WO2001078695A3 - Pharmaceutical formulations for dry powder inhalers - Google Patents

Pharmaceutical formulations for dry powder inhalers Download PDF

Info

Publication number
WO2001078695A3
WO2001078695A3 PCT/GB2001/001751 GB0101751W WO0178695A3 WO 2001078695 A3 WO2001078695 A3 WO 2001078695A3 GB 0101751 W GB0101751 W GB 0101751W WO 0178695 A3 WO0178695 A3 WO 0178695A3
Authority
WO
WIPO (PCT)
Prior art keywords
dry powder
powder
fine particle
active ingredients
pharmaceutical formulations
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/GB2001/001751
Other languages
French (fr)
Other versions
WO2001078695A2 (en
Inventor
John Nicholas Staniforth
David Alexander Vodden Morton
Rajbir Gill
Gaetano Brambilla
Rossella Musa
Lorenzo Ferrarini
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vectura Ltd
Original Assignee
Vectura Ltd
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=WO2001078695(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 CA2405767A priority Critical patent/CA2405767C/en
Priority to AU48595/01A priority patent/AU4859501A/en
Priority to US10/257,886 priority patent/US7541022B2/en
Priority to EP10185445.3A priority patent/EP2272508B1/en
Priority to HU0300499A priority patent/HU229270B1/en
Priority to PL359289A priority patent/PL204251B1/en
Priority to EP01921625A priority patent/EP1276473B1/en
Application filed by Vectura Ltd filed Critical Vectura Ltd
Priority to BR0110139-0A priority patent/BR0110139A/en
Priority to DE60131265T priority patent/DE60131265T2/en
Priority to MXPA02010212A priority patent/MXPA02010212A/en
Publication of WO2001078695A2 publication Critical patent/WO2001078695A2/en
Publication of WO2001078695A3 publication Critical patent/WO2001078695A3/en
Priority to NO20024973A priority patent/NO342999B1/en
Anticipated expiration legal-status Critical
Priority to US12/386,758 priority patent/US8871274B2/en
Priority to US14/492,156 priority patent/US9566239B2/en
Ceased legal-status Critical Current

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
    • A61K9/0012—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
    • 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
    • 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Diabetes (AREA)
  • Pain & Pain Management (AREA)
  • Dispersion Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (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

A powder for use in a dry powder inhaler comprises: i) a fractio n of fine particle size constituted by a mixture of physiologically acceptable excipient and an additive; ii) a fraction of coarse particles; and iii) at least one active ingredient. The powder is suitable for efficacious delivery of active ingredients into the low respiratory tract of patients suffering from pulmonary diseases such as asthma. In particular, the invention provides a formulation to be administered as dry powder for inhalation which is freely flowable, can be produced in a simple way, is physically and chemically stable and capable of delivering accurate doses and/or high fine particle fraction of low strength active ingredients by using a high- or medium resistance device.
PCT/GB2001/001751 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers Ceased WO2001078695A2 (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
BR0110139-0A BR0110139A (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers
DE60131265T DE60131265T2 (en) 2000-04-17 2001-04-17 PHARMACEUTICAL FORMULATIONS FOR DRY POWDER INHALATORS
MXPA02010212A MXPA02010212A (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers.
AU48595/01A AU4859501A (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers
US10/257,886 US7541022B2 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers
EP10185445.3A EP2272508B1 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers
HU0300499A HU229270B1 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers
PL359289A PL204251B1 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers
EP01921625A EP1276473B1 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers
CA2405767A CA2405767C (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers
NO20024973A NO342999B1 (en) 2000-04-17 2002-10-16 Powder for use in a dry powder inhaler, as well as a process for its preparation
US12/386,758 US8871274B2 (en) 2000-04-17 2009-04-21 Pharmaceutical formulations for dry powder inhalers
US14/492,156 US9566239B2 (en) 2000-04-17 2014-09-22 Pharmaceutical formulations for dry powder inhalers

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
EP00113608.4 2000-06-27
EP00113608 2000-06-27

Related Child Applications (3)

Application Number Title Priority Date Filing Date
US10257886 A-371-Of-International 2001-04-17
US10/257,886 A-371-Of-International US7541022B2 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers
US12/386,758 Continuation US8871274B2 (en) 2000-04-17 2009-04-21 Pharmaceutical formulations for dry powder inhalers

Publications (2)

Publication Number Publication Date
WO2001078695A2 WO2001078695A2 (en) 2001-10-25
WO2001078695A3 true WO2001078695A3 (en) 2002-03-14

Family

ID=26071084

Family Applications (3)

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

Family Applications Before (2)

Application Number Title Priority Date Filing Date
PCT/EP2001/004338 Ceased WO2001078693A2 (en) 2000-04-17 2001-04-17 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets
PCT/GB2001/001732 Ceased 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) EP1276473B1 (en)
JP (2) JP2003530425A (en)
KR (1) KR20030069047A (en)
CN (1) CN1424909A (en)
AT (5) ATE348603T1 (en)
AU (3) AU784719B2 (en)
BR (3) BR0110139A (en)
CA (3) CA2406119C (en)
CY (1) CY1107315T1 (en)
CZ (1) CZ301904B6 (en)
DE (3) DE60131265T2 (en)
DK (3) DK1719505T3 (en)
DZ (1) DZ3315A1 (en)
EE (1) EE05257B1 (en)
ES (3) ES2292576T3 (en)
GB (2) GB2363988A (en)
HU (4) HU229270B1 (en)
IL (1) IL152306A0 (en)
MA (1) MA26892A1 (en)
MX (3) MXPA02010213A (en)
MY (1) MY129384A (en)
NO (4) NO332025B1 (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) WO2001078693A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12097329B2 (en) 2018-10-30 2024-09-24 Chiesi Farmaceutici S.P.A. Apparatus to administer drugs to mechanically ventilated patients

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