RU2015143135A - Микронизированные фармацевтические композиции - Google Patents
Микронизированные фармацевтические композиции Download PDFInfo
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- RU2015143135A RU2015143135A RU2015143135A RU2015143135A RU2015143135A RU 2015143135 A RU2015143135 A RU 2015143135A RU 2015143135 A RU2015143135 A RU 2015143135A RU 2015143135 A RU2015143135 A RU 2015143135A RU 2015143135 A RU2015143135 A RU 2015143135A
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- powder
- sodium
- colistimetate
- less
- micronized particles
- Prior art date
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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
- 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
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- 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
- A61J1/035—Blister-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
-
- 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
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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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- 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
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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
-
- 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
- A61K9/4825—Proteins, e.g. gelatin
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
- B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
- B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
- B65D75/36—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
- B65D75/367—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed and forming several compartments
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Gastroenterology & Hepatology (AREA)
- Otolaryngology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Mechanical Engineering (AREA)
- Composite Materials (AREA)
- Molecular Biology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Biophysics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (14)
1. Порошок микронизированных частиц колистиметата натрия, в котором по меньшей мере 50 об.% микронизированных частиц имеют диаметр менее чем 7 мкм, но не менее чем 3 мкм и порошок имеет общее содержание влаги от 5 до 10 мас.%, для применения в лечении легочной инфекции путем ингаляции порошка, в котором колистиметат натрия не разделен на компоненты.
2. Порошок микронизированных частиц колистиметата натрия по п. 1, отличающийся тем, что 10 об.% частиц имеют размер частиц менее чем 3 мкм, но не менее чем 1,5 мкм.
3. Фармацевтическая дозированная форма пригодная для применения с ингалятором сухого порошка, содержащая:
(а) порошок микронизированных частиц колистиметата натрия, в котором по меньшей мере 50 об.% микронизированных частиц имеют диаметр менее чем 7 мкм, но не менее чем 3 мкм, и порошок имеет общее содержание влаги от 5 до 10 мас.% для применения в лечении легочной инфекции путем ингаляции порошка, в котором колистиметат натрия не разделен на компоненты;
(б) контейнер для указанного порошка микронизированных частиц колистиметата натрия.
4. Фармацевтическая дозированная форма по п. 3, отличающаяся тем, что указанный контейнер является твердой желатиновой капсулой.
5. Фармацевтическая капсула, содержащая порошок микронизированных частиц колистиметата натрия, в котором по меньшей мере 50 об.% микронизированных частиц имеют диаметр менее чем 7 мкм, но не менее чем 3 мкм, и порошок имеет общее содержание влаги от 5 до 10 мас.%, для применения в лечении легочной инфекции путем ингаляции порошка, в котором колистиметат натрия не разделен на компоненты.
6. Фармацевтическая капсула по п. 5, отличающаяся тем, что капсула является прозрачной.
7. Фармацевтическая капсула по п. 5, отличающаяся тем, что капсула дополнительно содержит микронизированное бронхолитическое лекарственное средство.
8. Фармацевтическая капсула по п. 5, отличающаяся тем, что содержит от 1500000 до 2000000 ME колистиметата натрия.
9. Блистерная упаковка, содержащая алюминиевую фольгу с множеством фармацевтических капсул по п. 5.
10. Способ терапевтического лечения грамотрицательных инфекций дыхательных путей, который включает введение в дыхательные пути пациента порошка микронизированных частиц колистиметата натрия, в котором по меньшей мере 50 об.% микронизированных частиц имеют диаметр менее чем 7 мкм, но не менее чем 3 мкм и порошок имеет общее содержание влаги от 5 до 10 мас.%, в котором колистиметат натрия не разделен на компоненты.
11. Способ по п. 10, отличающийся тем, что пациентом, имеющим грамотрицательные инфекции, является педиатрический пациент.
