PE20160997A1 - Composicion combinada de bromuro de glicopirronio y formoterol en solucion estable presurizada para aerosol - Google Patents
Composicion combinada de bromuro de glicopirronio y formoterol en solucion estable presurizada para aerosolInfo
- Publication number
- PE20160997A1 PE20160997A1 PE2016000968A PE2016000968A PE20160997A1 PE 20160997 A1 PE20160997 A1 PE 20160997A1 PE 2016000968 A PE2016000968 A PE 2016000968A PE 2016000968 A PE2016000968 A PE 2016000968A PE 20160997 A1 PE20160997 A1 PE 20160997A1
- Authority
- PE
- Peru
- Prior art keywords
- composition
- aerosol
- formoterol
- cosolvent
- stabilizer
- Prior art date
Links
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
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- 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
- A61K31/40—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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- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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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
- A61K9/0012—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
- 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
- A61K9/124—Aerosols; Foams characterised by the propellant
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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
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
-
- 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
-
- 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
- A61M15/0086—Inhalation chambers
-
- 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
-
- 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
-
- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
-
- 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
-
- 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
-
- 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
Landscapes
- 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)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Dispersion Chemistry (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pain & Pain Management (AREA)
- Otolaryngology (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)
- Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
- Filling Or Discharging Of Gas Storage Vessels (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Steroid Compounds (AREA)
Abstract
Se refiere a una composicion farmaceutica en solucion para aerosol para utilizar en un inhalador presurizado de dosis medida que comprende: a) bromuro de glicopirronio con una dosificacion entre 5 y 26 ug por accionamiento; b) formoterol, o una sal del mismo o un solvato de dicha sal, con una dosificacion entre 1 y 25 ug por accionamiento; c) un propelente que consiste en un HFA; d) un cosolvente; y e) un acido mineral como estabilizante en una cantidad util. Dicha composicion esta contenida en una lata de aerosol recubierta internamente por una resina que comprende un copolimero de etilenopropileno fluorado (FEP). En un aspecto preferido, el acido mineral es acido clorhidrico 1M, en una cantidad entre 0,15 y 0,28 ug/ul como estabilizante; y el cosolvente es etanol. En otro aspecto, dicha composicion comprende opcionalmente uno o mas ingredientes farmaceuticamente activos, seleccionados entre beta2 agonistas; corticoesteroides para inhalacion (dipropionato de beclometasona, budesonida, propionato de fluticasona, triamcinolona, prednisona, entre otros); agentes antimuscarinicos, e inhibidores de fosfodiesterasa4. El almacenamiento de dicha composicion en latas de aluminio recubiertas internamente como se ha senalado anteriormente, minimiza las cantidades de productos de degradacion (particularmente DP3) durante su vida de estante, aun por debajo del umbral de deteccion despues del almacenamiento en condiciones severas de temperatura y humedad.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13199784 | 2013-12-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20160997A1 true PE20160997A1 (es) | 2016-10-14 |
Family
ID=49886777
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2016000968A PE20160997A1 (es) | 2013-12-30 | 2014-12-23 | Composicion combinada de bromuro de glicopirronio y formoterol en solucion estable presurizada para aerosol |
Country Status (34)
| Country | Link |
|---|---|
| US (2) | US10596113B2 (es) |
| EP (3) | EP3089735B1 (es) |
| JP (2) | JP6563950B2 (es) |
| KR (2) | KR101861119B1 (es) |
| CN (2) | CN111150728B (es) |
| AR (2) | AR098982A1 (es) |
| AU (1) | AU2014375301B2 (es) |
| BR (1) | BR112016014583B1 (es) |
| CA (1) | CA2935305C (es) |
| CL (1) | CL2016001653A1 (es) |
