JP2024530244A - 安定なシクロスポリン眼科用製剤及びその製造プロセス - Google Patents

安定なシクロスポリン眼科用製剤及びその製造プロセス Download PDF

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Publication number
JP2024530244A
JP2024530244A JP2024509421A JP2024509421A JP2024530244A JP 2024530244 A JP2024530244 A JP 2024530244A JP 2024509421 A JP2024509421 A JP 2024509421A JP 2024509421 A JP2024509421 A JP 2024509421A JP 2024530244 A JP2024530244 A JP 2024530244A
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JP
Japan
Prior art keywords
cyclosporine
temperature
mixture
stable
castor oil
Prior art date
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Pending
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JP2024509421A
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English (en)
Japanese (ja)
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JP2024530244A5 (https=
Inventor
コーパド，アジェイ・ジェイシン
ハルダー，アリンダム
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Sun Pharmaceutical Industries Ltd
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Sun Pharmaceutical Industries Ltd
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Publication date
Application filed by Sun Pharmaceutical Industries Ltd filed Critical Sun Pharmaceutical Industries Ltd
Publication of JP2024530244A publication Critical patent/JP2024530244A/ja
Publication of JP2024530244A5 publication Critical patent/JP2024530244A5/ja
Pending legal-status Critical Current

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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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13—Cyclosporins
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Ophthalmology & Optometry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
JP2024509421A 2021-08-20 2021-10-06 安定なシクロスポリン眼科用製剤及びその製造プロセス Pending JP2024530244A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN202121037917 2021-08-20
IN202121037917 2021-08-20
PCT/IB2021/059176 WO2021224901A2 (en) 2021-08-20 2021-10-06 Stable cyclosporine ophthalmic formulation and manufacturing process thereof

Publications (2)

Publication Number Publication Date
JP2024530244A true JP2024530244A (ja) 2024-08-16
JP2024530244A5 JP2024530244A5 (https=) 2024-10-16

Family

ID=78468801

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2024509421A Pending JP2024530244A (ja) 2021-08-20 2021-10-06 安定なシクロスポリン眼科用製剤及びその製造プロセス
JP2024509422A Pending JP2024530245A (ja) 2021-08-20 2022-08-22 安定なシクロスポリン眼科用製剤及びその製造プロセス

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2024509422A Pending JP2024530245A (ja) 2021-08-20 2022-08-22 安定なシクロスポリン眼科用製剤及びその製造プロセス

Country Status (8)

Country Link
US (2) US20240342086A1 (https=)
EP (2) EP4387589A4 (https=)
JP (2) JP2024530244A (https=)
CN (2) CN117957011A (https=)
AU (2) AU2021267217A1 (https=)
IL (2) IL310823A (https=)
MX (2) MX2024002234A (https=)
WO (2) WO2021224901A2 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4719350A1 (en) * 2023-05-29 2026-04-08 Sun Pharmaceutical Industries Limited Stable cyclosporine ophthalmic formulation and manufacturing process thereof
WO2025163677A1 (en) * 2024-01-31 2025-08-07 Registrar, Panjab University, Chandigarh Nanomicellar composition for high permeation and extended-release drug delivery system

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019507154A (ja) * 2016-02-29 2019-03-14 サン ファーマ グローバル エフジーイー 局所用シクロスポリン含有製剤およびその使用

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY180581A (en) * 2011-05-27 2020-12-02 Allergan Inc A crystalline form of cyclosporine a, methods of preparation, and methods for use thereof
HK1211867A1 (en) * 2012-08-24 2016-06-03 Sun Pharma Global Fze Ophthalmic formulation of polyoxyl lipid or polyoxyl fatty acid and treatment of ocular conditions
US20200237859A1 (en) * 2019-01-25 2020-07-30 Newport Research, Inc. Aqueous suspensions of cyclosporin
WO2017083167A1 (en) * 2015-11-10 2017-05-18 Ocular Technologies Sarl Topical formulations and uses thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019507154A (ja) * 2016-02-29 2019-03-14 サン ファーマ グローバル エフジーイー 局所用シクロスポリン含有製剤およびその使用

Also Published As

Publication number Publication date
CN117957011A (zh) 2024-04-30
US20240342086A1 (en) 2024-10-17
EP4387591A1 (en) 2024-06-26
WO2023021492A1 (en) 2023-02-23
JP2024530245A (ja) 2024-08-16
IL310823A (en) 2024-04-01
WO2021224901A3 (en) 2021-12-30
CN116528838A (zh) 2023-08-01
AU2021267217A1 (en) 2024-02-29
IL310887A (en) 2024-04-01
WO2021224901A2 (en) 2021-11-11
EP4387589A2 (en) 2024-06-26
EP4387589A4 (en) 2025-09-03
MX2024002235A (es) 2024-06-11
AU2022330409A1 (en) 2024-02-29
MX2024002234A (es) 2024-04-17
US20240423912A1 (en) 2024-12-26

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