12. Способ по п. 10, отличающийся тем, что грамотрицательные инфекции, вызваны бактериальными патогенами, выбранными из группы, состоящей из Pseudomonas aeruginosa, Escherichia coli и Klebsiella spp.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361779057P | 2013-03-13 | 2013-03-13 | |
| US61/779,057 | 2013-03-13 | ||
| PCT/US2014/021698 WO2014164280A1 (en) | 2013-03-13 | 2014-03-07 | Micronized pharmaceutical compositions |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2015143135A true RU2015143135A (ru) | 2017-04-28 |
| RU2659385C2 RU2659385C2 (ru) | 2018-06-29 |
Family
ID=51658844
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015143135A RU2659385C2 (ru) | 2013-03-13 | 2014-03-07 | Микронизированные фармацевтические композиции |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US10441536B2 (ru) |
| EP (1) | EP2968161A4 (ru) |
| JP (1) | JP6461902B2 (ru) |
| KR (1) | KR20180092324A (ru) |
| CN (1) | CN105555257A (ru) |
| AU (1) | AU2014249529B2 (ru) |
| BR (1) | BR112015022831A2 (ru) |
| CA (1) | CA2912485A1 (ru) |
| CL (1) | CL2015002702A1 (ru) |
| IL (1) | IL241283A0 (ru) |
| MX (1) | MX2015012931A (ru) |
| RU (1) | RU2659385C2 (ru) |
| SG (1) | SG11201507466XA (ru) |
| WO (1) | WO2014164280A1 (ru) |
| ZA (1) | ZA201506637B (ru) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117679487A (zh) | 2013-03-15 | 2024-03-12 | 得克萨斯州大学系统董事会 | 用Nutlin-3a和肽抑制肺纤维化 |
| US10617703B2 (en) * | 2014-12-10 | 2020-04-14 | Cmpd Licensing, Llc | Compositions and methods for treating an infection |
| BR112021004404A2 (pt) | 2018-09-10 | 2021-08-03 | Lung Therapeutics, Inc. | fragmentos de peptídeos modificados da proteína cav-1 e o uso destes no tratamento de fibrose |
| EP3849581A4 (en) * | 2018-09-10 | 2022-07-06 | Board of Regents, The University of Texas System | DRY POWDER FORMULATION OF CAVEOLIN-1 PEPTIDES AND METHODS OF USING THE SAME |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US16745A (en) * | 1857-03-03 | Improvement in sewing-machines | ||
| GB9820746D0 (en) * | 1998-09-23 | 1998-11-18 | Pharmax Limited | Micronised pharmaceutical compositions |
| MXPA04012712A (es) * | 2002-06-27 | 2005-03-23 | Nektar Therapeutics | Aparato y metodo para controlar el flujo de un polvo. |
| JO3102B1 (ar) * | 2004-03-17 | 2017-09-20 | Chiesi Framaceutici S P A | صيغ صيدلانية لوسائل استنشاق بها مسحوق جاف تشتمل على مكون فعال بقوة منخفضة الجرعة |
| 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' |
| PT105065B (pt) * | 2010-04-26 | 2012-07-31 | Hovione Farmaciencia S A | Um inalador simples de cápsulas |
| WO2012061902A1 (en) | 2010-11-12 | 2012-05-18 | Monash University | Micronised spray-dried particles comprising polymyxin |
-
2014
- 2014-03-07 SG SG11201507466XA patent/SG11201507466XA/en unknown
- 2014-03-07 BR BR112015022831A patent/BR112015022831A2/pt not_active Application Discontinuation
- 2014-03-07 JP JP2016500810A patent/JP6461902B2/ja not_active Expired - Fee Related
- 2014-03-07 WO PCT/US2014/021698 patent/WO2014164280A1/en active Application Filing
- 2014-03-07 CN CN201480025155.9A patent/CN105555257A/zh active Pending
- 2014-03-07 KR KR1020157028634A patent/KR20180092324A/ko not_active Application Discontinuation
- 2014-03-07 AU AU2014249529A patent/AU2014249529B2/en not_active Ceased
- 2014-03-07 CA CA2912485A patent/CA2912485A1/en not_active Abandoned
- 2014-03-07 MX MX2015012931A patent/MX2015012931A/es unknown
- 2014-03-07 US US14/772,748 patent/US10441536B2/en not_active Expired - Fee Related
- 2014-03-07 EP EP14778370.8A patent/EP2968161A4/en not_active Ceased
- 2014-03-07 RU RU2015143135A patent/RU2659385C2/ru not_active IP Right Cessation
-
2015
- 2015-09-07 IL IL241283A patent/IL241283A0/en unknown
- 2015-09-08 ZA ZA2015/06637A patent/ZA201506637B/en unknown
- 2015-09-14 CL CL2015002702A patent/CL2015002702A1/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CN105555257A (zh) | 2016-05-04 |
| RU2659385C2 (ru) | 2018-06-29 |
| JP6461902B2 (ja) | 2019-01-30 |
| CL2015002702A1 (es) | 2016-08-12 |
| IL241283A0 (en) | 2015-11-30 |
| MX2015012931A (es) | 2016-07-20 |
| AU2014249529B2 (en) | 2018-08-09 |
| WO2014164280A1 (en) | 2014-10-09 |
| JP2016512260A (ja) | 2016-04-25 |
| SG11201507466XA (en) | 2015-10-29 |
| KR20180092324A (ko) | 2018-08-20 |
| BR112015022831A2 (pt) | 2017-08-22 |
| ZA201506637B (en) | 2016-11-30 |
| US20160022577A1 (en) | 2016-01-28 |
| US10441536B2 (en) | 2019-10-15 |
| EP2968161A1 (en) | 2016-01-20 |
| EP2968161A4 (en) | 2016-10-26 |
| CA2912485A1 (en) | 2014-10-09 |
| WO2014164280A8 (en) | 2015-04-09 |
| AU2014249529A1 (en) | 2015-10-01 |
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| Date | Code | Title | Description |
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| PC41 | Official registration of the transfer of exclusive right |
Effective date: 20190905 |
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| MM4A | The patent is invalid due to non-payment of fees |
Effective date: 20200308 |