KR20220038443A - 무균 안과용 수성 플루티카손 프로피오네이트 a형 나노결정 현탁액을 제조하는 방법 - Google Patents

무균 안과용 수성 플루티카손 프로피오네이트 a형 나노결정 현탁액을 제조하는 방법 Download PDF

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Publication number
KR20220038443A
KR20220038443A KR1020227006020A KR20227006020A KR20220038443A KR 20220038443 A KR20220038443 A KR 20220038443A KR 1020227006020 A KR1020227006020 A KR 1020227006020A KR 20227006020 A KR20227006020 A KR 20227006020A KR 20220038443 A KR20220038443 A KR 20220038443A
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South Korea
Prior art keywords
fluticasone propionate
nanocrystals
nanosuspension
aqueous
adjust
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Legal status (The legal status 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 status listed.)
Ceased
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KR1020227006020A
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English (en)
Korean (ko)
Inventor
쟝-미첼 부코브스키
아크샤이 나드카르니
호세 엘. 보여
브리지트 듀케스로와-샤크룬
토마스 나브라틸
Original Assignee
니콕스 오프탈믹스,아이엔씨.
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Publication of KR20220038443A publication Critical patent/KR20220038443A/ko
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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
    • A61K9/08—Solutions
    • 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
    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
    • 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
    • A61K47/06—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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K47/36—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
    • A61K9/0048—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
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/04—Artificial tears; Irrigation solutions
    • 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]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J31/00—Normal steroids containing one or more sulfur atoms not belonging to a hetero ring
    • C07J31/006—Normal steroids containing one or more sulfur atoms not belonging to a hetero ring not covered by C07J31/003

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Ophthalmology & Optometry (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dispersion Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Nanotechnology (AREA)
  • Medical Informatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
KR1020227006020A 2019-07-23 2020-07-21 무균 안과용 수성 플루티카손 프로피오네이트 a형 나노결정 현탁액을 제조하는 방법 Ceased KR20220038443A (ko)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962877599P 2019-07-23 2019-07-23
US62/877,599 2019-07-23
US201962942551P 2019-12-02 2019-12-02
US62/942,551 2019-12-02
PCT/IB2020/056832 WO2021014348A1 (en) 2019-07-23 2020-07-21 Process for the preparation of sterile ophthalmic aqueous fluticasone propionate form a nanocrystals suspensions

Publications (1)

Publication Number Publication Date
KR20220038443A true KR20220038443A (ko) 2022-03-28

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KR1020227006020A Ceased KR20220038443A (ko) 2019-07-23 2020-07-21 무균 안과용 수성 플루티카손 프로피오네이트 a형 나노결정 현탁액을 제조하는 방법

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US (3) US11406596B2 (https=)
EP (1) EP3769753B1 (https=)
JP (2) JP7021301B2 (https=)
KR (1) KR20220038443A (https=)
CN (2) CN111821261B (https=)
AU (1) AU2020317084A1 (https=)
CA (1) CA3145055A1 (https=)
CY (1) CY1124930T1 (https=)
DK (1) DK3769753T3 (https=)
ES (1) ES2905793T3 (https=)
HR (1) HRP20220165T1 (https=)
HU (1) HUE057416T2 (https=)
LT (1) LT3769753T (https=)
MD (1) MD3769753T2 (https=)
MX (1) MX420447B (https=)
PH (1) PH12022550003A1 (https=)
PL (1) PL3769753T3 (https=)
PT (1) PT3769753T (https=)
RS (1) RS62932B1 (https=)
SI (1) SI3769753T1 (https=)
SM (1) SMT202200082T1 (https=)
TW (1) TWI864053B (https=)
WO (1) WO2021014348A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2905793T3 (es) * 2019-07-23 2022-04-12 Nicox Ophthalmics Inc Procedimiento para la preparación de suspensiones acuosas estériles oftálmicas de nanocristales de propionato de fluticasona de Forma A
CN115554238A (zh) * 2022-10-25 2023-01-03 苏州欧康维视生物科技有限公司 眼用混悬液及其制备方法
CN115887372A (zh) * 2022-10-25 2023-04-04 苏州欧康维视生物科技有限公司 丙酸氟替卡松混悬液及其制备方法

