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AR129501A2 - FORMULACIÓN EN POLVO SECO QUE COMPRENDE UN ANTICOLINÉRGICO, UN CORTICOSTEROIDE Y UN b-ADRENÉRGICO PARA ADMINISTRAR POR INHALACIÓN - Google Patents

FORMULACIÓN EN POLVO SECO QUE COMPRENDE UN ANTICOLINÉRGICO, UN CORTICOSTEROIDE Y UN b-ADRENÉRGICO PARA ADMINISTRAR POR INHALACIÓN

Info

Publication number
AR129501A2
AR129501A2 ARP230101391A ARP230101391A AR129501A2 AR 129501 A2 AR129501 A2 AR 129501A2 AR P230101391 A ARP230101391 A AR P230101391A AR P230101391 A ARP230101391 A AR P230101391A AR 129501 A2 AR129501 A2 AR 129501A2
Authority
AR
Argentina
Prior art keywords
microns
particles
anticholinergic
dry powder
corticosteroid
Prior art date
Application number
ARP230101391A
Other languages
English (en)
Inventor
Rossella Musa
Francesca Schiaretti
Irene Pasquali
Azita Askey-Sarvar
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=51292914&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR129501(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 AR129501A2 publication Critical patent/AR129501A2/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075Sprays 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/02Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • A61K31/573Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate 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
    • A61K9/145Intimate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/08Bronchodilators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Pain & Pain Management (AREA)
  • Otolaryngology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (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)
  • Reciprocating Pumps (AREA)

Abstract

Formulaciones en polvo seco para inhalación que comprenden una combinación de un anticolinérgico, un agonista de adrenoceptor b₂ de acción prolongada y un corticosteroide, proceso de preparación y usos terapéuticos de las mismas. Reivindicación 1: Una formulación en polvo seco para usar en un inhalador en polvo seco (DPI) caracterizada porque comprende: a) una fracción de partículas finas que consiste en una mezcla, que se prepara por comezclado en un aparato de alta energía durante un período de menos de 20 minutos, entre 90 y 99,5 por ciento en peso de partículas micronizadas de un excipiente fisiológicamente aceptable y entre 0,5 y 10 por ciento en peso de estereato de magnesio, en donde al menos el 90% de todas dichas partículas tiene un diámetro de volumen menor que 15 micrones, preferentemente menor que 12 micrones, y el diámetro mediano de volumen de dichas partículas está comprendido entre 3 y 7 micrones, preferentemente entre 4 y 6 micrones; b) una fracción de partículas gruesas que consiste en un excipiente fisiológicamente aceptable que tiene un diámetro mediano de masa igual o mayor que 100 micrones, en donde la proporción entre las partículas finas y las partículas gruesas es entre 1:99 y 30:70 por ciento en peso, y c) partículas micronizadas de un anticolinérgico, un corticosteroide para inhalación (ICS), y un agonista de b₂ de acción prolongada (LABA) como principios activos. Reivindicación 3: La formulación en polvo de acuerdo a la reivindicación 1 o 2, caracterizada porque el LABA es formoterol fumarato dihidratado, el ICS es dipropionato de beclometasona y el anticolinérgico es bromuro de glicopirronio.
ARP230101391A 2013-07-11 2023-06-01 FORMULACIÓN EN POLVO SECO QUE COMPRENDE UN ANTICOLINÉRGICO, UN CORTICOSTEROIDE Y UN b-ADRENÉRGICO PARA ADMINISTRAR POR INHALACIÓN AR129501A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13176114 2013-07-11
EP13194763 2013-11-28

Publications (1)

Publication Number Publication Date
AR129501A2 true AR129501A2 (es) 2024-09-04

Family

ID=51292914

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP230101391A AR129501A2 (es) 2013-07-11 2023-06-01 FORMULACIÓN EN POLVO SECO QUE COMPRENDE UN ANTICOLINÉRGICO, UN CORTICOSTEROIDE Y UN b-ADRENÉRGICO PARA ADMINISTRAR POR INHALACIÓN

Country Status (35)

