CA3192530A1 - Aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol - Google Patents

Aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol

Info

Publication number
CA3192530A1
CA3192530A1 CA3192530A CA3192530A CA3192530A1 CA 3192530 A1 CA3192530 A1 CA 3192530A1 CA 3192530 A CA3192530 A CA 3192530A CA 3192530 A CA3192530 A CA 3192530A CA 3192530 A1 CA3192530 A1 CA 3192530A1
Authority
CA
Canada
Prior art keywords
sodium phosphate
impurities
hydrocortisone sodium
monothioglycerol
pharmaceutical formulation
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
CA3192530A
Other languages
English (en)
French (fr)
Inventor
Xiaoming Chen
Shaowei Ong
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.)
Antares Pharma Inc
Original Assignee
Antares Pharma 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
Application filed by Antares Pharma Inc filed Critical Antares Pharma Inc
Publication of CA3192530A1 publication Critical patent/CA3192530A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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

Landscapes

  • 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)
CA3192530A 2020-09-21 2021-09-21 Aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol Pending CA3192530A1 (en)

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
CA3192530A1 true CA3192530A1 (en) 2022-03-24

Family

ID=80775681

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3192530A Pending CA3192530A1 (en) 2020-09-21 2021-09-21 Aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol

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
KR20230104131A (ko) 2023-07-07
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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