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WO2025146828A1 - Composition ophtalmique - Google Patents

Composition ophtalmique Download PDF

Info

Publication number
WO2025146828A1
WO2025146828A1 PCT/JP2025/000050 JP2025000050W WO2025146828A1 WO 2025146828 A1 WO2025146828 A1 WO 2025146828A1 JP 2025000050 W JP2025000050 W JP 2025000050W WO 2025146828 A1 WO2025146828 A1 WO 2025146828A1
Authority
WO
WIPO (PCT)
Prior art keywords
ophthalmic composition
salts
container
tramadol
acid
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
PCT/JP2025/000050
Other languages
English (en)
Japanese (ja)
Inventor
庸子 小川
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.)
Rohto Pharmaceutical Co Ltd
Original Assignee
Rohto Pharmaceutical Co Ltd
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 Rohto Pharmaceutical Co Ltd filed Critical Rohto Pharmaceutical Co Ltd
Publication of WO2025146828A1 publication Critical patent/WO2025146828A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • 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

Definitions

  • the present invention relates to an ophthalmic composition.
  • Tramadol is a non-narcotic analgesic classified as a weak opioid, and is used as a systemic analgesic for cancer pain and other conditions (Non-Patent Document 1).
  • the present inventors have found for the first time that when a tramadol-containing ophthalmic composition is filled into a plastic container at the same time as molding the container using the blow-fill-seal method, the amount of tramadol-derived impurities is reduced regardless of the tramadol content in the ophthalmic composition.
  • the present invention is based on this finding and provides the following inventions.
  • citrate buffers examples include citric acid or a salt thereof (sodium citrate, potassium citrate, calcium citrate, sodium dihydrogen citrate, disodium citrate, etc.);
  • the acetate buffer includes acetic acid or a salt thereof (ammonium acetate, sodium acetate, potassium acetate, calcium acetate, etc.);
  • the lactate buffer includes lactic acid or a salt thereof (sodium lactate, potassium lactate, calcium lactate, etc.);
  • succinate buffer includes succinic acid or a salt thereof (monosodium succinate, disodium succinate, etc.).
  • the capacity may be, for example, 1.5 to 7.5 mL, 2 to 6 mL, or 2.5 to 5.0 mL. If the container is a unit-dose container, the capacity may be, for example, 0.1 to 1.0 mL, 0.2 to 0.9 mL, or 0.3 to 0.8 mL.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Ophthalmology & Optometry (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une composition ophtalmique contenant du tramadol ou un sel de celui-ci. La composition ophtalmique est stockée dans un récipient dans lequel une partie ou la totalité d'une portion qui entre en contact avec la composition ophtalmique est formée à partir d'un plastique, et le récipient, qui est moulé par l'intermédiaire d'un procédé de formage-remplissage-scellage, est rempli avec la composition ophtalmique.
PCT/JP2025/000050 2024-01-05 2025-01-06 Composition ophtalmique Pending WO2025146828A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2024000720 2024-01-05
JP2024-000720 2024-01-05

Publications (1)

Publication Number Publication Date
WO2025146828A1 true WO2025146828A1 (fr) 2025-07-10

Family

ID=96300438

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2025/000050 Pending WO2025146828A1 (fr) 2024-01-05 2025-01-06 Composition ophtalmique

Country Status (1)

Country Link
WO (1) WO2025146828A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012516187A (ja) * 2009-02-20 2012-07-19 マイクロ ラブズ リミテッド 貯蔵安定性プロスタグランジン製品
JP2014513073A (ja) * 2011-04-05 2014-05-29 オプトソルヴ リミテッド ライアビリティー パートナーシップ 眼科治療
JP2016521252A (ja) * 2013-03-13 2016-07-21 イレブン・バイオセラピユーテイクス・インコーポレイテツド 眼送達のためのキメラサイトカイン製剤
JP2018188440A (ja) * 2017-05-11 2018-11-29 ネヴァカー・インコーポレイテッドNevakar Inc. アトロピン医薬組成物
US20190224114A1 (en) * 2015-09-09 2019-07-25 Farmalider, S.A. Pharmaceutical tramadol composition for ophthalmic use

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012516187A (ja) * 2009-02-20 2012-07-19 マイクロ ラブズ リミテッド 貯蔵安定性プロスタグランジン製品
JP2014513073A (ja) * 2011-04-05 2014-05-29 オプトソルヴ リミテッド ライアビリティー パートナーシップ 眼科治療
JP2016521252A (ja) * 2013-03-13 2016-07-21 イレブン・バイオセラピユーテイクス・インコーポレイテツド 眼送達のためのキメラサイトカイン製剤
US20190224114A1 (en) * 2015-09-09 2019-07-25 Farmalider, S.A. Pharmaceutical tramadol composition for ophthalmic use
JP2018188440A (ja) * 2017-05-11 2018-11-29 ネヴァカー・インコーポレイテッドNevakar Inc. アトロピン医薬組成物

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