EA201590734A8 - Вдыхаемые лекарственные средства - Google Patents

Вдыхаемые лекарственные средства

Info

Publication number
EA201590734A8
EA201590734A8 EA201590734A EA201590734A EA201590734A8 EA 201590734 A8 EA201590734 A8 EA 201590734A8 EA 201590734 A EA201590734 A EA 201590734A EA 201590734 A EA201590734 A EA 201590734A EA 201590734 A8 EA201590734 A8 EA 201590734A8
Authority
EA
Eurasian Patent Office
Prior art keywords
microns
dry powder
drug
feed channel
metered dose
Prior art date
Application number
EA201590734A
Other languages
English (en)
Other versions
EA201590734A1 (ru
EA034267B1 (ru
Inventor
Эрвин Ван Актховен
Йохан Кегстра
Майкл Имре Голлер
Original Assignee
Фармахеми Б.В.
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 Фармахеми Б.В. filed Critical Фармахеми Б.В.
Publication of EA201590734A1 publication Critical patent/EA201590734A1/ru
Publication of EA201590734A8 publication Critical patent/EA201590734A8/ru
Publication of EA034267B1 publication Critical patent/EA034267B1/ru

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/235Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
    • A61K31/24Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/47042-Quinolinones, e.g. carbostyril
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075Sprays 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate 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
    • A61K9/145Intimate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0005Details of inhalators; Constructional features thereof with means for agitating the medicament
    • A61M15/0006Details of inhalators; Constructional features thereof with means for agitating the medicament using rotating means
    • A61M15/0008Details of inhalators; Constructional features thereof with means for agitating the medicament using rotating means rotating by airflow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0021Mouthpieces therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • A61M15/0068Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/007Mechanical counters
    • A61M15/0071Mechanical counters having a display or indicator
    • A61M15/0078Mechanical counters having a display or indicator on a strip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0086Inhalation chambers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/009Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0091Inhalators mechanically breath-triggered
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0021Mouthpieces therefor
    • A61M15/0025Mouthpieces therefor with caps
    • A61M15/0026Hinged caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/06Solids
    • A61M2202/064Powder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2206/00Characteristics of a physical parameter; associated device therefor
    • A61M2206/10Flow characteristics
    • A61M2206/16Rotating swirling helical flow, e.g. by tangential inflows
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2206/00Characteristics of a physical parameter; associated device therefor
    • A61M2206/10Flow characteristics
    • A61M2206/20Flow characteristics having means for promoting or enhancing the flow, actively or passively

Abstract

В изобретении предложен ингалятор сухого порошка, содержащий емкость, содержащую композицию в виде сухого порошка и приспособление для подачи отмеренной дозы лекарственного средства из емкости; циклонный деагломератор для разрушения агломератов лекарственного средства в виде сухого порошка и проточный канал подачи для направления потока воздуха, обуславливаемого вдыханием, через мундштук, причем проточный канал подачи простирается до отмеренной дозы лекарственного средства, при этом композиция содержит вдыхаемый β-агонист, имеющий следующее распределение размеров частиц: d10<1 мкм, d50=1-3 мкм, d90=3,5-6 мкм и не менее 99%<10 мкм, а также носитель в виде лактозы.
EA201590734A 2013-12-09 2014-11-19 Композиция в виде сухого порошка для ингаляции для лечения респираторного заболевания, её применение и способ лечения респираторного заболевания EA034267B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1321717.9A GB201321717D0 (en) 2013-12-09 2013-12-09 Inhalable Medicaments
PCT/EP2014/075058 WO2015086278A1 (en) 2013-12-09 2014-11-19 Inhalable medicaments

Publications (3)

Publication Number Publication Date
EA201590734A1 EA201590734A1 (ru) 2015-09-30
EA201590734A8 true EA201590734A8 (ru) 2016-11-30
EA034267B1 EA034267B1 (ru) 2020-01-23

Family

ID=50000403

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201590734A EA034267B1 (ru) 2013-12-09 2014-11-19 Композиция в виде сухого порошка для ингаляции для лечения респираторного заболевания, её применение и способ лечения респираторного заболевания

Country Status (20)

Country Link
US (2) US11071835B2 (ru)
EP (3) EP3590499B1 (ru)
JP (2) JP6495916B2 (ru)
KR (2) KR102207557B1 (ru)
CN (1) CN105916491B (ru)
AR (1) AR099364A1 (ru)
AU (2) AU2014361087B2 (ru)
BR (1) BR112016011995A2 (ru)
CA (1) CA2930898A1 (ru)
DK (2) DK3590499T3 (ru)
EA (1) EA034267B1 (ru)
ES (2) ES2929348T3 (ru)
GB (1) GB201321717D0 (ru)
HU (2) HUE044901T2 (ru)
IL (1) IL246045B (ru)
MX (2) MX2016007181A (ru)
PL (2) PL3079655T3 (ru)
TR (1) TR201907647T4 (ru)
TW (1) TWI590846B (ru)
WO (1) WO2015086278A1 (ru)

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WO2023061508A1 (zh) * 2021-11-29 2023-04-20 康希诺生物股份公司 一种雾化杯及其在雾化吸入给药中的应用
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AR099364A1 (es) 2016-07-20
US20210379304A1 (en) 2021-12-09
JP6946363B2 (ja) 2021-10-06
TWI590846B (zh) 2017-07-11
IL246045A0 (en) 2016-07-31
US20160303337A1 (en) 2016-10-20
EA201590734A1 (ru) 2015-09-30
BR112016011995A2 (pt) 2018-07-10
CA2930898A1 (en) 2015-06-18
AU2014361087B2 (en) 2018-04-05
EP3590499A1 (en) 2020-01-08
DK3590499T3 (da) 2022-10-31
TW201531314A (zh) 2015-08-16
AU2014361087A1 (en) 2016-07-07
CN105916491B (zh) 2022-08-12
KR102207557B1 (ko) 2021-01-26
MX2021005056A (es) 2022-09-15
HUE060180T2 (hu) 2023-02-28
JP6495916B2 (ja) 2019-04-03
AU2018204860A1 (en) 2018-07-19
GB201321717D0 (en) 2014-01-22
JP2019111370A (ja) 2019-07-11
TR201907647T4 (tr) 2019-06-21
KR20180101625A (ko) 2018-09-12
PL3590499T3 (pl) 2022-11-28
DK3079655T3 (da) 2019-06-11
NZ721338A (en) 2022-03-25
ES2728076T3 (es) 2019-10-22
EP4190309A1 (en) 2023-06-07
KR20160101954A (ko) 2016-08-26
IL246045B (en) 2021-08-31
EP3079655B1 (en) 2019-05-08
WO2015086278A1 (en) 2015-06-18
MX2016007181A (es) 2016-10-28
CN105916491A (zh) 2016-08-31
HUE044901T2 (hu) 2019-11-28
AU2018204860B2 (en) 2019-07-18
PL3079655T3 (pl) 2019-08-30
EP3079655A1 (en) 2016-10-19
ES2929348T3 (es) 2022-11-28
US11071835B2 (en) 2021-07-27
EP3590499B1 (en) 2022-10-05
JP2017505157A (ja) 2017-02-16
EA034267B1 (ru) 2020-01-23

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