DK3096737T3 - Stabil tryksat aerosolopløsningssammensætning af glycopyrroniumbromid og formoterolkombination - Google Patents
Stabil tryksat aerosolopløsningssammensætning af glycopyrroniumbromid og formoterolkombination Download PDFInfo
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- DK3096737T3 DK3096737T3 DK14827449.1T DK14827449T DK3096737T3 DK 3096737 T3 DK3096737 T3 DK 3096737T3 DK 14827449 T DK14827449 T DK 14827449T DK 3096737 T3 DK3096737 T3 DK 3096737T3
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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- 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
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- A61M39/22—Valves or arrangement of valves
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/14—Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
- B65D83/44—Valves specially adapted therefor; Regulating devices
- B65D83/52—Valves specially adapted therefor; Regulating devices for metering
- B65D83/54—Metering valves ; Metering valve assemblies
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/14—Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
- B65D83/75—Aerosol containers not provided for in groups B65D83/16 - B65D83/74
- B65D83/752—Aerosol containers not provided for in groups B65D83/16 - B65D83/74 characterised by the use of specific products or propellants
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
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Claims (18)
1. Farmaceutisk aerosoloplesningssammensastning beregnet til anvendelse i en tryksat doseringsinhalator omfattende: (a) glycopyrroniumbromid i en dosering i omradetfra 5 til 26 pg pr. aktivering; (b) formoterol eller et salt deraf eller et solvat af saltet i en dosering i omradet fra 1 til 25 pg pr. aktivering; (c) et HFA-drivmiddel; (d) et co-oplosningsmiddel; (e) en stabiliserende magngde af en mineralsyre; hvor sammensastningen er indeholdt i en aerosolbeholder forsynet med en doseringsventil, der har mindst en butylgummipakning.
2. Farmaceutisk aerosoloplesningssammensastning ifelge krav 1, kendeteg-net ved, at masngden af nedbrydningsproduktet N-(3-brom)-[2-hydroxy-5-[1-hydroxy-2-[1 -(4-methoxyphenyl)propan-2-ylamino]ethyl] phenyl]formamid er mindre end 0,10 vasgtprocent i forhold til det teoretiske formoterolfumaratind-hold pa 6 pg/aktivering, nar det lagres under accelererede betingelser ved 25°C og 60 % relativ luftfugtighed (RFI) i mindst 6 maneder.
3. Farmaceutisk aerosoloplesningssammensastning ifelge krav 1 eller 2, hvor den stabiliserende masngde af en mineralsyre er en masngde syre svarende til 1M saltsyre i omradetfra 0,15 til 0,28 pg/pl.
4. Farmaceutisk aerosoloplesningssammensastning ifelge krav 3, hvor en mineralsyre er en masngde syre svarende til 0,22 pg/pl af 1M saltsyre.
5. Farmaceutisk aerosoloplesningssammensastning ifelge et af kravene 1 til 4, hvor co-opl0sningsmidlet er ethanol.
6. Farmaceutisk aerosoloplesningssammensastning ifelge krav 1, hvorformo-terolsaltet er formoterolfumarat.
7. Farmaceutisk aerosoloplesningssammensastning if0lge krav 1, hvor solvat-formen af formoterolsaltet erformoterolfumaratdihydrat.
8. Farmaceutisk aerosoloplesningssammensastning if0lge krav 1, yderligere omfattende en eller fiere farmaceutisk aktive bestanddele valgt fra gruppen bestaende af beta-2-agonister, inhalationscorticosteroider, antimuscarinmidler og phosphodiesterase (4)-inhibitorer.
9. Farmaceutisk aerosoloplesningssammensastning ifelge krav 8, hvor inhala-tionscorticosteroidet er valgt fra gruppen af beclometasondipropionat, budeso-nid ellerdets 22R-epimer, ciclesonid, flunisolid, fluticasonpropionat, fluticason-furoat, mometasonfuroat, butixocort, triamcinolonacetonid, triamcinolon, methylprednisolon, prednison, loteprednol og rofleponid.
10. Farmaceutisk sammensastning af aerosoloplesning ifelge krav 9, hvor in-halationscorticosteroidet beclometasondipropionat er til stede i en masngde i omradet fra 50 til 250 pg pr. aktivering.
11. Farmaceutisk aerosoloplesningssammensastning ifelge krav 9, hvor inha-lationcorticosteroidet budesonid er til stede i en masngde i omradet fra 50 til 250 pg pr. aktivering.
