EA201691126A1 - Находящаяся под давлением стабильная аэрозольная композиция комбинации гликопиррония бромида и формотерола в форме раствора - Google Patents
Находящаяся под давлением стабильная аэрозольная композиция комбинации гликопиррония бромида и формотерола в форме раствораInfo
- Publication number
- EA201691126A1 EA201691126A1 EA201691126A EA201691126A EA201691126A1 EA 201691126 A1 EA201691126 A1 EA 201691126A1 EA 201691126 A EA201691126 A EA 201691126A EA 201691126 A EA201691126 A EA 201691126A EA 201691126 A1 EA201691126 A1 EA 201691126A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- formoterol
- combination
- under pressure
- aerosol composition
- glycopronony
- Prior art date
Links
- 239000000443 aerosol Substances 0.000 title abstract 2
- BPZSYCZIITTYBL-UHFFFAOYSA-N formoterol Chemical compound C1=CC(OC)=CC=C1CC(C)NCC(O)C1=CC=C(O)C(NC=O)=C1 BPZSYCZIITTYBL-UHFFFAOYSA-N 0.000 title abstract 2
- 229960002848 formoterol Drugs 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- 239000004812 Fluorinated ethylene propylene Substances 0.000 abstract 2
- 239000004480 active ingredient Substances 0.000 abstract 2
- 229920009441 perflouroethylene propylene Polymers 0.000 abstract 2
- 150000003839 salts Chemical class 0.000 abstract 2
- KUVIULQEHSCUHY-XYWKZLDCSA-N Beclometasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(Cl)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COC(=O)CC)(OC(=O)CC)[C@@]1(C)C[C@@H]2O KUVIULQEHSCUHY-XYWKZLDCSA-N 0.000 abstract 1
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 abstract 1
- LUKZNWIVRBCLON-GXOBDPJESA-N Ciclesonide Chemical compound C1([C@H]2O[C@@]3([C@H](O2)C[C@@H]2[C@@]3(C[C@H](O)[C@@H]3[C@@]4(C)C=CC(=O)C=C4CC[C@H]32)C)C(=O)COC(=O)C(C)C)CCCCC1 LUKZNWIVRBCLON-GXOBDPJESA-N 0.000 abstract 1
- VPNYRYCIDCJBOM-UHFFFAOYSA-M Glycopyrronium bromide Chemical compound [Br-].C1[N+](C)(C)CCC1OC(=O)C(O)(C=1C=CC=CC=1)C1CCCC1 VPNYRYCIDCJBOM-UHFFFAOYSA-M 0.000 abstract 1
- 239000002253 acid Substances 0.000 abstract 1
- 229950000210 beclometasone dipropionate Drugs 0.000 abstract 1
- 229960004436 budesonide Drugs 0.000 abstract 1
- 229960003728 ciclesonide Drugs 0.000 abstract 1
- 239000003246 corticosteroid Substances 0.000 abstract 1
- 238000000354 decomposition reaction Methods 0.000 abstract 1
- 229960000676 flunisolide Drugs 0.000 abstract 1
- 229960001469 fluticasone furoate Drugs 0.000 abstract 1
- XTULMSXFIHGYFS-VLSRWLAYSA-N fluticasone furoate Chemical compound O([C@]1([C@@]2(C)C[C@H](O)[C@]3(F)[C@@]4(C)C=CC(=O)C=C4[C@@H](F)C[C@H]3[C@@H]2C[C@H]1C)C(=O)SCF)C(=O)C1=CC=CO1 XTULMSXFIHGYFS-VLSRWLAYSA-N 0.000 abstract 1
- 229960000289 fluticasone propionate Drugs 0.000 abstract 1
- WMWTYOKRWGGJOA-CENSZEJFSA-N fluticasone propionate Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@@H](C)[C@@](C(=O)SCF)(OC(=O)CC)[C@@]2(C)C[C@@H]1O WMWTYOKRWGGJOA-CENSZEJFSA-N 0.000 abstract 1
- 229960002462 glycopyrronium bromide Drugs 0.000 abstract 1
- 229910052500 inorganic mineral Inorganic materials 0.000 abstract 1
- 229940071648 metered dose inhaler Drugs 0.000 abstract 1
- 239000011707 mineral Substances 0.000 abstract 1
- 229960002744 mometasone furoate Drugs 0.000 abstract 1
