ES2626648T3 - Composición farmacéutica que comprende sal L-hemitartrato de levalbuterol como formulación en aerosol - Google Patents

Composición farmacéutica que comprende sal L-hemitartrato de levalbuterol como formulación en aerosol Download PDF

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Publication number
ES2626648T3
ES2626648T3 ES10176026.2T ES10176026T ES2626648T3 ES 2626648 T3 ES2626648 T3 ES 2626648T3 ES 10176026 T ES10176026 T ES 10176026T ES 2626648 T3 ES2626648 T3 ES 2626648T3
Authority
ES
Spain
Prior art keywords
levalbuterol
mcg
aerosol formulation
average
pharmaceutical composition
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 - Lifetime
Application number
ES10176026.2T
Other languages
English (en)
Spanish (es)
Inventor
Paul Mcglynn
Roger Bakale
Craig Sturge
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.)
Sunovion Pharmaceuticals Inc
Original Assignee
Sunovion Pharmaceuticals Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32507867&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2626648(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sunovion Pharmaceuticals Inc filed Critical Sunovion Pharmaceuticals Inc
Application granted granted Critical
Publication of ES2626648T3 publication Critical patent/ES2626648T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C215/00—Compounds containing amino and hydroxy groups bound to the same carbon skeleton
    • C07C215/46—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton
    • C07C215/56—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton with amino groups linked to the six-membered aromatic ring, or to the condensed ring system containing that ring, by carbon chains further substituted by hydroxy groups
    • C07C215/58—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton with amino groups linked to the six-membered aromatic ring, or to the condensed ring system containing that ring, by carbon chains further substituted by hydroxy groups with hydroxy groups and the six-membered aromatic ring, or the condensed ring system containing that ring, bound to the same carbon atom of the carbon chain
    • C07C215/60—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton with amino groups linked to the six-membered aromatic ring, or to the condensed ring system containing that ring, by carbon chains further substituted by hydroxy groups with hydroxy groups and the six-membered aromatic ring, or the condensed ring system containing that ring, bound to the same carbon atom of the carbon chain the chain having two carbon atoms between the amino groups and the six-membered aromatic ring or the condensed ring system containing that ring
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/002—Details of inhalators; Constructional features thereof with air flow regulating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • 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
    • A61P11/08—Bronchodilators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C59/00—Compounds having carboxyl groups bound to acyclic carbon atoms and containing any of the groups OH, O—metal, —CHO, keto, ether, groups, groups, or groups
    • C07C59/235—Saturated compounds containing more than one carboxyl group
    • C07C59/245—Saturated compounds containing more than one carboxyl group containing hydroxy or O-metal groups
    • C07C59/255—Tartaric acid
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09K—MATERIALS FOR MISCELLANEOUS APPLICATIONS, NOT PROVIDED FOR ELSEWHERE
    • C09K3/00—Materials not provided for elsewhere
    • C09K3/30—Materials not provided for elsewhere for aerosols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0468—Liquids non-physiological
    • A61M2202/0484—Alcohol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0468—Liquids non-physiological
    • A61M2202/0488—Surfactant, e.g. for the lung
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/07—Optical isomers
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Dispersion Chemistry (AREA)
  • Materials Engineering (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Steroid Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cosmetics (AREA)
ES10176026.2T 2002-12-10 2003-12-08 Composición farmacéutica que comprende sal L-hemitartrato de levalbuterol como formulación en aerosol Expired - Lifetime ES2626648T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US43219502P 2002-12-10 2002-12-10
US432195P 2002-12-10

Publications (1)

Publication Number Publication Date
ES2626648T3 true ES2626648T3 (es) 2017-07-25

Family

ID=32507867

Family Applications (3)

Application Number Title Priority Date Filing Date
ES10176026.2T Expired - Lifetime ES2626648T3 (es) 2002-12-10 2003-12-08 Composición farmacéutica que comprende sal L-hemitartrato de levalbuterol como formulación en aerosol
ES06110646.4T Expired - Lifetime ES2361172T5 (es) 2002-12-10 2003-12-08 Formulación de aerosol que comprende sal L-tartrato de levalbuterol
ES03786896T Expired - Lifetime ES2263051T3 (es) 2002-12-10 2003-12-08 Uso de l-tartrato de levalbuterol en la produccion de un inhalador de dosis medias.