12. Farmaceutisk aerosoloplesningssammensastning ifelge krav 1, hvor ni-veauet for formoterolnedbrydningsproduktet er lavere end 10 vasgtprocent i forhold til det teoretiske formoterolfumaratindhold pa 6pg/aktivering og det resterende niveau af formoterolfumarat er hejere end 90 vasgtprocent i forhold til dets oprindelige indhold.
13. Farmaceutisk aerosoloplesningssammensastning ifelge krav 12, hvor det samlede niveau forformoterolnedbrydningsproduktet er lavere end 2 vasgtpro-cent i forhold til det teoretiske formoterolfumaratindhold pa 6pg/aktivering, og det resterende niveau af formoterolfumarat er hejere end 95 vasgtprocent i forhold til dets oprindelige indhold.
14. Tryksat doseringsinhalator, herunder en aerosolbeholderforsynet med en doseringsventil med mindst en butylgummipakning, hvor beholderen indeholder en farmaceutisk aerosoloplesnngssammensastning omfattende: (a) glycopyrroniumbromid i en dosering i omradetfra 5 til 26 pg pr. aktivering; (b) formoterol eller et salt deraf eller et solvat af saltet i en dosering i omradet fra 1 til 25 pg pr. aktivering; (c) et HFA-drivmiddel; (d) et co-oplosningsmiddel; (e) en stabiliserende masngde mineralsyre; og eventuelt (f) et inhalationscorticosteroid.
15. Fremgangsmade til at sasnke masngden af nedbrydningsproduktet N-(3-brom)-[2-hydroxy-5-[1-hydroxy-2-[1-(4-methoxyphenyl)propan-2-ylamino] ethyl] phenyl]formamid (DP3) i holdbarhedsperioden for en farmaceutisk aero-soloplosningssammensastning beregnet til anvendelse i en tryksat doseringsinhalator omfattende: (a) glycopyrroniumbromid i en dosering i omradetfra 5 til 26 pg pr. aktivering; (b) formoterol eller et salt deraf eller et solvat af saltet i en dosering i omradet fra 1 til 25 pg pr. aktivering; (c) et FIFA-drivmiddel; (d) et co-oplosningsmiddel; (e) en stabiliserende masngde mineralsyre; og eventuelt (f) et inhalationscorticosteroid hvor fremgangsmaden er den ovenstaende sammensastning i en aerosolbe-holder forsynet med en doseringsventil, der mindst har en butylgummipakning.
16. Fremgangsmade ifelge krav 15, yderligere kendetegnet ved, at det sam-lede niveau for formoterolnedbrydningsproduktet er lavere end 10 vasgtpro-cent i forhold til det teoretiske formoterolfumaratindhold pa 6pg/aktivering, og det resterende formoterolfumarat er hejere end 90 vasgtprocent i forhold til dets oprindelige indhold.
17. Fremgangsmade ifelge krav 15 eller 16 yderligere kendetegnet ved, at det samlede niveau forformoterolnedbrydningsproduktet er lavere end 2 vasgt-procent i forhold til det teoretiske formoterolfumaratindhold pa 6pg/aktivering, og det resterende formoterolfumarat er hejere end 95 vasgtprocent i forhold til dets oprindelige indhold.
