AR115897A2 - Composición farmacéutica para enfermedad pulmonar obstructiva crónica (epoc), frasco de aerosol que lo comprende, y método para rellenarlo - Google Patents
Composición farmacéutica para enfermedad pulmonar obstructiva crónica (epoc), frasco de aerosol que lo comprende, y método para rellenarloInfo
- Publication number
- AR115897A2 AR115897A2 ARP190102199A ARP190102199A AR115897A2 AR 115897 A2 AR115897 A2 AR 115897A2 AR P190102199 A ARP190102199 A AR P190102199A AR P190102199 A ARP190102199 A AR P190102199A AR 115897 A2 AR115897 A2 AR 115897A2
- Authority
- AR
- Argentina
- Prior art keywords
- pharmaceutical composition
- bottle
- copd
- refilling
- aerosol bottle
- Prior art date
Links
- 239000000443 aerosol Substances 0.000 title abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 238000000034 method Methods 0.000 title abstract 2
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 title 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 2
- 239000006184 cosolvent Substances 0.000 abstract 2
- 229960002462 glycopyrronium bromide Drugs 0.000 abstract 2
- 239000003380 propellant Substances 0.000 abstract 2
- OBRNDARFFFHCGE-PERKLWIXSA-N (S,S)-formoterol fumarate Chemical compound OC(=O)\C=C\C(O)=O.C1=CC(OC)=CC=C1C[C@H](C)NC[C@@H](O)C1=CC=C(O)C(NC=O)=C1.C1=CC(OC)=CC=C1C[C@H](C)NC[C@@H](O)C1=CC=C(O)C(NC=O)=C1 OBRNDARFFFHCGE-PERKLWIXSA-N 0.000 abstract 1
- 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
- 229950000210 beclometasone dipropionate Drugs 0.000 abstract 1
- 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 abstract 1
- 229960002848 formoterol Drugs 0.000 abstract 1
- 229960000193 formoterol fumarate Drugs 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
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
- A61K9/0012—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
-
- 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
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
- A61K9/124—Aerosols; Foams characterised by the propellant
-
- 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
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/04—Methods of, or means for, filling the material into the containers or receptacles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
- B65B31/003—Adding propellants in fluid form to aerosol containers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B7/00—Closing containers or receptacles after filling
- B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
- B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
- B65B7/2842—Securing closures on containers
- B65B7/285—Securing closures on containers by deformation of the closure
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Dispersion Chemistry (AREA)
- Mechanical Engineering (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Otolaryngology (AREA)
- Pain & Pain Management (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Anesthesiology (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)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- External Artificial Organs (AREA)
Abstract
Reivindicación 1: Una composición farmacéutica que comprende: (a) bromuro de glicopirronio en una dosis en el rango entre 0,5 y 100 mg por accionamiento; (b) formoterol o una sal del mismo en una dosis en el rango entre 1 y 25 mg por accionamiento; disueltos en un propelente de HFA y un cosolvente, caracterizada porque dicha composición contiene una cantidad de HCl 1 M en el rango entre 0,1 y 0,3 mg/ml. Reivindicación 10: Un frasco de aerosol, caracterizado porque comprende la composición farmacéutica de cualquier reivindicación precedente. Reivindicación 12: Un método para rellenar el frasco de acuerdo a la reivindicación 10 o reivindicación 11 caracterizado porque comprende los pasos de: (a) preparar una solución de bromuro de glicopirronio, fumarato de formoterol y opcionalmente dipropionato de beclometasona en un cosolvente al que se ha agregado HCl 1 M en una cantidad de entre 0,1 y 0,3 mg/ml de la solución final; (b) rellenar el frasco de aerosol con dicha solución; (c) colocar la válvula sobre el frasco y corrugar (al vacío); y (d) rellenar a presión el recipiente con propelente de HFA a través de la válvula.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09180671 | 2009-12-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR115897A2 true AR115897A2 (es) | 2021-03-10 |
Family
ID=42107420
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP100104922A AR079726A1 (es) | 2009-12-23 | 2010-12-22 | Terapia combinada para enfermedad pulmonar obstructiva cronica (epoc) . composicion farmaceutica.frasco de aerosol. metodo.conjunto de componentes |
| ARP190102199A AR115897A2 (es) | 2009-12-23 | 2019-08-02 | Composición farmacéutica para enfermedad pulmonar obstructiva crónica (epoc), frasco de aerosol que lo comprende, y método para rellenarlo |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP100104922A AR079726A1 (es) | 2009-12-23 | 2010-12-22 | Terapia combinada para enfermedad pulmonar obstructiva cronica (epoc) . composicion farmaceutica.frasco de aerosol. metodo.conjunto de componentes |
