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CA2733294A1 - Pharmaceutical combination of a tiotropium salt and ciclesonide - Google Patents

Pharmaceutical combination of a tiotropium salt and ciclesonide Download PDF

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Publication number
CA2733294A1
CA2733294A1 CA2733294A CA2733294A CA2733294A1 CA 2733294 A1 CA2733294 A1 CA 2733294A1 CA 2733294 A CA2733294 A CA 2733294A CA 2733294 A CA2733294 A CA 2733294A CA 2733294 A1 CA2733294 A1 CA 2733294A1
Authority
CA
Canada
Prior art keywords
pharmaceutical combination
combination according
combination
pharmaceutical
treatment
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.)
Granted
Application number
CA2733294A
Other languages
French (fr)
Other versions
CA2733294C (en
Inventor
Michel Pairet
Michael Paul Pieper
Christopher John Montague Meade
Richard Reichl
Christel Schmelzer
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
Boehringer Ingelheim Pharma GmbH and 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
Priority claimed from DE10062712A external-priority patent/DE10062712A1/en
Application filed by Boehringer Ingelheim Pharma GmbH and Co KG filed Critical Boehringer Ingelheim Pharma GmbH and Co KG
Priority claimed from CA2614631A external-priority patent/CA2614631C/en
Publication of CA2733294A1 publication Critical patent/CA2733294A1/en
Application granted granted Critical
Publication of CA2733294C publication Critical patent/CA2733294C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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
    • A61K9/0012—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
    • A61K31/33—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
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • 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
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Otolaryngology (AREA)
  • Emergency Medicine (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Steroid Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Abstract

The present invention relates to novel pharmaceutical combinations based on a tiotropium salt and ciciesonide, and the use thereof in the treatment of respiratory tract diseases.

Claims (14)

1. Pharmaceutical combination of a tiotropium salt (1) with the steroid ciclesonide (2), optionally in the form of the enantiomers, mixtures of the enantiomers or in the form of the racemates thereof, optionally in the form of the solvates or hydrates and optionally together with a pharmaceutically acceptable excipient.
2. Pharmaceutical combination according to claim 1, wherein 1 is present in the form of the chloride, bromide, iodide, methanesulphonate, sulphonate or paratoluene sulphonate.
3. Pharmaceutical combination according to claim 1, wherein 1 is present in the form of the bromide.
4. Pharmaceutical combination according to claim 1, wherein 1 is present in the form of the bromide monohydrate.
5. Pharmaceutical combination according to any one of claims 1 to 4, wherein weight ratios of 1 and 2 are in the range from 1:300 to 50:1.
6. Pharmaceutical combination according to any one of claims 1 to 4, wherein weight ratios of 1 and 2 are in the range from 1:250 to 40:1.
7. Pharmaceutical combination according to any one of claims 1 to 6, wherein a single application corresponds to a dosage of the combination 1 and 2 of 0.1 to 10000 µg.
8. Pharmaceutical combination according to any one of claims 1 to 6, wherein a single application corresponds to a dosage of the combination 1 and from 0.1 to 2000 µg.
9. Use of a combination as defined in claim 1, 2, 3, 4, 5, 6, 7 or 8 for preparing a medicament for treating an inflammatory or an obstructive disease of the respiratory tract.
10. Use of a combination as defined in claim 1, 2, 3, 4, 5, 6, 7 or 8 for preparing a medicament for treating asthma.
11. Use of a combination as defined in claim 1, 2, 3, 4, 5, 6, 7 or 8 for preparing a medicament for treating chronic obstructive pulmonary disease.
12. Pharmaceutical combination according to any one of claims 1 to 8 for use in the treatment of asthma or chronic obstructive pulmonary disease.
13. Use of a combination as defined in claim 1, 2, 3, 4, 5, 6, 7 or 8 for treatment of asthma.
14. Use of a combination as defined in claim 1, 2, 3, 4, 5, 6, 7 or 8 for treatment of chronic obstructive pulmonary disease.
CA2733294A 2000-10-31 2001-10-23 Pharmaceutical combination of a tiotropium salt and ciclesonide Expired - Fee Related CA2733294C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE10054042.2 2000-10-31
DE10054042 2000-10-31
DE10062712A DE10062712A1 (en) 2000-12-15 2000-12-15 New drug compositions based on anticholinergics and corticosteroids
DE10062712.9 2000-12-15
CA2614631A CA2614631C (en) 2000-10-31 2001-10-23 Pharmaceutical compositions based on anticholinergics and corticosteroids in the form of an inhalable solution or suspension

