HRP20130076T1 - Formulacije tobramicina za lijeäśenje endobronhijalnih infekcija - Google Patents
Formulacije tobramicina za lijeäśenje endobronhijalnih infekcija Download PDFInfo
- Publication number
- HRP20130076T1 HRP20130076T1 HRP20130076TT HRP20130076T HRP20130076T1 HR P20130076 T1 HRP20130076 T1 HR P20130076T1 HR P20130076T T HRP20130076T T HR P20130076TT HR P20130076 T HRP20130076 T HR P20130076T HR P20130076 T1 HRP20130076 T1 HR P20130076T1
- Authority
- HR
- Croatia
- Prior art keywords
- dry powder
- aerosol composition
- use according
- powder aerosol
- tobramycin
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 30
- NLVFBUXFDBBNBW-PBSUHMDJSA-N tobramycin Chemical compound N[C@@H]1C[C@H](O)[C@@H](CN)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](N)[C@H](O)[C@@H](CO)O2)O)[C@H](N)C[C@@H]1N NLVFBUXFDBBNBW-PBSUHMDJSA-N 0.000 title claims 15
- 229960000707 tobramycin Drugs 0.000 title claims 15
- 208000015181 infectious disease Diseases 0.000 title claims 4
- 238000009472 formulation Methods 0.000 title 1
- 239000000843 powder Substances 0.000 claims 31
- 239000000443 aerosol Substances 0.000 claims 26
- 201000003883 Cystic fibrosis Diseases 0.000 claims 4
- 230000002045 lasting effect Effects 0.000 claims 3
- NRJAVPSFFCBXDT-HUESYALOSA-N 1,2-distearoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCCCCCCCCCCC NRJAVPSFFCBXDT-HUESYALOSA-N 0.000 claims 2
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 2
- 241000589517 Pseudomonas aeruginosa Species 0.000 claims 2
- 229910001628 calcium chloride Inorganic materials 0.000 claims 2
- 239000001110 calcium chloride Substances 0.000 claims 2
- 229940112141 dry powder inhaler Drugs 0.000 claims 2
- 229940126574 aminoglycoside antibiotic Drugs 0.000 claims 1
- 239000002647 aminoglycoside antibiotic agent Substances 0.000 claims 1
- 230000003115 biocidal effect Effects 0.000 claims 1
- 239000000839 emulsion Substances 0.000 claims 1
- 210000004072 lung Anatomy 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- WTWWXOGTJWMJHI-UHFFFAOYSA-N perflubron Chemical compound FC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)Br WTWWXOGTJWMJHI-UHFFFAOYSA-N 0.000 claims 1
- 229960001217 perflubron Drugs 0.000 claims 1
- 150000003904 phospholipids Chemical class 0.000 claims 1
- 239000012798 spherical particle Substances 0.000 claims 1
- 238000001694 spray drying Methods 0.000 claims 1
Classifications
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
-
- 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
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
-
- 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
- A61P3/00—Drugs for disorders of the metabolism
-
- 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
-
- 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
- A61P31/02—Local antiseptics
-
- 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
Claims (20)
1. Suhi sastav praškastog aerosola, naznačen time, da sadrži od 100 do 130 mg tobramicina po jednoj dozi za uporabu u liječenju endobronhijalne infekcije kod pacijenta koji pati od cistične fibroze, pri čemu se sastav primjenjuje na endobronhijalni sustav pacijenta, gdje se jedna doza sastava daje jednom do tri puta dnevno za vrijeme prvog perioda liječenja u trajanju od 20 do 36 dana.
2. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 1, naznačen time, da nakon prvog perioda liječenja slijedi drugi period bez liječenja, pri čemu se ne primjenjuje aminoglikozidni antibiotik na endobronhijalni sustav pacijenta.
3. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 1, naznačen time, da jedna doza suhog sastava praškastog aerosola sadrži od 100 do 120 mg tobramicina.
4. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 3, naznačen time, da jedna doza suhog sastava praškastog aerosola sadrži od 110 do 115 mg tobramicina.
5. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 1, naznačen time, da je jedna doza suhog sastava praškastog aerosola podijeljena u dvije do šest jediničnih doza, poželjno u tri do pet jediničnih doza, a najbolje u četiri jedinične doze.
6. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 2, naznačen time, da je drugi period bez liječenja u trajanju od 20 do 36 dana, poželjno od 26 do 30 dana.
7. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 2 ili zahtjevu 6, naznačen time, da je prvi period liječenja u trajanju od 26 do 30 dana, poželjno traje 28 dana.
8. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 2, naznačen time, da se režim liječenja ponavlja više puta, kod kojega nakon prvog perioda liječenja slijedi drugi period bez liječenja.
9. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 1, naznačen time, da suhi sastav praškastog aerosola sadrži čestice od kojih najmanje 50% imaju aerodinamični promjer u rasponu od 1 μm do 5 μm.
10. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 1, naznačen time, da je prašak pripremljen pomoću sušenja raspršivanjem.
11. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 1, naznačen time, da prašak sadrži od 30 masenih % do 80 masenih % tobramicina.
12. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 1, naznačen time, da prašak sadrži od 40 masenih % do 70 masenih % tobramicina.
13. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 1, naznačen time, da se prašak priprema od emulzije koja obuhvaća tobramicin, 1,2-distearoil-sn-glicero-3-fosfokolin, kalcijev klorid i perfluorooktil-bromid.
14. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 13, naznačen time, da prašak sadrži kuglaste čestice na bazi fosfolipida, koje imaju poroznu strukturu sa sadržajem koji obuhvaća tobramicin, 1,2-distearoil-sn-glicero-3-fosfokolin i kalcijev klorid.
15. Suhi sastav praškastog aerosola za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time, da pacijent koji boluje od cistične fibroze, pati od endobronhijalne infekcije uzrokovane Pseudomonas aeruginosa.
16. Suhi sastav praškastog aerosola za uporabu prema bilo kojem od prethodnih zahtjeva, naznačen time, da se suhi sastav praškastog aerosola formulira za davanje pacijentu uporabom inhalatora za suhi prašak.
17. Suhi sastav praškastog aerosola za uporabu prema zahtjevu 1, naznačen time, da se suhi sastav praškastog aerosola raspoređuje unutar jednog spremnika ili unutar više spremnika u inhalatoru za suhi prašak, gdje se praškasti aerosol prenosi pomoću inhalatora iz spremnika u pluća pacijenta koji pati od cistične fibroze.
18. Tobramicin, naznačen time, da se upotrebljava za liječenje endobronhijalne infekcije uzrokovane Pseudomonas aeruginosa kod pacijenta koji pati od cistične fibroze, gdje je tobramicin u obliku suhog sastava praškastog aerosola koji sadrži od 110 do 115 mg tobramicina po jednoj dozi, pri čemu se sastav formulira za primjenu u endobronhijalni sustav pacijenta, kada se jedna doza sastava daje dva puta dnevno za vrijeme prvog perioda liječenja u trajanju od 28 dana, zatim slijedi drugi period bez liječenja u trajanju od 26 do 30 dana, kada se antibiotik tobramicin ne daje u endobronhijalni sustav pacijenta, te se nakon toga ponavljaju prvi i drugi period liječenja.
19. Tobramicin za uporabu prema zahtjevu 18, naznačen time, da je jedna doza suhog sastava praškastog aerosola, koja sadrži od 110 do 115 mg tobramicina, podijeljena u tri do pet jediničnih doza, poželjno u četiri jedinične doze.
