AU2021267217A1 - Stable cyclosporine ophthalmic formulation and manufacturing process thereof - Google Patents

Stable cyclosporine ophthalmic formulation and manufacturing process thereof Download PDF

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Publication number
AU2021267217A1
AU2021267217A1 AU2021267217A AU2021267217A AU2021267217A1 AU 2021267217 A1 AU2021267217 A1 AU 2021267217A1 AU 2021267217 A AU2021267217 A AU 2021267217A AU 2021267217 A AU2021267217 A AU 2021267217A AU 2021267217 A1 AU2021267217 A1 AU 2021267217A1
Authority
AU
Australia
Prior art keywords
cyclosporine
temperature
mixture
stable
mixing
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
AU2021267217A
Other languages
English (en)
Inventor
Arindam Halder
Ajay Jaysingh Khopade
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.)
Sun Pharmaceutical Industries Ltd
Original Assignee
Sun Pharmaceutical Industries 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 Sun Pharmaceutical Industries Ltd filed Critical Sun Pharmaceutical Industries Ltd
Publication of AU2021267217A1 publication Critical patent/AU2021267217A1/en
Pending legal-status Critical Current

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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)
AU2021267217A 2021-08-20 2021-10-06 Stable cyclosporine ophthalmic formulation and manufacturing process thereof Pending AU2021267217A1 (en)

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 (1)

Publication Number Publication Date
AU2021267217A1 true AU2021267217A1 (en) 2024-02-29

Family

ID=78468801

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2021267217A Pending AU2021267217A1 (en) 2021-08-20 2021-10-06 Stable cyclosporine ophthalmic formulation and manufacturing process thereof
AU2022330409A Pending AU2022330409A1 (en) 2021-08-20 2022-08-22 Stable cyclosporine ophthalmic formulation and manufacturing process thereof

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2022330409A Pending AU2022330409A1 (en) 2021-08-20 2022-08-22 Stable cyclosporine ophthalmic formulation and manufacturing process thereof

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
IL310823A (en) 2024-04-01
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
WO2021224901A2 (en) 2021-11-11

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