WO2021113580A1 - Ophthalmic pharmaceutical compositions - Google Patents

Ophthalmic pharmaceutical compositions Download PDF

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Publication number
WO2021113580A1
WO2021113580A1 PCT/US2020/063218 US2020063218W WO2021113580A1 WO 2021113580 A1 WO2021113580 A1 WO 2021113580A1 US 2020063218 W US2020063218 W US 2020063218W WO 2021113580 A1 WO2021113580 A1 WO 2021113580A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
months
ophthalmic
formula
compound
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.)
Ceased
Application number
PCT/US2020/063218
Other languages
English (en)
French (fr)
Inventor
Udaya KOTREKA
Deepak Phadke
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.)
Vanda Pharmaceuticals Inc
Original Assignee
Vanda Pharmaceuticals Inc
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
Priority to KR1020227022823A priority Critical patent/KR20220128619A/ko
Priority to CA3160484A priority patent/CA3160484A1/en
Priority to IL293541A priority patent/IL293541A/en
Priority to AU2020398224A priority patent/AU2020398224B2/en
Priority to BR112022010871A priority patent/BR112022010871A2/pt
Priority to US17/782,197 priority patent/US20230026577A1/en
Priority to MX2022006776A priority patent/MX2022006776A/es
Priority to EP20830416.2A priority patent/EP4069195A1/en
Application filed by Vanda Pharmaceuticals Inc filed Critical Vanda Pharmaceuticals Inc
Priority to JP2022533510A priority patent/JP7833399B2/ja
Priority to CN202080094414.9A priority patent/CN115397392A/zh
Publication of WO2021113580A1 publication Critical patent/WO2021113580A1/en
Anticipated expiration legal-status Critical
Priority to CONC2022/0009260A priority patent/CO2022009260A2/es
Priority to JP2025117830A priority patent/JP2025160247A/ja
Ceased legal-status Critical Current

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • 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
    • A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • 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
    • A61K47/06—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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/08—Solutions
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the sample solution has a nominal concentration of the compound of Formula (I) of 68 ⁇ g/mL.
  • the sample solution injection is bracketed by injections of the working standard solution.
  • An aqueous ophthalmic composition comprising a compound of Formula I: F and not more than 0.5%, preferably not more than 0.2%, (by HPLC) of the compound of Formula II, F relative to the amount of the compound of Formula I after storage in a closed container for at least 6 months, for at least 12 months, for at least 18 months, for at least 24 months, or prior to a commercially acceptable expiration date for the composition.
  • Aspect 61. The aqueous ophthalmic composition of aspect 60, wherein said composition comprises not more than 0.5%, preferably not more than 0.2%, (by HPLC) of the compound of Formula II, relative to the amount of the compound of Formula I, after storage in a closed container prior to a commercially acceptable expiration date for the composition.
  • Aspect 81 The ophthalmic pharmaceutical composition of any one of aspects 39-80, wherein by HPLC is by HPLC area %.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Ophthalmology & Optometry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
PCT/US2020/063218 2019-12-05 2020-12-04 Ophthalmic pharmaceutical compositions Ceased WO2021113580A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
MX2022006776A MX2022006776A (es) 2019-12-05 2020-12-04 Composiciones farmaceuticas oftalmicas.
IL293541A IL293541A (en) 2019-12-05 2020-12-04 Ophthalmic preparations
AU2020398224A AU2020398224B2 (en) 2019-12-05 2020-12-04 Ophthalmic pharmaceutical compositions
BR112022010871A BR112022010871A2 (pt) 2019-12-05 2020-12-04 Composições farmacêuticas oftalmológicas
US17/782,197 US20230026577A1 (en) 2019-12-05 2020-12-04 Ophthalmic Pharmaceutical Compositions
EP20830416.2A EP4069195A1 (en) 2019-12-05 2020-12-04 Ophthalmic pharmaceutical compositions
JP2022533510A JP7833399B2 (ja) 2019-12-05 2020-12-04 眼科用医薬組成物
KR1020227022823A KR20220128619A (ko) 2019-12-05 2020-12-04 안과용 약학 조성물
CA3160484A CA3160484A1 (en) 2019-12-05 2020-12-04 Ophthalmic pharmaceutical compositions
CN202080094414.9A CN115397392A (zh) 2019-12-05 2020-12-04 眼用药物组合物
CONC2022/0009260A CO2022009260A2 (es) 2019-12-05 2022-07-01 Composiciones farmacéuticas oftálmicas
JP2025117830A JP2025160247A (ja) 2019-12-05 2025-07-14 眼科用医薬組成物

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201962944074P 2019-12-05 2019-12-05
US62/944,074 2019-12-05
US202063077196P 2020-09-11 2020-09-11
US63/077,196 2020-09-11

Publications (1)

Publication Number Publication Date
WO2021113580A1 true WO2021113580A1 (en) 2021-06-10

Family

ID=74104179

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2020/063218 Ceased WO2021113580A1 (en) 2019-12-05 2020-12-04 Ophthalmic pharmaceutical compositions

Country Status (14)

