AR038641A1 - Formulacion superfina de formoterol - Google Patents
Formulacion superfina de formoterolInfo
- Publication number
- AR038641A1 AR038641A1 ARP030100684A ARP030100684A AR038641A1 AR 038641 A1 AR038641 A1 AR 038641A1 AR P030100684 A ARP030100684 A AR P030100684A AR P030100684 A ARP030100684 A AR P030100684A AR 038641 A1 AR038641 A1 AR 038641A1
- Authority
- AR
- Argentina
- Prior art keywords
- formulation
- hfa
- formoterol
- administered
- metered dose
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 5
- 239000000203 mixture Substances 0.000 title abstract 5
- 229960002848 formoterol Drugs 0.000 title abstract 3
- 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
- 150000005828 hydrofluoroalkanes Chemical class 0.000 abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- 239000003380 propellant Substances 0.000 abstract 2
- YFMFNYKEUDLDTL-UHFFFAOYSA-N 1,1,1,2,3,3,3-heptafluoropropane Chemical compound FC(F)(F)C(F)C(F)(F)F YFMFNYKEUDLDTL-UHFFFAOYSA-N 0.000 abstract 1
- LVGUZGTVOIAKKC-UHFFFAOYSA-N 1,1,1,2-tetrafluoroethane Chemical compound FCC(F)(F)F LVGUZGTVOIAKKC-UHFFFAOYSA-N 0.000 abstract 1
- 229940121786 Beta 2 adrenoreceptor agonist Drugs 0.000 abstract 1
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 abstract 1
- 239000004480 active ingredient Substances 0.000 abstract 1
- 208000006673 asthma Diseases 0.000 abstract 1
- 239000006184 cosolvent Substances 0.000 abstract 1
- -1 formoterol HFA Chemical class 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 210000004072 lung Anatomy 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 230000035515 penetration Effects 0.000 abstract 1
- 239000008249 pharmaceutical aerosol Substances 0.000 abstract 1
- 208000023504 respiratory system disease Diseases 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000012453 solvate Substances 0.000 abstract 1
- 239000002351 wastewater Substances 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
-
- 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
- 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
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4704—2-Quinolinones, e.g. carbostyril
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- 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
- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/16—Central respiratory analeptics
-
- 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
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Emergency Medicine (AREA)
- Otolaryngology (AREA)
- Dispersion Chemistry (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Quinoline Compounds (AREA)
Abstract
Formulación farmacéutica para usar en la administración por inhalación de un agonista b2 de acción prolongada. En particular, se relaciona con una formulación en solución estable, altamente eficiente, de formoterol HFA, que puede administrarse por medio de inhaladores dosificadores presurizados (pMDI) caracterizados por un penetración pulmonar profunda. Métodos para preparar dicha formulación y usarla para tratar enfermedades respiratorias, tales como el asma y la enfermedad obstructiva pulmonar crónica (COPD). Reivindicación 1: Una formulación farmacéutica en aerosol que puede administrarse por medio de inhaladores dosificadores presurizados caracterizada porque comprende un ingrediente activo seleccionado entre formoterol, o un estereoisómero, una sal o solvato aceptable para el uso fisiológico del mismo, en una solución de propelente HFA licuado y un co-solvente, donde la cantidad de agua residual es de menos de 1500 ppm, sobre el peso total de la formulación. Reivindicación 11: Una formulación farmacéutica de acuerdo con cualquier reivindicación precedente, caracterizada porque el propelente incluye uno o más hidrofluoroalcanos [HFA] seleccionados del grupo que consiste en HFA 134a y HFA 227.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP02004786A EP1340492A1 (en) | 2002-03-01 | 2002-03-01 | Aerosol formulations for pulmonary administration of medicaments having systemic effects |
