CA2510043A1 - Formulations de solutions aux hfc contenant du tiotropium - Google Patents

Formulations de solutions aux hfc contenant du tiotropium Download PDF

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Publication number
CA2510043A1
CA2510043A1 CA002510043A CA2510043A CA2510043A1 CA 2510043 A1 CA2510043 A1 CA 2510043A1 CA 002510043 A CA002510043 A CA 002510043A CA 2510043 A CA2510043 A CA 2510043A CA 2510043 A1 CA2510043 A1 CA 2510043A1
Authority
CA
Canada
Prior art keywords
acid
hfc
solution formulation
aerosol solution
formulation according
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.)
Abandoned
Application number
CA002510043A
Other languages
English (en)
Inventor
Sabine Six
Christel Schmelzer
Friedrich Schmidt
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.)
Boehringer Ingelheim Pharma GmbH and Co KG
Original Assignee
Individual
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
Application filed by Individual filed Critical Individual
Publication of CA2510043A1 publication Critical patent/CA2510043A1/fr
Abandoned legal-status Critical Current

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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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • 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
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic 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
    • A61K31/439—Heterocyclic 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
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic 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
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61P11/16—Central respiratory analeptics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof

Landscapes

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

Abstract

L'invention a trait à des formulations de solutions pharmaceutiques stables contenant du tiotropium et pouvant être administrées en aérosol. Plus précisément, la présente invention concerne une formulation de solution pharmaceutique stable contenant du tiotropium et pouvant être administrée en aérosol, dans laquelle un acide soit minéral soit organique est ajouté à la formulation de solution pour aérosol, qui contient un sel de tiotropium, de préférence du bromure de tiotropium en solution, un hydrofluorocarbone (HFC) servant de propulseur, et un composé organique faisant fonction de cosolvant. L'acide procure au médicament une stabilité lui permettant de résister à la dégradation ou la décomposition, lesquelles sont causées principalement par l'interaction du médicament avec le cosolvant et/ou l'eau présents dans la formulation de solution.
CA002510043A 2002-12-16 2003-12-04 Formulations de solutions aux hfc contenant du tiotropium Abandoned CA2510043A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP02028238 2002-12-16
EP02028238.0 2002-12-16
PCT/EP2003/013692 WO2004054580A1 (fr) 2002-12-16 2003-12-04 Formulations de solutions aux hfc contenant du tiotropium

Publications (1)

Publication Number Publication Date
CA2510043A1 true CA2510043A1 (fr) 2004-07-01

Family

ID=32524008

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002510043A Abandoned CA2510043A1 (fr) 2002-12-16 2003-12-04 Formulations de solutions aux hfc contenant du tiotropium

Country Status (13)

Country Link
EP (1) EP1575588A1 (fr)
JP (1) JP2006510680A (fr)
KR (1) KR20050085650A (fr)
CN (1) CN1726038A (fr)
AU (1) AU2003303029A1 (fr)
BR (1) BR0317340A (fr)
CA (1) CA2510043A1 (fr)
IL (1) IL169178A0 (fr)
MX (1) MXPA05006383A (fr)
PL (1) PL375868A1 (fr)
RU (1) RU2005122444A (fr)
WO (1) WO2004054580A1 (fr)
ZA (1) ZA200503546B (fr)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7273603B2 (en) * 2003-07-11 2007-09-25 Boehringer Ingelheim International Gmbh HFC solution formulations containing an anticholinergic
CN101203513A (zh) * 2005-05-02 2008-06-18 贝林格尔·英格海姆国际有限公司 噻托溴铵的晶型
ES2393794T3 (es) * 2005-05-02 2012-12-28 Boehringer Ingelheim International Gmbh Nuevas formas cristalinas de bromuro de tiotropio
US9108962B2 (en) 2005-12-19 2015-08-18 Sicor, Inc. Forms of tiotropium bromide and processes for preparation thereof
US8163913B2 (en) * 2005-12-19 2012-04-24 Sicor Inc. Forms of tiotropium bromide and processes for preparation thereof
EP2201934A1 (fr) 2008-12-23 2010-06-30 CHIESI FARMACEUTICI S.p.A. Produits de formule d'aérosol de tiotropium avec stabilité chimique améliorée
SG181870A1 (en) 2009-12-23 2012-07-30 Chiesi Farma Spa Aerosol formulation for copd
EP2515855B3 (fr) 2009-12-23 2023-05-03 Chiesi Farmaceutici S.p.A. Polythérapie pour la COPD
GB201200525D0 (en) * 2011-12-19 2012-02-29 Teva Branded Pharmaceutical Prod R & D Inc An inhalable medicament
GB201200504D0 (en) * 2011-12-19 2012-02-22 Teva Branded Pharmaceutical Prod R & D Inc An inhaler
WO2013127738A1 (fr) 2012-02-28 2013-09-06 Boehringer Ingelheim International Gmbh Nouvelle formulation de tiotropium contenant un gaz propulseur
CA2885767A1 (fr) * 2012-10-23 2014-05-01 Cipla Limited Composition pharmaceutique
US20160250197A1 (en) * 2013-11-22 2016-09-01 Teva Branded Pharmaceutical Products R&D, Inc. An inhalable medicament
US10034866B2 (en) 2014-06-19 2018-07-31 Teva Branded Pharmaceutical Products R&D, Inc. Inhalable medicament comprising tiotropium
ES2904823T3 (es) * 2016-09-19 2022-04-06 Mexichem Fluor Sa De Cv Composición farmacéutica que comprende bromuro de tiotropio
ES2841649T5 (es) * 2016-09-19 2024-04-24 Mexichem Fluor Sa De Cv Composición farmacéutica
CA3037080C (fr) 2016-09-19 2021-05-18 Mexichem Fluor S.A. De C.V. Compositions pharmaceutiques stables comprenant de l'indacaterol et du 1,1-difluoroethane (hfa 152a) pour utilisation dans des aerosols-doseurs
BR112019005168A2 (pt) 2016-09-19 2019-06-11 Mexichem Fluor Sa De Cv composição farmacêutica, recipiente vedado, inalador de dose medida, e, métodos para tratar um paciente que sofre ou susceptível de sofrer de um distúrbio respiratório, para melhoria da estabilidade de uma composição farmacêutica e do desempenho de aerossolização de uma composição farmacêutica e para reduzir o potencial de aquecimento global de uma composição farmacêutica
EP3515432B1 (fr) 2016-09-19 2021-08-25 Mexichem Fluor S.A. de C.V. Composition pharmaceutique comprenant glycopyrrolate

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100312357B1 (ko) * 1992-12-09 2002-04-24 데이비드 이. 프랭크하우저 안정화된약제의에어로졸용액제제
DE10056104A1 (de) * 2000-11-13 2002-05-23 Boehringer Ingelheim Pharma Neue Arzneimittelkompositionen auf der Basis von Tiotropiumsalzen und Salzen des Salmeterols

Also Published As

Publication number Publication date
CN1726038A (zh) 2006-01-25
WO2004054580A1 (fr) 2004-07-01
AU2003303029A1 (en) 2004-07-09
PL375868A1 (en) 2005-12-12
RU2005122444A (ru) 2007-01-27
KR20050085650A (ko) 2005-08-29
ZA200503546B (en) 2006-10-25
BR0317340A (pt) 2005-11-08
JP2006510680A (ja) 2006-03-30
EP1575588A1 (fr) 2005-09-21
MXPA05006383A (es) 2005-08-29
IL169178A0 (en) 2007-07-04

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Legal Events

Date Code Title Description
FZDE Discontinued