CY1124930T1 - Διεργασια για την παρασκευη στειρων οφθαλμικων υδατικων εναιωρηματων νανοκρυσταλλων μορφης α προπιονικης φλουτικαζονης - Google Patents

Διεργασια για την παρασκευη στειρων οφθαλμικων υδατικων εναιωρηματων νανοκρυσταλλων μορφης α προπιονικης φλουτικαζονης

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Publication number
CY1124930T1
CY1124930T1 CY20221100069T CY221100069T CY1124930T1 CY 1124930 T1 CY1124930 T1 CY 1124930T1 CY 20221100069 T CY20221100069 T CY 20221100069T CY 221100069 T CY221100069 T CY 221100069T CY 1124930 T1 CY1124930 T1 CY 1124930T1
Authority
CY
Cyprus
Prior art keywords
sterile
nanocrystals
preparation
ophtical
aqueous suspensions
Prior art date
Application number
CY20221100069T
Other languages
English (en)
Inventor
Jean-Michel BUKOWSKI
Akshay NADKARNI
José L. BOYER
Brigitte DUQUESROIX-CHAKROUN
Tomas Navratil
Original Assignee
Nicox Ophthalmics, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Nicox Ophthalmics, Inc. filed Critical Nicox Ophthalmics, Inc.
Publication of CY1124930T1 publication Critical patent/CY1124930T1/el

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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
    • 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
    • A61K9/0012—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
    • 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
    • A61K9/14—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

Landscapes

  • 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)

Abstract

Η παρούσα εφεύρεση αφορά μια βελτιωμένη διεργασία παρασκευής στείρων τοπικών οφθαλμικών υδατικών νανοεναιωρημάτων νανοκρυστάλλων Μορφής Α προπιονικής φλουτικαζόνης. Τα στείρα τοπικά οφθαλμικά νανοεναιωρήματα είναι χρήσιμα στη θεραπεία καταστάσεων φλεγμονής των οφθαλμών, όπως βλεφαρίτιδα, οπίσθια βλεφαρίτιδα, δυσλειτουργία του Μεϊβομιανού αδένα ή ξηροφθαλμία μέσω τοπικής χορήγησης των εν λόγω νανοεναιωρημάτων στα βλέφαρα, τις βλεφαρίδες και τα περιθώρια των βλεφάρων.
CY20221100069T 2019-07-23 2022-01-27 Διεργασια για την παρασκευη στειρων οφθαλμικων υδατικων εναιωρηματων νανοκρυσταλλων μορφης α προπιονικης φλουτικαζονης CY1124930T1 (el)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962877599P 2019-07-23 2019-07-23
US201962942551P 2019-12-02 2019-12-02
EP20186965.8A EP3769753B1 (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
CY1124930T1 true CY1124930T1 (el) 2023-01-05

Family

ID=71738074

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Application Number Title Priority Date Filing Date
CY20221100069T CY1124930T1 (el) 2019-07-23 2022-01-27 Διεργασια για την παρασκευη στειρων οφθαλμικων υδατικων εναιωρηματων νανοκρυσταλλων μορφης α προπιονικης φλουτικαζονης

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US (3) US20220241296A1 (el)
EP (1) EP3769753B1 (el)
JP (1) JP7021301B2 (el)
KR (1) KR20220038443A (el)
CN (2) CN115120557B (el)
AU (1) AU2020317084A1 (el)
CA (1) CA3145055A1 (el)
CY (1) CY1124930T1 (el)
DK (1) DK3769753T3 (el)
ES (1) ES2905793T3 (el)
HR (1) HRP20220165T1 (el)
HU (1) HUE057416T2 (el)
LT (1) LT3769753T (el)
MD (1) MD3769753T2 (el)
MX (1) MX2022000928A (el)
PL (1) PL3769753T3 (el)
PT (1) PT3769753T (el)
RS (1) RS62932B1 (el)
SI (1) SI3769753T1 (el)
TW (1) TW202116326A (el)
WO (1) WO2021014348A1 (el)

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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
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JP3337218B2 (ja) * 1992-05-06 2002-10-21 アルコン ラボラトリーズ，インコーポレイテッド 眼科用組成物におけるホウ酸塩−ポリオール複合体の使用
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
EP2847207B1 (en) * 2012-05-08 2019-03-27 Nicox Ophthalmics, Inc. Fluticasone propionate nanocrystals
CA2893654A1 (en) * 2012-12-17 2014-06-26 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

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Publication number Publication date
HRP20220165T1 (hr) 2022-04-29
CN115120557A (zh) 2022-09-30
EP3769753A1 (en) 2021-01-27
CN115120557B (zh) 2024-05-07
PT3769753T (pt) 2022-02-15
MX2022000928A (es) 2022-02-22
KR20220038443A (ko) 2022-03-28
LT3769753T (lt) 2022-05-10
RS62932B1 (sr) 2022-03-31
US20210023001A1 (en) 2021-01-28
MD3769753T2 (ro) 2022-04-30
ES2905793T3 (es) 2022-04-12
JP7021301B2 (ja) 2022-02-16
US11406596B2 (en) 2022-08-09
JP2021017449A (ja) 2021-02-15
WO2021014348A1 (en) 2021-01-28
US20220241296A1 (en) 2022-08-04
TW202116326A (zh) 2021-05-01
AU2020317084A1 (en) 2022-03-03
HUE057416T2 (hu) 2022-05-28
US20220323352A1 (en) 2022-10-13
CA3145055A1 (en) 2021-01-28
CN111821261A (zh) 2020-10-27
CN111821261B (zh) 2022-07-26
EP3769753B1 (en) 2021-11-17
PL3769753T3 (pl) 2022-04-04
DK3769753T3 (da) 2022-01-31
SI3769753T1 (sl) 2022-04-29
JP2022062172A (ja) 2022-04-19

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