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2614631A Division CA2614631C (en) 2000-10-31 2001-10-23 Pharmaceutical compositions based on anticholinergics and corticosteroids in the form of an inhalable solution or suspension

Publications (2)

Publication Number Publication Date
CA2733294A1 true CA2733294A1 (en) 2002-05-10
CA2733294C CA2733294C (en) 2011-12-20

Family

ID=26007540

Family Applications (2)

Application Number Title Priority Date Filing Date
CA002436540A Expired - Fee Related CA2436540C (en) 2000-10-31 2001-10-23 Pharmaceutical compositions based on anticholinergics and corticosteroids
CA2733294A Expired - Fee Related CA2733294C (en) 2000-10-31 2001-10-23 Pharmaceutical combination of a tiotropium salt and ciclesonide

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA002436540A Expired - Fee Related CA2436540C (en) 2000-10-31 2001-10-23 Pharmaceutical compositions based on anticholinergics and corticosteroids

Country Status (8)

Country Link
EP (1) EP1333830A2 (en)
JP (1) JP2004512359A (en)
AU (1) AU2002210575A1 (en)
CA (2) CA2436540C (en)
MX (1) MXPA03003751A (en)
PE (1) PE20020576A1 (en)
UY (1) UY26992A1 (en)
WO (1) WO2002036106A2 (en)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2165768B1 (en) 1999-07-14 2003-04-01 Almirall Prodesfarma Sa NEW DERIVATIVES OF QUINUCLIDINE AND PHARMACEUTICAL COMPOSITIONS THAT CONTAIN THEM.
US7214687B2 (en) 1999-07-14 2007-05-08 Almirall Ag Quinuclidine derivatives and medicinal compositions containing the same
US6777399B2 (en) 2000-08-05 2004-08-17 Smithkline Beecham Corporation Anti-inflammatory androstane derivative compositions
GB0019172D0 (en) 2000-08-05 2000-09-27 Glaxo Group Ltd Novel compounds
US6858596B2 (en) 2000-08-05 2005-02-22 Smithkline Beecham Corporation Formulation containing anti-inflammatory androstane derivative
AU7576001A (en) 2000-08-05 2002-02-18 Glaxo Group Ltd 6.alpha., 9.alpha.-difluoro-17.alpha.-`(2-furanylcarboxyl) oxy]-11.beta.-hydroxy-16.alpha.-methyl-3-oxo-androst-1,4,-diene-17-carbothioic acid s-fluoromethyl ester as an anti-inflammatory agent
WO2002088167A1 (en) 2001-04-30 2002-11-07 Glaxo Group Limited Anti-inflammatory 17.beta.-carbothioate ester derivatives of androstane with a cyclic ester group in position 17.alpha
US7311894B2 (en) 2002-03-28 2007-12-25 Boehringer Ingelheim Pharma Gmbh & Co. Kg HFA suspension formulations containing an anticholinergic
US7244415B2 (en) 2002-03-28 2007-07-17 Boehringer Ingelheim Pharma Gmbh & Co. Kg HFA suspension formulations of an anhydrate
DE10214263A1 (en) * 2002-03-28 2003-10-16 Boehringer Ingelheim Pharma HFA suspension formulations containing an anticholinergic
DE10216429A1 (en) * 2002-04-12 2003-10-23 Boehringer Ingelheim Pharma Synergistic medicaments for treating inflammatory or obstructive respiratory tract diseases, containing quaternized scopine ester anticholinergic agent and steroid, e.g. budesonide
US7084153B2 (en) 2002-04-12 2006-08-01 Boehringer Ingelheim Pharma Gmbh & Co. Kg Medicaments comprising steroids and a novel anticholinergic
GB2389530B (en) 2002-06-14 2007-01-10 Cipla Ltd Pharmaceutical compositions
