AU2021345429A1 - Aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol - Google Patents
Aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol Download PDFInfo
- Publication number
- AU2021345429A1 AU2021345429A1 AU2021345429A AU2021345429A AU2021345429A1 AU 2021345429 A1 AU2021345429 A1 AU 2021345429A1 AU 2021345429 A AU2021345429 A AU 2021345429A AU 2021345429 A AU2021345429 A AU 2021345429A AU 2021345429 A1 AU2021345429 A1 AU 2021345429A1
- Authority
- AU
- Australia
- 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
Links
Classifications
-
- 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
Landscapes
- 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)
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 (2)
| Publication Number | Publication Date |
|---|---|
| AU2021345429A1 true AU2021345429A1 (en) | 2023-05-04 |
| AU2021345429A9 AU2021345429A9 (en) | 2024-08-08 |
Family
ID=80775681
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2021345429A Pending AU2021345429A1 (en) | 2020-09-21 | 2021-09-21 | Aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol |
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)
| 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 |
Family Cites Families (19)
| 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 |
| 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 |
| UA119324C2 (uk) * | 2013-04-02 | 2019-06-10 | Теміс Медікер Лімітед | Композиції фармацевтично активних речовин, що містять моноетиловий ефір діетиленгліколю або інші алкільні похідні |
| 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 |
-
2021
- 2021-09-21 AU AU2021345429A patent/AU2021345429A1/en active Pending
- 2021-09-21 WO PCT/US2021/051349 patent/WO2022061303A1/en not_active Ceased
- 2021-09-21 JP JP2023518141A patent/JP2023542345A/ja active Pending
- 2021-09-21 EP EP21870423.7A patent/EP4213827A4/en active Pending
- 2021-09-21 CA CA3192530A patent/CA3192530A1/en active Pending
- 2021-09-21 CN CN202180074582.6A patent/CN116367835A/zh active Pending
- 2021-09-21 IL IL301352A patent/IL301352A/en unknown
- 2021-09-21 KR KR1020237012932A patent/KR20230104131A/ko active Pending
- 2021-09-21 MX MX2023003197A patent/MX2023003197A/es unknown
- 2021-10-05 US US17/494,340 patent/US20220096496A1/en not_active Abandoned
-
2022
- 2022-11-18 US US18/056,997 patent/US11857555B2/en active Active
-
2023
- 2023-10-27 US US18/496,559 patent/US20240131035A1/en active Pending
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 |
| CA3192530A1 (en) | 2022-03-24 |
| IL301352A (en) | 2023-05-01 |
| CN116367835A (zh) | 2023-06-30 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| SREP | Specification republished |