ES2552237T3 - Composición para inhalación que contiene aclidinio para el tratamiento del asma - Google Patents

Composición para inhalación que contiene aclidinio para el tratamiento del asma Download PDF

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Publication number
ES2552237T3
ES2552237T3 ES09720773.2T ES09720773T ES2552237T3 ES 2552237 T3 ES2552237 T3 ES 2552237T3 ES 09720773 T ES09720773 T ES 09720773T ES 2552237 T3 ES2552237 T3 ES 2552237T3
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Spain
Prior art keywords
aclidinium
asthma
treatment
composition
inhalation containing
Prior art date
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ES09720773.2T
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English (en)
Inventor
Rosa Lamarca Casado
Gonzalo De Miquel Serra
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Almirall SA
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Almirall SA
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Application filed by Almirall SA filed Critical Almirall SA
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Publication of ES2552237T3 publication Critical patent/ES2552237T3/es
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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
    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/439Heterocyclic 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 the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/468-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K9/0075Sprays 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
    • 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
    • A61M15/0065Inhalators with dosage or measuring devices
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Otolaryngology (AREA)
  • Emergency Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Abstract

Una composición farmacéutica que comprende aclidinio en forma de un polvo seco de una sal farmacéuticamente aceptable mezclado con un vehículo de polvo seco farmacéuticamente aceptable, que proporciona una dosis nominal medida de aclidinio equivalente a 200 microgramos (más/menos 10%) de bromuro de aclidinio para su uso mediante inhalación en el tratamiento del asma.

Description

imagen1
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A diferencia del tiotropio, el efecto broncodilatador de aclidinio durante las 6 primeras horas después de la dosis el Día 29 fue comparable con el del Día 1 (todas las dosis). El tiempo hasta el FEV1 máximo se consiguió a las 3 horas después de la dosis para aclidinio 100-400 µg. Aclidinio fue bien tolerado, sin efectos dependientes de la dosis sobre el ECG, parámetros de laboratorio o acontecimientos adversos.
5 Conclusiones: Aclidinio produjo una broncodilatación sostenida durante 24 horas y fue bien tolerado. Aclidinio 200 y 400 µg tuvo unos efectos broncodilatadores comparables al de tiotropio 18 µg en abierto. Basándose en los datos de eficacia y tolerabilidad, se seleccionó aclidinio 200 µg como dosis de investigación para un futuro ensayo clínico de larga duración en la EPOC.
10
7

Claims (1)

  1. imagen1
    imagen2
ES09720773.2T 2008-03-13 2009-03-13 Composición para inhalación que contiene aclidinio para el tratamiento del asma Active ES2552237T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08382009 2008-03-13
EP08382009A EP2100598A1 (en) 2008-03-13 2008-03-13 Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease
PCT/EP2009/001831 WO2009112273A2 (en) 2008-03-13 2009-03-13 Novel dosage and formulation

Publications (1)

Publication Number Publication Date
ES2552237T3 true ES2552237T3 (es) 2015-11-26

Family

ID=39581534

Family Applications (1)

Application Number Title Priority Date Filing Date
ES09720773.2T Active ES2552237T3 (es) 2008-03-13 2009-03-13 Composición para inhalación que contiene aclidinio para el tratamiento del asma

Country Status (32)

Country Link
US (2) US20110020454A1 (es)
EP (4) EP2100598A1 (es)
JP (3) JP2011513450A (es)
KR (1) KR20100134565A (es)
CN (2) CN102083417A (es)
AR (1) AR070834A1 (es)
CA (1) CA2716723C (es)
CL (1) CL2009000601A1 (es)
CO (1) CO6290637A2 (es)
CY (1) CY1117224T1 (es)
DK (1) DK2265258T3 (es)
EC (1) ECSP10010301A (es)
ES (1) ES2552237T3 (es)
HK (2) HK1214762A1 (es)
HR (1) HRP20160015T1 (es)
HU (1) HUE026037T2 (es)
IL (1) IL206288A0 (es)
ME (1) ME02318B (es)
MX (1) MX2010008234A (es)
NZ (1) NZ585856A (es)
PE (2) PE20091691A1 (es)
PL (1) PL2265258T3 (es)
PT (1) PT2265258E (es)
RS (1) RS54310B1 (es)
RU (2) RU2010141331A (es)
SG (1) SG188824A1 (es)
SI (1) SI2265258T1 (es)
TW (1) TWI419691B (es)
UA (1) UA101653C2 (es)
UY (1) UY31686A1 (es)
WO (1) WO2009112273A2 (es)
ZA (1) ZA201003899B (es)

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