CA3145055A1 - Process for the preparation of sterile ophthalmic aqueous fluticasone propionate form a nanocrystals suspensions - Google Patents

Process for the preparation of sterile ophthalmic aqueous fluticasone propionate form a nanocrystals suspensions Download PDF

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Publication number
CA3145055A1
CA3145055A1 CA3145055A CA3145055A CA3145055A1 CA 3145055 A1 CA3145055 A1 CA 3145055A1 CA 3145055 A CA3145055 A CA 3145055A CA 3145055 A CA3145055 A CA 3145055A CA 3145055 A1 CA3145055 A1 CA 3145055A1
Authority
CA
Canada
Prior art keywords
fluticasone propionate
nanocrystals
nanosuspension
phase
concentration
Prior art date
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.)
Pending
Application number
CA3145055A
Other languages
English (en)
French (fr)
Inventor
Jean-Michel BUKOWSKI
Akshay NADKARNI
Jose L. Boyer
Brigitte DUQUESROIX-CHAKROUN
Tomas Navratil
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nicox Ophthalmics Inc
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA3145055A1 publication Critical patent/CA3145055A1/en
Pending legal-status Critical Current

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Classifications

    • 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

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)
  • 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)
CA3145055A 2019-07-23 2020-07-21 Process for the preparation of sterile ophthalmic aqueous fluticasone propionate form a nanocrystals suspensions Pending CA3145055A1 (en)

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
CA3145055A1 true CA3145055A1 (en) 2021-01-28

Family

ID=71738074

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3145055A Pending CA3145055A1 (en) 2019-07-23 2020-07-21 Process for the preparation of sterile ophthalmic aqueous fluticasone propionate form a nanocrystals suspensions

Country Status (23)

Country Link
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

Also Published As

Publication number Publication date
HUE057416T2 (hu) 2022-05-28
MD3769753T2 (ro) 2022-04-30
DK3769753T3 (da) 2022-01-31
CN115120557A (zh) 2022-09-30
KR20220038443A (ko) 2022-03-28
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
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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