Family Applications After (2)

Application Number Title Priority Date Filing Date
ES06110646.4T Expired - Lifetime ES2361172T5 (es) 2002-12-10 2003-12-08 Formulación de aerosol que comprende sal L-tartrato de levalbuterol
ES03786896T Expired - Lifetime ES2263051T3 (es) 2002-12-10 2003-12-08 Uso de l-tartrato de levalbuterol en la produccion de un inhalador de dosis medias.

Country Status (19)

Country Link
US (8) US7256310B2 (enExample)
EP (3) EP1671942B2 (enExample)
JP (1) JP4570960B2 (enExample)
KR (3) KR101166955B1 (enExample)
AT (2) ATE324364T1 (enExample)
AU (1) AU2003295695B2 (enExample)
CA (1) CA2507572C (enExample)
CY (2) CY1106315T1 (enExample)
DE (2) DE60304900T2 (enExample)
DK (3) DK1671942T4 (enExample)
ES (3) ES2626648T3 (enExample)
IL (2) IL168739A (enExample)
MX (1) MXPA05006087A (enExample)
NO (1) NO331649B1 (enExample)
NZ (1) NZ541168A (enExample)
PL (1) PL212725B1 (enExample)
PT (3) PT1572622E (enExample)
SI (2) SI1671942T2 (enExample)
WO (1) WO2004052835A1 (enExample)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6466862B1 (en) * 1999-04-19 2002-10-15 Bruce DeKock System for providing traffic information
JP2008512434A (ja) * 2004-09-09 2008-04-24 シプラ・リミテッド ベータ擬似剤の異性体及び抗コリン作用剤を含む医薬組成物
RU2440972C2 (ru) 2004-12-17 2012-01-27 Сипла Лимитед Кристаллический сульфат левосальбутамола, способ его получения и фармацевтическая композиция, содержащая его
EP2311793A1 (en) 2004-12-17 2011-04-20 Cipla Ltd. Crystalline levosalbutamol sulphate (Form II)
US8751589B2 (en) 2011-04-13 2014-06-10 Jingle Technologies Llc Systems and methods for transmitting information, alerts, and/or comments to participants based on location information
EP3042892A1 (en) 2015-01-09 2016-07-13 Deva Holding Anonim Sirketi Amorphisation of levosalbutamol tartrate
CN106727318A (zh) * 2016-12-22 2017-05-31 山东京卫制药有限公司 一种气雾剂及其制备方法
US20210290568A1 (en) * 2020-03-19 2021-09-23 Cai Gu Huang Inhalable formulation of a solution containing levalbuterol tartrate

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1200886A (en) * 1966-09-23 1970-08-05 Allen & Hanburys Ltd Phenylaminoethanol derivatives
US5225183A (en) 1988-12-06 1993-07-06 Riker Laboratories, Inc. Medicinal aerosol formulations
GB8828477D0 (en) † 1988-12-06 1989-01-05 Riker Laboratories Inc Medical aerosol formulations
US5766573A (en) 1988-12-06 1998-06-16 Riker Laboratories, Inc. Medicinal aerosol formulations
US5345980A (en) 1989-09-21 1994-09-13 Glaxo Group Limited Method and apparatus an aerosol container
US5362755A (en) 1990-01-05 1994-11-08 Sepracor, Inc. Method for treating asthma using optically pure (R)-albuterol
US5255183A (en) * 1990-05-29 1993-10-19 Interactive Voice Data System Inc. Telephone-based personnel tracking system
ATE226067T1 (de) * 1991-06-10 2002-11-15 Schering Corp Fluorchlorkohlenwasserstofffreie aerosolformulierungen
NZ246421A (en) 1991-12-18 1996-05-28 Minnesota Mining & Mfg Aerosol formulation containing a drug and a propellant and which is substantially free of surfactant
US5399765A (en) * 1994-05-23 1995-03-21 Sepracor, Inc. Enantioselective preparation of optically pure albuterol
US5545745A (en) * 1994-05-23 1996-08-13 Sepracor, Inc. Enantioselective preparation of optically pure albuterol
BR9604976A (pt) * 1995-04-14 1998-06-09 Glaxo Wellcome Inc Inalador de dose medida sistema inalador de dose medida e uso do mesmo
US5603918A (en) 1995-06-09 1997-02-18 Boehringer Ingelheim Pharmaceuticals, Inc. Aerosol composition of a salt of ipratropium and a salt of albuterol
US6040344A (en) 1996-11-11 2000-03-21 Sepracor Inc. Formoterol process
US20010031244A1 (en) * 1997-06-13 2001-10-18 Chiesi Farmaceutici S.P.A. Pharmaceutical aerosol composition
GB9806462D0 (en) 1998-03-26 1998-05-27 Glaxo Group Ltd Improved compositions for inhalation
ATE283033T1 (de) * 1998-07-24 2004-12-15 Jago Res Ag Medizinische aerosolformulierungen
EP1102579B1 (de) * 1998-08-04 2003-03-19 Jago Research Ag Medizinische aerosolformulierungen
DK1131059T3 (da) * 1998-11-13 2003-06-30 Jago Res Ag Tørpulver til inhalation
CN1173929C (zh) 1999-10-19 2004-11-03 中国科学院成都有机化学研究所 光学纯肾上腺素类β-激动剂的组合拆分制备法
US6451289B2 (en) 2000-03-24 2002-09-17 Sepracor Inc. Albuterol formulations
GB0030171D0 (en) 2000-12-11 2001-01-24 Cipla Ltd Process for preparing isomers of salbutamol
DE50211045D1 (de) * 2001-03-30 2007-11-22 Jagotec Ag Medizinische aerosolformulierungen
DE10120531A1 (de) * 2001-04-26 2002-10-31 Basf Ag Neue Reaktivfarbstoffe und deren Verwendung zum Färben von Substraten, welche nucleophile Gruppen enthalten
CN1206205C (zh) * 2001-04-26 2005-06-15 中国科学院成都有机化学研究所 R－沙丁胺醇酒石酸盐的制备方法