18. Farmaceutisk aerosoloplesningssammensastning if0lge et af kravene 1 til 13 til anvendelse ved forebyggelse og/eller behandling af en obstruktiv luft-vejslidelse valgt blandt astma og KOL.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13199783 | 2013-12-30 | ||
| PCT/EP2014/079258 WO2015101575A1 (en) | 2013-12-30 | 2014-12-23 | Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3096737T3 true DK3096737T3 (da) | 2018-06-25 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK14827449.1T DK3096737T3 (da) | 2013-12-30 | 2014-12-23 | Stabil tryksat aerosolopløsningssammensætning af glycopyrroniumbromid og formoterolkombination |
Country Status (36)
| Country | Link |
|---|---|
| US (3) | US20150182459A1 (da) |
| EP (1) | EP3096737B1 (da) |
| JP (2) | JP6534397B2 (da) |
| KR (1) | KR101865131B1 (da) |
| CN (2) | CN113143894A (da) |
| AR (1) | AR098983A1 (da) |
| AU (1) | AU2014375300B2 (da) |
| BR (1) | BR112016014586A2 (da) |
| CA (1) | CA2935302C (da) |
| CL (1) | CL2016001652A1 (da) |
| CY (1) | CY1120205T1 (da) |
| DK (1) | DK3096737T3 (da) |
| EA (1) | EA033228B1 (da) |
| ES (1) | ES2666905T4 (da) |
| GE (1) | GEP20186870B (da) |
| HR (1) | HRP20180944T1 (da) |
| HU (1) | HUE039359T2 (da) |
| IL (1) | IL246502B (da) |
| LT (1) | LT3096737T (da) |
| MA (1) | MA39154A1 (da) |
| ME (1) | ME03076B (da) |
| MX (1) | MX368834B (da) |
| MY (1) | MY176191A (da) |
| NO (1) | NO3096737T3 (da) |
| PE (1) | PE20161132A1 (da) |
| PH (1) | PH12016501269A1 (da) |
| PL (1) | PL3096737T3 (da) |
| PT (1) | PT3096737T (da) |
| RS (1) | RS57269B1 (da) |
| SA (1) | SA516371428B1 (da) |
| SG (1) | SG11201605309UA (da) |
| SI (1) | SI3096737T1 (da) |
| TN (1) | TN2016000262A1 (da) |
| TR (1) | TR201809356T4 (da) |
| UA (1) | UA117846C2 (da) |
| WO (1) | WO2015101575A1 (da) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20160853A1 (es) | 2009-12-23 | 2016-09-14 | Chiesi Farm Spa | Terapia combinada para enfermedad pulmonar obstructiva cronica (epoc) |
| SG181870A1 (en) | 2009-12-23 | 2012-07-30 | Chiesi Farma Spa | Aerosol formulation for copd |
| BR112012015334A2 (pt) * | 2009-12-23 | 2016-03-15 | Chiesi Farma Spa | terapia combinada para doença pulmonar obstrutiva crônica |
| WO2015101575A1 (en) * | 2013-12-30 | 2015-07-09 | Chiesi Farmaceutici S.P.A. | Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination |
| PL3089735T3 (pl) * | 2013-12-30 | 2018-12-31 | Chiesi Farmaceutici S.P.A. | Trwała ciśnieniowa kompozycja roztworu aerozolowego kombinacji bromku glikopironium i formoterolu |
| GB201520862D0 (en) * | 2015-11-25 | 2016-01-13 | Jagotec Ag | Pharmaceutical composition |
| TW201735914A (zh) * | 2015-12-22 | 2017-10-16 | 阿斯特捷利康公司 | 用於治療慢性阻塞性肺疾病之醫藥組成物 |
| US10098837B2 (en) * | 2016-07-28 | 2018-10-16 | Chiesi Farmaceutici S.P.A. | Combination therapy for COPD |
| ES2968453T3 (es) | 2016-09-19 | 2024-05-09 | Mexichem Fluor Sa De Cv | Composición farmacéutica que comprende glicopirrolato |
| EP3996681A1 (en) * | 2019-07-12 | 2022-05-18 | Kindeva Drug Delivery L.P. | Aerosol formulation, canister and inhaler containing the formulation, and method of use |
| WO2021033081A1 (en) * | 2019-08-16 | 2021-02-25 | Glenmark Pharmaceutical Limited | Stable aerosol composition for inhalation comprising glycopyrronium, formoterol and corticosteroid |
| CN112438966B (zh) * | 2019-08-30 | 2022-08-26 | 四川普锐特药业有限公司 | 一种医用定量吸入气雾剂 |
| MX2022004781A (es) | 2019-12-02 | 2022-05-16 | Chiesi Farm Spa | Lata de acero inoxidable para inhaladores dosificadores presurizados. |
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| EA200602112A1 (ru) * | 2004-05-13 | 2007-04-27 | Кьези Фармачеутичи С. П. А. | Изделие для медицинского аэрозоля |
| GB0613161D0 (en) * | 2006-06-30 | 2006-08-09 | Novartis Ag | Organic Compounds |
| EP2201934A1 (en) * | 2008-12-23 | 2010-06-30 | CHIESI FARMACEUTICI S.p.A. | Tiotropium aerosol formulation products with improved chemical stability |
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| SG181870A1 (en) * | 2009-12-23 | 2012-07-30 | Chiesi Farma Spa | Aerosol formulation for copd |
| PE20160853A1 (es) | 2009-12-23 | 2016-09-14 | Chiesi Farm Spa | Terapia combinada para enfermedad pulmonar obstructiva cronica (epoc) |
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| PL3089735T3 (pl) * | 2013-12-30 | 2018-12-31 | Chiesi Farmaceutici S.P.A. | Trwała ciśnieniowa kompozycja roztworu aerozolowego kombinacji bromku glikopironium i formoterolu |
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