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RU2005122444A - COMPOSITIONS IN THE FORM OF THYOTROPY-CONTAINING SOLUTIONS WITH HYDROFLUOROCHLORIDE - Google Patents

COMPOSITIONS IN THE FORM OF THYOTROPY-CONTAINING SOLUTIONS WITH HYDROFLUOROCHLORIDE Download PDF

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Publication number
RU2005122444A
RU2005122444A RU2005122444/15A RU2005122444A RU2005122444A RU 2005122444 A RU2005122444 A RU 2005122444A RU 2005122444/15 A RU2005122444/15 A RU 2005122444/15A RU 2005122444 A RU2005122444 A RU 2005122444A RU 2005122444 A RU2005122444 A RU 2005122444A
Authority
RU
Russia
Prior art keywords
acid
composition according
hfc
tiotropium
solvent
Prior art date
Application number
RU2005122444/15A
Other languages
Russian (ru)
Inventor
Забине ЗИКС (DE)
Забине ЗИКС
Кристель ШМЕЛЬЦЕР (DE)
Кристель Шмельцер
Фридрих ШМИДТ (DE)
Фридрих Шмидт
Original Assignee
Берингер Ингельхайм Фарма Гмбх Унд Ко.Кг (De)
Берингер Ингельхайм Фарма Гмбх Унд Ко.Кг
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 Берингер Ингельхайм Фарма Гмбх Унд Ко.Кг (De), Берингер Ингельхайм Фарма Гмбх Унд Ко.Кг filed Critical Берингер Ингельхайм Фарма Гмбх Унд Ко.Кг (De)
Publication of RU2005122444A publication Critical patent/RU2005122444A/en

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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)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (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)

Claims (11)

1. Композиция в виде раствора для аэрозольного распыления, содержащая соль тиотропия, гидрофторуглерод (HFC) в качестве пропеллента, сорастворитель и неорганическую или органическую кислоту, отличающаяся тем, что концентрация кислоты лежит в интервале, который соответствует интервалу значений рН от 2,5 до 4,5 в водном растворе.1. The composition in the form of a solution for aerosol spraying, containing a salt of tiotropium, hydrofluorocarbon (HFC) as a propellant, a co-solvent and inorganic or organic acid, characterized in that the acid concentration lies in the range that corresponds to a pH range from 2.5 to 4 5 in aqueous solution. 2. Композиция по п.1, отличающаяся тем, что она содержит тиотропий в количестве от 0,00008 до 0,4%.2. The composition according to claim 1, characterized in that it contains tiotropium in an amount of from 0.00008 to 0.4%. 3. Композиция по п.1 или 2, отличающаяся тем, что противоион (анион), образующий вместе с тиотропием его соль, может представлять собой хлорид, бромид, иодид, метансульфонат или пара-толуолсульфонат.3. The composition according to claim 1 or 2, characterized in that the counterion (anion) that forms its salt together with tiotropium can be chloride, bromide, iodide, methanesulfonate or para-toluenesulfonate. 4. Композиция по п.1 или 2, отличающаяся тем, что гидрофторуглеродный пропеллент выбран из HFC-134(a), HFC-227, HFC-32, HFC-143(a), HFC-134, HFC-152a и их смесей.4. The composition according to claim 1 or 2, characterized in that the hydrofluorocarbon propellant is selected from HFC-134 (a), HFC-227, HFC-32, HFC-143 (a), HFC-134, HFC-152a and mixtures thereof . 5. Композиция по п.1 или 2, отличающаяся тем, что кислота выбрана из группы неорганических кислот, включающей соляную кислоту, серную кислоту, азотную кислоту и фосфорную кислоту.5. The composition according to claim 1 or 2, characterized in that the acid is selected from the group of inorganic acids, including hydrochloric acid, sulfuric acid, nitric acid and phosphoric acid. 6. Композиция по п.1 или 2, отличающаяся тем, что кислота выбрана из группы органических кислот, включающей аскорбиновую кислоту, лимонную кислоту, молочную кислоту, яблочную кислоту, бензойную кислоту и винную кислоту.6. The composition according to claim 1 or 2, characterized in that the acid is selected from the group of organic acids, including ascorbic acid, citric acid, lactic acid, malic acid, benzoic acid and tartaric acid. 7. Композиция по п.1 или 2, отличающаяся тем, что она содержит воду в количестве до примерно 5%.7. The composition according to claim 1 or 2, characterized in that it contains water in an amount up to about 5%. 8. Композиция по п.1 или 2, отличающаяся тем, что она содержит в качестве сорастворителя спирты, гликоли, простые эфиры гликоля, блоксополимеры этиленоксида и пропиленоксида, глицерин, полиоксиэтиленовые спирты, эфиры полиоксиэтилена и жирных кислот или гликофуролы.8. The composition according to claim 1 or 2, characterized in that it contains alcohols, glycols, glycol ethers, block copolymers of ethylene oxide and propylene oxide, glycerin, polyoxyethylene alcohols, polyoxyethylene fatty acid esters or glycofurols as co-solvent. 9. Композиция по п.1 или 2, отличающаяся тем, что сорастворитель присутствует в количестве от 5 до 50 мас.%.9. The composition according to claim 1 or 2, characterized in that the co-solvent is present in an amount of from 5 to 50 wt.%. 10. Композиция по п.1 или 2, отличающаяся тем, что она не содержит воду.10. The composition according to claim 1 or 2, characterized in that it does not contain water. 11. Применение композиции в виде раствора для аэрозольного распыления по одному из пп.1-10 для получения лекарственного средства, предназначенного для лечения заболеваний дыхательных путей.11. The use of the composition in the form of a solution for aerosol spraying according to one of claims 1 to 10 for the manufacture of a medicinal product intended for the treatment of diseases of the respiratory tract.
RU2005122444/15A 2002-12-16 2003-12-04 COMPOSITIONS IN THE FORM OF THYOTROPY-CONTAINING SOLUTIONS WITH HYDROFLUOROCHLORIDE RU2005122444A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP02028238.0 2002-12-16
EP02028238 2002-12-16

