RU2676093C2 - Капсулы, содержащие высокие дозы леводопы, для применения путем ингаляции - Google Patents

Капсулы, содержащие высокие дозы леводопы, для применения путем ингаляции Download PDF

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RU2676093C2
RU2676093C2 RU2015121092A RU2015121092A RU2676093C2 RU 2676093 C2 RU2676093 C2 RU 2676093C2 RU 2015121092 A RU2015121092 A RU 2015121092A RU 2015121092 A RU2015121092 A RU 2015121092A RU 2676093 C2 RU2676093 C2 RU 2676093C2
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Russia
Prior art keywords
powder
capsule
levodopa
dispenser
density
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RU2015121092A
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English (en)
Russian (ru)
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RU2015121092A (ru
Inventor
Кевин Д. КИ
Эрнест Д. ПЕНАКЬО
Абхиджит КАМЕРКАР
Майкл М. ЛИПП
Ричард П. БАТИКИ
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Сивитас Терапьютикс, Инк.
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Priority claimed from US13/679,245 external-priority patent/US8545878B1/en
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Publication of RU2015121092A publication Critical patent/RU2015121092A/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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/074—Filling capsules; Related operations
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
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    • 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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • 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
    • 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
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—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
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00—Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/04—Methods of, or means for, filling the material into the containers or receptacles
    • B65B1/16—Methods of, or means for, filling the material into the containers or receptacles by pneumatic means, e.g. by suction
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00—Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/20—Reducing volume of filled material
    • B65B1/26—Reducing volume of filled material by pneumatic means, e.g. suction
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00—Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/30—Devices or methods for controlling or determining the quantity or quality or the material fed or filled
    • B65B1/36—Devices or methods for controlling or determining the quantity or quality or the material fed or filled by volumetric devices or methods
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B63/00—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged
    • B65B63/02—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for compressing or compacting articles or materials prior to wrapping or insertion in containers or receptacles
    • B65B63/028—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for compressing or compacting articles or materials prior to wrapping or insertion in containers or receptacles by pneumatic means

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Mechanical Engineering (AREA)
  • Pulmonology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Inorganic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Psychology (AREA)
  • Quality & Reliability (AREA)
  • Dispersion Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Basic Packing Technique (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
RU2015121092A 2012-11-09 2013-11-08 Капсулы, содержащие высокие дозы леводопы, для применения путем ингаляции RU2676093C2 (ru)

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US201261724781P 2012-11-09 2012-11-09
US61/724,781 2012-11-09
US13/679,245 US8545878B1 (en) 2012-11-09 2012-11-16 Capsules containing high doses of levodopa for pulmonary use
US13/679,245 2012-11-16
US13/945,160 2013-07-18
US13/945,160 US8685442B1 (en) 2012-11-09 2013-07-18 Capsules containing high doses of levodopa for pulmonary use
US201361884436P 2013-09-30 2013-09-30
US201361884315P 2013-09-30 2013-09-30
US201361884319P 2013-09-30 2013-09-30
US61/884,315 2013-09-30
US61/884,319 2013-09-30
US61/884,436 2013-09-30
PCT/US2013/069102 WO2014074795A1 (en) 2012-11-09 2013-11-08 High dose levodopa capsules for pulmonary use

Related Child Applications (1)

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RU2018144622A Division RU2018144622A (ru) 2012-11-16 2013-11-08 Капсулы, содержащие высокие дозы леводопы, для применения путем ингаляции

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RU2015121092A RU2015121092A (ru) 2017-01-10
RU2676093C2 true RU2676093C2 (ru) 2018-12-26

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RU2015121092A RU2676093C2 (ru) 2012-11-09 2013-11-08 Капсулы, содержащие высокие дозы леводопы, для применения путем ингаляции
RU2015121091A RU2670987C2 (ru) 2012-11-09 2013-11-08 Порошки для ингаляции с ультранизкой плотностью

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US (3) US9539211B2 (enExample)
EP (5) EP2925611B1 (enExample)
JP (6) JP6348501B2 (enExample)
KR (7) KR102257164B1 (enExample)
CN (4) CN104918607B (enExample)
AU (6) AU2013342246B2 (enExample)
BR (2) BR112015010601B1 (enExample)
CA (3) CA2890451C (enExample)
DK (1) DK2916821T3 (enExample)
ES (2) ES2880271T3 (enExample)
HK (1) HK1212884A1 (enExample)
MX (4) MX371008B (enExample)
NZ (4) NZ708684A (enExample)
PL (1) PL2916821T3 (enExample)
PT (1) PT2916821T (enExample)
RU (2) RU2676093C2 (enExample)
SG (5) SG10201706465XA (enExample)
WO (3) WO2014074797A1 (enExample)
ZA (2) ZA201504060B (enExample)

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EP3608015B1 (de) * 2018-08-08 2021-10-06 Harro Höfliger Verpackungsmaschinen GmbH Pulverbereitstellungseinrichtung für einen pulverdosierer
CN108995838A (zh) * 2018-09-10 2018-12-14 江西克莱威纳米碳材料有限公司 一种粉体装罐系统
CN109178367B (zh) * 2018-10-15 2021-01-26 楚天科技股份有限公司 用于粉体分装的灌装头和灌装装置
CN110040519B (zh) * 2019-04-30 2024-12-24 裕东（中山）机械工程有限公司 一种定量气固两相流输送装置及定量输送系统
EP3756640A1 (en) 2019-06-26 2020-12-30 Fette Compacting GmbH System and method for continuous production of solid dosage forms
RU2716294C1 (ru) * 2019-10-04 2020-03-11 Владимир Александрович Трусов Двухванная отражательная печь для переплава алюминиевого лома
ES2949238T3 (es) * 2020-04-22 2023-09-26 Capsugel Belgium Nv Cápsula de HPMC con retención de polvo reducida
IT202000008962A1 (it) * 2020-04-24 2021-10-24 Romaco Srl Apparecchiatura per il riempimento di contenitori con un materiale in polvere
TW202237102A (zh) * 2020-12-11 2022-10-01 大陸商江蘇恒瑞醫藥股份有限公司 用於肺部遞送的藥物組合物
EP4201390A1 (de) * 2021-12-21 2023-06-28 Harro Höfliger Verpackungsmaschinen GmbH Kapselfüllmaschine zur befüllung zweiteiliger kapseln und verfahren zur befüllung zweiteiliger kapseln
EP4220101A1 (de) * 2022-01-26 2023-08-02 Harro Höfliger Verpackungsmaschinen GmbH Fülleinrichtung und füllsystem zum volumetrischen dosieren von pulver

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