JP2016532723A - 眼内投与のためのエピネフリン系点眼用組成物及びその製造のための方法 - Google Patents

眼内投与のためのエピネフリン系点眼用組成物及びその製造のための方法 Download PDF

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Publication number
JP2016532723A
JP2016532723A JP2016546889A JP2016546889A JP2016532723A JP 2016532723 A JP2016532723 A JP 2016532723A JP 2016546889 A JP2016546889 A JP 2016546889A JP 2016546889 A JP2016546889 A JP 2016546889A JP 2016532723 A JP2016532723 A JP 2016532723A
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Japan
Prior art keywords
pharmaceutical composition
epinephrine
group
composition
sulfite
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Pending
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JP2016546889A
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English (en)
Japanese (ja)
Inventor
カロルチーク，ジョン，スコット
バーム，マーク，エル
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Harrow Inc
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Imprimis Pharmaceuticals Inc
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Publication of JP2016532723A publication Critical patent/JP2016532723A/ja
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    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4409—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts or implants
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • 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
    • A61P27/12—Ophthalmic agents for cataracts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/02—Internal fittings
    • B65D25/04—Partitions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Ophthalmology & Optometry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Mechanical Engineering (AREA)
  • Inorganic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2016546889A 2013-10-03 2014-10-03 眼内投与のためのエピネフリン系点眼用組成物及びその製造のための方法 Pending JP2016532723A (ja)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201361886269P 2013-10-03 2013-10-03
US61/886,269 2013-10-03
US201361892872P 2013-10-18 2013-10-18
US61/892,872 2013-10-18
US201461947778P 2014-03-04 2014-03-04
US61/947,778 2014-03-04
PCT/US2014/059077 WO2015051264A1 (en) 2013-10-03 2014-10-03 Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricatiing thereof

Related Child Applications (1)

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JP2019088480A Division JP2019142964A (ja) 2013-10-03 2019-05-08 眼内投与のためのエピネフリン系点眼用組成物及びその製造のための方法

Publications (1)

Publication Number Publication Date
JP2016532723A true JP2016532723A (ja) 2016-10-20

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JP2016546889A Pending JP2016532723A (ja) 2013-10-03 2014-10-03 眼内投与のためのエピネフリン系点眼用組成物及びその製造のための方法
JP2019088480A Pending JP2019142964A (ja) 2013-10-03 2019-05-08 眼内投与のためのエピネフリン系点眼用組成物及びその製造のための方法

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Country Status (10)

Country Link
US (4) US10993921B2 (enExample)
EP (1) EP3052095A4 (enExample)
JP (2) JP2016532723A (enExample)
KR (1) KR20160070077A (enExample)
AU (2) AU2014329412B2 (enExample)
BR (1) BR112016007328A2 (enExample)
CA (1) CA2925008A1 (enExample)
IL (1) IL244687A0 (enExample)
MX (1) MX2016004257A (enExample)
WO (1) WO2015051264A1 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019142964A (ja) * 2013-10-03 2019-08-29 ハーロウ・ヘルス・インコーポレイテッドＨａｒｒｏｗ Ｈｅａｌｔｈ， Ｉｎｃ． 眼内投与のためのエピネフリン系点眼用組成物及びその製造のための方法
US12702651B2 (en) 2013-10-03 2026-08-11 Harrow Ip, Llc Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof

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TWI705812B (zh) 2014-12-01 2020-10-01 奥默羅斯公司 用於抑制術後眼睛炎性病況的抗炎和散瞳前房溶液
US20170189352A1 (en) 2015-03-13 2017-07-06 Par Pharmaceutical, Inc. Epinephrine formulations
WO2017218918A1 (en) 2016-06-17 2017-12-21 Ys Pharmtech Stabilization of epinephrine formulations
WO2018039420A1 (en) * 2016-08-25 2018-03-01 Imprimis Pharmaceuticals, Inc. Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof
US20180318319A1 (en) 2017-05-04 2018-11-08 Ocular Science, Inc. Compositions and Methods for Treating Eyes and Methods of Preparation
EP3687475A4 (en) * 2017-09-26 2021-07-28 YS Pharmtech STABILIZATION OF EPINEPHRIN FORMULATIONS
WO2019182745A1 (en) 2018-03-19 2019-09-26 Bryn Pharma, LLC Epinephrine spray formulations
CA3093725C (en) 2018-03-23 2021-08-24 Nevakar Inc. Epinephrine compositions and containers
US11071724B2 (en) 2019-05-17 2021-07-27 Ocular Science, Inc. Compositions and methods for treating presbyopia
US20230277694A1 (en) * 2022-03-04 2023-09-07 Harrow Ip, Llc Ophthalmic dye composition and method for administering same

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019142964A (ja) * 2013-10-03 2019-08-29 ハーロウ・ヘルス・インコーポレイテッドＨａｒｒｏｗ Ｈｅａｌｔｈ， Ｉｎｃ． 眼内投与のためのエピネフリン系点眼用組成物及びその製造のための方法
US10993921B2 (en) 2013-10-03 2021-05-04 Harrow Ip, Llc Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof
US11045432B2 (en) 2013-10-03 2021-06-29 Harrow Ip, Llc Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof
US12702651B2 (en) 2013-10-03 2026-08-11 Harrow Ip, Llc Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof

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Publication number Publication date
US20170049721A1 (en) 2017-02-23
EP3052095A4 (en) 2017-07-05
US11045432B2 (en) 2021-06-29
US20210275471A1 (en) 2021-09-09
EP3052095A1 (en) 2016-08-10
KR20160070077A (ko) 2016-06-17
MX2016004257A (es) 2016-08-17
CA2925008A1 (en) 2015-04-09
US10993921B2 (en) 2021-05-04
US20150119440A1 (en) 2015-04-30
BR112016007328A2 (pt) 2017-08-01
AU2014329412A1 (en) 2016-05-05
JP2019142964A (ja) 2019-08-29
WO2015051264A8 (en) 2016-04-07
IL244687A0 (en) 2016-04-21
AU2014329412B2 (en) 2020-02-27
WO2015051264A1 (en) 2015-04-09
AU2020203044A1 (en) 2020-05-28
US20160354308A1 (en) 2016-12-08

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