KR20230104131A - 히드로코티손 인산나트륨 및 모노티오글리세롤의 수성 약학 제형 - Google Patents

히드로코티손 인산나트륨 및 모노티오글리세롤의 수성 약학 제형 Download PDF

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Publication number
KR20230104131A
KR20230104131A KR1020237012932A KR20237012932A KR20230104131A KR 20230104131 A KR20230104131 A KR 20230104131A KR 1020237012932 A KR1020237012932 A KR 1020237012932A KR 20237012932 A KR20237012932 A KR 20237012932A KR 20230104131 A KR20230104131 A KR 20230104131A
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KR
South Korea
Prior art keywords
impurities
hydrocortisone
monothioglycerol
less
sodium phosphate
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
KR1020237012932A
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English (en)
Korean (ko)
Inventor
샤오밍 첸
샤오웨이 옹
Original Assignee
안타레스 팔마, 인코퍼레이티드
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.)
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Application filed by 안타레스 팔마, 인코퍼레이티드 filed Critical 안타레스 팔마, 인코퍼레이티드
Publication of KR20230104131A publication Critical patent/KR20230104131A/ko
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
KR1020237012932A 2020-09-21 2021-09-21 히드로코티손 인산나트륨 및 모노티오글리세롤의 수성 약학 제형 Pending KR20230104131A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063081164P 2020-09-21 2020-09-21
US63/081,164 2020-09-21
PCT/US2021/051349 WO2022061303A1 (en) 2020-09-21 2021-09-21 Aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol

Publications (1)

Publication Number Publication Date
KR20230104131A true KR20230104131A (ko) 2023-07-07

Family

ID=80775681

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020237012932A Pending KR20230104131A (ko) 2020-09-21 2021-09-21 히드로코티손 인산나트륨 및 모노티오글리세롤의 수성 약학 제형

Country Status (10)

Country Link
US (3) US20220096496A1 (https=)
EP (1) EP4213827A4 (https=)
JP (1) JP2023542345A (https=)
KR (1) KR20230104131A (https=)
CN (1) CN116367835A (https=)
AU (1) AU2021345429A1 (https=)
CA (1) CA3192530A1 (https=)
IL (1) IL301352A (https=)
MX (1) MX2023003197A (https=)
WO (1) WO2022061303A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023183807A1 (en) * 2022-03-21 2023-09-28 Antares Pharma, Inc. Aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol
JP2025509955A (ja) * 2022-03-21 2025-04-11 アンタレス・ファーマ・インコーポレーテッド リン酸ヒドロコルチゾンナトリウム及びモノチオグリセロール水性医薬製剤
US11904046B1 (en) 2022-11-14 2024-02-20 Eton Pharmaceuticals, Inc. Hydrocortisone oral liquid formulations
WO2024214110A1 (en) * 2023-04-08 2024-10-17 Cipla Limited A safe pharmaceutical composition of hydrocortisone

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA911885A (en) * 1972-10-10 Gruppo Lepetit S.P.A. Stable aqueous steroid phosphate solutions
US2970944A (en) 1958-04-04 1961-02-07 Merck & Co Inc Parenteral solutions of steroid phosphates stabilized with creatinines
IL34366A (en) * 1969-05-07 1973-06-29 Lepetit Spa Stable aqueous 21-hydroxy steroid phosphate solutions
US5173488A (en) 1989-08-21 1992-12-22 American Cyanamid Company Stable injectable pharmaceutical formulation for folic acid and leucovorin salts and method
US5733572A (en) * 1989-12-22 1998-03-31 Imarx Pharmaceutical Corp. Gas and gaseous precursor filled microspheres as topical and subcutaneous delivery vehicles
AU702871B2 (en) * 1993-08-23 1999-03-11 Nexell Therapeutics Inc. (In vitro) growth of neutrophil and megakaryocyte precursors in serum-free media
US6090800A (en) * 1997-05-06 2000-07-18 Imarx Pharmaceutical Corp. Lipid soluble steroid prodrugs
US20020039594A1 (en) * 1997-05-13 2002-04-04 Evan C. Unger Solid porous matrices and methods of making and using the same
CN101132820B (zh) 2005-01-24 2010-05-19 安塔雷斯制药公司 预充式针辅助喷射注入器
JP2009514969A (ja) * 2005-11-09 2009-04-09 コンビナトアールエックス インコーポレーティッド 医学的状態を治療するための方法、組成物、およびキット
EP2990067B1 (en) 2008-03-10 2019-09-04 Antares Pharma, Inc. Injector safety device
AU2010226442A1 (en) 2009-03-20 2011-10-13 Antares Pharma, Inc. Hazardous agent injection system
US10300207B2 (en) 2013-03-13 2019-05-28 Antares Pharma, Inc. Multiple dosage injector with rotating screw dosage system
UA119324C2 (uk) * 2013-04-02 2019-06-10 Теміс Медікер Лімітед Композиції фармацевтично активних речовин, що містять моноетиловий ефір діетиленгліколю або інші алкільні похідні
ES2673290T3 (es) * 2016-01-11 2018-06-21 Lamda Laboratories S.A. Soluciones farmacéuticas orales que contienen fosfato sódico de hidrocortisona
FR3047904B1 (fr) 2016-02-18 2018-03-23 Crossject Dispositif d’injection sans aiguille a membrane coulissante
FR3057775B1 (fr) 2016-10-26 2018-11-02 Crossject Solution pharmaceutique d’hydrocortisone pour dispositif d’injection
US11814341B2 (en) * 2018-05-04 2023-11-14 Ohio State Innovation Foundation Non-peptidic cell-penetrating motifs
US11034710B2 (en) * 2018-12-04 2021-06-15 Sumitomo Dainippon Pharma Oncology, Inc. CDK9 inhibitors and polymorphs thereof for use as agents for treatment of cancer

Also Published As

Publication number Publication date
WO2022061303A1 (en) 2022-03-24
AU2021345429A9 (en) 2024-08-08
US20240131035A1 (en) 2024-04-25
EP4213827A1 (en) 2023-07-26
CA3192530A1 (en) 2022-03-24
US11857555B2 (en) 2024-01-02
EP4213827A4 (en) 2024-10-23
IL301352A (en) 2023-05-01
US20220096496A1 (en) 2022-03-31
CN116367835A (zh) 2023-06-30
JP2023542345A (ja) 2023-10-06
MX2023003197A (es) 2023-08-04
US20230099165A1 (en) 2023-03-30
AU2021345429A1 (en) 2023-05-04

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PA0105 International application

Patent event date: 20230417

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
A201 Request for examination
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20240920

Comment text: Request for Examination of Application