US20040102469A1 (en) * 2002-09-13 2004-05-27 Boehringer Ingelheim Pharma Gmbh & Co. Kg Method for reducing the mortality rate
ES2257152B1 (en) 2004-05-31 2007-07-01 Laboratorios Almirall S.A. COMBINATIONS THAT INCLUDE ANTIMUSCARINIC AGENTS AND BETA-ADRENERGIC AGONISTS.
PT1765404E (en) 2004-05-31 2009-03-31 Almirall Lab Combinations comprising antimuscarinic agents and beta-adrenergic agonists
EP1763344A1 (en) * 2004-06-29 2007-03-21 Boehringer Ingelheim International GmbH Medicaments for inhalation comprising steroids and an anticholinergic
GB0523653D0 (en) * 2005-11-21 2005-12-28 Novartis Ag Organic compounds
ES2298049B1 (en) 2006-07-21 2009-10-20 Laboratorios Almirall S.A. PROCEDURE FOR MANUFACTURING BROMIDE OF 3 (R) - (2-HIDROXI-2,2-DITIEN-2-ILACETOXI) -1- (3-PHENOXIPROPIL) -1-AZONIABICICLO (2.2.2) OCTANO.
WO2008102128A2 (en) 2007-02-19 2008-08-28 Cipla Limited Pharmaceutical combinations of at least two bronchodilators or of a bronchodilator with a corticosteroid
EP2100599A1 (en) * 2008-03-13 2009-09-16 Laboratorios Almirall, S.A. Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease
EP2100598A1 (en) * 2008-03-13 2009-09-16 Laboratorios Almirall, S.A. Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease
TR200909792A2 (en) * 2009-12-25 2011-07-21 B�Lg�� Mahmut Dry powder combination containing tiotropium, corticosteroid and a combination of chromoglycic acid derivative
TR200909793A2 (en) * 2009-12-25 2011-07-21 B�Lg�� Mahmut Combination of dry powder containing a combination of tiotropium, mometasone and a chromoglycic acid derivative.
US8834931B2 (en) 2009-12-25 2014-09-16 Mahmut Bilgic Dry powder formulation containing tiotropium for inhalation
TR200909789A2 (en) * 2009-12-25 2011-07-21 B�Lg�� Mahmut Dry powder combination containing tiotropium, budesonide and a chromoglycic acid derivative combination
EP2510928A1 (en) 2011-04-15 2012-10-17 Almirall, S.A. Aclidinium for use in improving the quality of sleep in respiratory patients
EP4188327B1 (en) 2020-07-31 2025-05-28 Chemo Research, S.L. Combination therapy for inhalation administration

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0504112A3 (en) * 1991-03-14 1993-04-21 Ciba-Geigy Ag Pharmaceutical aerosol formulations
DE19835346A1 (en) * 1998-08-05 2000-02-10 Boehringer Ingelheim Pharma Two-part capsule for pharmaceutical preparations for powder inhalers
GB0009606D0 (en) * 2000-04-18 2000-06-07 Glaxo Group Ltd Therapeutic combinations
GB0009605D0 (en) * 2000-04-18 2000-06-07 Glaxo Group Ltd Medicaments
GB0009592D0 (en) * 2000-04-18 2000-06-07 Glaxo Group Ltd Respiratory combinations

Also Published As

Publication number Publication date
WO2002036106A3 (en) 2002-09-19
AU2002210575A1 (en) 2002-05-15
JP2004512359A (en) 2004-04-22
UY26992A1 (en) 2002-06-20
CA2436540A1 (en) 2002-05-10
CA2436540C (en) 2008-01-29
EP1333830A2 (en) 2003-08-13
CA2733294C (en) 2011-12-20
MXPA03003751A (en) 2004-10-15
WO2002036106A2 (en) 2002-05-10
PE20020576A1 (en) 2002-08-09

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Effective date: 20201023