AU2019300203B2 - Ophthalmic compositions containing a nitric oxide releasing prostamide - Google Patents

Ophthalmic compositions containing a nitric oxide releasing prostamide Download PDF

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Publication number
AU2019300203B2
AU2019300203B2 AU2019300203A AU2019300203A AU2019300203B2 AU 2019300203 B2 AU2019300203 B2 AU 2019300203B2 AU 2019300203 A AU2019300203 A AU 2019300203A AU 2019300203 A AU2019300203 A AU 2019300203A AU 2019300203 B2 AU2019300203 B2 AU 2019300203B2
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AU
Australia
Prior art keywords
ophthalmic
aqueous composition
solution
composition according
hydroxystearate
Prior art date
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Application number
AU2019300203A
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English (en)
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AU2019300203A1 (en
Inventor
Marina Do
Frédéric Pilotaz
Julien SALDO
Alan L. Weiner
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Nicox SA
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Nicox SA
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Publication of AU2019300203B2 publication Critical patent/AU2019300203B2/en
Priority to AU2025203019A priority Critical patent/AU2025203019A1/en
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Classifications

    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
    • 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
    • A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
    • A61K31/5575—Eicosanoids, e.g. leukotrienes or prostaglandins having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides 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
    • A61K47/06—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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K9/08—Solutions
    • 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
    • A61P27/06—Antiglaucoma agents or miotics

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Ophthalmology & Optometry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2019300203A 2018-07-12 2019-07-10 Ophthalmic compositions containing a nitric oxide releasing prostamide Active AU2019300203B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2025203019A AU2025203019A1 (en) 2018-07-12 2025-04-29 Ophthalmic Compositions Containing A Nitric Oxide Releasing Prostamide

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP18290082.9 2018-07-12
EP18290082 2018-07-12
PCT/EP2019/068511 WO2020011845A1 (en) 2018-07-12 2019-07-10 Ophthalmic compositions containing a nitric oxide releasing prostamide

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2025203019A Division AU2025203019A1 (en) 2018-07-12 2025-04-29 Ophthalmic Compositions Containing A Nitric Oxide Releasing Prostamide

Publications (2)

Publication Number Publication Date
AU2019300203A1 AU2019300203A1 (en) 2021-03-04
AU2019300203B2 true AU2019300203B2 (en) 2025-01-30

Family

ID=63012964

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2019300203A Active AU2019300203B2 (en) 2018-07-12 2019-07-10 Ophthalmic compositions containing a nitric oxide releasing prostamide
AU2025203019A Pending AU2025203019A1 (en) 2018-07-12 2025-04-29 Ophthalmic Compositions Containing A Nitric Oxide Releasing Prostamide

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2025203019A Pending AU2025203019A1 (en) 2018-07-12 2025-04-29 Ophthalmic Compositions Containing A Nitric Oxide Releasing Prostamide

Country Status (28)

Country Link
US (5) US10688073B2 (https=)
EP (2) EP3718535B1 (https=)
JP (4) JP6672512B2 (https=)
KR (1) KR102861273B1 (https=)
CN (2) CN111249228B (https=)
AR (1) AR115734A1 (https=)
AU (2) AU2019300203B2 (https=)
BR (1) BR112021000240A2 (https=)
CA (1) CA3105989A1 (https=)
CY (1) CY1123706T1 (https=)
DK (1) DK3593788T3 (https=)
ES (2) ES2847853T3 (https=)
HR (2) HRP20251098T1 (https=)
HU (2) HUE072927T2 (https=)
LT (1) LT3593788T (https=)
MA (2) MA52258B1 (https=)
MD (2) MD3593788T2 (https=)
MX (2) MX2021000411A (https=)
MY (1) MY205816A (https=)
PH (1) PH12020552112A1 (https=)
PL (2) PL3718535T3 (https=)
PT (1) PT3593788T (https=)
RS (2) RS61348B1 (https=)
SG (1) SG11202100064WA (https=)
SI (1) SI3593788T1 (https=)
SM (2) SMT202100034T1 (https=)
TW (1) TWI839364B (https=)
WO (1) WO2020011845A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2019300203B2 (en) * 2018-07-12 2025-01-30 Nicox S.A. Ophthalmic compositions containing a nitric oxide releasing prostamide
EP4404936A1 (en) * 2021-09-20 2024-07-31 Nicox SA Nitric oxide releasing prostamide as neuroprotective agent
JP7665073B1 (ja) 2024-04-05 2025-04-18 ロート製薬株式会社 容器に収容してなる眼科用組成物
US20260053768A1 (en) * 2024-05-07 2026-02-26 Maher Hadaya Sustained Nitric Oxide Releasing Drug Delivery Systems

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009136281A1 (en) * 2008-05-09 2009-11-12 Nicox S.A. Nitric oxide donating prostamides
WO2013003827A2 (en) * 2011-06-29 2013-01-03 Allergan, Inc. Macrogol 15 hydroxystearate formulations
US8772337B2 (en) * 2007-07-20 2014-07-08 Laboratoires Thea Preservative-free prostaglandin-based ophthalmic solution