Country Link
US (1) US20230026577A1 (https=)
EP (1) EP4069195A1 (https=)
JP (2) JP7833399B2 (https=)
KR (1) KR20220128619A (https=)
CN (1) CN115397392A (https=)
AU (1) AU2020398224B2 (https=)
BR (1) BR112022010871A2 (https=)
CA (1) CA3160484A1 (https=)
CL (1) CL2022001463A1 (https=)
CO (1) CO2022009260A2 (https=)
IL (1) IL293541A (https=)
MX (1) MX2022006776A (https=)
TW (1) TWI845795B (https=)
WO (1) WO2021113580A1 (https=)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4210674A1 (en) * 2020-09-10 2023-07-19 Vanda Pharmaceuticals Inc. Methods of treating pde iv-mediated diseases or conditions
JP2024546189A (ja) * 2021-12-28 2024-12-17 センメルベイス エジェテム 点眼製剤
WO2025179141A1 (en) 2024-02-22 2025-08-28 Vanda Pharmaceuticals, Inc. Treatment of dry eye disease

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20250073125A1 (en) * 2023-09-06 2025-03-06 Opus Life Sciences, Llc High ph formulations and kits
KR20260048121A (ko) * 2024-10-02 2026-04-09 주식회사 대웅테라퓨틱스 개선된 안정성 및 투약 편의성을 갖는 레바미피드를 포함하는 조성물

Citations (2)

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WO2017112951A1 (en) 2015-12-24 2017-06-29 The Regents Of The University Of California Cftr regulators and methods of use thereof
WO2019040919A1 (en) * 2017-08-24 2019-02-28 The Regents Of The University Of California OCULAR PHARMACEUTICAL COMPOSITIONS

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DK1321144T3 (da) * 2000-09-13 2011-03-07 Santen Pharmaceutical Co Ltd Øjendråber
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CN101690712B (zh) 2009-08-25 2011-06-15 武汉武药科技有限公司 一种西他沙星滴眼剂及其制备方法
US20110178147A1 (en) 2009-10-20 2011-07-21 Allergan, Inc. Compositions and methods for controlling pupil dilation
FR2961694B1 (fr) 2010-06-29 2013-01-25 Thea Lab Systeme de delivrance polymerique d'une solution non visqueuse a base de prostaglandine sans conservateur
CN102988280B (zh) 2012-10-08 2014-03-19 新乡医学院 一种加雷沙星滴眼剂
CN109481392B (zh) * 2015-09-02 2021-12-24 盛世泰科生物医药技术(苏州)有限公司 一种用于预防和治疗白内障的眼用制剂及其制备方法
WO2017083799A1 (en) * 2015-11-13 2017-05-18 Ohr Pharmaceutical, Inc. Ophthalmic formulations of squalamine
US20180236077A1 (en) 2017-02-21 2018-08-23 Avedro, Inc. Formulations for eye treatments

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Publication number Priority date Publication date Assignee Title
WO2017112951A1 (en) 2015-12-24 2017-06-29 The Regents Of The University Of California Cftr regulators and methods of use thereof
WO2019040919A1 (en) * 2017-08-24 2019-02-28 The Regents Of The University Of California OCULAR PHARMACEUTICAL COMPOSITIONS

Non-Patent Citations (4)

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"Handbook of Pharmaceutical Excipients - Sixth edition", 2009, PHARMACEUTICAL PRESS AND AMERICAN PHARMACISTS ASSOCIATION, article SHAH S ET AL: "Disodium Edetate and Sodium Thiosulfate", XP055778774 *
ALLEN JR L V: "Basics of Sterile Compounding: Ophthalmic Preparations, Part 1: Ophthalmic Solutions", INTERNATIONAL JOURNAL OF PHARMACEUTICAL COMPOUNDING, vol. 20, no. 5, 2016, US, pages 399 - 404, XP055778499, ISSN: 1092-4221 *
LEE SUJIN ET AL: "Nanomolar-Potency Aminophenyl-1,3,5-triazine Activators of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Chloride Channel for Prosecretory Therapy of Dry Eye Diseases", JOURNAL OF MEDICINAL CHEMISTRY, vol. 60, no. 3, 31 January 2017 (2017-01-31), US, pages 1210 - 1218, XP055778516, ISSN: 0022-2623, DOI: 10.1021/acs.jmedchem.6b01792 *
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4210674A1 (en) * 2020-09-10 2023-07-19 Vanda Pharmaceuticals Inc. Methods of treating pde iv-mediated diseases or conditions
JP2024546189A (ja) * 2021-12-28 2024-12-17 センメルベイス エジェテム 点眼製剤
WO2025179141A1 (en) 2024-02-22 2025-08-28 Vanda Pharmaceuticals, Inc. Treatment of dry eye disease

Also Published As

Publication number Publication date
KR20220128619A (ko) 2022-09-21
TWI845795B (zh) 2024-06-21
AU2020398224A1 (en) 2022-06-30
AU2020398224B2 (en) 2026-02-19
JP7833399B2 (ja) 2026-03-19
JP2025160247A (ja) 2025-10-22
CA3160484A1 (en) 2021-06-10
CN115397392A (zh) 2022-11-25
CO2022009260A2 (es) 2022-09-20
JP2023505255A (ja) 2023-02-08
TW202128178A (zh) 2021-08-01
BR112022010871A2 (pt) 2022-08-23
EP4069195A1 (en) 2022-10-12
MX2022006776A (es) 2022-09-19
IL293541A (en) 2022-08-01
US20230026577A1 (en) 2023-01-26
CL2022001463A1 (es) 2023-02-10

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