BR112017007435A2 - formulações contendo tiotrópio, aminoácido e ácido e seus métodos - Google Patents

formulações contendo tiotrópio, aminoácido e ácido e seus métodos

Info

Publication number
BR112017007435A2
BR112017007435A2 BR112017007435A BR112017007435A BR112017007435A2 BR 112017007435 A2 BR112017007435 A2 BR 112017007435A2 BR 112017007435 A BR112017007435 A BR 112017007435A BR 112017007435 A BR112017007435 A BR 112017007435A BR 112017007435 A2 BR112017007435 A2 BR 112017007435A2
Authority
BR
Brazil
Prior art keywords
acid
amino acid
tiotropium
sodium chloride
dry
Prior art date
Application number
BR112017007435A
Other languages
English (en)
Inventor
C. Sung Jean
M. Perry Jason
Tauber Michael
Original Assignee
Pulmatrix Operating Company, 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
Application filed by Pulmatrix Operating Company, Inc. filed Critical Pulmatrix Operating Company, Inc.
Publication of BR112017007435A2 publication Critical patent/BR112017007435A2/pt

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
    • A61K9/0012—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
    • A61K31/56—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D333/00—Heterocyclic compounds containing five-membered rings having one sulfur atom as the only ring hetero atom
    • C07D333/02—Heterocyclic compounds containing five-membered rings having one sulfur atom as the only ring hetero atom not condensed with other rings
    • C07D333/04—Heterocyclic compounds containing five-membered rings having one sulfur atom as the only ring hetero atom not condensed with other rings not substituted on the ring sulphur atom
    • C07D333/06—Heterocyclic compounds containing five-membered rings having one sulfur atom as the only ring hetero atom not condensed with other rings not substituted on the ring sulphur atom with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached to the ring carbon atoms
    • C07D333/08—Hydrogen atoms or radicals containing only hydrogen and carbon atoms
    • C07D333/10—Thiophene
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D419/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen, oxygen, and sulfur atoms as the only ring hetero atoms
    • C07D419/14—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen, oxygen, and sulfur atoms as the only ring hetero atoms containing three or more hetero rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

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

Abstract

um pó seco que contém partículas secas que contêm um sal de tiotrópio, um ou mais aminoácidos e um teor de ácido, e, opcionalmente, cloreto de sódio e/ou um ou mais agentes terapêuticos adicionais, em que a razão molar de ácido por aminoácido é de cerca de 0,0005 para cerca de 5 ou de cerca de 0,002 para 1. em um aspecto, o pó seco contendo partículas secas é adequado para administração ao trato respiratório. em um aspecto, o pó seco inalável que contém partículas secas inaláveis que contêm um sal de tiotrópio, um ou mais aminoácidos, conteúdo de ácido, cloreto de sódio, e, opcionalmente, um ou mais agentes terapêuticos adicionais, em que o sal de tiotrópio é de cerca de 0,01% a cerca de 0,5%, a leucina é cerca de 5% a cerca de 40%, o cloreto de sódio é de cerca de 50% a cerca de 90%, os um ou mais agentes terapêuticos adicionais opcionais são até cerca de 30%, e a proporção molar de ácido para aminoácido é desde cerca de 0,002 a cerca de 1, em que todas as percentagens são percentagens em peso em base seca e todos os componentes da quantidade de partículas secas inaláveis totalizam 100%.
BR112017007435A 2014-10-08 2015-10-07 formulações contendo tiotrópio, aminoácido e ácido e seus métodos BR112017007435A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462061436P 2014-10-08 2014-10-08
PCT/US2015/054447 WO2016057641A1 (en) 2014-10-08 2015-10-07 Formulations containing tiotropium, amino acid and acid and methods thereof

Publications (1)

Publication Number Publication Date
BR112017007435A2 true BR112017007435A2 (pt) 2018-01-16

Family

ID=54337449

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017007435A BR112017007435A2 (pt) 2014-10-08 2015-10-07 formulações contendo tiotrópio, aminoácido e ácido e seus métodos

Country Status (11)

Country Link
US (1) US20170304197A1 (pt)
EP (1) EP3203982A1 (pt)
JP (1) JP2017530988A (pt)
KR (1) KR20170068497A (pt)
AU (1) AU2015328153A1 (pt)
BR (1) BR112017007435A2 (pt)
CA (1) CA2963666A1 (pt)
IL (1) IL251656A0 (pt)
MX (1) MX2017004633A (pt)
RU (1) RU2017112547A (pt)
WO (1) WO2016057641A1 (pt)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109745565B (zh) * 2019-01-28 2021-05-18 上海方予健康医药科技有限公司 一种用于吸入的干粉组合物及其制备方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1593414A (zh) * 2004-07-02 2005-03-16 上海华拓医药科技发展有限公司 一种噻托溴铵胶囊型吸入粉雾剂及其制备方法
EP2201934A1 (en) * 2008-12-23 2010-06-30 CHIESI FARMACEUTICI S.p.A. Tiotropium aerosol formulation products with improved chemical stability
WO2012030664A1 (en) * 2010-08-30 2012-03-08 Pulmatrix, Inc. Dry powder formulations and methods for treating pulmonary diseases
AU2011308865B2 (en) * 2010-09-29 2017-01-05 Pulmatrix, Inc. Monovalent metal cation dry powders for inhalation
MX2015013845A (es) * 2013-04-01 2016-05-09 Pulmatrix Inc Polvos secos de tiotropio.

Also Published As

Publication number Publication date
RU2017112547A (ru) 2018-11-12
AU2015328153A1 (en) 2017-04-27
WO2016057641A1 (en) 2016-04-14
JP2017530988A (ja) 2017-10-19
RU2017112547A3 (pt) 2019-04-17
IL251656A0 (en) 2017-06-29
CA2963666A1 (en) 2016-04-14
MX2017004633A (es) 2017-10-04
EP3203982A1 (en) 2017-08-16
US20170304197A1 (en) 2017-10-26
KR20170068497A (ko) 2017-06-19

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements