WO2001078693A3 - Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets - Google Patents

Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets Download PDF

Info

Publication number
WO2001078693A3
WO2001078693A3 PCT/EP2001/004338 EP0104338W WO0178693A3 WO 2001078693 A3 WO2001078693 A3 WO 2001078693A3 EP 0104338 W EP0104338 W EP 0104338W WO 0178693 A3 WO0178693 A3 WO 0178693A3
Authority
WO
WIPO (PCT)
Prior art keywords
dry powder
pellets
hard
pharmaceutical formulations
powder inhalers
Prior art date
Application number
PCT/EP2001/004338
Other languages
French (fr)
Other versions
WO2001078693A2 (en
Inventor
John Nicholas Staniforth
Morton David Alexander Vodden
Rajbir Gill
Gaetano Brambilla
Rossella Musa
Lorenzo Ferrarini
Original Assignee
Chiesi Farma Spa
John Nicholas Staniforth
Morton David Alexander Vodden
Rajbir Gill
Gaetano Brambilla
Rossella Musa
Lorenzo Ferrarini
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=26071084&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2001078693(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from GBGB0009469.8A external-priority patent/GB0009469D0/en
Priority to CA002406119A priority Critical patent/CA2406119C/en
Priority to HU1300117A priority patent/HU230464B1/en
Priority to EEP200200593A priority patent/EE05257B1/en
Priority to HU0300593A priority patent/HU229797B1/en
Priority to DZ013315A priority patent/DZ3315A1/en
Priority to DE60123031T priority patent/DE60123031T2/en
Priority to MXPA02010218A priority patent/MXPA02010218A/en
Priority to US10/257,368 priority patent/US6884794B2/en
Application filed by Chiesi Farma Spa, John Nicholas Staniforth, Morton David Alexander Vodden, Rajbir Gill, Gaetano Brambilla, Rossella Musa, Lorenzo Ferrarini filed Critical Chiesi Farma Spa
Priority to PL358875A priority patent/PL204213B1/en
Priority to AU2001258343A priority patent/AU2001258343A1/en
Priority to BR0110301-6A priority patent/BR0110301A/en
Priority to SI200130658T priority patent/SI1274406T1/en
Priority to SK1491-2002A priority patent/SK284248B6/en
Priority to EP01931612A priority patent/EP1274406B1/en
Publication of WO2001078693A2 publication Critical patent/WO2001078693A2/en
Publication of WO2001078693A3 publication Critical patent/WO2001078693A3/en
Priority to NO20024980A priority patent/NO332025B1/en
Priority to US11/073,625 priority patent/US7223748B2/en
Priority to NO20110885A priority patent/NO336687B1/en

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
    • 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
    • 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
    • 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
    • A61K31/56—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K9/0078—Sprays 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
    • 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
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Diabetes (AREA)
  • Dispersion Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

The invention provides a formulation to be administered as dry powder for inhalation suitable for efficacious delivery of active ingredients into the low respiratory tract of patients suffering of pulmonary diseases such as asthma. In particular, the invention provides a formulation to be administered as dry powder for inhalation freely flowable, which can be produced in a simple way, physically and chemically stable and able of delivering either accurate doses and high fine particle fraction of low strength active ingredients by using a high- or medium resistance device.
PCT/EP2001/004338 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets WO2001078693A2 (en)

Priority Applications (17)

Application Number Priority Date Filing Date Title
SK1491-2002A SK284248B6 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets
EP01931612A EP1274406B1 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets
PL358875A PL204213B1 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets
EEP200200593A EE05257B1 (en) 2000-04-17 2001-04-17 Pharmaceutical preparations in the form of hard pellets for dry powder inhalers
HU0300593A HU229797B1 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets
DZ013315A DZ3315A1 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets
DE60123031T DE60123031T2 (en) 2000-04-17 2001-04-17 PHARMACEUTICAL FORMULATIONS FOR DRY POWDER INHALATORS IN THE FORM OF HARTPELLETS
MXPA02010218A MXPA02010218A (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets.
US10/257,368 US6884794B2 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets
CA002406119A CA2406119C (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets
HU1300117A HU230464B1 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard pellets
AU2001258343A AU2001258343A1 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets
BR0110301-6A BR0110301A (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard pellets
SI200130658T SI1274406T1 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets
NO20024980A NO332025B1 (en) 2000-04-17 2002-10-16 Pharmaceutical formulations for dry powder inhalers in the form of hard pellets
US11/073,625 US7223748B2 (en) 2000-04-17 2005-03-08 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets
NO20110885A NO336687B1 (en) 2000-04-17 2011-06-20 Pharmaceutical formulations for dry powder inhalers in the form of hard pellets

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GBGB0009469.8A GB0009469D0 (en) 2000-04-17 2000-04-17 Improvements in or relating to formalities for use in inhaler devices
GB0009469.8 2000-04-17
EP00113608 2000-06-27
EP00113608.4 2000-06-27

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US10257368 A-371-Of-International 2001-04-17
US11/073,625 Continuation US7223748B2 (en) 2000-04-17 2005-03-08 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets

Publications (2)

Publication Number Publication Date
WO2001078693A2 WO2001078693A2 (en) 2001-10-25
WO2001078693A3 true WO2001078693A3 (en) 2002-01-17

Family

ID=26071084

Family Applications (3)

Application Number Title Priority Date Filing Date
PCT/GB2001/001751 WO2001078695A2 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers
PCT/GB2001/001732 WO2001078694A2 (en) 2000-04-17 2001-04-17 Formulations for use in inhaler devices
PCT/EP2001/004338 WO2001078693A2 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets

Family Applications Before (2)

Application Number Title Priority Date Filing Date
PCT/GB2001/001751 WO2001078695A2 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers
PCT/GB2001/001732 WO2001078694A2 (en) 2000-04-17 2001-04-17 Formulations for use in inhaler devices

Country Status (32)

Country Link
US (4) US6884794B2 (en)
EP (6) EP1274406B1 (en)
JP (2) JP2003530425A (en)
KR (1) KR20030069047A (en)
CN (1) CN1424909A (en)
AT (5) ATE339195T1 (en)
AU (3) AU4859501A (en)
BR (3) BR0110139A (en)
CA (3) CA2406201C (en)
CY (1) CY1107315T1 (en)
CZ (1) CZ301904B6 (en)
DE (3) DE60125344T2 (en)
DK (3) DK1274406T3 (en)
DZ (1) DZ3315A1 (en)
EE (1) EE05257B1 (en)
ES (3) ES2275669T3 (en)
GB (2) GB2363988A (en)
HU (4) HU229797B1 (en)
IL (1) IL152306A0 (en)
MA (1) MA26892A1 (en)
MX (3) MXPA02010212A (en)
MY (1) MY129384A (en)
NO (4) NO342999B1 (en)
NZ (1) NZ521887A (en)
PE (1) PE20011227A1 (en)
PL (3) PL204251B1 (en)
PT (3) PT1719505E (en)
SA (1) SA01220062B1 (en)
SI (2) SI1719505T1 (en)
SK (1) SK284248B6 (en)
TN (1) TNSN01060A1 (en)
WO (3) WO2001078695A2 (en)

Cited By (1)

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US9011852B2 (en) 2010-04-30 2015-04-21 Alexion Pharmaceuticals, Inc. Anti-C5a antibodies

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