- WOFMFGQZHJDGCX-ZULDAHANSA-N mometasone furoate Chemical compound O([C@]1([C@@]2(C)C[C@H](O)[C@]3(Cl)[C@@]4(C)C=CC(=O)C=C4CC[C@H]3[C@@H]2C[C@H]1C)C(=O)CCl)C(=O)C1=CC=CO1 WOFMFGQZHJDGCX-ZULDAHANSA-N 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- MIXMJCQRHVAJIO-TZHJZOAOSA-N qk4dys664x Chemical compound O.C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@@H]1[C@@H]2[C@@H]2C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]2(C)C[C@@H]1O.C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@@H]1[C@@H]2[C@@H]2C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]2(C)C[C@@H]1O MIXMJCQRHVAJIO-TZHJZOAOSA-N 0.000 abstract 1
- 239000011347 resin Substances 0.000 abstract 1
- 229920005989 resin Polymers 0.000 abstract 1
- 239000012453 solvate Substances 0.000 abstract 1
Classifications
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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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-
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- 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
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- A61K31/33—Heterocyclic compounds
- 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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- A61K31/56—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
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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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- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- 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]
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Dispersion Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Otolaryngology (AREA)
- Pain & Pain Management (AREA)
- Biophysics (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Steroid Compounds (AREA)
Abstract
Изобретение относится к аэрозольной композиции в форме раствора, предназначенной для применения с дозирующим ингалятором под давлением, содержащей гликопиррония бромид и формотерол или его соль, или сольват указанной соли, возможно в комбинации с одним или более дополнительными активными ингредиентами, стабилизированной посредством выбраннного количества минеральной кислоты, и где количество продукта разложения, представляющего собой N-(3-бром)-[2-гидрокси-5-[1-гидрокси-2-[1-(4-метоксифенил)пропан-2-иламино]этил]фенил]формамид, ниже предела количественного определения при хранении в условиях ускоренных испытаний при 25°С и относительной влажности (ОВ) 60% в течение 6 месяцев в баллоне, покрытом с внутренней стороны смолой, содержащей фторированный этилен-пропиленовый (ФЭП) полимер. Возможный один или более активный ингредиент может представлять собой ингаляционный кортикостероид, выбранный из беклометазона дипропионата, будесонида или его 22R-эпимера, циклезонида, флунизолида, флутиказона пропионата, флутиказона фуроата, мометазона фуроата и т.п.
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 (2)
| Publication Number | Publication Date |
|---|---|
| EA201691126A1 true EA201691126A1 (ru) | 2016-12-30 |
| EA033227B1 EA033227B1 (ru) | 2019-09-30 |
Family
ID=49886777
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA201691126A EA033227B1 (ru) | 2013-12-30 | 2014-12-23 | Находящаяся под давлением стабильная аэрозольная композиция комбинации гликопиррония бромида и формотерола в форме раствора |
Country Status (33)
| Country | Link |
|---|---|
| US (2) | US10596113B2 (ru) |
| EP (3) | EP3384898A1 (ru) |
| JP (2) | JP6563950B2 (ru) |
| KR (2) | KR101861117B1 (ru) |
