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AR086248A1 - Formulacion en forma de suspension mejorada de un corticosteroide que puede administrarse por inhalacion - Google Patents

Formulacion en forma de suspension mejorada de un corticosteroide que puede administrarse por inhalacion

Info

Publication number
AR086248A1
AR086248A1 ARP120101550A ARP120101550A AR086248A1 AR 086248 A1 AR086248 A1 AR 086248A1 AR P120101550 A ARP120101550 A AR P120101550A AR P120101550 A ARP120101550 A AR P120101550A AR 086248 A1 AR086248 A1 AR 086248A1
Authority
AR
Argentina
Prior art keywords
particles
formulation
administered
corticosteroid
formulation according
Prior art date
Application number
ARP120101550A
Other languages
English (en)
Inventor
Anna Maria Cantarelli
Stefano Minari
Barbara Bassi
Original Assignee
Chiesi Farma 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=44584766&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR086248(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Chiesi Farma Spa filed Critical Chiesi Farma Spa
Publication of AR086248A1 publication Critical patent/AR086248A1/es

Links

Classifications

    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K9/0012Galenical 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
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • 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
    • 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
    • A61P11/08Bronchodilators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Emergency Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

Formulación en forma de suspensión acuosa que comprende partículas de drogas, particularmente de corticosteroides, que puede administrarse por nebulización y que presenta una distribución óptima del tamaño de las partículas.Reivindicación 1: Una formulación farmacéutica estéril libre de propelentes que puede administrarse por nebulización, caracterizada porque comprende partículas micronizadas de un corticosteroide cristalino suspendidas en una solución acuosa, donde i) no más de 10% de las partículas suspendidas tienen un diámetro basado en el volumen [d(v,0,1)] inferior a 0,6 mm, ii) no más de 50% de las partículas tienen un diámetro basado en el volumen [d(v,0,5)] de entre 1,5 mm y 1,9 mm; y iii) al menos 90% de las partículas [d(v,0,9)] tienen un diámetro basado en el volumen igual o inferior a 4,7 mm, y donde las partículas tienen un rango de tamaños, definido como [d(v,0,9) - d(v,0,1)] / d(v,0,5), de entre 1,2 y 2,2. Reivindicación 6: La formulación de acuerdo con la reivindicación 5, caracterizada porque el corticoide es dipropionato de beclometasona. Reivindicación 13: La formulación de acuerdo con la reivindicación 12, caracterizada porque el ingrediente activo adicional es sulfato de salbutamol. Reivindicación 14: Un recipiente caracterizado porque está lleno con una formulación de acuerdo con cualquiera de las reivindicaciones 1 a 13. Reivindicación 15: Un conjunto de elementos caracterizado porque comprende (a) una formulación de acuerdo con cualquiera de las reivindicaciones 1 a 13 en un recipiente para dosis individuales; y (b) un nebulizador.
ARP120101550A 2011-05-03 2012-05-02 Formulacion en forma de suspension mejorada de un corticosteroide que puede administrarse por inhalacion AR086248A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP11164575 2011-05-03

Publications (1)

Publication Number Publication Date
AR086248A1 true AR086248A1 (es) 2013-11-27

Family

ID=44584766

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP120101550A AR086248A1 (es) 2011-05-03 2012-05-02 Formulacion en forma de suspension mejorada de un corticosteroide que puede administrarse por inhalacion

Country Status (18)

Country Link
EP (2) EP2704724B1 (es)
CN (1) CN103501791B (es)
AR (1) AR086248A1 (es)
BR (1) BR112013027391A2 (es)
CY (1) CY1118315T1 (es)
DK (1) DK2704724T3 (es)
ES (2) ES2974900T3 (es)
HR (1) HRP20161757T1 (es)
HU (1) HUE030016T2 (es)
LT (1) LT2704724T (es)
ME (1) ME02586B (es)
PL (2) PL3097915T3 (es)
PT (1) PT2704724T (es)
RS (1) RS55477B1 (es)
RU (1) RU2611665C2 (es)
SI (1) SI2704724T1 (es)
WO (1) WO2012150131A1 (es)
ZA (1) ZA201308158B (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HRP20161757T1 (hr) 2011-05-03 2017-02-10 Chiesi Farmaceutici S.P.A. Poboljšana formulacija suspenzije beklometazon-dipropionata za davanje inhalacijom
CN107260665B (zh) * 2016-04-08 2021-03-30 天津金耀集团有限公司 一种吸入用糠酸莫米松混悬液组合物
CN107510687B (zh) * 2017-08-18 2020-07-03 南京海纳医药科技股份有限公司 一种供雾化用含有福莫特罗和布地奈德的吸入混悬液及其制备方法