Country Link
US (2) US9402825B2 (es)
EP (3) EP3569222B1 (es)
JP (1) JP6426167B2 (es)
KR (2) KR102275904B1 (es)
CN (1) CN105338960B (es)
AR (1) AR129501A2 (es)
AU (1) AU2014289185B2 (es)
BR (1) BR112015030914B1 (es)
CA (1) CA2917752C (es)
CL (1) CL2016000028A1 (es)
CY (2) CY1120806T1 (es)
DK (3) DK3409270T3 (es)
EA (1) EA029125B1 (es)
ES (3) ES2699986T3 (es)
FI (1) FI3569222T3 (es)
GE (2) GEP20186853B (es)
HR (3) HRP20241300T1 (es)
HU (3) HUE068270T2 (es)
IL (1) IL243507A0 (es)
LT (3) LT3569222T (es)
MX (1) MX2016000290A (es)
MY (1) MY176176A (es)
NZ (1) NZ715797A (es)
PE (2) PE20160372A1 (es)
PH (1) PH12016500043B1 (es)
PL (3) PL3019153T3 (es)
PT (1) PT3019153T (es)
RS (3) RS57799B1 (es)
SA (1) SA516370373B1 (es)
SG (1) SG11201600110RA (es)
SI (3) SI3569222T1 (es)
TN (1) TN2016000007A1 (es)
TW (1) TWI642450B (es)
UA (1) UA116907C2 (es)
WO (1) WO2015004243A1 (es)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK2515855T6 (da) * 2009-12-23 2023-06-06 Chiesi Farm Spa Kombinationsterapi til COPD
HUE060421T2 (hu) * 2012-01-25 2023-02-28 Chiesi Farm Spa Kortikoszteroidot és béta-adrenerg szert tartalmazó száraz porkészítmény inhalálással történõ beadásra
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
GB201321717D0 (en) * 2013-12-09 2014-01-22 Pharmachemie Bv Inhalable Medicaments
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
TR201407010A2 (tr) 2014-06-16 2015-12-21 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Vilanterol formülasyonları.
JP6600961B2 (ja) * 2015-03-30 2019-11-06 ブラザー工業株式会社 表示制御装置、表示制御方法及び記憶媒体
US20180147161A1 (en) * 2015-05-01 2018-05-31 Board Of Regents, The University Of Texas System Multidrug brittle matrix compositions
AR106687A1 (es) * 2015-11-16 2018-02-07 Chiesi Farm Spa PROCESO PARA PREPARAR UNA FORMULACIÓN EN POLVO SECO QUE COMPRENDE UN ANTICOLINÉRGICO, UN CORTICOSTEROIDE Y UN b-ADRENÉRGICO
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
CA3062126C (en) 2016-11-10 2021-04-27 Medisca Pharmaceutique Inc. Container assembly and adapter therefor
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
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
CN109200034A (zh) * 2017-06-30 2019-01-15 正大天晴药业集团股份有限公司 一种可吸入干粉形式的组合物及其制备方法
WO2019060595A1 (en) 2017-09-20 2019-03-28 Teva Branded Pharmaceutical Products R&D, Inc. INHALABLE DRY POWDER MEDICINAL PRODUCT COMPRISING GLYCOPYRRONIUM
AU2020356243A1 (en) * 2019-09-24 2022-03-24 Chiesi Farmaceutici S.P.A. Novel carrier particles for dry powder formulations for inhalation
US12029709B2 (en) * 2022-08-11 2024-07-09 De Motu Cordis Pty Ltd Inhalable epinephrine formulation

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NZ511527A (en) * 1998-11-13 2002-10-25 Jago Res A Dry powder for inhalation
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PE20011227A1 (es) * 2000-04-17 2002-01-07 Chiesi Farma Spa Formulaciones farmaceuticas para inhaladores de polvo seco en la forma de aglomerados duros
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JP5698423B2 (ja) * 2000-06-27 2015-04-08 ベクトゥラ・リミテッド 医薬組成物で使用するための粒子の製造法
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JO3102B1 (ar) * 2004-03-17 2017-09-20 Chiesi Framaceutici S P A صيغ صيدلانية لوسائل استنشاق بها مسحوق جاف تشتمل على مكون فعال بقوة منخفضة الجرعة
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EP1944018A1 (en) * 2007-01-10 2008-07-16 CHIESI FARMACEUTICI S.p.A. Micronised particles of low-dosage strength active agents for powder formulations for inhalation
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DK2515855T6 (da) 2009-12-23 2023-06-06 Chiesi Farm Spa Kombinationsterapi til COPD
TR201000681A2 (tr) 2010-01-29 2011-08-22 B�Lg�� Mahmut İnhalasyon yoluyla alınan kuru toz formülasyonları.
PL2552424T3 (pl) 2010-04-01 2018-10-31 Chiesi Farmaceutici S.P.A. Sposób wytwarzania cząstek nośnika do suchych proszków do inhalacji
HRP20180488T1 (hr) * 2010-04-21 2018-07-13 Chiesi Farmaceutici S.P.A. Postupak priprave čestica sa smanjenim elektrostatičkim nabojem
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HUE060421T2 (hu) * 2012-01-25 2023-02-28 Chiesi Farm Spa Kortikoszteroidot és béta-adrenerg szert tartalmazó száraz porkészítmény inhalálással történõ beadásra
US9393202B2 (en) 2013-04-26 2016-07-19 Chiesi Farmaceutici S.P.A Particle size reduction of an antimuscarinic compound
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