20. Tobramicin za uporabu prema zahtjevu 19, naznačen time, da se prvi i drugi period liječenja ponavljaju više puta.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US58084804P | 2004-06-18 | 2004-06-18 | |
PCT/US2005/021952 WO2006002178A1 (en) | 2004-06-18 | 2005-06-20 | Methods of treatment of endobronchial infections |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20130076T1 true HRP20130076T1 (hr) | 2013-03-31 |
Family
ID=35782127
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20130076TT HRP20130076T1 (hr) | 2004-06-18 | 2013-01-29 | Formulacije tobramicina za lijeäśenje endobronhijalnih infekcija |
Country Status (25)
Country | Link |
---|---|
US (3) | US20080214481A1 (hr) |
EP (1) | EP1765288B1 (hr) |
JP (3) | JP2008503500A (hr) |
KR (2) | KR20070026604A (hr) |
CN (1) | CN101014320B (hr) |
AU (1) | AU2005258078B2 (hr) |
BR (1) | BRPI0512146A (hr) |
CA (1) | CA2570976C (hr) |
DK (1) | DK1765288T3 (hr) |
EC (1) | ECSP077182A (hr) |
ES (1) | ES2399279T3 (hr) |
HR (1) | HRP20130076T1 (hr) |
IL (1) | IL179873A (hr) |
MA (1) | MA28740B1 (hr) |
MX (1) | MXPA06014567A (hr) |
NO (1) | NO338799B1 (hr) |
NZ (1) | NZ552047A (hr) |
PL (1) | PL1765288T3 (hr) |
PT (1) | PT1765288E (hr) |
RU (1) | RU2389477C2 (hr) |
SG (1) | SG153833A1 (hr) |
SI (1) | SI1765288T1 (hr) |
TN (1) | TNSN06420A1 (hr) |
WO (1) | WO2006002178A1 (hr) |
ZA (1) | ZA200700420B (hr) |
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ATE508735T1 (de) | 2001-12-19 | 2011-05-15 | Novartis Ag | Pulmonale verabreichung von aminoglykosiden |
US7381184B2 (en) | 2002-11-05 | 2008-06-03 | Abbott Diabetes Care Inc. | Sensor inserter assembly |
USD902408S1 (en) | 2003-11-05 | 2020-11-17 | Abbott Diabetes Care Inc. | Analyte sensor control unit |
US8333714B2 (en) | 2006-09-10 | 2012-12-18 | Abbott Diabetes Care Inc. | Method and system for providing an integrated analyte sensor insertion device and data processing unit |
US8029441B2 (en) | 2006-02-28 | 2011-10-04 | Abbott Diabetes Care Inc. | Analyte sensor transmitter unit configuration for a data monitoring and management system |
US10226207B2 (en) | 2004-12-29 | 2019-03-12 | Abbott Diabetes Care Inc. | Sensor inserter having introducer |
US7883464B2 (en) | 2005-09-30 | 2011-02-08 | Abbott Diabetes Care Inc. | Integrated transmitter unit and sensor introducer mechanism and methods of use |
US9788771B2 (en) | 2006-10-23 | 2017-10-17 | Abbott Diabetes Care Inc. | Variable speed sensor insertion devices and methods of use |
US9259175B2 (en) | 2006-10-23 | 2016-02-16 | Abbott Diabetes Care, Inc. | Flexible patch for fluid delivery and monitoring body analytes |
US8512243B2 (en) | 2005-09-30 | 2013-08-20 | Abbott Diabetes Care Inc. | Integrated introducer and transmitter assembly and methods of use |
US9398882B2 (en) | 2005-09-30 | 2016-07-26 | Abbott Diabetes Care Inc. | Method and apparatus for providing analyte sensor and data processing device |
US7697967B2 (en) | 2005-12-28 | 2010-04-13 | Abbott Diabetes Care Inc. | Method and apparatus for providing analyte sensor insertion |
US9521968B2 (en) | 2005-09-30 | 2016-12-20 | Abbott Diabetes Care Inc. | Analyte sensor retention mechanism and methods of use |
US11298058B2 (en) | 2005-12-28 | 2022-04-12 | Abbott Diabetes Care Inc. | Method and apparatus for providing analyte sensor insertion |
WO2008043825A2 (en) * | 2006-10-11 | 2008-04-17 | Laboratoires Smb S.A. | Pharmaceutical anti-infective composition for inhalation. |
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AU2009246217B2 (en) * | 2008-05-15 | 2013-01-10 | Novartis Ag | Pulmonary delivery of a fluoroquinolone |