Country Status (40)
| Country | Link |
|---|---|
| US (3) | US20110150782A1 (es) |
| EP (1) | EP2515855B3 (es) |
| JP (2) | JP5914354B2 (es) |
| KR (2) | KR101757951B1 (es) |
| CN (2) | CN102665679B (es) |
| AR (2) | AR079726A1 (es) |
| AU (3) | AU2010334859A1 (es) |
| BR (1) | BR112012015337B8 (es) |
| CA (1) | CA2785321C (es) |
| CL (1) | CL2012001705A1 (es) |
| CO (1) | CO6541628A2 (es) |
| CY (2) | CY1115116T1 (es) |
| DK (1) | DK2515855T6 (es) |
| EA (2) | EA021917B1 (es) |
| ES (1) | ES2468840T7 (es) |
| FI (2) | FI2515855T6 (es) |
| GE (1) | GEP20156311B (es) |
| HR (1) | HRP20140582T4 (es) |
| HU (1) | HUS1800001I1 (es) |
| IL (1) | IL260932B (es) |
| LT (1) | LTC2515855I2 (es) |
| LU (1) | LUC00060I2 (es) |
| MA (1) | MA33823B1 (es) |
| MX (1) | MX2012006878A (es) |
| MY (1) | MY156949A (es) |
| NL (1) | NL300923I2 (es) |
| NO (1) | NO2018001I1 (es) |
| NZ (1) | NZ600790A (es) |
| PE (2) | PE20121396A1 (es) |
| PH (1) | PH12012501066A1 (es) |
| PL (1) | PL2515855T6 (es) |
| PT (1) | PT2515855E (es) |
| RS (1) | RS53391B2 (es) |
| SG (1) | SG181868A1 (es) |
| SI (1) | SI2515855T1 (es) |
| TN (1) | TN2012000269A1 (es) |
| TW (1) | TWI495468B (es) |
| UA (1) | UA113832C2 (es) |
| WO (1) | WO2011076843A2 (es) |
| ZA (1) | ZA201204615B (es) |
Families Citing this family (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK2515855T6 (da) * | 2009-12-23 | 2023-06-06 | Chiesi Farm Spa | Kombinationsterapi til COPD |
| WO2011076841A2 (en) * | 2009-12-23 | 2011-06-30 | Chiesi Farmaceutici S.P.A. | Combination therapy for copd |
| PT2515854E (pt) | 2009-12-23 | 2014-05-27 | Chiesi Farma Spa | Formulação de aerossol para dpoc |
| EP2749280A3 (en) * | 2011-02-17 | 2014-08-20 | Cipla Limited | Combination of glycopyrronium and formoterol |
| PL2765994T3 (pl) * | 2011-10-11 | 2019-09-30 | Chiesi Farmaceutici S.P.A. | Krystaliczne mikrocząstki beta-agonisty pokryte kwasem tłuszczowym |
| JP2016503390A (ja) * | 2012-10-23 | 2016-02-04 | シプラ・リミテッド | 医薬組成物 |
| ES2699986T3 (es) | 2013-07-11 | 2019-02-13 | Chiesi Farm Spa | Formulación de polvo seco que comprende un anticolinérgico, un corticosteroide y un betaadrenérgico para administración por inhalación |
| 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. |
| US11039620B2 (en) | 2014-02-19 | 2021-06-22 | Corning Incorporated | Antimicrobial glass compositions, glasses and polymeric articles incorporating the same |
| US9622483B2 (en) | 2014-02-19 | 2017-04-18 | Corning Incorporated | Antimicrobial glass compositions, glasses and polymeric articles incorporating the same |
| US11039621B2 (en) | 2014-02-19 | 2021-06-22 | Corning Incorporated | Antimicrobial glass compositions, glasses and polymeric articles incorporating the same |
| US9554992B2 (en) * | 2014-06-09 | 2017-01-31 | Chiesi Farmaceutici S.P.A. | Inhalation particles comprising a combination of an anticholinergic, a corticosteroid and a beta-adrenergic |
| GB201416909D0 (en) * | 2014-09-25 | 2014-11-12 | Prosonix Ltd | Method of forming concentrated solution |
| US20160310410A1 (en) | 2015-04-24 | 2016-10-27 | Glenmark Specialty S.A. | Pharmaceutical compositions comprising arformoterol and glycopyrronium |
| LT3377108T (lt) | 2015-11-16 | 2020-07-10 | Chiesi Farmaceutici S.P.A. | Inhaliacinių miltelių kompozicijos, apimančios anticholinerginį agentą, kortikosteroidą ir beta adrenerginį agentą, paruošimo būdas |
| GB2545025A (en) * | 2015-12-04 | 2017-06-07 | Mexichem Fluor Sa De Cv | Pharmaceutical composition |
| MA43782A (fr) | 2016-03-31 | 2021-04-28 | Chiesi Farm Spa | Dispositif d'inhalation d'aérosol |
| US10098837B2 (en) | 2016-07-28 | 2018-10-16 | Chiesi Farmaceutici S.P.A. | Combination therapy for COPD |
| JP6781828B2 (ja) | 2016-09-19 | 2020-11-04 | メキシケム フロー エセ・ア・デ・セ・ヴェ | 医薬組成物 |
| US20190374519A1 (en) * | 2016-09-19 | 2019-12-12 | Mexichem Fluor S.A. De C.V. | Pharmaceutical composition |
| PE20191043A1 (es) | 2016-09-19 | 2019-08-06 | Mexichem Fluor Sa De Cv | Composicion farmaceutica |
| US10350164B2 (en) | 2017-05-11 | 2019-07-16 | Chiesi Farmaceutici S.P.A. | Process for preparing a dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic |
| CN110582269B (zh) * | 2017-05-11 | 2023-02-28 | 奇斯药制品公司 | 制备包含抗胆碱能药、皮质类固醇和β-肾上腺素能药的干粉制剂的方法 |
| MA52756A (fr) * | 2018-06-04 | 2021-04-14 | Lupin Inc | Compositions pharmaceutiques stables pour inhalateurs doseurs sous pression |
| KR102835735B1 (ko) * | 2019-12-02 | 2025-07-21 | 키에시 파르마슈티시 엣스. 피. 에이. | 가압 정량 흡입기를 위한 스테인리스 스틸 캔 |
| 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 |
| 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 |
| 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 |
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