Also Published As

Publication number Publication date
NZ541168A (en) 2008-10-31
IL212369A (en) 2013-08-29
US20100272654A1 (en) 2010-10-28
KR20080103614A (ko) 2008-11-27
EP1572622B1 (en) 2006-04-26
ES2361172T5 (es) 2014-09-22
NO20053339L (no) 2005-09-07
KR101166955B1 (ko) 2012-07-19
DE60304900T2 (de) 2006-10-19
JP2006509802A (ja) 2006-03-23
EP2292584A1 (en) 2011-03-09
PL212725B1 (pl) 2012-11-30
US20130236515A1 (en) 2013-09-12
KR20050088307A (ko) 2005-09-05
SI1572622T1 (sl) 2006-10-31
WO2004052835A1 (en) 2004-06-24
ES2361172T3 (es) 2011-06-14
DK1671942T3 (da) 2011-04-26
KR20100080865A (ko) 2010-07-12
US20040115136A1 (en) 2004-06-17
US20150071969A1 (en) 2015-03-12
ATE324364T1 (de) 2006-05-15
PT1572622E (pt) 2006-08-31
SI1671942T2 (sl) 2014-10-30
DK1572622T3 (da) 2006-08-28
US8765153B2 (en) 2014-07-01
US20180222845A1 (en) 2018-08-09
EP1572622A1 (en) 2005-09-14
NO20053339D0 (no) 2005-07-08
EP1671942A1 (en) 2006-06-21
US20160368858A1 (en) 2016-12-22
CY1111330T1 (el) 2015-08-05
EP1671942B2 (en) 2014-07-23
CA2507572A1 (en) 2004-06-24
EP1671942B1 (en) 2011-02-16
DE60336089D1 (de) 2011-03-31
US20080119564A1 (en) 2008-05-22
ES2263051T3 (es) 2006-12-01
MXPA05006087A (es) 2005-09-30
NO331649B1 (no) 2012-02-13
PL377336A1 (pl) 2006-01-23
IL168739A (en) 2011-06-30
AU2003295695B2 (en) 2009-08-20
SI1671942T1 (sl) 2011-04-29
JP4570960B2 (ja) 2010-10-27
DE60304900D1 (de) 2006-06-01
DK1671942T4 (da) 2014-09-22
DK2292584T3 (en) 2017-05-01
PT2292584T (pt) 2017-06-12
PT1671942E (pt) 2011-05-11
ATE498604T1 (de) 2011-03-15
IL212369A0 (en) 2011-06-30
US20130028845A1 (en) 2013-01-31
EP2292584B1 (en) 2017-03-01
US7256310B2 (en) 2007-08-14
AU2003295695A1 (en) 2004-06-30
CY1106315T1 (el) 2011-10-12
CA2507572C (en) 2011-04-19

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