DK3089735T3 - Stabil tryksat aerosolopløsningssammensætning af glycopyrroniumbromid og formoterolkombination - Google Patents
Stabil tryksat aerosolopløsningssammensætning af glycopyrroniumbromid og formoterolkombination Download PDFInfo
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- DK3089735T3 DK3089735T3 DK14825154.9T DK14825154T DK3089735T3 DK 3089735 T3 DK3089735 T3 DK 3089735T3 DK 14825154 T DK14825154 T DK 14825154T DK 3089735 T3 DK3089735 T3 DK 3089735T3
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- formoterol
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- A61K9/12—Aerosols; Foams
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- 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
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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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- A61K31/57—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
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- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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- 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]
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
- A61K9/124—Aerosols; Foams characterised by the propellant
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- A—HUMAN NECESSITIES
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- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0065—Inhalators with dosage or measuring devices
- A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
- A61M15/007—Mechanical counters
- A61M15/0071—Mechanical counters having a display or indicator
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M15/00—Inhalators
- A61M15/0086—Inhalation chambers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- 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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- 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
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- 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
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- 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
- A61P11/08—Bronchodilators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- 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
- A61M2039/226—Spindles or actuating means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
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Claims (19)
1. Farmaceutisk aerosolopløsningssammensætning beregnet til anvendelse i en tryksat doseringsinhalator omfattende: (a) glycopyrroniumbromid i en dosering i området fra 5 til 26 pg pr. aktivering; (b) formoterol eller et salt deraf eller et solvat af saltet i en dosering i området fra 1 til 25 pg pr. aktivering; (c) et HFA-drivmiddel; (d) et co-opløsningsmiddel; (e) en stabiliserende mængde af en mineralsyre; hvilken sammensætning er indeholdt i en aerosolbeholder, der indvendigt er coatet med et resin omfattende en fluorineret ethylenpropylen (FEP)-polymer.
2. Farmaceutisk aerosolopløsningssammensætning ifølge krav 1 kendetegnet ved, at mængden af nedbrydningsproduktet N-(3-brom)-[2-hydroxy-5-[1-hydroxy-2-[1-(4-methoxyphenyl)propan-2-ylamino]ethyl]phenyl]formamid (DP3), er mindre end 0,10 % v/v i forhold til det teoretiske formoterolfumarat-indhold på 6 pg/aktivering, når det lagres under accelerede betingelser ved 25 °C og 60 % relativ luftfugtighed i mindst 6 måneder.
3. Farmaceutisk aerosolopløsningssammensætning ifølge krav 1 eller 2, hvor den stabiliserende mængde af en mineralsyre er en mængde syre svarende til 1M saltsyre i området fra 0,15 til 0,28 pg/pl.
4. Farmaceutisk aerosolopløsningssammensætning ifølge krav 3, hvor den stabiliserende mængde af en mineralsyre er en mængde syre svarende til 1M saltsyre i området fra 0,200 til 0,240 pg/pl.
5. Farmaceutisk aerosolopløsningssammensætning ifølge krav 4, hvor den stabiliserende mængde af en mineralsyre er en mængde syre svarende til 1M saltsyre i området fra 0,200 til 0,227 pg/pl.
6. Farmaceutisk aerosolopløsningssammensætning ifølge et af kravene 1 til 5, hvor co-opløsningsmidlet er ethanol.
7. Farmaceutisk aerosolopløsningssammensætning ifølge krav 1, hvor formo-terolsaltet er formoterolfumarat.
8. Farmaceutisk aerosolopløsningssammensætning ifølge krav 1, hvor solvat-formen af formoterolsaltet er formoterolfumaratdihydrat.
9. Farmaceutisk aerosolopløsningssammensætning ifølge krav 1, yderligere omfattende en eller flere farmaceutisk aktive bestanddele udvalgt fra gruppen bestående af beta-2-agonister, inhalationscorticosteroider, antimuscarinmidler og phosphodiesterase (4)-inhibitorer.
10. Farmaceutisk aerosolopløsningssammensætning ifølge krav 9, hvor inha-lationscorticosteroidet er udvalgt fra gruppen af beclometasondipropionat, bu-desonid eller dets 22R-epimer, ciclesonid, flunisolid, fluticasonpropionat, fluti-casonfuroat, mometasonfuroat, butixocort, triamcinolonacetonid, triamcinolon, methylprednisolon, prednison, loteprednol og rofleponid.
