DK2727582T3 - Farmaceutiske aerosolformuleringer af formoterol og beclometasondipropionat - Google Patents
Farmaceutiske aerosolformuleringer af formoterol og beclometasondipropionat Download PDFInfo
- Publication number
- DK2727582T3 DK2727582T3 DK14153337.2T DK14153337T DK2727582T3 DK 2727582 T3 DK2727582 T3 DK 2727582T3 DK 14153337 T DK14153337 T DK 14153337T DK 2727582 T3 DK2727582 T3 DK 2727582T3
- Authority
- DK
- Denmark
- Prior art keywords
- formulation
- fumarate dihydrate
- formoterol fumarate
- formoterol
- beclomethasone dipropionate
- Prior art date
Links
Classifications
-
- 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
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- 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
-
- 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
- A61K31/537—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 spiro-condensed or forming part of bridged ring systems
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
-
- 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
- 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
- A61P11/06—Antiasthmatics
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Claims (20)
1. Farmaceutisk aerosolformulering til anvendelse i en tryksat inhalator med afmålt dosis, omfattende: (a) fra 0,001 til 0,05 % v/v af et formoterolfumaratdihydrat; (b) fra 0,05 til 0,16 % v/v beclometasondipropionat; (c) fra 2,0 til 4,8 % v/v ethanol; (d) 1,1,1,2-tetrafluorethan (HFA 134a); og (e) fra 0,002 til 0,05 % v/v af lecithin eller oleinsyre som et overfladeaktivt stof; kendetegnet ved, at FIFA 134a er det eneste drivmiddel, og formoterolfumaratdihydrat er suspenderet i mikroniseret form i formuleringen, mens beclometasondipropionat er helt opløst.
2. Formulering ifølge krav 1, der som aktive bestanddele kun omfatter kombinationen formoterolfumaratdihydrat og beclometasondipropionat.
3. Formulering ifølge et af kravene 1 til 2, hvor koncentrationen af formoterolfumaratdihydrat ligger mellem 0,002 og 0,03 % v/v.
4. Formulering ifølge krav 3, hvor koncentrationen af formoterolfumaratdihydrat ligger mellem 0,0025 % og 0,01 % v/v.
5. Formulering ifølge et af kravene 1 til 5, hvor koncentrationen af beclometasondipropionat ligger mellem 0,06 og 0,12 % v/v.
6. Formulering ifølge krav 5, hvor koncentrationen af beclometasondipropionat ligger mellem 0,07 og 0,1 % v/v.
7. Formulering ifølge et af de foregående krav, hvor mængden af ethanol ligger mellem 2,2 og 4,5 % v/v.
8. Formulering ifølge krav 7, hvor mængden ligger mellem 2,5 og 4,0 % v/v.
9. Formulering ifølge krav 8, hvor mængden ligger mellem 2,6 og 3,5 % v/v.
10. Formulering ifølge krav 9, hvor mængden ligger mellem 3,0 og 3,5 % v/v.
11. Formulering ifølge krav 1, hvor mængden af oliesyre ligger mellem 0,002 og 0,05 % v/v.
12. Formulering ifølge et af de foregående krav, hvilken er i stand til at levere 6 eller 12 μg formoterolfumaratdihydrat og 50 eller 100 μg beclometason-dipropionat pr. aktivering.
13. Formulering ifølge krav 12, hvilken er i stand til at levere 6 pg formoterolfumaratdihydrat og 100 pg beclometasondipropionat pr. aktivering.
14. Farmaceutisk aerosolformulering ifølge krav 1 til anvendelse i tryksatte inhalatorer med afmålt dosis, hvilken er i stand til at levere 6 pg formoterolfumaratdihydrat og 100 pg beclometasondipropionat pr. aktivering, hvilken formulering omfatter: (a) fra 0,001 til 0,05 % v/v af et formoterolfumaratdihydrat; (b) fra 0,05 til 0,16 % v/v beclometasondipropionat; (c) fra 2,0 til 4,8 % v/v ethanol; (d) 1,1,1,2-tetrafluorethan (FIFA 134a); og (e) fra 0,002 og 0,05 % v/v oliesyre; kendetegnet ved, at FIFA 134a er det eneste drivmiddel, og formoterolfumaratdihydrat er suspenderet i mikroniseret form i formuleringen, mens beclometasondipropionat er helt opløst.
