CN116367835A - 氢化可的松磷酸钠和单硫代甘油的水性药物调配物 - Google Patents

氢化可的松磷酸钠和单硫代甘油的水性药物调配物 Download PDF

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Publication number
CN116367835A
CN116367835A CN202180074582.6A CN202180074582A CN116367835A CN 116367835 A CN116367835 A CN 116367835A CN 202180074582 A CN202180074582 A CN 202180074582A CN 116367835 A CN116367835 A CN 116367835A
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CN
China
Prior art keywords
sodium phosphate
hydrocortisone sodium
monothioglycerol
pharmaceutical formulation
impurities
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
CN202180074582.6A
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English (en)
Chinese (zh)
Inventor
X·陈
S·昂
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
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Antares Pharma Inc
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Filing date
Publication date
Application filed by Antares Pharma Inc filed Critical Antares Pharma Inc
Publication of CN116367835A publication Critical patent/CN116367835A/zh
Pending legal-status Critical Current

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    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds 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
    • A61K31/573—Compounds 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
    • 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
    • A61K47/16—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61P1/00—Drugs 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
CN202180074582.6A 2020-09-21 2021-09-21 氢化可的松磷酸钠和单硫代甘油的水性药物调配物 Pending CN116367835A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063081164P 2020-09-21 2020-09-21
US63/081164 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
CN116367835A true CN116367835A (zh) 2023-06-30

Family

ID=80775681

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180074582.6A Pending CN116367835A (zh) 2020-09-21 2021-09-21 氢化可的松磷酸钠和单硫代甘油的水性药物调配物

Country Status (10)

Country Link
US (3) US20220096496A1 (cg-RX-API-DMAC7.html)
EP (1) EP4213827A4 (cg-RX-API-DMAC7.html)
JP (1) JP2023542345A (cg-RX-API-DMAC7.html)
KR (1) KR20230104131A (cg-RX-API-DMAC7.html)
CN (1) CN116367835A (cg-RX-API-DMAC7.html)
AU (1) AU2021345429A1 (cg-RX-API-DMAC7.html)
CA (1) CA3192530A1 (cg-RX-API-DMAC7.html)
IL (1) IL301352A (cg-RX-API-DMAC7.html)
MX (1) MX2023003197A (cg-RX-API-DMAC7.html)
WO (1) WO2022061303A1 (cg-RX-API-DMAC7.html)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3128874B1 (fr) * 2021-11-09 2025-04-18 Crossject Solution pharmaceutique d’hydrocortisone pour dispositif d’injection
EP4496575A4 (en) 2022-03-21 2026-04-01 Antares Pharma Inc AQUEOUS PHARMACEUTICAL FORMULATION OF SODIUM PHOSPHATE, HYDROCORTISONE AND MONOTHIOGLYCEROL
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

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1270614A (en) * 1969-05-07 1972-04-12 Lepetit Spa Stable aqueous steroid phosphate solutions
CA911885A (en) * 1972-10-10 Gruppo Lepetit S.P.A. Stable aqueous steroid phosphate solutions
CA2168091A1 (en) * 1993-08-23 1995-03-02 Stephen L. Smith In vitro growth of neutrophil and megakaryocyte precursors in serum-free media
CN105392469A (zh) * 2013-04-02 2016-03-09 西弥斯医疗有限公司 包含二甘醇单乙醚或其他烷基衍生物的药物活性剂的组合物

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2970944A (en) 1958-04-04 1961-02-07 Merck & Co Inc Parenteral solutions of steroid phosphates stabilized with creatinines
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
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
WO2006079064A1 (en) 2005-01-24 2006-07-27 Antares Pharma, Inc. Prefilled needle assisted jet injector
US8067433B2 (en) * 2005-11-09 2011-11-29 Zalicus Inc. Methods, compositions, and kits for the treatment of ophthalmic disorders
ES2548447T3 (es) 2008-03-10 2015-10-16 Antares Pharma, Inc. Dispositivo de seguridad para inyector
US8579865B2 (en) 2009-03-20 2013-11-12 Antares Pharma, Inc. Hazardous agent injection system
WO2014165142A1 (en) 2013-03-13 2014-10-09 Benjamin Newton Multiple dosage injector with rotating screw dosage system
EP3189855B1 (en) * 2016-01-11 2018-03-21 Lamda Laboratories S.A. Oral pharmaceutical solutions containing hydrocortisone sodium phosphate
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
EP3787671A4 (en) * 2018-05-04 2022-06-15 Ohio State Innovation Foundation NON-PEPTIDE 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

Patent Citations (4)

* 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
GB1270614A (en) * 1969-05-07 1972-04-12 Lepetit Spa Stable aqueous steroid phosphate solutions
CA2168091A1 (en) * 1993-08-23 1995-03-02 Stephen L. Smith In vitro growth of neutrophil and megakaryocyte precursors in serum-free media
CN105392469A (zh) * 2013-04-02 2016-03-09 西弥斯医疗有限公司 包含二甘醇单乙醚或其他烷基衍生物的药物活性剂的组合物

Also Published As

Publication number Publication date
EP4213827A4 (en) 2024-10-23
US20220096496A1 (en) 2022-03-31
MX2023003197A (es) 2023-08-04
US11857555B2 (en) 2024-01-02
AU2021345429A9 (en) 2024-08-08
KR20230104131A (ko) 2023-07-07
EP4213827A1 (en) 2023-07-26
JP2023542345A (ja) 2023-10-06
US20230099165A1 (en) 2023-03-30
WO2022061303A1 (en) 2022-03-24
US20240131035A1 (en) 2024-04-25
AU2021345429A1 (en) 2023-05-04
CA3192530A1 (en) 2022-03-24
IL301352A (en) 2023-05-01

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