11. Farmaceutisk sammensætning af aerosolopløsning ifølge krav 10, hvor in-halationscorticosteroidet beclometasondipropionat er til stede i en mængde i området fra 50 til 250 pg pr. aktivering.
12. Farmaceutisk aerosolopløsningssammensætning ifølge krav 10, hvor in-halationcorticosteroidet budesonid er til stede i en mængde i området fra 50 til 250 pg pr. aktivering.
13. Farmaceutisk aerosolopløsningssammensætning ifølge krav 1, hvor det samlede niveau af formoterolnedbrydningsprodukter er lavere end 10 % w/w i forhold til det teoretiske formoterolfumaratindhold på 6pg/aktivering, og det resterende niveau af formoterolfumarat er højere end 90 % w/w i forhold til dets oprindelige indhold.
14. Farmaceutisk aerosolopløsningssammensætning ifølge krav 13, hvor det samlede niveau af formoterolnedbrydningsprodukter er lavere end 2 % w/w i forhold til det teoretiske formoterolfumaratindhold på 6pg/aktivering, og det resterende niveau af formoterolfumarat er højere end 95 % w/w i forhold til dets oprindelige indhold.
15. Tryksat doseringsinhalator indbefattende en aerosolbeholder, der indvendigt er coatet med et resin omfattende en fluorineret ethylenpropylen (FEP)-polymer, hvilken beholder indeholder en farmaceutisk aerosolopløsningssammensætning omfattende: (a) glycopyrroniumbromid i en dosering i området fra 5 til 26 pg pr. aktivering; (b) formoterol eller et salt deraf eller et solvat af saltet i en dosering i området fra 1 til 25 pg pr. aktivering; (c) et HFA-drivmiddel; (d) et co-opløsningsmiddel; (e) en stabiliserende mængde mineralsyre; og eventuelt (f) et inhalationscorticosteroid.
16. Fremgangsmåde til at sænke mængden af nedbrydningsproduktet N-(3-brom)-[2-hydroxy-5-[1-hydroxy-2-[1-(4-methoxyphenyl)propan-2-yla-mino]ethyl]phenyl]formamid (DP3) i holdbarhedsperioden for en farmaceutisk aerosolopløsningssammensætning beregnet til anvendelse i en tryksat doseringsinhalator omfattende: (a) glycopyrroniumbromid i en dosering i området fra 5 til 26 pg pr. aktivering; (b) formoterol eller et salt deraf eller et solvat af saltet i en dosering i området fra 1 til 25 pg pr. aktivering; (c) et HFA-drivmiddel; (d) et co-opløsningsmiddel; (e) en stabiliserende mængde mineralsyre; og eventuelt (f) et inhalationscorticosteroid kendetegnet ved, at fremgangsmåden omfatter at indeholde ovennævnte sammensætning i en aerosolbeholder, der indvendigt er coatet med et resin omfattende en fluorineret ethylenpropylen (FEP)-polymer.
17. Fremgangsmåde ifølge krav 16, yderligere kendetegnet ved, at det samlede niveau af formoterolnedbrydningsprodukter er lavere end 10 % w/w i forhold til det teoretiske formoterolfumaratindhold på 6pg/aktivering, og det resterende niveau af formoterolfumarat er højere end 90 % w/w i forhold til dets oprindelige indhold.
18. Fremgangsmåde ifølge krav 16 eller 17, yderligere kendetegnet ved, at det samlede niveau af formoterolnedbrydningsprodukter er lavere end 2 % w/w i forhold til det teoretiske formoterolfumaratindhold på 6pg/aktivering, og det resterende niveau af formoterolfumarat er højere end 95 % w/w i forhold til dets oprindelige indhold.
