BR0317340A - Hfc formulations in tiotropium containing solution - Google Patents

Hfc formulations in tiotropium containing solution

Info

Publication number
BR0317340A
BR0317340A BR0317340-2A BR0317340A BR0317340A BR 0317340 A BR0317340 A BR 0317340A BR 0317340 A BR0317340 A BR 0317340A BR 0317340 A BR0317340 A BR 0317340A
Authority
BR
Brazil
Prior art keywords
solution
tiotropium
formulations
hfc
solvent
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.)
Expired - Fee Related
Application number
BR0317340-2A
Other languages
Portuguese (pt)
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 Co KG
Original Assignee
Boehringer Ingelheim Pharma GmbH Co KG
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 Boehringer Ingelheim Pharma GmbH Co KG filed Critical Boehringer Ingelheim Pharma GmbH Co KG
Publication of BR0317340A publication Critical patent/BR0317340A/en
Expired - Fee Related 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

"FORMULAçõES DE HFC EM SOLUçãO CONTENDO TIOTRóPIO". A presente invenção refere-se a formulações farmacêuticas em solução estáveis que contêm tiotrópio adequadas para administração por aerossol. Mais particularmente, esta invenção refere-se a formulações farmacêuticas em solução estáveis que contêm tiotrópio adequadas para administração por aerossol em que um ácido inorgânico ou um ácido orgânico é adicionado à formulação em solução por aerossol que contém um sal de tiotrópio, de preferência o brometo de tiotrópio em solução com um hidrofluorocarboneto (HFC) ambientalmente inofensivo como um propulsor, juntamente com um composto orgânico como um co-solvente. O ácido fornece estabilidade contra a degradação ou a decomposição do medicamento resultante amplamente da interação do medicamento com o co-solvente e/ou com a água presente na formulação em solução."HFC FORMULATIONS IN SOLUTION CONTAINING THIOTROPE". The present invention relates to stable solution pharmaceutical formulations containing tiotropium suitable for aerosol administration. More particularly, this invention relates to stable tiotropium-containing pharmaceutical solution formulations suitable for aerosol administration wherein an inorganic acid or an organic acid is added to the aerosol solution-formulation containing a tiotropium salt, preferably bromide. of tiotropium in solution with an environmentally harmless hydrofluorocarbon (HFC) as a propellant, together with an organic compound as a co-solvent. The acid provides stability against drug degradation or decomposition largely resulting from drug interaction with the co-solvent and / or water present in the solution formulation.

BR0317340-2A 2002-12-16 2003-12-04 Hfc formulations in tiotropium containing solution Expired - Fee Related BR0317340A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP02028238 2002-12-16
PCT/EP2003/013692 WO2004054580A1 (en) 2002-12-16 2003-12-04 Tiotropium containing hfc solution formulations

Publications (1)

Publication Number Publication Date
BR0317340A true BR0317340A (en) 2005-11-08

Family

ID=32524008

Family Applications (1)

Application Number Title Priority Date Filing Date
BR0317340-2A Expired - Fee Related BR0317340A (en) 2002-12-16 2003-12-04 Hfc formulations in tiotropium containing solution

Country Status (13)

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

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
BRPI0609295A2 (en) * 2005-05-02 2010-03-23 Boehringer Ingelheim Int crystalline forms of tiotropium bromide, pharmaceutical composition, use and method for preparing same
CA2606552A1 (en) * 2005-05-02 2006-11-09 Boehringer Ingelheim International Gmbh Crystalline forms of tiotropium bromide
PT1869035E (en) * 2005-12-19 2013-01-10 Sicor Inc Novel crystalline form of tiotropium bromide and process for preparation thereof
US9108962B2 (en) 2005-12-19 2015-08-18 Sicor, Inc. Forms of tiotropium bromide and processes for preparation thereof
EP2201934A1 (en) 2008-12-23 2010-06-30 CHIESI FARMACEUTICI S.p.A. Tiotropium aerosol formulation products with improved chemical stability
SG181870A1 (en) 2009-12-23 2012-07-30 Chiesi Farma Spa Aerosol formulation for copd
PT2515855E (en) 2009-12-23 2014-06-11 Chiesi Farma Spa Combination therapy for 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
EP2819669B1 (en) 2012-02-28 2021-04-21 Boehringer Ingelheim International GmbH New tiotropium formula containing propellant
KR20150096371A (en) * 2012-10-23 2015-08-24 시플라 리미티드 Pharmaceutical composition
KR20160101929A (en) * 2013-11-22 2016-08-26 테바 브랜디드 파마슈티컬 프로덕츠 알앤디, 인코포레이티드 An inhalable medicament
US10034866B2 (en) 2014-06-19 2018-07-31 Teva Branded Pharmaceutical Products R&D, Inc. Inhalable medicament comprising tiotropium
ES2968453T3 (en) 2016-09-19 2024-05-09 Mexichem Fluor Sa De Cv Pharmaceutical composition comprising glycopyrrolate
CN113288869A (en) 2016-09-19 2021-08-24 墨西哥氟石股份公司 Pharmaceutical composition
EP3922240B1 (en) * 2016-09-19 2023-06-21 Mexichem Fluor S.A. de C.V. Pharmaceutical composition comprising tiotropium bromide
JP6781832B2 (en) * 2016-09-19 2020-11-04 メキシケム フロー エセ・ア・デ・セ・ヴェ Pharmaceutical composition
AU2017328910B2 (en) 2016-09-19 2020-04-09 Mexichem Fluor S.A. De C.V. Pharmaceutical composition

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK0673240T3 (en) * 1992-12-09 1999-10-11 Boehringer Ingelheim Pharma Stabilized medical aerosol solution formulations
DE10056104A1 (en) * 2000-11-13 2002-05-23 Boehringer Ingelheim Pharma Drug compositions useful for treatment of respiratory diseases, especially asthma and chronic obstructive pulmonary disease comprises tiotropium salts and salmeterol salts

Also Published As

Publication number Publication date
ZA200503546B (en) 2006-10-25
EP1575588A1 (en) 2005-09-21
IL169178A0 (en) 2007-07-04
PL375868A1 (en) 2005-12-12
JP2006510680A (en) 2006-03-30
RU2005122444A (en) 2007-01-27
KR20050085650A (en) 2005-08-29
CA2510043A1 (en) 2004-07-01
CN1726038A (en) 2006-01-25
MXPA05006383A (en) 2005-08-29
WO2004054580A1 (en) 2004-07-01
AU2003303029A1 (en) 2004-07-09

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Legal Events

Date Code Title Description
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 5A, 6A E 7A ANUIDADE(S).

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2073 DE 28/09/2010.