US9402544B2 (en) | 2009-02-03 | 2016-08-02 | Abbott Diabetes Care Inc. | Analyte sensor and apparatus for insertion of the sensor |
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BR112012014405B1 (pt) * | 2009-12-14 | 2019-05-14 | Chiesi Farmaceutici S.P.A. | Formulação de pó seco, micropartícula, cápsula para uso com um inalador de pó seco, método para preparação de uma micropartícula e uso de uma micropartícula |
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WO2014055456A1 (en) * | 2012-10-07 | 2014-04-10 | Abbott Diabetes Care Inc. | Medical device insertion indicators |
CN102949379B (zh) * | 2012-11-14 | 2014-11-05 | 中山大学 | 硫酸奈替米星吸入粉雾剂及其制备方法 |
JP6454323B2 (ja) | 2013-03-15 | 2019-01-16 | パール セラピューティクス,インコーポレイテッド | 粒子状結晶性材料のコンディショニングのための方法及びシステム |
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AU2016260547B2 (en) | 2015-05-14 | 2020-09-03 | Abbott Diabetes Care Inc. | Compact medical device inserters and related systems and methods |
WO2018136898A1 (en) | 2017-01-23 | 2018-07-26 | Abbott Diabetes Care Inc. | Systems, devices and methods for analyte sensor insertion |
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USD1002852S1 (en) | 2019-06-06 | 2023-10-24 | Abbott Diabetes Care Inc. | Analyte sensor device |
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-
2005
- 2005-06-20 EP EP05766064A patent/EP1765288B1/en active Active
- 2005-06-20 NZ NZ552047A patent/NZ552047A/xx not_active IP Right Cessation
- 2005-06-20 SI SI200531661T patent/SI1765288T1/sl unknown
- 2005-06-20 DK DK05766064.9T patent/DK1765288T3/da active
- 2005-06-20 US US11/570,584 patent/US20080214481A1/en not_active Abandoned
- 2005-06-20 SG SG200904155-9A patent/SG153833A1/en unknown
- 2005-06-20 KR KR1020067026608A patent/KR20070026604A/ko not_active Application Discontinuation
- 2005-06-20 CN CN2005800201762A patent/CN101014320B/zh active Active
- 2005-06-20 CA CA2570976A patent/CA2570976C/en active Active
- 2005-06-20 PT PT57660649T patent/PT1765288E/pt unknown
- 2005-06-20 BR BRPI0512146-9A patent/BRPI0512146A/pt not_active Application Discontinuation
- 2005-06-20 MX MXPA06014567A patent/MXPA06014567A/es active IP Right Grant
- 2005-06-20 JP JP2007516838A patent/JP2008503500A/ja active Pending
- 2005-06-20 KR KR1020127029971A patent/KR20120131245A/ko not_active Application Discontinuation
- 2005-06-20 WO PCT/US2005/021952 patent/WO2006002178A1/en active Application Filing
- 2005-06-20 AU AU2005258078A patent/AU2005258078B2/en active Active
- 2005-06-20 RU RU2007101906/14A patent/RU2389477C2/ru active
- 2005-06-20 PL PL05766064T patent/PL1765288T3/pl unknown
- 2005-06-20 ES ES05766064T patent/ES2399279T3/es active Active
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2006
- 2006-12-06 IL IL179873A patent/IL179873A/en active IP Right Grant
- 2006-12-18 TN TNP2006000420A patent/TNSN06420A1/en unknown
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2007
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- 2007-01-15 ZA ZA200700420A patent/ZA200700420B/xx unknown
- 2007-01-17 MA MA29618A patent/MA28740B1/fr unknown
- 2007-01-18 EC EC2007007182A patent/ECSP077182A/es unknown
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2011
- 2011-01-04 US US12/984,110 patent/US20110097412A1/en not_active Abandoned
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2012
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- 2012-02-24 US US13/404,359 patent/US8664187B2/en active Active
- 2012-12-27 JP JP2012284937A patent/JP2013056947A/ja active Pending
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2013
- 2013-01-29 HR HRP20130076TT patent/HRP20130076T1/hr unknown
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