PE20181377A1 - Proceso para preparar una formulacion en polvo seco que comprende un anticolinergico, un corticosteroide y un beta-adrenergico - Google Patents
Proceso para preparar una formulacion en polvo seco que comprende un anticolinergico, un corticosteroide y un beta-adrenergicoInfo
- Publication number
- PE20181377A1 PE20181377A1 PE2018000972A PE2018000972A PE20181377A1 PE 20181377 A1 PE20181377 A1 PE 20181377A1 PE 2018000972 A PE2018000972 A PE 2018000972A PE 2018000972 A PE2018000972 A PE 2018000972A PE 20181377 A1 PE20181377 A1 PE 20181377A1
- Authority
- PE
- Peru
- Prior art keywords
- corticosteroid
- inhalation
- anticholinergic
- long
- dry powder
- 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
- A61K9/0012—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
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
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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
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
-
- 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
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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
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- 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
- A61K47/06—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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- 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
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pulmonology (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biophysics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pain & Pain Management (AREA)
- Otolaryngology (AREA)
- Biochemistry (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Se refiere a un proceso para preparar una formulacion en polvo seco para inhalacion que comprende una combinacion de un anticolinergico, un agonista del receptor adrenergico beta2 de accion prolongada, y opcionalmente un corticosteroide para inhalacion. El proceso comprende: Mezclar un vehiculo, un agonista beta2 de accion prolongada y un corticosteroide en una mezcladora por agitacion durante 60 minutos y luego agregar un farmaco antimuscarinico y mezclar por segunda vez durante 40 minutos. Dicho proceso es utilizado para la terapia combinada contra las enfermedades respiratorias (EPOC) moderada a severa. La formulacion asi obtenida comprende: a) un vehiculo, conformado por una fraccion de particulas gruesas con tamano de particula de 175 um y una fraccion de particulas finas consistente en una mezcla de 90 a 99,5% de particulas y de 0,5 a 10% de una sal de un acido graso; b) particulas micronizadas de un farmaco antimuscarinico, un agonista beta2 de accion prolongada, y opcionalmente un corticosteroride para inhalacion, como ingredientes activos.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15194661 | 2015-11-16 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20181377A1 true PE20181377A1 (es) | 2018-09-05 |
Family
ID=54548063
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2018000972A PE20181377A1 (es) | 2015-11-16 | 2016-11-14 | Proceso para preparar una formulacion en polvo seco que comprende un anticolinergico, un corticosteroide y un beta-adrenergico |
Country Status (32)
| Country | Link |
|---|---|
| US (3) | US10086003B2 (es) |
| EP (2) | EP3377109B1 (es) |
| JP (1) | JP6942126B2 (es) |
| KR (1) | KR20180082442A (es) |
| CN (1) | CN108348614B (es) |
| AR (1) | AR106687A1 (es) |
| AU (1) | AU2016357988B2 (es) |
| CA (1) | CA3005291C (es) |
| CL (1) | CL2018001297A1 (es) |
| CO (1) | CO2018005139A2 (es) |
| DK (2) | DK3689379T3 (es) |
| EA (1) | EA037346B1 (es) |
| ES (2) | ES2890409T3 (es) |
| GE (1) | GEP20207178B (es) |
| HK (1) | HK1256859A1 (es) |
| HR (2) | HRP20211599T1 (es) |
| HU (2) | HUE056402T2 (es) |
| IL (1) | IL259327B (es) |
| MA (1) | MA52437A (es) |
| MX (1) | MX2018005979A (es) |
| MY (1) | MY198321A (es) |
| PE (1) | PE20181377A1 (es) |
| PH (1) | PH12018501023B1 (es) |
| PL (2) | PL3689379T3 (es) |
| PT (2) | PT3377109T (es) |
| SA (1) | SA518391574B1 (es) |
| SG (2) | SG10201912090UA (es) |
| SI (2) | SI3689379T1 (es) |
| TW (1) | TWI729025B (es) |
| UA (1) | UA125173C2 (es) |
| WO (1) | WO2017085007A1 (es) |
| ZA (1) | ZA201803167B (es) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110612095A (zh) | 2017-05-11 | 2019-12-24 | 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 |
| CA3060020A1 (en) | 2017-05-11 | 2018-11-15 | Chiesi Farmaceutici S.P.A. | A process for preparing a dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic |
| WO2019060595A1 (en) * | 2017-09-20 | 2019-03-28 | Teva Branded Pharmaceutical Products R&D, Inc. | INHALABLE DRY POWDER MEDICINAL PRODUCT COMPRISING GLYCOPYRRONIUM |
| US11304901B2 (en) * | 2019-08-28 | 2022-04-19 | Anovent Pharmaceutical (U.S.), Llc | Liposome formulation of fluticasone furoate and method of preparation |
| WO2021143785A1 (zh) * | 2020-01-15 | 2021-07-22 | 四川海思科制药有限公司 | 一种含茚达特罗的吸入气雾剂药物组合物及其制备方法 |
| CN111467498A (zh) * | 2020-05-14 | 2020-07-31 | 王兆霖 | 药物组合物制剂 |
| CN117064869A (zh) * | 2023-09-27 | 2023-11-17 | 山东京卫制药有限公司 | 一种胶囊型吸入粉雾剂及其制备方法 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20011227A1 (es) | 2000-04-17 | 2002-01-07 | Chiesi Farma Spa | Formulaciones farmaceuticas para inhaladores de polvo seco en la forma de aglomerados duros |
| GB0015043D0 (en) | 2000-06-21 | 2000-08-09 | Glaxo Group Ltd | Medicament dispenser |
| SI1658872T2 (sl) | 2002-07-31 | 2019-12-31 | Chiesi Farmacetuici S.P.A. | Inhalator prahu |
| JP2009514779A (ja) * | 2003-07-11 | 2009-04-09 | グラクソ グループ リミテッド | 医薬製剤 |
| GB0410399D0 (en) * | 2004-05-10 | 2004-06-16 | Arakis Ltd | The treatment of respiratory disease |
| SG184964A1 (en) | 2010-04-21 | 2012-11-29 | Chiesi Farma Spa | Process for providing particles with reduced electrostatic charges |
| US9393202B2 (en) | 2013-04-26 | 2016-07-19 | Chiesi Farmaceutici S.P.A | Particle size reduction of an antimuscarinic compound |
| EP3019153B1 (en) | 2013-07-11 | 2018-09-05 | Chiesi Farmaceutici S.p.A. | Dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic for administration by inhalation |
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2016
- 2016-11-14 HU HUE20156815A patent/HUE056402T2/hu unknown
- 2016-11-14 UA UAA201805272A patent/UA125173C2/uk unknown
- 2016-11-14 DK DK20156815.1T patent/DK3689379T3/da active
- 2016-11-14 SI SI201631330T patent/SI3689379T1/sl unknown
- 2016-11-14 EP EP16801984.2A patent/EP3377109B1/en active Active
- 2016-11-14 HU HUE16801984A patent/HUE050343T2/hu unknown
- 2016-11-14 PT PT168019842T patent/PT3377109T/pt unknown
- 2016-11-14 AR ARP160103472A patent/AR106687A1/es unknown
- 2016-11-14 MY MYPI2018000703A patent/MY198321A/en unknown
- 2016-11-14 CA CA3005291A patent/CA3005291C/en active Active
- 2016-11-14 AU AU2016357988A patent/AU2016357988B2/en active Active
- 2016-11-14 DK DK16801984.2T patent/DK3377109T3/da active
- 2016-11-14 PE PE2018000972A patent/PE20181377A1/es unknown
- 2016-11-14 PL PL20156815T patent/PL3689379T3/pl unknown
- 2016-11-14 GE GEAP201614782A patent/GEP20207178B/en unknown
- 2016-11-14 HR HRP20211599TT patent/HRP20211599T1/hr unknown
- 2016-11-14 EP EP20156815.1A patent/EP3689379B1/en active Active
- 2016-11-14 TW TW105137047A patent/TWI729025B/zh active
- 2016-11-14 SI SI201630738T patent/SI3377109T1/sl unknown
- 2016-11-14 MX MX2018005979A patent/MX2018005979A/es active IP Right Grant
- 2016-11-14 ES ES20156815T patent/ES2890409T3/es active Active
- 2016-11-14 ES ES16801984T patent/ES2789365T3/es active Active
- 2016-11-14 PT PT201568151T patent/PT3689379T/pt unknown
- 2016-11-14 EA EA201890967A patent/EA037346B1/ru unknown
- 2016-11-14 KR KR1020187013284A patent/KR20180082442A/ko unknown
- 2016-11-14 SG SG10201912090UA patent/SG10201912090UA/en unknown
- 2016-11-14 SG SG11201804048WA patent/SG11201804048WA/en unknown
- 2016-11-14 MA MA052437A patent/MA52437A/fr unknown
- 2016-11-14 CN CN201680066805.3A patent/CN108348614B/zh active Active
- 2016-11-14 JP JP2018524831A patent/JP6942126B2/ja active Active
- 2016-11-14 PL PL16801984T patent/PL3377109T3/pl unknown
- 2016-11-14 WO PCT/EP2016/077566 patent/WO2017085007A1/en active Application Filing
- 2016-11-15 US US15/351,510 patent/US10086003B2/en active Active
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2018
- 2018-05-14 CL CL2018001297A patent/CL2018001297A1/es unknown
- 2018-05-14 IL IL259327A patent/IL259327B/en active IP Right Grant
- 2018-05-14 SA SA518391574A patent/SA518391574B1/ar unknown
- 2018-05-14 ZA ZA2018/03167A patent/ZA201803167B/en unknown
- 2018-05-15 PH PH12018501023A patent/PH12018501023B1/en unknown
- 2018-05-16 CO CONC2018/0005139A patent/CO2018005139A2/es unknown
- 2018-08-27 US US16/113,051 patent/US10786451B2/en active Active
- 2018-12-12 HK HK18115947.2A patent/HK1256859A1/zh unknown
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2020
- 2020-04-08 HR HRP20200571TT patent/HRP20200571T1/hr unknown
- 2020-08-06 US US16/986,796 patent/US10959944B2/en active Active
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