IL310823A - Stable cyclosporine ophthalmic formulation and manufacturing process thereof - Google Patents

Stable cyclosporine ophthalmic formulation and manufacturing process thereof

Info

Publication number
IL310823A
IL310823A IL310823A IL31082324A IL310823A IL 310823 A IL310823 A IL 310823A IL 310823 A IL310823 A IL 310823A IL 31082324 A IL31082324 A IL 31082324A IL 310823 A IL310823 A IL 310823A
Authority
IL
Israel
Prior art keywords
cyclosporine
temperature
mixture
stable
mixing
Prior art date
Application number
IL310823A
Other languages
English (en)
Hebrew (he)
Inventor
Ajay Jaysingh Khopade
Arindam Halder
Original Assignee
Sun Pharmaceutical Ind Ltd
Ajay Jaysingh Khopade
Arindam Halder
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 Sun Pharmaceutical Ind Ltd, Ajay Jaysingh Khopade, Arindam Halder filed Critical Sun Pharmaceutical Ind Ltd
Publication of IL310823A publication Critical patent/IL310823A/en

Links

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
    • A61K9/10—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

Landscapes

  • 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)
IL310823A 2021-08-20 2021-10-06 Stable cyclosporine ophthalmic formulation and manufacturing process thereof IL310823A (en)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
IL310823A true IL310823A (en) 2024-04-01

Family

ID=78468801

Family Applications (2)

Application Number Title Priority Date Filing Date
IL310823A IL310823A (en) 2021-08-20 2021-10-06 Stable cyclosporine ophthalmic formulation and manufacturing process thereof
IL310887A IL310887A (en) 2021-08-20 2022-08-22 Stable cyclosporine ophthalmic formulation and its manufacturing process

Family Applications After (1)

Application Number Title Priority Date Filing Date
IL310887A IL310887A (en) 2021-08-20 2022-08-22 Stable cyclosporine ophthalmic formulation and its manufacturing process

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

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2836946C (en) * 2011-05-27 2017-08-01 Allergan, Inc. A crystalline form of cyclosporine a, methods of preparation, and methods for use thereof
PL2887923T3 (pl) * 2012-08-24 2023-08-14 Sun Pharmaceutical Industries Limited Preparat okulistyczny polioksylipidu lub polioksylowego kwasu tłuszczowego i leczenie chorób oczu
US20200237859A1 (en) * 2019-01-25 2020-07-30 Newport Research, Inc. Aqueous suspensions of cyclosporin
EP3373976B1 (en) * 2015-11-10 2024-01-03 Sun Pharmaceutical Industries Limited Topical formulations and uses thereof
US10918694B2 (en) * 2016-02-29 2021-02-16 Sun Pharma Global Fze Topical cyclosporine-containing formulations and uses thereof

Also Published As

Publication number Publication date
EP4387589A2 (en) 2024-06-26
EP4387589A4 (en) 2025-09-03
AU2022330409A1 (en) 2024-02-29
US20240423912A1 (en) 2024-12-26
IL310887A (en) 2024-04-01
EP4387591A1 (en) 2024-06-26
MX2024002235A (es) 2024-06-11
JP2024530245A (ja) 2024-08-16
MX2024002234A (es) 2024-04-17
CN117957011A (zh) 2024-04-30
WO2021224901A3 (en) 2021-12-30
US20240342086A1 (en) 2024-10-17
JP2024530244A (ja) 2024-08-16
WO2023021492A1 (en) 2023-02-23
CN116528838A (zh) 2023-08-01
AU2021267217A1 (en) 2024-02-29
WO2021224901A2 (en) 2021-11-11

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