15. Tryksat inhalator med afmålt dosis, omfattende en kanister fyldt med den farmaceutiske aerosolformulering ifølge et hvilket som helst af kravene 1 til 14 og en doseringsventil til afgivelse af terapeutisk virksomme doser af de aktive bestanddele.
16. Tryksat inhalator med afmålt dosis ifølge krav 15, hvor kanisteren er fremstillet af aluminium.
17. Tryksat inhalator med afmålt dosis ifølge krav 15 eller 16, hvor doseringsventilen er i stand til at levere et volumen, der ligger mellem 50 og 100 pi.
18. Tryksat inhalator med afmålt dosis ifølge krav 17, hvor doseringsventilen er i stand til at levere et volumen på 50 eller 63 μΙ.
19. Farmaceutisk aerosolformulering ifølge et hvilket som helst af kravene 1 til 14 til anvendelse til forebyggelse og/eller behandling af milde, moderate eller svære, akutte eller kroniske symptomer eller til profylaktisk behandling af en luftvejssygdom.
20. Formulering ifølge krav 19, hvor sygdommen er astma eller kronisk obstruktiv lungesygdom.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09172083 | 2009-10-02 | ||
| EP10763317.4A EP2482799B1 (en) | 2009-10-02 | 2010-09-27 | Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2727582T3 true DK2727582T3 (da) | 2016-05-17 |
Family
ID=42035850
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10763317.4T DK2482799T3 (da) | 2009-10-02 | 2010-09-27 | Farmaceutiske aerosolformuleringer af formoterol og beclometasondipropionat |
| DK14153337.2T DK2727582T3 (da) | 2009-10-02 | 2010-09-27 | Farmaceutiske aerosolformuleringer af formoterol og beclometasondipropionat |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10763317.4T DK2482799T3 (da) | 2009-10-02 | 2010-09-27 | Farmaceutiske aerosolformuleringer af formoterol og beclometasondipropionat |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US8420060B2 (da) |
| EP (2) | EP2482799B1 (da) |
| KR (1) | KR101778814B1 (da) |
| CN (2) | CN102548537B (da) |
| AR (2) | AR078494A1 (da) |
| BR (1) | BR112012007484A2 (da) |
| CA (1) | CA2776266C (da) |
| CY (2) | CY1115266T1 (da) |
| DK (2) | DK2482799T3 (da) |
| ES (2) | ES2568913T3 (da) |
| HK (2) | HK1167817A1 (da) |
| HR (2) | HRP20140818T1 (da) |
| HU (1) | HUE029159T2 (da) |
| JO (1) | JO3024B1 (da) |
| ME (1) | ME02398B (da) |
| PL (2) | PL2727582T3 (da) |
| PT (1) | PT2482799E (da) |
| RS (2) | RS53514B1 (da) |
| RU (1) | RU2650175C2 (da) |
| SI (2) | SI2727582T1 (da) |
| TW (1) | TWI449523B (da) |
| WO (1) | WO2011038872A1 (da) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9119777B2 (en) * | 2008-05-30 | 2015-09-01 | Microdose Therapeutx, Inc. | Methods and compositions for administration of oxybutynin |
| BR112014017481A8 (pt) * | 2012-01-25 | 2021-06-15 | Chiesi Farm Spa | formulação em pó seco para uso em um inalador de pó seco, inalador de pó seco e uso de uma formulação |
| US11052202B2 (en) * | 2012-11-07 | 2021-07-06 | Chiesi Farmaceutici S.P.A. | Drug delivery device for the treatment of patients with respiratory diseases |
| EP3383366B1 (en) | 2015-12-04 | 2020-03-25 | Mexichem Fluor S.A. de C.V. | Pharmaceutical composition |
| 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 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5290539A (en) | 1990-12-21 | 1994-03-01 | Minnesota Mining And Manufacturing Company | Device for delivering an aerosol |
| AU680530B2 (en) | 1993-07-15 | 1997-07-31 | Minnesota Mining And Manufacturing Company | Seals for use in an aerosol delivery device |
| GB9612297D0 (en) * | 1996-06-11 | 1996-08-14 | Minnesota Mining & Mfg | Medicinal aerosol formulations |
| US6423298B2 (en) * | 1998-06-18 | 2002-07-23 | Boehringer Ingelheim Pharmaceuticals, Inc. | Pharmaceutical formulations for aerosols with two or more active substances |