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19653969A1 (de) * 1996-12-20 1998-06-25 Boehringer Ingelheim Kg Neue wässrige Arzneimittelzubereitung zur Erzeugung treibgasfreier Aerosole
SE9704186D0 (sv) 1997-11-14 1997-11-14 Astra Ab New composition of matter
IT1303692B1 (it) 1998-11-03 2001-02-23 Chiesi Farma Spa Procedimento per la preparazione di sospensioni di particelle difarmaci da somministrare per inalazione.
CA2481239A1 (en) 2002-04-05 2003-10-23 University Of Utah Research Foundation Regulation of a novel colon specific retinol dehydrogenase by apc and cdx2
ITMI20020808A1 (it) * 2002-04-17 2003-10-17 Chiesi Farma Spa Procedimento per la preparazione di una sospensione sterile di particelle di beclometasone dipropionato da somministrare per inalazione
ITMI20022674A1 (it) 2002-12-18 2004-06-19 Chiesi Farma Spa Procedimento per la preparazione di formulazioni sterili a base di principi attivi farmaceutici cristallini micronizzati da somministrare come sospensioni acquose per inalazione.
EP1454636A1 (en) 2003-03-04 2004-09-08 Dompé S.P.A. Sterilization of glucocorticoid drug particles for pulmonary delivery
US8912174B2 (en) * 2003-04-16 2014-12-16 Mylan Pharmaceuticals Inc. Formulations and methods for treating rhinosinusitis
US7811606B2 (en) * 2003-04-16 2010-10-12 Dey, L.P. Nasal pharmaceutical formulations and methods of using the same
GB0410995D0 (en) * 2004-05-17 2004-06-23 Norton Healthcare Ltd Heat sterilization of glucocorticosteroids
ITMI20051999A1 (it) * 2005-10-21 2007-04-22 Eratech S R L Formulazioni inalatorie di farmaci in fora di polvere secca per somministrazione come tale o con nebulizzatore e dotate di elevata erogabilita' respirabilita' e stabilita'
US20090252801A1 (en) 2005-11-29 2009-10-08 Farmbios S.P.A. Process for the Preparation of Micronised Sterile Steroids
AU2008334547B2 (en) * 2007-12-13 2011-06-30 Novartis Ag Organic compounds
HRP20161757T1 (hr) 2011-05-03 2017-02-10 Chiesi Farmaceutici S.P.A. Poboljšana formulacija suspenzije beklometazon-dipropionata za davanje inhalacijom

Also Published As

Publication number Publication date
CN103501791A (zh) 2014-01-08
WO2012150131A1 (en) 2012-11-08
ZA201308158B (en) 2014-09-25
ES2612257T3 (es) 2017-05-16
SI2704724T1 (sl) 2017-01-31
PL3097915T3 (pl) 2024-05-20
DK2704724T3 (en) 2017-01-09
CN103501791B (zh) 2016-05-18
ES2974900T3 (es) 2024-07-02
LT2704724T (lt) 2017-01-10
EP2704724A1 (en) 2014-03-12
BR112013027391A2 (pt) 2017-01-17
RU2013148786A (ru) 2015-05-10
CY1118315T1 (el) 2017-06-28
HRP20161757T1 (hr) 2017-02-10
ME02586B (me) 2017-06-20
RS55477B1 (sr) 2017-04-28
RU2611665C2 (ru) 2017-02-28
EP2704724B1 (en) 2016-10-26
EP3097915A1 (en) 2016-11-30
PL2704724T3 (pl) 2017-03-31
PT2704724T (pt) 2017-02-02
HUE030016T2 (en) 2017-04-28
EP3097915B1 (en) 2024-01-24

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