BR112017007587A2 - processo para preparar uma formulação farmacêutica em pó seca e inalável - Google Patents

processo para preparar uma formulação farmacêutica em pó seca e inalável

Info

Publication number
BR112017007587A2
BR112017007587A2 BR112017007587A BR112017007587A BR112017007587A2 BR 112017007587 A2 BR112017007587 A2 BR 112017007587A2 BR 112017007587 A BR112017007587 A BR 112017007587A BR 112017007587 A BR112017007587 A BR 112017007587A BR 112017007587 A2 BR112017007587 A2 BR 112017007587A2
Authority
BR
Brazil
Prior art keywords
dry
preparing
inhalable
pharmaceutical formulation
powder pharmaceutical
Prior art date
Application number
BR112017007587A
Other languages
English (en)
Inventor
Mukul Dalvi
Seah Kee Tee
Original Assignee
Teva Branded Pharmaceutical Products R&D 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=54427855&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112017007587(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Teva Branded Pharmaceutical Products R&D Inc filed Critical Teva Branded Pharmaceutical Products R&D Inc
Publication of BR112017007587A2 publication Critical patent/BR112017007587A2/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
    • 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
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/573—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 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Emergency Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

processo para preparar uma formulação farmacêutica em pó seca e inalável a presente invenção refere-se a um processo para preparar uma formulação farmacêutica inalável em pó e seca que compreende a etapa de aquecer um envelope vedado contendo um dessecante e um inalável ou cápsula, o inalável ou cápsula contém uma formulação seca em pó que compreende um ingrediente farmacêutico ativo inalável e um veículo em que o envelope forma uma barreira para os ingredientes contra a umidade e em que o aquecimento do envelope vedado e seu conteúdo é realizado a uma temperatura 30-50°c.
BR112017007587A 2014-10-16 2015-10-16 processo para preparar uma formulação farmacêutica em pó seca e inalável BR112017007587A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462064690P 2014-10-16 2014-10-16
PCT/US2015/055919 WO2016061448A1 (en) 2014-10-16 2015-10-16 Dry powder formulation

Publications (1)

Publication Number Publication Date
BR112017007587A2 true BR112017007587A2 (pt) 2018-01-30

Family

ID=54427855

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017007587A BR112017007587A2 (pt) 2014-10-16 2015-10-16 processo para preparar uma formulação farmacêutica em pó seca e inalável

Country Status (15)

Country Link
US (1) US9980904B2 (pt)
EP (1) EP3206668A1 (pt)
JP (1) JP6653324B2 (pt)
KR (1) KR20170068571A (pt)
CN (1) CN107106514A (pt)
AR (1) AR102305A1 (pt)
AU (1) AU2015331915A1 (pt)
BR (1) BR112017007587A2 (pt)
CA (1) CA2963146A1 (pt)
CO (1) CO2017004787A2 (pt)
EA (1) EA201790833A1 (pt)
IL (1) IL251665A0 (pt)
MX (1) MX2017004764A (pt)
PE (1) PE20170690A1 (pt)
WO (1) WO2016061448A1 (pt)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20170070151A (ko) * 2014-10-16 2017-06-21 테바 브랜디드 파마슈티컬 프로덕츠 알앤디, 인코포레이티드 흡입형 제제
EP3833964B1 (en) 2018-08-07 2023-07-26 Norton (Waterford) Limited Application of raman spectroscopy for the manufacture of inhalation powders
JP2023539073A (ja) 2020-08-14 2023-09-13 ノートン （ウォーターフォード） リミテッド プロピオン酸フルチカゾンと硫酸アルブテロールの吸入製剤
GB202012742D0 (en) * 2020-08-14 2020-09-30 Norton Waterford Ltd An inhalable medicament
US20240050382A1 (en) * 2022-08-11 2024-02-15 De Motu Cordis Pty Ltd Inhalable Epinephrine Formulation

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9027234D0 (en) 1990-12-15 1991-02-06 Harris Pharma Ltd An inhalation device
US6258341B1 (en) 1995-04-14 2001-07-10 Inhale Therapeutic Systems, Inc. Stable glassy state powder formulations
SE0303570L (sv) 2003-12-03 2005-06-04 Microdrug Ag Fukt-känslig medicinsk produkt
PL1718353T3 (pl) 2004-02-24 2020-06-01 Microdose Therapeutx, Inc. Urządzenie do dostarczania leku na bazie strugi syntetycznej
GB0409703D0 (en) 2004-04-30 2004-06-02 Vectura Ltd Pharmaceutical compositions
US8196576B2 (en) 2007-02-28 2012-06-12 Microdose Therapeutx, Inc. Inhaler
PE20090907A1 (es) * 2007-07-21 2009-08-05 Boehringer Ingelheim Int Nuevos medicamentos pulverulentos que contienen tiotropio y salmeterol, asi como lactosa como excipiente
GB0919465D0 (en) 2009-11-06 2009-12-23 Norton Healthcare Ltd Airflow adaptor for a breath-actuated dry powder inhaler

Also Published As

Publication number Publication date
EA201790833A1 (ru) 2017-09-29
KR20170068571A (ko) 2017-06-19
AR102305A1 (es) 2017-02-15
CA2963146A1 (en) 2016-04-21
CN107106514A (zh) 2017-08-29
PE20170690A1 (es) 2017-05-25
JP2017530995A (ja) 2017-10-19
WO2016061448A1 (en) 2016-04-21
US9980904B2 (en) 2018-05-29
US20170239177A1 (en) 2017-08-24
MX2017004764A (es) 2017-07-27
CO2017004787A2 (es) 2017-09-20
EP3206668A1 (en) 2017-08-23
AU2015331915A1 (en) 2017-05-25
IL251665A0 (en) 2017-06-29
JP6653324B2 (ja) 2020-02-26

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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