DK3769753T3 - Fremgangsmåde til fremstilling af sterile oftalmiske vandige suspensioner af nanokrystaller af fluticasonpropionat-form A - Google Patents

Fremgangsmåde til fremstilling af sterile oftalmiske vandige suspensioner af nanokrystaller af fluticasonpropionat-form A Download PDF

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Publication number
DK3769753T3
DK3769753T3 DK20186965.8T DK20186965T DK3769753T3 DK 3769753 T3 DK3769753 T3 DK 3769753T3 DK 20186965 T DK20186965 T DK 20186965T DK 3769753 T3 DK3769753 T3 DK 3769753T3
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Prior art keywords
nanocrystals
preparation
aqueous suspensions
fluticasone propionate
ophthalmic aqueous
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Application number
DK20186965.8T
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English (en)
Inventor
Jean-Michel Bukowski
Akshay Nadkarni
José L Boyer
Brigitte Duquesroix-Chakroun
Tomas Navratil
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Nicox Ophthalmics Inc
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Publication of DK3769753T3 publication Critical patent/DK3769753T3/da

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • 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
    • A61K31/565Compounds 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
    • A61K31/567Compounds 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
    • 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
    • A61K31/565Compounds 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
    • A61K31/568Compounds 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
    • A61K31/569Compounds 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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • A61P27/04Artificial tears; Irrigation solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B82NANOTECHNOLOGY
    • B82YSPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07JSTEROIDS
    • C07J31/00Normal steroids containing one or more sulfur atoms not belonging to a hetero ring
    • C07J31/006Normal 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Rheumatology (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
DK20186965.8T 2019-07-23 2020-07-21 Fremgangsmåde til fremstilling af sterile oftalmiske vandige suspensioner af nanokrystaller af fluticasonpropionat-form A DK3769753T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962877599P 2019-07-23 2019-07-23
US201962942551P 2019-12-02 2019-12-02

Publications (1)

Publication Number Publication Date
DK3769753T3 true DK3769753T3 (da) 2022-01-31

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DK20186965.8T DK3769753T3 (da) 2019-07-23 2020-07-21 Fremgangsmåde til fremstilling af sterile oftalmiske vandige suspensioner af nanokrystaller af fluticasonpropionat-form A

Country Status (21)

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US (3) US11406596B2 (da)
EP (1) EP3769753B1 (da)
JP (2) JP7021301B2 (da)
KR (1) KR20220038443A (da)
CN (2) CN111821261B (da)
AU (1) AU2020317084A1 (da)
CA (1) CA3145055A1 (da)
CY (1) CY1124930T1 (da)
DK (1) DK3769753T3 (da)
ES (1) ES2905793T3 (da)
HR (1) HRP20220165T1 (da)
HU (1) HUE057416T2 (da)
LT (1) LT3769753T (da)
MD (1) MD3769753T2 (da)
MX (1) MX2022000928A (da)
PL (1) PL3769753T3 (da)
PT (1) PT3769753T (da)
RS (1) RS62932B1 (da)
SI (1) SI3769753T1 (da)
TW (1) TW202116326A (da)
WO (1) WO2021014348A1 (da)

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Publication number Priority date Publication date Assignee Title
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 (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0639070B2 (en) * 1992-05-06 2010-09-08 Alcon Laboratories, Inc. 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
JP2012528889A (ja) 2009-06-05 2012-11-15 アーシエックス セラピューティックス, インコーポレイテッド フルチカゾンの眼科処方物および使用方法
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
RU2663117C2 (ru) 2012-05-08 2018-08-01 Никокс Офтэлмикс, Инк. Препараты гидрофобных терапевтических средств, способы их получения и применения
BR112015014262A8 (pt) * 2012-12-17 2019-10-08 Glaxo Group Ltd formulação farmacêutica, dispositivo adaptado para distribuição intranasal de uma formulação farmacêutica, e, uso de uma formulação farmacêutica
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

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Publication number Publication date
PT3769753T (pt) 2022-02-15
CN115120557A (zh) 2022-09-30
MD3769753T2 (ro) 2022-04-30
US20210023001A1 (en) 2021-01-28
HUE057416T2 (hu) 2022-05-28
LT3769753T (lt) 2022-05-10
AU2020317084A1 (en) 2022-03-03
KR20220038443A (ko) 2022-03-28
CN111821261B (zh) 2022-07-26
CA3145055A1 (en) 2021-01-28
JP7494230B2 (ja) 2024-06-03
RS62932B1 (sr) 2022-03-31
EP3769753A1 (en) 2021-01-27
CN115120557B (zh) 2024-05-07
CY1124930T1 (el) 2023-01-05
JP2021017449A (ja) 2021-02-15
JP2022062172A (ja) 2022-04-19
MX2022000928A (es) 2022-02-22
US11406596B2 (en) 2022-08-09
PL3769753T3 (pl) 2022-04-04
WO2021014348A1 (en) 2021-01-28
JP7021301B2 (ja) 2022-02-16
SI3769753T1 (sl) 2022-04-29
US20220323352A1 (en) 2022-10-13
ES2905793T3 (es) 2022-04-12
EP3769753B1 (en) 2021-11-17
HRP20220165T1 (hr) 2022-04-29
TW202116326A (zh) 2021-05-01
US20220241296A1 (en) 2022-08-04
CN111821261A (zh) 2020-10-27

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