| CY (1) | CY1120668T1 (es) |
| DK (1) | DK3089735T3 (es) |
| EA (1) | EA033227B1 (es) |
| ES (1) | ES2687345T3 (es) |
| GE (1) | GEP20186855B (es) |
| HR (1) | HRP20181551T1 (es) |
| HU (1) | HUE039513T2 (es) |
| IL (1) | IL246498B (es) |
| LT (1) | LT3089735T (es) |
| MA (1) | MA39155A1 (es) |
| MX (1) | MX368835B (es) |
| MY (1) | MY182861A (es) |
| PE (1) | PE20160997A1 (es) |
| PH (1) | PH12016501268A1 (es) |
| PL (1) | PL3089735T3 (es) |
| PT (1) | PT3089735T (es) |
| RS (1) | RS57687B1 (es) |
| SA (1) | SA516371427B1 (es) |
| SG (1) | SG11201605311UA (es) |
| SI (1) | SI3089735T1 (es) |
| TN (1) | TN2016000261A1 (es) |
| TW (1) | TWI660747B (es) |
| UA (1) | UA117845C2 (es) |
| WO (1) | WO2015101576A1 (es) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK2515855T6 (da) | 2009-12-23 | 2023-06-06 | Chiesi Farm Spa | Kombinationsterapi til COPD |
| PT2515854E (pt) | 2009-12-23 | 2014-05-27 | Chiesi Farma Spa | Formulação de aerossol para dpoc |
| WO2011076841A2 (en) * | 2009-12-23 | 2011-06-30 | Chiesi Farmaceutici S.P.A. | Combination therapy for copd |
| CA2935305C (en) * | 2013-12-30 | 2022-07-12 | Chiesi Farmaceutici S.P.A. | Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination |
| TN2016000262A1 (en) | 2013-12-30 | 2017-10-06 | Chiesi Farm Spa | Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination. |
| EP3383366B2 (en) | 2015-12-04 | 2024-06-05 | Mexichem Fluor S.A. de C.V. | Pharmaceutical composition |
| 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 |
| PE20191043A1 (es) | 2016-09-19 | 2019-08-06 | Mexichem Fluor Sa De Cv | Composicion farmaceutica |
| 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 |
| EP3860580A4 (en) * | 2018-10-01 | 2022-07-20 | Kindeva Drug Delivery L.P. | FORMULATION AND AEROSOL CARTRIDGES, INHALATORS 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 |
| KR102835735B1 (ko) | 2019-12-02 | 2025-07-21 | 키에시 파르마슈티시 엣스. 피. 에이. | 가압 정량 흡입기를 위한 스테인리스 스틸 캔 |
| PE20221867A1 (es) | 2020-01-28 | 2022-12-02 | Chiesi Farm Spa | Inhaladores de dosis medida presurizada que comprenden una formulacion farmaceutica amortiguada |
| AU2021223587A1 (en) | 2020-02-20 | 2022-09-29 | Chiesi Farmaceutici S.P.A. | Pressurised metered dose inhalers comprising a buffered pharmaceutical formulation |
| CN115989032A (zh) * | 2020-07-31 | 2023-04-18 | 化学研究有限公司 | 用于吸入施用的组合疗法 |
| 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 |
| JP2023546025A (ja) | 2020-10-09 | 2023-11-01 | キエシ・フアルマチエウテイチ・ソチエタ・ペル・アチオニ | 加圧定量吸入器のための医薬製剤 |
| WO2023117985A1 (en) * | 2021-12-21 | 2023-06-29 | Chiesi Farmaceutici S.P.A. | Dry powder formulations filled in an inhaler with improved resistance to humidity |
| CN116338014A (zh) * | 2021-12-23 | 2023-06-27 | 上海医药工业研究院有限公司 | 一种吸入用药物组合物的组分分离检测方法 |
| CA3257044A1 (en) | 2022-05-27 | 2023-11-30 | Chiesi Farmaceutici S.P.A. | PHARMACEUTICAL FORMULATION FOR PRESSURIZED DOSING AEROSOL |
| CN119255820A (zh) | 2022-05-27 | 2025-01-03 | 奇斯药制品公司 | 用于加压定量吸入器的药物制剂 |
| CN119630425A (zh) | 2022-05-27 | 2025-03-14 | 奇斯药制品公司 | 用于加压定量吸入器的药物制剂 |
| CN117679423A (zh) | 2022-09-05 | 2024-03-12 | 立生医药(苏州)有限公司 | 预防或治疗呼吸系统疾病的吸入用药物组合物 |
| WO2025179179A1 (en) * | 2024-02-23 | 2025-08-28 | Astrazeneca Ab | Triple combination therapy for copd |
| WO2026006658A1 (en) | 2024-06-27 | 2026-01-02 | Lupin Inc. | Stable pharmaceutical compositions for pressurized metered dose inhalers |
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| PT2515854E (pt) | 2009-12-23 | 2014-05-27 | Chiesi Farma Spa | Formulação de aerossol para dpoc |
| WO2011076841A2 (en) * | 2009-12-23 | 2011-06-30 | Chiesi Farmaceutici S.P.A. | Combination therapy for copd |
| DK2515855T6 (da) * | 2009-12-23 | 2023-06-06 | Chiesi Farm Spa | Kombinationsterapi til COPD |
| CN102695496B (zh) | 2009-12-23 | 2014-10-01 | 奇斯药制品公司 | 用于copd的气雾剂制剂 |
| BR112013005283A2 (pt) | 2010-09-06 | 2019-09-24 | Chiesi Farm Spa | atuador de inalador dosimetrado, de inalador dosimetrado e uso de um atuador |
| PH12013502270A1 (en) * | 2011-05-17 | 2014-01-27 | Pearl Therapeutics Inc | Compositions, methods & systems for respiratory delivery of two or more active agents |
| BR112015002757A2 (pt) | 2012-08-29 | 2017-07-04 | Chiesi Farm Spa | acionador para dispositivo inalador de aerossol, objeto em forma cilíndrica oca, inalador, acionador de inalador dosimétrico, kit e uso de um acionador |
| TN2016000262A1 (en) * | 2013-12-30 | 2017-10-06 | Chiesi Farm Spa | Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination. |
| CA2935305C (en) * | 2013-12-30 | 2022-07-12 | Chiesi Farmaceutici S.P.A. | Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination |
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