CO5611092A2 - Formulacion superfina de formoterol - Google Patents
Formulacion superfina de formoterolInfo
- Publication number
- CO5611092A2 CO5611092A2 CO04084191A CO04084191A CO5611092A2 CO 5611092 A2 CO5611092 A2 CO 5611092A2 CO 04084191 A CO04084191 A CO 04084191A CO 04084191 A CO04084191 A CO 04084191A CO 5611092 A2 CO5611092 A2 CO 5611092A2
- Authority
- CO
- Colombia
- Prior art keywords
- less
- wastewater
- ppm
- amount
- pharmaceutical formulation
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 3
- 239000000203 mixture Substances 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
- 229960002848 formoterol Drugs 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 3
- 239000002351 wastewater Substances 0.000 abstract 3
- 239000004480 active ingredient Substances 0.000 abstract 1
- 239000006184 cosolvent Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- 239000008249 pharmaceutical aerosol Substances 0.000 abstract 1
- 239000003380 propellant Substances 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000012453 solvate 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
- 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
- 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
-
- 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
1.- Una formulación de aerosol farmacéutico para ser administrada mediante inhaladores de dosis medidas presurizadas que comprende un ingrediente activo seleccionado de formoterol o un estereoisómero, sal y solvato fisiológicamente aceptables de los mismos, en una solución de un propelente HFA licuado, y un cosolvente, caracterizada porque la cantidad de agua residual es menor a 1500 ppm en el peso total de la formulación.2.- La formulación farmacéutica de conformidad con la reivindicación 1, caracterizada porque la cantidad de agua residual es menor a 1000 ppm.3.- La formulación farmacéutica de conformidad con la reivindicación 1, caracterizada porque la cantidad de agua residual es menor a 500 ppm.4.- La formulación farmacéutica de conformidad con las reivindicaciones 1-3, caracterizada porque la fracción de partículas igual o menor a 1.1 µm suministradas en el accionamiento del inhalador es superior o igual a 30% como se define mediante el contenido de las etapas S6-AF de un Impactor en Cascada Andersen, con relación al contenido de las etapas S6-AF, de acuerdo con el método al que se hace referencia en la descripción en la página 17 líneas 4 a 12.
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 |
|---|---|
| CO5611092A2 true CO5611092A2 (es) | 2006-02-28 |
Family
ID=27790093
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CO04084184A CO5611091A2 (es) | 2002-03-01 | 2004-08-27 | Inhaladores de dosis medidas presurizadas que contienen soluciones de beta-2 agonistas |
| CO04084191A CO5611092A2 (es) | 2002-03-01 | 2004-08-27 | Formulacion superfina de formoterol |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CO04084184A CO5611091A2 (es) | 2002-03-01 | 2004-08-27 | Inhaladores de dosis medidas presurizadas que contienen soluciones de beta-2 agonistas |
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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| US3361306A (en) * | 1966-03-31 | 1968-01-02 | Merck & Co Inc | Aerosol unit dispensing uniform amounts of a medically active ingredient |
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