Also Published As

Publication number Publication date
AU2014289185B2 (en) 2019-05-23
RS61652B1 (sr) 2021-04-29
US9402825B2 (en) 2016-08-02
HUE068270T2 (hu) 2024-12-28
EA029125B1 (ru) 2018-02-28
PT3019153T (pt) 2018-12-04
PH12016500043A1 (en) 2016-03-28
ES2986128T3 (es) 2024-11-08
US9808422B2 (en) 2017-11-07
CY1123937T1 (el) 2022-05-27
CY1120806T1 (el) 2019-12-11
NZ715797A (en) 2020-06-26
HUE053957T2 (hu) 2021-08-30
GEP20186853B (en) 2018-05-25
BR112015030914B1 (pt) 2023-04-04
SG11201600110RA (en) 2016-02-26
PE20212110A1 (es) 2021-11-04
DK3019153T3 (en) 2018-11-19
PE20160372A1 (es) 2016-05-19
SI3019153T1 (sl) 2018-12-31
AU2014289185A1 (en) 2016-02-04
SI3569222T1 (sl) 2024-10-30
DK3569222T3 (da) 2024-08-19
CA2917752A1 (en) 2015-01-15
ES2867552T3 (es) 2021-10-20
PH12016500043B1 (en) 2018-11-23
LT3019153T (lt) 2018-11-26
RS65951B1 (sr) 2024-10-31
SI3409270T1 (sl) 2021-07-30
KR102275904B1 (ko) 2021-07-13
BR112015030914A2 (es) 2017-07-25
CN105338960B (zh) 2019-06-04
PL3569222T3 (pl) 2024-10-28
FI3569222T3 (fi) 2024-09-24
EP3569222B1 (en) 2024-06-26
EP3019153B1 (en) 2018-09-05
EA201690006A1 (ru) 2016-07-29
HRP20241300T1 (hr) 2024-12-06
US20160263027A1 (en) 2016-09-15
HUE039827T2 (hu) 2019-02-28
ES2699986T3 (es) 2019-02-13
JP2016523950A (ja) 2016-08-12
HK1218712A1 (zh) 2017-03-10
CN105338960A (zh) 2016-02-17
LT3569222T (lt) 2024-09-25
UA116907C2 (uk) 2018-05-25
WO2015004243A1 (en) 2015-01-15
EP3019153A1 (en) 2016-05-18
EP3409270A1 (en) 2018-12-05
PL3019153T3 (pl) 2019-02-28
KR20210075217A (ko) 2021-06-22
EP3569222A1 (en) 2019-11-20
GEAP201814032A (en) 2018-01-25
RS57799B1 (sr) 2018-12-31
HRP20182008T1 (hr) 2019-01-25
KR20160029797A (ko) 2016-03-15
TWI642450B (zh) 2018-12-01
HRP20210704T1 (hr) 2021-06-11
JP6426167B2 (ja) 2018-11-21
MX2016000290A (es) 2016-04-13
IL243507A0 (en) 2016-02-29
SA516370373B1 (ar) 2017-10-11
US20150017248A1 (en) 2015-01-15
DK3409270T3 (da) 2021-04-26
TW201536352A (zh) 2015-10-01
MY176176A (en) 2020-07-24
EP3409270B1 (en) 2021-02-24
CA2917752C (en) 2022-05-03
LT3409270T (lt) 2021-07-26
PL3409270T3 (pl) 2021-08-09
CL2016000028A1 (es) 2016-08-05
TN2016000007A1 (en) 2017-07-05

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