KR102345084B1 - 매크롤라이드계 항균제의 나노미립자를 함유하는 수성 현탁액제 - Google Patents

매크롤라이드계 항균제의 나노미립자를 함유하는 수성 현탁액제 Download PDF

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KR102345084B1
KR102345084B1 KR1020217013681A KR20217013681A KR102345084B1 KR 102345084 B1 KR102345084 B1 KR 102345084B1 KR 1020217013681 A KR1020217013681 A KR 1020217013681A KR 20217013681 A KR20217013681 A KR 20217013681A KR 102345084 B1 KR102345084 B1 KR 102345084B1
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clarithromycin
formulation
pharmaceutical composition
macrolide
diameter
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KR20210054068A (ko
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다카히로 다다
가즈히로 가가미
시로 요코타
겐타 기쿠치
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액티버스 파마 컴퍼니 리미티드
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Assigned to 포모사 파머시큐티컬즈 잉크. reassignment 포모사 파머시큐티컬즈 잉크. 권리의 전부이전등록 Assignors: 액티버스 파마 컴퍼니 리미티드
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    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/0043—Nose
    • 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
    • A61K9/0046—Ear
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P31/02—Local antiseptics
    • 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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Ophthalmology & Optometry (AREA)
  • Biochemistry (AREA)
  • Otolaryngology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
KR1020217013681A 2013-11-08 2014-11-07 매크롤라이드계 항균제의 나노미립자를 함유하는 수성 현탁액제 Active KR102345084B1 (ko)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2013231796 2013-11-08
JPJP-P-2013-231796 2013-11-08
PCT/JP2014/005603 WO2015068397A1 (ja) 2013-11-08 2014-11-07 マクロライド系抗菌剤のナノ微粒子を含有する水性懸濁液剤
KR1020167010042A KR20160079781A (ko) 2013-11-08 2014-11-07 매크롤라이드계 항균제의 나노미립자를 함유하는 수성 현탁액제

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KR1020167010042A Division KR20160079781A (ko) 2013-11-08 2014-11-07 매크롤라이드계 항균제의 나노미립자를 함유하는 수성 현탁액제

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KR20210054068A KR20210054068A (ko) 2021-05-12
KR102345084B1 true KR102345084B1 (ko) 2021-12-29

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KR1020167010042A Ceased KR20160079781A (ko) 2013-11-08 2014-11-07 매크롤라이드계 항균제의 나노미립자를 함유하는 수성 현탁액제

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US (1) US10792248B2 (enExample)
EP (1) EP3067045B1 (enExample)
JP (1) JP6407882B2 (enExample)
KR (2) KR102345084B1 (enExample)
CN (1) CN105658203B (enExample)
AU (1) AU2014345193C1 (enExample)
BR (1) BR112016010358B1 (enExample)
CA (1) CA2929361C (enExample)
ES (1) ES3003920T3 (enExample)
IL (1) IL245406B (enExample)
MX (1) MX2016005764A (enExample)
PL (1) PL3067045T3 (enExample)
PT (1) PT3067045T (enExample)
RU (1) RU2707748C2 (enExample)
TW (3) TWI747209B (enExample)
WO (1) WO2015068397A1 (enExample)

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EP3067045B1 (en) * 2013-11-08 2024-12-04 Activus Pharma Co., Ltd. Aqueous suspension preparation comprising nanoparticles of macrolide antibacterial agent
EP3962533A4 (en) 2019-04-30 2023-01-25 The Medical College of Wisconsin, Inc. PLATFORM FOR THROAT ADMINISTRATION AND USES THEREOF
CN113484436B (zh) * 2021-07-06 2022-07-12 云南中烟工业有限责任公司 同时测定抑菌纸张中五种禁限用物质含量的方法及其用途
US20230226541A1 (en) * 2022-01-18 2023-07-20 Hollister Incorporated Fluid absorption test tube
WO2023229667A1 (en) * 2022-05-24 2023-11-30 The Cleveland Clinic Foundation Topical angiotensin ii receptor blockers (arbs) for treating eye conditions
US20240009124A1 (en) * 2022-07-05 2024-01-11 Primera Compounding, LLC Ophthalmic Suspension Base having a Micro-fluidized Positively Charged Nanoparticle
CN116686841B (zh) * 2023-06-07 2024-07-19 丽珠集团新北江制药股份有限公司 一种含有多烯烃大环内酯类物质的液态组合物的制备方法
WO2024121651A1 (en) * 2023-11-10 2024-06-13 Amiri ِAmir Ali A liquid herbal antibiotic and a powder herbal antibiotic containing a herbal antibacterial formulation
CN121338014B (zh) * 2025-12-16 2026-03-27 山东齐都药业有限公司 罗红霉素制剂及其制备方法

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ES3003920T3 (en) 2025-03-11
TWI691341B (zh) 2020-04-21
KR20160079781A (ko) 2016-07-06
US10792248B2 (en) 2020-10-06
IL245406A0 (en) 2016-06-30
RU2707748C2 (ru) 2019-11-29
PL3067045T3 (pl) 2025-04-07
AU2014345193A1 (en) 2016-06-02
EP3067045B1 (en) 2024-12-04
MX2016005764A (es) 2017-01-05
RU2016122544A3 (enExample) 2018-05-29
CN105658203B (zh) 2021-03-16
TW201521785A (zh) 2015-06-16
CA2929361A1 (en) 2015-05-14
WO2015068397A1 (ja) 2015-05-14
BR112016010358B1 (pt) 2022-07-26
EP3067045A1 (en) 2016-09-14
TWI747209B (zh) 2021-11-21
CN105658203A (zh) 2016-06-08
PT3067045T (pt) 2025-02-13
CA2929361C (en) 2022-05-31
IL245406B (en) 2021-03-25
KR20210054068A (ko) 2021-05-12
TW201828923A (zh) 2018-08-16
EP3067045A4 (en) 2016-11-16
TW202027726A (zh) 2020-08-01
BR112016010358A2 (enExample) 2017-08-08
JPWO2015068397A1 (ja) 2017-03-09
AU2014345193C1 (en) 2020-09-10
US20160271057A1 (en) 2016-09-22
JP6407882B2 (ja) 2018-10-17
RU2016122544A (ru) 2017-12-13
AU2014345193B2 (en) 2020-03-05

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