EA201591869A1 - Композиция, содержащая для повышения стабильности лекарственной формы по меньшей мере два сухих порошка, получаемых распылительной сушкой - Google Patents

Композиция, содержащая для повышения стабильности лекарственной формы по меньшей мере два сухих порошка, получаемых распылительной сушкой

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Publication number
EA201591869A1
EA201591869A1 EA201591869A EA201591869A EA201591869A1 EA 201591869 A1 EA201591869 A1 EA 201591869A1 EA 201591869 A EA201591869 A EA 201591869A EA 201591869 A EA201591869 A EA 201591869A EA 201591869 A1 EA201591869 A1 EA 201591869A1
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EA
Eurasian Patent Office
Prior art keywords
powder
dry powder
stability
improve
composition containing
Prior art date
Application number
EA201591869A
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English (en)
Other versions
EA036669B1 (ru
Inventor
Джованни Капонетти
Лоретта Маджи
Кристина Венецьяни
Паоло Вентура
Лаура Цанеллотти
Original Assignee
Эратек С.Р.Л.
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.)
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Publication date
Application filed by Эратек С.Р.Л. filed Critical Эратек С.Р.Л.
Publication of EA201591869A1 publication Critical patent/EA201591869A1/ru
Publication of EA036669B1 publication Critical patent/EA036669B1/ru

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    • 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
    • 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
    • A61K31/33—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
    • A61K31/56—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
    • 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
    • A61K9/0012—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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Otolaryngology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Изобретение относится к ингаляционным (вводимым через органы дыхания) лекарственным формам медикаментов, находящихся в виде сухого порошка, предназначенным для ингаляционного введения в том виде, в котором они находятся, через ингаляционное устройство, которые отличаются легкостью доставки, пригодностью для дыхания и высокой стабильностью. В частности, изобретение относится к фармацевтической композиции для ингаляционного введения в виде порошка, которая содержит, по меньшей мере, первый и второй порошки, где, по меньшей мере, первый порошок содержит активное вещество в количестве, превышающем 1 мас.% от массы первого порошка. Оба порошка содержат лейцин в количестве, составляющем от 5 до 70 мас.% от массы каждого порошка, и сахар в количестве, составляющем от 20 до 90 мас.% от массы каждого порошка. Содержание фракции мелких частиц (ФМЧ) в композиции превышает 60%, и содержание выдаваемой из устройства фракции (ВФ) превышает 80%.
EA201591869A 2013-04-10 2014-04-09 Композиция, содержащая для повышения стабильности лекарственной формы по меньшей мере два сухих порошка, получаемых распылительной сушкой EA036669B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000572A ITMI20130572A1 (it) 2013-04-10 2013-04-10 Composizione comprendente almeno due polveri secche ottenute per spray dry per aumentare la stabilita' della formulazione
PCT/EP2014/057200 WO2014167023A1 (en) 2013-04-10 2014-04-09 Composition comprising at least two dry powders obtained by spray drying to increase the stability of the formulation

Publications (2)

Publication Number Publication Date
EA201591869A1 true EA201591869A1 (ru) 2016-02-29
EA036669B1 EA036669B1 (ru) 2020-12-07

Family

ID=48446463

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201591869A EA036669B1 (ru) 2013-04-10 2014-04-09 Композиция, содержащая для повышения стабильности лекарственной формы по меньшей мере два сухих порошка, получаемых распылительной сушкой

Country Status (15)

Country Link
US (1) US10583082B2 (ru)
EP (1) EP2983645B1 (ru)
JP (1) JP6509193B2 (ru)
CN (1) CN105101955B (ru)
AU (1) AU2014253115B2 (ru)
BR (1) BR112015025814B1 (ru)
CA (1) CA2908428C (ru)
EA (1) EA036669B1 (ru)
ES (1) ES2953878T3 (ru)
IL (1) IL241852B (ru)
IT (1) ITMI20130572A1 (ru)
MX (1) MX2015014337A (ru)
MY (1) MY175781A (ru)
WO (1) WO2014167023A1 (ru)
ZA (1) ZA201508248B (ru)