| EP02023589A EP1415647A1 (en) | 2002-10-23 | 2002-10-23 | "Long-acting beta-2 agonists ultrafine formulations" |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR038641A1 true AR038641A1 (es) | 2005-01-19 |
Family
ID=27790093
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP030100687A AR038644A1 (es) | 2002-03-01 | 2003-02-28 | Formulaciones hfa de agonistas beta-2 de derivados de 2 (1h)-quinolinona de accion prolongada |
| ARP030100684A AR038641A1 (es) | 2002-03-01 | 2003-02-28 | Formulacion superfina de formoterol |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP030100687A AR038644A1 (es) | 2002-03-01 | 2003-02-28 | Formulaciones hfa de agonistas beta-2 de derivados de 2 (1h)-quinolinona de accion prolongada |
Country Status (35)
| Country | Link |
|---|---|
| US (4) | US20050152846A1 (es) |
| EP (6) | EP3384931B1 (es) |
| JP (3) | JP2005523905A (es) |
| KR (2) | KR100947409B1 (es) |
| CN (2) | CN100398094C (es) |
| AR (2) | AR038644A1 (es) |
| AT (1) | ATE465712T1 (es) |
| AU (2) | AU2003222753B2 (es) |
| BR (2) | BRPI0308274B8 (es) |
| CA (2) | CA2477881C (es) |
| CO (2) | CO5611091A2 (es) |
| CY (4) | CY1111133T1 (es) |
| DE (1) | DE60332321D1 (es) |
| DK (4) | DK3494995T3 (es) |
| EA (2) | EA007735B1 (es) |
| ES (4) | ES2779273T3 (es) |
| GE (2) | GEP20063986B (es) |
| HR (2) | HRP20040752B1 (es) |
| HU (3) | HUE049426T2 (es) |
| IL (3) | IL163843A0 (es) |
| LT (3) | LT3536344T (es) |
| MA (1) | MA27175A1 (es) |
| ME (3) | MEP30108A (es) |
| MX (2) | MXPA04008372A (es) |
| MY (2) | MY143517A (es) |
| NO (2) | NO20043625L (es) |
| NZ (2) | NZ535018A (es) |
| PE (2) | PE20030827A1 (es) |
| PL (2) | PL209212B1 (es) |
| PT (4) | PT3384931T (es) |
| RS (2) | RS52387B (es) |
| SI (4) | SI3536344T1 (es) |
| TN (2) | TNSN04147A1 (es) |
| TW (2) | TWI347197B (es) |
| WO (2) | WO2003074024A1 (es) |
Families Citing this family (45)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20010031244A1 (en) * | 1997-06-13 | 2001-10-18 | Chiesi Farmaceutici S.P.A. | Pharmaceutical aerosol composition |
| IT1303788B1 (it) * | 1998-11-25 | 2001-02-23 | Chiesi Farma Spa | Formulazioni di aerosol medicinali. |
| DZ2947A1 (fr) * | 1998-11-25 | 2004-03-15 | Chiesi Farma Spa | Inhalateur à compteur de dose sous pression. |
| US6315985B1 (en) * | 1999-06-18 | 2001-11-13 | 3M Innovative Properties Company | C-17/21 OH 20-ketosteroid solution aerosol products with enhanced chemical stability |
| ES2165768B1 (es) | 1999-07-14 | 2003-04-01 | Almirall Prodesfarma Sa | Nuevos derivados de quinuclidina y composiciones farmaceuticas que los contienen. |
| IT1317720B1 (it) * | 2000-01-07 | 2003-07-15 | Chiesi Farma Spa | Dispositivo per la somministrazione di aerosol dosati pressurizzati inpropellenti idrofluoroalcani. |
| IT1318514B1 (it) * | 2000-05-12 | 2003-08-27 | Chiesi Farma Spa | Formulazioni contenenti un farmaco glucocorticosteroide per iltrattamento di patologie broncopolmonari. |
| US20060257324A1 (en) * | 2000-05-22 | 2006-11-16 | Chiesi Farmaceutici S.P.A. | Pharmaceutical solution formulations for pressurised metered dose inhalers |
| CN1213732C (zh) * | 2000-05-22 | 2005-08-10 | 奇斯药制品公司 | 用于加压计量吸入器的稳定药用溶液制剂 |
| US20040101483A1 (en) * | 2001-03-30 | 2004-05-27 | Rudi Muller-Walz | Medical aerosol formulations |
| EP1273292B1 (en) * | 2001-07-02 | 2004-05-26 | CHIESI FARMACEUTICI S.p.A. | Optimised formulation of tobramycin for aerosolization |
| AU2003222753B2 (en) * | 2002-03-01 | 2008-04-17 | Chiesi Farmaceutici S.P.A. | Formoterol superfine formulation |
| EP1340492A1 (en) * | 2002-03-01 | 2003-09-03 | CHIESI FARMACEUTICI S.p.A. | Aerosol formulations for pulmonary administration of medicaments having systemic effects |
| EP1415647A1 (en) * | 2002-10-23 | 2004-05-06 | CHIESI FARMACEUTICI S.p.A. | "Long-acting beta-2 agonists ultrafine formulations" |
| EP1452179A1 (en) * | 2003-02-27 | 2004-09-01 | CHIESI FARMACEUTICI S.p.A. | Novel medicament combination of a highly potent long-lasting beta2-agonist and a corticosteroid |
| JP2007500676A (ja) * | 2003-07-31 | 2007-01-18 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | 抗コリン作用薬とベータ受容体刺激薬を含む吸入用薬剤 |
| GB0323684D0 (en) | 2003-10-09 | 2003-11-12 | Jagotec Ag | Improvements in or relating to organic compounds |
| GB0323685D0 (en) * | 2003-10-09 | 2003-11-12 | Jagotec Ag | Improvements in or relating to organic compounds |
| EP1595531A1 (en) * | 2004-05-13 | 2005-11-16 | CHIESI FARMACEUTICI S.p.A. | Stable pharmaceutical solution formulations for pressurized metered dose inhalers |
| IL177103A0 (en) * | 2004-02-27 | 2006-12-10 | Chiesi Farma Spa | Stable pharmaceutical solution formulations for pressurized metered dose inhalers |
| CN100457087C (zh) * | 2004-02-27 | 2009-02-04 | 奇斯药制品公司 | 用于加压计量吸入器的稳定的药用溶液制剂 |
| EP1746981B1 (en) * | 2004-05-13 | 2008-08-13 | CHIESI FARMACEUTICI S.p.A. | Medicinal aerosol formulation products with improved chemical stability |
| MXPA06015204A (es) * | 2004-07-02 | 2007-03-15 | Boehringer Ingelheim Int | Formulaciones en suspension de aerosol con tg 227 ea o tg 134 a como agentes propulsores. |
| GB0420722D0 (en) * | 2004-09-17 | 2004-10-20 | Addex Pharmaceuticals Sa | Novel allosteric modulators |
| UA92732C2 (ru) * | 2005-02-25 | 2010-12-10 | КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. | Фармацевтические аэрозольные композиции для ингаляторов под давлением с вымеренными дозами, которые содержат связующее соединение |
| DE102006017320A1 (de) * | 2006-04-11 | 2007-10-18 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Aerosolsuspensionsformulierungen mit TG 227 ea oder TG 134 a als Treibmittel |
| 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 |
| EP2100598A1 (en) | 2008-03-13 | 2009-09-16 | Laboratorios Almirall, S.A. | Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease |
| EP2100599A1 (en) | 2008-03-13 | 2009-09-16 | Laboratorios Almirall, S.A. | Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease |
| GB2461752B (en) * | 2008-07-14 | 2013-04-17 | Neo Inhalation Products Ltd | Metered dose inhaler |
| AU2009308412B2 (en) * | 2008-10-23 | 2015-11-26 | Sunovion Pharmaceuticals Inc. | Arformoterol and tiotropium compositions and methods for use |
| GB0918149D0 (en) | 2009-10-16 | 2009-12-02 | Jagotec Ag | Improved medicinal aerosol formulation |
| WO2011076842A2 (en) | 2009-12-23 | 2011-06-30 | Chiesi Farmaceutici S.P.A. | Aerosol formulation for copd |
| RS53391B2 (sr) | 2009-12-23 | 2023-09-29 | Chiesi Farm Spa | Kombinovana terapija copd-a (hroničnih obstruktivnih bolesti pluća) |
| EP2360147A1 (en) * | 2010-02-22 | 2011-08-24 | CHIESI FARMACEUTICI S.p.A. | Process for preparing crystalline particles of a salt of 8-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino] ethyl]-2(1H)-quinolinone (carmoterol) |
| BR112013001119A2 (pt) * | 2010-07-16 | 2016-05-24 | Cipla Ltd | composição farmacêutica, processo para fabricar uma composição farmacêutica, uso de r(+)budesonida e um broncodilatador, e método de profilaxia ou tratamento de uma doença respiratória, inflamatória ou obstrutiva das vias aéreas |
| TWI399202B (zh) | 2011-03-17 | 2013-06-21 | Intech Biopharm Ltd | 製備用於治療呼吸道疾病之定量噴霧吸入劑的製程方法 |
| EP2510928A1 (en) | 2011-04-15 | 2012-10-17 | Almirall, S.A. | Aclidinium for use in improving the quality of sleep in respiratory patients |
| CN104797190B (zh) * | 2012-11-15 | 2018-07-17 | 杰普呼吸技术公司 | 用于肺机能测量的装置和方法 |
| RU2504402C1 (ru) * | 2012-11-20 | 2014-01-20 | Шолекс Девелопмент Гмбх | Ингаляционный состав в форме аэрозоля для лечения бронхиальной астмы и хронической обструктивной болезни легких |
| CN106667973A (zh) * | 2017-01-22 | 2017-05-17 | 西咸新区世云工研坊生物科技有限公司 | 一种用于防雾霾损伤的组合物及其制备方法和喷剂 |
| US20220040086A1 (en) * | 2018-10-01 | 2022-02-10 | Kindeva Drug Delivery L.P. | Formulation and aerosol canisters, inhalers, and the like containing the formulation |
| 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 |
| EP4531920A1 (en) | 2022-05-27 | 2025-04-09 | Chiesi Farmaceutici S.p.A. | A pharmaceutical formulation for pressurised metered dose inhaler |
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