| SE9900833D0 (sv) * | 1999-03-09 | 1999-03-09 | Astra Ab | Novel combination |
| IT1317720B1 (it) | 2000-01-07 | 2003-07-15 | Chiesi Farma Spa | Dispositivo per la somministrazione di aerosol dosati pressurizzati inpropellenti idrofluoroalcani. |
| HU230804B1 (hu) * | 2000-05-22 | 2018-06-28 | Chiesi Farmaceutici S.P.A | Gyógyászati célú stabil aeroszol összetétel, inhalátor az aeroszol pontos adagolásához és eljárás ennek feltöltésére |
| US6472563B1 (en) * | 2001-11-09 | 2002-10-29 | Sepracor Inc. | Formoterol tartrate process and polymorph |
| GB0205327D0 (en) * | 2002-03-06 | 2002-04-17 | Glaxo Group Ltd | compounds |
| GB0323685D0 (en) * | 2003-10-09 | 2003-11-12 | Jagotec Ag | Improvements in or relating to organic compounds |
| EP1982709A1 (en) * | 2007-04-19 | 2008-10-22 | CHIESI FARMACEUTICI S.p.A. | Use of a composition comprising formoterol and beclomethasone dipropionate for the prevention or treatment of an acute condition of asthma |
| RU2356537C2 (ru) * | 2007-07-25 | 2009-05-27 | Закрытое Акционерное Общество (ЗАО) "Пульмомед" | Фармацевтический состав дозированных аэрозолей, содержащий противоастматические лекарственные средства в виде суспензий, растворов, эмульсий, растворов и эмульсий |
-
2010
- 2010-09-27 WO PCT/EP2010/005879 patent/WO2011038872A1/en active Application Filing
- 2010-09-27 EP EP10763317.4A patent/EP2482799B1/en active Active
- 2010-09-27 SI SI201031156A patent/SI2727582T1/sl unknown
- 2010-09-27 EP EP14153337.2A patent/EP2727582B1/en active Active
- 2010-09-27 ES ES14153337.2T patent/ES2568913T3/es active Active
- 2010-09-27 PT PT107633174T patent/PT2482799E/pt unknown
- 2010-09-27 HU HUE14153337A patent/HUE029159T2/hu unknown
- 2010-09-27 KR KR1020127008437A patent/KR101778814B1/ko active IP Right Grant
- 2010-09-27 ME MEP-2016-85A patent/ME02398B/me unknown
- 2010-09-27 PL PL14153337T patent/PL2727582T3/pl unknown
- 2010-09-27 PL PL10763317T patent/PL2482799T3/pl unknown
- 2010-09-27 RS RSP20140459 patent/RS53514B1/en unknown
- 2010-09-27 BR BR112012007484A patent/BR112012007484A2/pt not_active Application Discontinuation
- 2010-09-27 SI SI201030721T patent/SI2482799T1/sl unknown
- 2010-09-27 CA CA2776266A patent/CA2776266C/en active Active
- 2010-09-27 DK DK10763317.4T patent/DK2482799T3/da active
- 2010-09-27 RS RS20160274A patent/RS54721B1/en unknown
- 2010-09-27 CN CN201080044596.5A patent/CN102548537B/zh active Active
- 2010-09-27 ES ES10763317.4T patent/ES2487626T3/es active Active
- 2010-09-27 DK DK14153337.2T patent/DK2727582T3/da active
- 2010-09-27 CN CN201410156323.XA patent/CN103919785B/zh active Active
- 2010-09-27 RU RU2012112454A patent/RU2650175C2/ru active
- 2010-09-30 JO JOP/2010/0338A patent/JO3024B1/ar active
- 2010-10-01 TW TW099133496A patent/TWI449523B/zh active
- 2010-10-01 AR ARP100103583A patent/AR078494A1/es not_active Application Discontinuation
- 2010-10-04 US US12/897,117 patent/US8420060B2/en active Active
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2012
- 2012-08-31 HK HK12108522.6A patent/HK1167817A1/xx unknown
- 2012-08-31 HK HK14112828.7A patent/HK1199214A1/xx unknown
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2014
- 2014-07-10 CY CY20141100517T patent/CY1115266T1/el unknown
- 2014-09-01 HR HRP20140818AT patent/HRP20140818T1/hr unknown
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2016
- 2016-04-26 CY CY20161100345T patent/CY1117596T1/el unknown
- 2016-06-08 HR HRP20160630TT patent/HRP20160630T1/hr unknown
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2020
- 2020-05-07 AR ARP200101303A patent/AR123674A2/es unknown
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