CO2018005139A2 - Proceso para preparar una formulación en polvo seco que comprende un anticolinérgico, un corticosteroide y un beta-adrenérgico - Google Patents

Proceso para preparar una formulación en polvo seco que comprende un anticolinérgico, un corticosteroide y un beta-adrenérgico

Info

Publication number
CO2018005139A2
CO2018005139A2 CONC2018/0005139A CO2018005139A CO2018005139A2 CO 2018005139 A2 CO2018005139 A2 CO 2018005139A2 CO 2018005139 A CO2018005139 A CO 2018005139A CO 2018005139 A2 CO2018005139 A2 CO 2018005139A2
Authority
CO
Colombia
Prior art keywords
anticholinergic
corticosteroid
dry powder
powder formulation
adrenergic
Prior art date
Application number
CONC2018/0005139A
Other languages
English (en)
Inventor
Claudio Cafiero
Leonardo Ortenzi
Original Assignee
Chiesi Farm Spa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54548063&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CO2018005139(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Chiesi Farm Spa filed Critical Chiesi Farm Spa
Publication of CO2018005139A2 publication Critical patent/CO2018005139A2/es

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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

La invención se relaciona con una formulación en polvo seco para inhalación que comprende una combinación de un anticolinérgico, un agonista del receptor adrenérgico beta2 de acción prolongada, y, opcionalmente, un corticosteroide para inhalación, y con un proceso para la preparación de la misma.
CONC2018/0005139A 2015-11-16 2018-05-16 Proceso para preparar una formulación en polvo seco que comprende un anticolinérgico, un corticosteroide y un beta-adrenérgico CO2018005139A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP15194661 2015-11-16
PCT/EP2016/077566 WO2017085007A1 (en) 2015-11-16 2016-11-14 A process for preparing a dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic

Publications (1)

Publication Number Publication Date
CO2018005139A2 true CO2018005139A2 (es) 2018-08-10

Family

ID=54548063

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2018/0005139A CO2018005139A2 (es) 2015-11-16 2018-05-16 Proceso para preparar una formulación en polvo seco que comprende un anticolinérgico, un corticosteroide y un beta-adrenérgico

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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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

Also Published As

Publication number Publication date
CA3005291A1 (en) 2017-05-26
CL2018001297A1 (es) 2018-08-10
AR106687A1 (es) 2018-02-07
CN108348614B (zh) 2021-09-21
EA037346B1 (ru) 2021-03-16
AU2016357988B2 (en) 2021-12-16
IL259327B (en) 2020-11-30
TWI729025B (zh) 2021-06-01
ZA201803167B (en) 2019-07-31
US20200360278A1 (en) 2020-11-19
PL3377109T3 (pl) 2020-09-21
EP3689379B1 (en) 2021-08-11
SA518391574B1 (ar) 2021-06-13
JP2018537453A (ja) 2018-12-20
HRP20211599T1 (hr) 2022-01-07
US20170136034A1 (en) 2017-05-18
GEAP201614782A (es) 2020-04-27
GEP20207178B (en) 2020-11-10
MA52437A (fr) 2021-05-05
TW201722403A (zh) 2017-07-01
DK3377109T3 (da) 2020-04-20
CA3005291C (en) 2024-01-16
HRP20200571T1 (hr) 2020-07-10
ES2789365T3 (es) 2020-10-26
AU2016357988A1 (en) 2018-05-31
US10786451B2 (en) 2020-09-29
JP6942126B2 (ja) 2021-09-29
DK3689379T3 (da) 2021-09-06
EP3377109A1 (en) 2018-09-26
WO2017085007A1 (en) 2017-05-26
PT3377109T (pt) 2020-05-13
MX2018005979A (es) 2018-08-29
UA125173C2 (uk) 2022-01-26
EP3689379A1 (en) 2020-08-05
PH12018501023A1 (en) 2018-12-17
BR112018009811A2 (pt) 2018-11-13
HUE056402T2 (hu) 2022-02-28
BR112018009811A8 (pt) 2019-02-26
SG11201804048WA (en) 2018-06-28
ES2890409T3 (es) 2022-01-19
SI3689379T1 (sl) 2021-11-30
IL259327A (en) 2018-07-31
PH12018501023B1 (en) 2018-12-17
US10959944B2 (en) 2021-03-30
PT3689379T (pt) 2021-09-24
PE20181377A1 (es) 2018-09-05
MY198321A (en) 2023-08-24
KR20180082442A (ko) 2018-07-18
SI3377109T1 (sl) 2020-07-31
HUE050343T2 (hu) 2020-11-30
US20190021994A1 (en) 2019-01-24
SG10201912090UA (en) 2020-02-27
EA201890967A1 (ru) 2018-12-28
CN108348614A (zh) 2018-07-31
EP3377109B1 (en) 2020-03-04
PL3689379T3 (pl) 2021-12-13
HK1256859A1 (zh) 2019-10-04
US10086003B2 (en) 2018-10-02

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