19. Farmaceutisk aerosolopløsningssammensætning ifølge et hvilket som helst af kravene 1 til 14 til anvendelse ved forebyggelse og/eller behandling af en obstruktiv luftvejssygdom udvalgt blandt astma og KOL.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13199784 | 2013-12-30 | ||
| PCT/EP2014/079259 WO2015101576A1 (en) | 2013-12-30 | 2014-12-23 | Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3089735T3 true DK3089735T3 (da) | 2018-09-17 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK14825154.9T DK3089735T3 (da) | 2013-12-30 | 2014-12-23 | Stabil tryksat aerosolopløsningssammensætning af glycopyrroniumbromid og formoterolkombination |
Country Status (34)
| Country | Link |
|---|---|
| US (2) | US10596113B2 (da) |
| EP (3) | EP3566694A1 (da) |
| JP (2) | JP6563950B2 (da) |
| KR (2) | KR101861117B1 (da) |
| CN (2) | CN105848641B (da) |
| AR (1) | AR098982A1 (da) |
| AU (1) | AU2014375301B2 (da) |
| BR (1) | BR112016014583B1 (da) |
| CA (1) | CA2935305C (da) |
| CL (1) | CL2016001653A1 (da) |
| CY (1) | CY1120668T1 (da) |
| DK (1) | DK3089735T3 (da) |
| EA (1) | EA033227B1 (da) |
| ES (1) | ES2687345T3 (da) |
| HK (1) | HK1225313A1 (da) |
| HR (1) | HRP20181551T1 (da) |
| HU (1) | HUE039513T2 (da) |
| IL (1) | IL246498B (da) |
| LT (1) | LT3089735T (da) |
| MA (1) | MA39155A1 (da) |
| MX (1) | MX368835B (da) |
| MY (1) | MY182861A (da) |
| PE (1) | PE20160997A1 (da) |
| PH (1) | PH12016501268B1 (da) |
| PL (1) | PL3089735T3 (da) |
| PT (1) | PT3089735T (da) |
| RS (1) | RS57687B1 (da) |
| SA (1) | SA516371427B1 (da) |
| SG (1) | SG11201605311UA (da) |
| SI (1) | SI3089735T1 (da) |
| TN (1) | TN2016000261A1 (da) |
| TW (1) | TWI660747B (da) |
| UA (1) | UA117845C2 (da) |
| WO (1) | WO2015101576A1 (da) |
Families Citing this family (22)
| 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 |
| BR122020022602B1 (pt) | 2015-12-04 | 2024-03-05 | Mexichem Fluor S.A. De C.V. | Composição farmacêutica |
| GB2545025A (en) * | 2015-12-04 | 2017-06-07 | Mexichem Fluor Sa De Cv | Pharmaceutical composition |
| 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 |
| CN107233311B (zh) * | 2017-06-27 | 2020-12-04 | 长风药业股份有限公司 | 一种以阿福特罗和格隆溴铵为活性成分的雾化剂及其制备方法 |
| WO2020084549A1 (en) * | 2018-10-25 | 2020-04-30 | Glenmark Specialty S.A. | Nebulization composition comprising glycopyrrolate and formoterol |
| WO2021009572A1 (en) * | 2019-07-12 | 2021-01-21 | Kindeva Drug Delivery L.P. | Aerosol formulation, canister and inhaler containing the formulation, and method of use |
| MX2022004781A (es) | 2019-12-02 | 2022-05-16 | Chiesi Farm Spa | Lata de acero inoxidable para inhaladores dosificadores presurizados. |
| CA3163599A1 (en) | 2020-01-28 | 2021-08-05 | Enrico Zambelli | Pressurised metered dose inhalers comprising a buffered pharmaceutical formulation |
| AU2021223587A1 (en) * | 2020-02-20 | 2022-09-29 | Chiesi Farmaceutici S.P.A. | Pressurised metered dose inhalers comprising a buffered pharmaceutical formulation |
| CA3186956A1 (en) | 2020-07-31 | 2022-02-03 | Chemo Research , S.L. | Combination therapy for inhalation administration |
| CN112051346A (zh) * | 2020-09-24 | 2020-12-08 | 珠海瑞思普利生物制药有限公司 | 一种同时测定茚达特罗和格隆溴铵含量的hplc方法 |
| WO2022074183A1 (en) | 2020-10-09 | 2022-04-14 | Chiesi Farmaceutici S.P.A. | A pharmaceutical formulation for pressurised metered dose inhaler |
| CN118475343A (zh) * | 2021-12-21 | 2024-08-09 | 凯西制药公司 | 填充在具有改善的耐湿性的吸入器中的干粉制剂 |
| WO2023227781A1 (en) | 2022-05-27 | 2023-11-30 | Chiesi Farmaceutici S.P.A. | A pharmaceutical formulation for pressurised metered dose inhaler |
| WO2023227783A1 (en) | 2022-05-27 | 2023-11-30 | Chiesi Farmaceutici S.P.A. | A pharmaceutical formulation for pressurised metered dose inhaler |
| WO2023227782A1 (en) | 2022-05-27 | 2023-11-30 | Chiesi Farmaceutici S.P.A. | A pharmaceutical formulation for pressurised metered dose inhaler |
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| Publication number | Priority date | Publication date | Assignee | Title |
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