Publications (1)

Publication Number Publication Date
RU2005122444A true RU2005122444A (en) 2007-01-27

Family

ID=32524008

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2005122444/15A RU2005122444A (en) 2002-12-16 2003-12-04 COMPOSITIONS IN THE FORM OF THYOTROPY-CONTAINING SOLUTIONS WITH HYDROFLUOROCHLORIDE

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
RU2007144531A (en) * 2005-05-02 2009-06-10 БЕРИНГЕР ИНГЕЛЬХАЙМ ИНТЕРНАЦИОНАЛЬ ГмбХ (DE) NEW CRYSTAL FORMS OF THIOTROPYBROMIDE
SI1881980T1 (en) * 2005-05-02 2012-12-31 Boehringer Ingelheim International Gmbh Novel crystalline forms of tiotropium bromide
BRPI0608427A2 (en) 2005-12-19 2009-12-29 Sicor Inc new forms of tiotropium bromide and processes for its preparation
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
JP5914354B2 (en) 2009-12-23 2016-05-11 シエシー ファルマセウティチィ ソシエタ ペル アチオニ Combination therapy for COPD
GEP20166479B (en) 2009-12-23 2016-05-25 Chiesi Farma Spa Aerosol formulation for copd
GB201200504D0 (en) * 2011-12-19 2012-02-22 Teva Branded Pharmaceutical Prod R & D Inc An inhaler
GB201200525D0 (en) * 2011-12-19 2012-02-29 Teva Branded Pharmaceutical Prod R & D Inc An inhalable medicament
WO2013127738A1 (en) 2012-02-28 2013-09-06 Boehringer Ingelheim International Gmbh Novel propellant-gas-containing tiotropium formulation
CN104918604A (en) * 2012-10-23 2015-09-16 西普拉有限公司 Pharmaceutical composition
JP2016539126A (en) * 2013-11-22 2016-12-15 テバ ブランデッド ファーマシューティカル プロダクツ アール アンド ディー インコーポレイテッド Inhalable drug
US10034866B2 (en) 2014-06-19 2018-07-31 Teva Branded Pharmaceutical Products R&D, Inc. Inhalable medicament comprising tiotropium
EP3607936B1 (en) 2016-09-19 2023-11-08 Mexichem Fluor S.A. de C.V. Pharmaceutical composition comprising glycopyrrolate
CA3037107C (en) 2016-09-19 2021-05-18 Mexichem Fluor S.A. De C.V. Stable pharmaceutical compositions comprising salmeterol and 1,1-difluoroethane (hfa-152a) suitable for use in metered dose inhalers (mdis)
CN113288869A (en) 2016-09-19 2021-08-24 墨西哥氟石股份公司 Pharmaceutical composition
KR102279445B1 (en) * 2016-09-19 2021-07-22 멕시켐 플루어 소시에다드 아노니마 데 카피탈 바리아블레 pharmaceutical composition
WO2018051132A1 (en) * 2016-09-19 2018-03-22 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
ES2129117T3 (en) * 1992-12-09 1999-06-01 Boehringer Ingelheim Pharma DISSOLUTION FORMULATIONS IN THE FORM OF STABILIZED MEDICINAL SPRAY.
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
CN1726038A (en) 2006-01-25
AU2003303029A1 (en) 2004-07-09
JP2006510680A (en) 2006-03-30
KR20050085650A (en) 2005-08-29
PL375868A1 (en) 2005-12-12
EP1575588A1 (en) 2005-09-21
CA2510043A1 (en) 2004-07-01
IL169178A0 (en) 2007-07-04
BR0317340A (en) 2005-11-08
WO2004054580A1 (en) 2004-07-01
MXPA05006383A (en) 2005-08-29

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Legal Events

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FA92 Acknowledgement of application withdrawn (lack of supplementary materials submitted)

Effective date: 20080220