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

Formulations de solutions aux hfc contenant du tiotropium Download PDF

Info

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

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
    • 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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (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
EP02028238.0 2002-12-16
EP02028238 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
DK1881980T3 (da) * 2005-05-02 2012-10-01 Boehringer Ingelheim Int Nye krystalline former af tiotropiumbromid
AU2006243239A1 (en) * 2005-05-02 2006-11-09 Boehringer Ingelheim International Gmbh Crystalline forms of tiotropium bromide
US9108962B2 (en) 2005-12-19 2015-08-18 Sicor, Inc. Forms of tiotropium bromide and processes for preparation thereof
JP5086267B2 (ja) * 2005-12-19 2012-11-28 シコール インコーポレイティド 臭化チオトロピウムの新規な形態およびそれを製造する方法
EP2201934A1 (fr) 2008-12-23 2010-06-30 CHIESI FARMACEUTICI S.p.A. Produits de formule d'aérosol de tiotropium avec stabilité chimique améliorée
RS53391B2 (sr) 2009-12-23 2023-09-29 Chiesi Farm Spa Kombinovana terapija copd-a (hroničnih obstruktivnih bolesti pluća)
WO2011076842A2 (fr) 2009-12-23 2011-06-30 Chiesi Farmaceutici S.P.A. Préparation aérosol pour copd (bronchopneumopathie chronique obstructive)
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
JP6335798B2 (ja) 2012-02-28 2018-05-30 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 新規噴射剤含有チオトロピウム製剤
AU2013336492A1 (en) * 2012-10-23 2015-04-09 Cipla Limited Pharmaceutical composition comprising tiotropium and a hydrofluoroalkane
WO2015077594A1 (fr) * 2013-11-22 2015-05-28 Teva Branded Pharmaceutical Products R&D, Inc. Médicament inhalable
US10034866B2 (en) 2014-06-19 2018-07-31 Teva Branded Pharmaceutical Products R&D, Inc. Inhalable medicament comprising tiotropium
MX384545B (es) 2016-09-19 2025-03-14 Mexichem Fluor Sa De Cv Composicion farmaceutica
AU2017328907B2 (en) 2016-09-19 2020-04-09 Mexichem Fluor S.A. De C.V. Pharmaceutical composition
WO2018051132A1 (fr) * 2016-09-19 2018-03-22 Mexichem Fluor S.A. De C.V. Composition pharmaceutique
EP3610877A1 (fr) * 2016-09-19 2020-02-19 Mexichem Fluor S.A. de C.V. Composition pharmaceutique
ES2949975T3 (es) 2016-09-19 2023-10-04 Mexichem Fluor Sa De Cv Composición farmacéutica que comprende indacaterol

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0673240B1 (fr) * 1992-12-09 1999-03-24 Boehringer Ingelheim Pharmaceuticals Inc. Formulations de solutions medicinales aerosol stabilisees
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
ZA200503546B (en) 2006-10-25
AU2003303029A1 (en) 2004-07-09
MXPA05006383A (es) 2005-08-29
PL375868A1 (en) 2005-12-12
CN1726038A (zh) 2006-01-25
IL169178A0 (en) 2007-07-04
JP2006510680A (ja) 2006-03-30
WO2004054580A1 (fr) 2004-07-01
EP1575588A1 (fr) 2005-09-21
BR0317340A (pt) 2005-11-08
RU2005122444A (ru) 2007-01-27
KR20050085650A (ko) 2005-08-29

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Legal Events

Date Code Title Description
FZDE Discontinued