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WO2016124605A1 (en) * 2015-02-02 2016-08-11 Repoceuticals Aps Compositions comprising melatonin for preventing and treating pulmonary injury due to ionizing radiation or cytotoxic drugs
EP3288591A1 (en) * 2015-05-01 2018-03-07 Civitas Therapeutics, Inc. Zolmitriptan powders for pulmonary delivery
WO2017132601A1 (en) * 2016-01-29 2017-08-03 Mannkind Corporation Dry powder inhaler
US10898494B2 (en) 2016-05-05 2021-01-26 Liquidia Technologies, Inc. Dry powder treprostinil for the treatment of pulmonary hypertension
GB201609940D0 (en) * 2016-06-07 2016-07-20 Novabiotics Ltd Microparticles
WO2018002779A1 (en) * 2016-06-30 2018-01-04 Philip Morris Products S.A. Nicotine particles
CN106727348B (zh) * 2016-12-20 2020-10-13 广州中大南沙科技创新产业园有限公司 防潮抗湿的低密度载体颗粒及其制备方法和应用
WO2019213685A1 (en) * 2018-05-10 2019-11-14 Biomass Technologies Pty Ltd Method and apparatus for manufacture of dry powders
CN108939040A (zh) * 2018-10-18 2018-12-07 云南德彩堂生物医药科技有限公司 一种抗辐射组合物及其制备方法和应用
CN112089686A (zh) * 2020-10-12 2020-12-18 郑鉴忠 游离药物黏膜皮肤给药制剂生产方法
CN113331294B (zh) * 2021-06-03 2024-02-09 谷创芯生物科技(厦门)有限公司 一种低升糖指数健康糖的制备方法

Family Cites Families (7)

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Publication number Priority date Publication date Assignee Title
WO2002000197A1 (en) * 2000-06-27 2002-01-03 Vectura Limited Method of making particles for use in a pharmaceutical composition
US20040204439A1 (en) * 2003-04-14 2004-10-14 Staniforth John Nicholas Composition, device, and method for treating sexual dysfunction via inhalation
CA2522158C (en) * 2003-04-14 2018-03-20 Vectura Ltd. Devices and pharmaceutical compositions for enhancing dosing efficiency
GB0425758D0 (en) * 2004-11-23 2004-12-22 Vectura Ltd Preparation of pharmaceutical compositions
ITMI20051999A1 (it) * 2005-10-21 2007-04-22 Eratech S R L Formulazioni inalatorie di farmaci in fora di polvere secca per somministrazione come tale o con nebulizzatore e dotate di elevata erogabilita' respirabilita' e stabilita'
JP2014504260A (ja) * 2010-10-15 2014-02-20 グラクソ グループ リミテッド 集合ナノ粒子状薬物製剤、その製造及び使用
ITMI20130571A1 (it) * 2013-04-10 2014-10-11 Zambon Spa Composizione farmaceutica contenente budesonide e formoterolo

Also Published As

Publication number Publication date
ZA201508248B (en) 2017-01-25
MY175781A (en) 2020-07-08
EP2983645A1 (en) 2016-02-17
EA036669B1 (ru) 2020-12-07
WO2014167023A1 (en) 2014-10-16
CA2908428C (en) 2021-12-07
CN105101955B (zh) 2021-02-23
ITMI20130572A1 (it) 2014-10-11
ES2953878T3 (es) 2023-11-16
CN105101955A (zh) 2015-11-25
AU2014253115B2 (en) 2019-06-06
BR112015025814B1 (pt) 2023-04-18
MX2015014337A (es) 2016-06-21
JP6509193B2 (ja) 2019-05-08
CA2908428A1 (en) 2014-10-16
JP2016515640A (ja) 2016-05-30
BR112015025814A2 (pt) 2017-07-25
EP2983645B1 (en) 2023-07-19
US10583082B2 (en) 2020-03-10
AU2014253115A1 (en) 2015-11-26
US20160045434A1 (en) 2016-02-18
IL241852B (en) 2022-03-01

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