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9629852B2 (en) 2007-10-16 2017-04-25 Sun Pharma Advanced Research Company Ltd. Ophthalmic composition comprising a prostaglandin
MX2011002688A (es) 2008-09-12 2011-04-12 Critical Pharmaceuticals Ltd Mejoramientos en la absorcion de agentes terapeuticos a traves de las membranas mucosas o la piel.
US20130267591A1 (en) * 2010-05-07 2013-10-10 Sun Pharma Advanced Research Company Limited Novel ophthalmic compositions
FR2961694B1 (fr) * 2010-06-29 2013-01-25 Thea Lab Systeme de delivrance polymerique d'une solution non visqueuse a base de prostaglandine sans conservateur
CA2841644A1 (en) 2011-08-02 2013-02-07 Cipla Limited Pharmaceutical composition comprising ebastine and fluticasone
CN105012231A (zh) * 2014-04-30 2015-11-04 四川科伦药物研究院有限公司 一种包含PGF2α衍生物的稳定性良好的眼用制剂及其制备方法
CN105380901B (zh) * 2015-11-18 2018-07-17 侯宇华 一种他氟前列素滴眼剂及其制备方法
AU2019300203B2 (en) * 2018-07-12 2025-01-30 Nicox S.A. Ophthalmic compositions containing a nitric oxide releasing prostamide

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8772337B2 (en) * 2007-07-20 2014-07-08 Laboratoires Thea Preservative-free prostaglandin-based ophthalmic solution
WO2009136281A1 (en) * 2008-05-09 2009-11-12 Nicox S.A. Nitric oxide donating prostamides
WO2013003827A2 (en) * 2011-06-29 2013-01-03 Allergan, Inc. Macrogol 15 hydroxystearate formulations

Also Published As

Publication number Publication date
US12178793B2 (en) 2024-12-31
DK3593788T3 (da) 2021-01-11
PH12020552112A1 (en) 2021-05-31
BR112021000240A2 (pt) 2021-04-06
RS61348B1 (sr) 2021-02-26
SMT202100034T1 (it) 2021-03-15
ES2847853T3 (es) 2021-08-04
CN111249228B (zh) 2022-05-03
JP2022116147A (ja) 2022-08-09
JP2020011955A (ja) 2020-01-23
SI3593788T1 (sl) 2021-03-31
EP3718535C0 (en) 2025-06-18
US11020368B2 (en) 2021-06-01
MX2023007091A (es) 2023-06-27
EP3593788B1 (en) 2020-10-28
AU2019300203A1 (en) 2021-03-04
US20200206176A1 (en) 2020-07-02
PL3718535T3 (pl) 2025-10-13
KR102861273B1 (ko) 2025-09-17
AR115734A1 (es) 2021-02-17
LT3593788T (lt) 2021-04-12
SG11202100064WA (en) 2021-02-25
MA48919B1 (fr) 2021-02-26
MA48919A (fr) 2020-01-15
MY205816A (en) 2024-11-14
JP2020105201A (ja) 2020-07-09
EP3593788A1 (en) 2020-01-15
MA52258B1 (fr) 2025-07-31
SMT202500425T1 (it) 2026-01-12
MX2021000411A (es) 2021-03-25
US20200016108A1 (en) 2020-01-16
MD3593788T2 (ro) 2021-03-31
CY1123706T1 (el) 2022-05-27
CN110237031B (zh) 2022-02-11
KR20210032435A (ko) 2021-03-24
MA52258A (fr) 2021-02-17
PL3593788T3 (pl) 2021-05-31
PT3593788T (pt) 2021-01-21
HUE052747T2 (hu) 2021-05-28
TW202019401A (zh) 2020-06-01
RS67054B1 (sr) 2025-08-29
EP3718535A1 (en) 2020-10-07
HRP20210138T1 (hr) 2021-03-19
EP3718535B1 (en) 2025-06-18
CN110237031A (zh) 2019-09-17
CN111249228A (zh) 2020-06-09
ES3036636T3 (en) 2025-09-23
HUE072927T2 (hu) 2025-12-28
JP7397910B2 (ja) 2023-12-13
CA3105989A1 (en) 2020-01-16
TWI839364B (zh) 2024-04-21
US20210128458A1 (en) 2021-05-06
WO2020011845A1 (en) 2020-01-16
MD3718535T2 (ro) 2025-08-31
AU2025203019A1 (en) 2025-05-15
US12186295B2 (en) 2025-01-07
JP6672512B2 (ja) 2020-03-25
JP2024023498A (ja) 2024-02-21
HRP20251098T1 (hr) 2025-11-07
US10688073B2 (en) 2020-06-23
US20250073196A1 (en) 2025-03-06
US20210220316A1 (en) 2021-07-22
JP7080268B2 (ja) 2022-06-03

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