000 claims 2
- 206010001076 Acute sinusitis Diseases 0.000 claims 1
- 239000004475 Arginine Substances 0.000 claims 1
- 108010011485 Aspartame Proteins 0.000 claims 1
- 206010006458 Bronchitis chronic Diseases 0.000 claims 1
- 241000589513 Burkholderia cepacia Species 0.000 claims 1
- 229920001661 Chitosan Polymers 0.000 claims 1
- 241001647372 Chlamydia pneumoniae Species 0.000 claims 1
- 206010009137 Chronic sinusitis Diseases 0.000 claims 1
- 229920000858 Cyclodextrin Polymers 0.000 claims 1
- 201000003883 Cystic fibrosis Diseases 0.000 claims 1
- 241000588724 Escherichia coli Species 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- 241000589242 Legionella pneumophila Species 0.000 claims 1
- 241000202934 Mycoplasma pneumoniae Species 0.000 claims 1
- 208000009362 Pneumococcal Pneumonia Diseases 0.000 claims 1
- 206010035728 Pneumonia pneumococcal Diseases 0.000 claims 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 claims 1
- 241000607715 Serratia marcescens Species 0.000 claims 1
- 206010052779 Transplant rejections Diseases 0.000 claims 1
- 230000009798 acute exacerbation Effects 0.000 claims 1
- 229960003121 arginine Drugs 0.000 claims 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 1
- 235000009697 arginine Nutrition 0.000 claims 1
- 239000000605 aspartame Substances 0.000 claims 1
- 235000010357 aspartame Nutrition 0.000 claims 1
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims 1
- 229960003438 aspartame Drugs 0.000 claims 1
- 230000001580 bacterial effect Effects 0.000 claims 1
- 230000003115 biocidal effect Effects 0.000 claims 1
- 208000007451 chronic bronchitis Diseases 0.000 claims 1
- 208000027157 chronic rhinosinusitis Diseases 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 230000005713 exacerbation Effects 0.000 claims 1
- 230000003176 fibrotic effect Effects 0.000 claims 1
- 235000019634 flavors Nutrition 0.000 claims 1
- 235000013355 food flavoring agent Nutrition 0.000 claims 1
- 235000003599 food sweetener Nutrition 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 229940115932 legionella pneumophila Drugs 0.000 claims 1
- 239000008263 liquid aerosol Substances 0.000 claims 1
- 230000014759 maintenance of location Effects 0.000 claims 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims 1
- 201000009890 sinusitis Diseases 0.000 claims 1
- 208000022218 streptococcal pneumonia Diseases 0.000 claims 1
- 150000005846 sugar alcohols Chemical class 0.000 claims 1
- 239000003765 sweetening agent Substances 0.000 claims 1
- 238000002054 transplantation Methods 0.000 claims 1
- 230000002861 ventricular Effects 0.000 claims 1
- 208000035473 Communicable disease Diseases 0.000 abstract 1
- 239000013543 active substance Substances 0.000 abstract 1
- 210000000621 bronchi Anatomy 0.000 abstract 1
- 230000002265 prevention Effects 0.000 abstract 1
- LISFMEBWQUVKPJ-UHFFFAOYSA-N quinolin-2-ol Chemical compound C1=CC=C2NC(=O)C=CC2=C1 LISFMEBWQUVKPJ-UHFFFAOYSA-N 0.000 abstract 1
- 239000008247 solid mixture Substances 0.000 abstract 1
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- A61K9/00—Medicinal preparations characterised by special physical form
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- 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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- A61K31/395—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
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Claims (16)
- NEBULIZIRANI ANTIBIOTIKI ZA INHALACIJSKO TERAPIJO PATENTNI ZAHTEVKI1. 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. Aerosol po zahtevku 1, kjer je vsaj en ekscipient izbran iz skupine magnezijevih soli.
- 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. 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. Tekoči farmacevtski sestavek po zahtevku 4, kjer je vsaj en ekscipient izbran iz skupine magnezijevih soli.
- 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. 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. 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. Komplet po zahtevku 8, kjer je vsaj en ekscipient izbran iz skupine magnezijevih soli.
- 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. 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. Metoda po zahtevku 11, kjer je vsaj en ekscipient izbran iz skupine magnezijevih soli.
- 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. Uporaba po zahtevku 13, kjer je zdravilo dano pulmonalno.
- 15. Uporaba po katerem koli izmed zahtevkov od 13 do 14, kjer je zdravilo prilagojeno za dajanje dvakrat ali enkrat na dan.
- 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.
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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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SI200732031T SI1991201T1 (sl) | 2006-02-10 | 2007-02-08 | Nebulizirani antibiotiki za inhalacijsko terapijo |
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EP (1) | EP1991201B1 (sl) |
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LT (1) | LT1991201T (sl) |
MX (1) | MX2008010222A (sl) |
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PT (1) | PT1991201T (sl) |
RU (1) | RU2008136460A (sl) |
SI (1) | SI1991201T1 (sl) |
TR (1) | TR201807714T4 (sl) |
WO (1) | WO2007090646A1 (sl) |
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2007
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- 2007-02-08 WO PCT/EP2007/001080 patent/WO2007090646A1/en active Application Filing
- 2007-02-08 PL PL07703355T patent/PL1991201T3/pl unknown
- 2007-02-08 HU HUE07703355A patent/HUE037773T2/hu unknown
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- 2007-02-08 CA CA002641827A patent/CA2641827A1/en not_active Abandoned
- 2007-02-08 BR BRPI0707641-0A patent/BRPI0707641A2/pt not_active IP Right Cessation
- 2007-02-08 CN CNA2007800068534A patent/CN101389313A/zh active Pending
- 2007-02-08 PT PT77033553T patent/PT1991201T/pt unknown
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- 2007-02-08 LT LTEP07703355.3T patent/LT1991201T/lt unknown
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Also Published As
Publication number | Publication date |
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CN101389313A (zh) | 2009-03-18 |
PL1991201T3 (pl) | 2018-09-28 |
CY1120284T1 (el) | 2019-07-10 |
BRPI0707641A2 (pt) | 2011-05-10 |
DK1991201T3 (en) | 2018-06-14 |
ES2671342T3 (es) | 2018-06-06 |
AU2007213983B2 (en) | 2012-09-20 |
EP1991201A1 (en) | 2008-11-19 |
CA2641827A1 (en) | 2007-08-16 |
EP1991201B1 (en) | 2018-03-28 |
RU2008136460A (ru) | 2010-03-20 |
LT1991201T (lt) | 2018-07-25 |
JP2009526003A (ja) | 2009-07-16 |
MX2008010222A (es) | 2008-10-17 |
WO2007090646A1 (en) | 2007-08-16 |
HUE037773T2 (hu) | 2018-09-28 |
AU2007213983A1 (en) | 2007-08-16 |
PT1991201T (pt) | 2018-06-12 |
TR201807714T4 (tr) | 2018-06-21 |
US20090025713A1 (en) | 2009-01-29 |
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