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2132826C (en) 1992-05-06 1999-01-05 Masood Chowhan Use of borate-polyol complexes in ophthalmic compositions
JP3450805B2 (ja) * 2000-08-08 2003-09-29 わかもと製薬株式会社 水性医薬組成物
US6900184B2 (en) * 2003-04-14 2005-05-31 Wyeth Holdings Corporation Compositions containing pipercillin and tazobactam useful for injection
US20060229219A1 (en) * 2005-04-11 2006-10-12 Advanced Medical Optics, Inc. Borate-polyol mixtures as a buffering system
US8010032B2 (en) * 2005-05-23 2011-08-30 Xerox Corporation Fuser member comprising deflocculated material
WO2010141834A1 (en) 2009-06-05 2010-12-09 Aciex Therapeutics, Inc. Ophthalmic formulations of fluticasone and methods of use
TWI489997B (zh) 2009-06-19 2015-07-01 Alcon Res Ltd 含有硼酸－多元醇錯合物之水性藥學組成物
US20130065888A1 (en) * 2011-08-15 2013-03-14 Biserka Cetina-Cizmek Ophthalmic formulations and processes for their preparation
AU2013259872B2 (en) * 2012-05-08 2018-06-28 Nicox Ophthalmics, Inc. Preparations of hydrophobic therapeutic agents, methods of manufacture and use thereof
US9675624B2 (en) * 2012-12-17 2017-06-13 Glaxo Group Limited Combination of levocabastine and fluticasone furoate for the treatment of inflammatory and/or allergic conditions
TWI773641B (zh) 2015-05-08 2022-08-11 日商活效製藥股份有限公司 含有糖皮質類固醇（ｇｌｕｃｏｃｏｒｔｉｃｏｉｄｓ）之奈米微粒子之水性懸浮液劑
ES2905793T3 (es) * 2019-07-23 2022-04-12 Nicox Ophthalmics Inc Procedimiento para la preparación de suspensiones acuosas estériles oftálmicas de nanocristales de propionato de fluticasona de Forma A

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HUE057416T2 (hu) 2022-05-28
MD3769753T2 (ro) 2022-04-30
DK3769753T3 (da) 2022-01-31
CN115120557A (zh) 2022-09-30
EP3769753B1 (en) 2021-11-17
ES2905793T3 (es) 2022-04-12
PH12022550003A1 (en) 2022-11-14
RS62932B1 (sr) 2022-03-31
JP7494230B2 (ja) 2024-06-03
CA3145055A1 (en) 2021-01-28
US20220323352A1 (en) 2022-10-13
WO2021014348A1 (en) 2021-01-28
JP2021017449A (ja) 2021-02-15
LT3769753T (lt) 2022-05-10
JP2022062172A (ja) 2022-04-19
MX2022000928A (es) 2022-02-22
TW202116326A (zh) 2021-05-01
JP7021301B2 (ja) 2022-02-16
US11406596B2 (en) 2022-08-09
US20210023001A1 (en) 2021-01-28
SI3769753T1 (sl) 2022-04-29
PT3769753T (pt) 2022-02-15
MX420447B (es) 2025-02-10
AU2020317084A1 (en) 2022-03-03
CN115120557B (zh) 2024-05-07
HRP20220165T1 (hr) 2022-04-29
CN111821261B (zh) 2022-07-26
CY1124930T1 (el) 2023-01-05
US20220241296A1 (en) 2022-08-04
PL3769753T3 (pl) 2022-04-04
TWI864053B (zh) 2024-12-01
SMT202200082T1 (it) 2022-03-21
CN111821261A (zh) 2020-10-27
EP3769753A1 (en) 2021-01-27

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