| CN (2) | CN105848641B (ru) |
| AR (2) | AR098982A1 (ru) |
| AU (1) | AU2014375301B2 (ru) |
| BR (1) | BR112016014583B1 (ru) |
| CA (1) | CA2935305C (ru) |
| CL (1) | CL2016001653A1 (ru) |
| CY (1) | CY1120668T1 (ru) |
| DK (1) | DK3089735T3 (ru) |
| EA (1) | EA033227B1 (ru) |
| ES (1) | ES2687345T3 (ru) |
| HR (1) | HRP20181551T1 (ru) |
| HU (1) | HUE039513T2 (ru) |
| IL (1) | IL246498B (ru) |
| LT (1) | LT3089735T (ru) |
| MA (1) | MA39155A1 (ru) |
| MX (1) | MX368835B (ru) |
| MY (1) | MY182861A (ru) |
| PE (1) | PE20160997A1 (ru) |
| PH (1) | PH12016501268A1 (ru) |
| PL (1) | PL3089735T3 (ru) |
| PT (1) | PT3089735T (ru) |
| RS (1) | RS57687B1 (ru) |
| SA (1) | SA516371427B1 (ru) |
| SG (1) | SG11201605311UA (ru) |
| SI (1) | SI3089735T1 (ru) |
| TN (1) | TN2016000261A1 (ru) |
| TW (1) | TWI660747B (ru) |
| UA (1) | UA117845C2 (ru) |
| WO (1) | WO2015101576A1 (ru) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RS53391B2 (sr) * | 2009-12-23 | 2023-09-29 | Chiesi Farm Spa | Kombinovana terapija copd-a (hroničnih obstruktivnih bolesti pluća) |
| CA2785349C (en) * | 2009-12-23 | 2018-07-03 | Chiesi Farmaceutici S.P.A. | Combination therapy for copd |
| WO2011076842A2 (en) | 2009-12-23 | 2011-06-30 | Chiesi Farmaceutici S.P.A. | Aerosol formulation for copd |
| CN105848642A (zh) | 2013-12-30 | 2016-08-10 | 奇斯药制品公司 | 格隆溴铵和福莫特罗组合的稳定的加压气雾剂溶液组合物 |
| DK3089735T3 (en) * | 2013-12-30 | 2018-09-17 | Chiesi Farm Spa | STABLE PRESSURE AEROSOL SOLUTION COMPOSITION OF GLYCOPYRRONIUM BROMIDE AND FORMOTEROL COMBINATION |
| GB2545025A (en) * | 2015-12-04 | 2017-06-07 | Mexichem Fluor Sa De Cv | Pharmaceutical composition |
| EP3701940B1 (en) | 2015-12-04 | 2025-11-12 | Mexichem Fluor S.A. de C.V. | Pharmaceutical composition |
| US10098837B2 (en) | 2016-07-28 | 2018-10-16 | Chiesi Farmaceutici S.P.A. | Combination therapy for COPD |
| AU2017328907B2 (en) | 2016-09-19 | 2020-04-09 | Mexichem Fluor S.A. De C.V. | Pharmaceutical composition |
| 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 |
| US20220040086A1 (en) * | 2018-10-01 | 2022-02-10 | Kindeva Drug Delivery L.P. | Formulation and aerosol canisters, inhalers, and the like containing the formulation |
| WO2020084549A1 (en) * | 2018-10-25 | 2020-04-30 | Glenmark Specialty S.A. | Nebulization composition comprising glycopyrrolate and formoterol |
| US20220241524A1 (en) * | 2019-07-12 | 2022-08-04 | Kindeva Drug Delivery L.P. | Aerosol formulation, canister, and inhaler containing the formulation, and method of use |
| CA3152578A1 (en) | 2019-12-02 | 2021-06-10 | Enrico Zambelli | Stainles steel can for pressurised metered dose inhalers |
| PE20221867A1 (es) * | 2020-01-28 | 2022-12-02 | Chiesi Farm Spa | Inhaladores de dosis medida presurizada que comprenden una formulacion farmaceutica amortiguada |
| CN115087431A (zh) * | 2020-02-20 | 2022-09-20 | 奇斯药制品公司 | 包含缓冲药物制剂的加压定量吸入器 |
| FI4188327T3 (fi) * | 2020-07-31 | 2025-07-25 | Chemo Res S L | Yhdistelmähoito inhalaatioannosteluun |
| 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 |
| PE20240629A1 (es) * | 2020-10-09 | 2024-03-26 | Chiesi Farm Spa | Formulacion farmaceutica para inhalador presurizado de dosis medidas |
| US20250058063A1 (en) * | 2021-12-21 | 2025-02-20 | Chiesi Farmaceutici S.P.A. | Dry powder formulations filled in an inhaler with improved resistance to humidity |
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