Pharmaceutical hydrocortisone solution for an injection device
Inventors
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Assignees
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CrossjectCrossject is a specialty pharmaceutical company focused on drug-device combination products for emergency medicine. Leveraging a proprietary needle-free auto-injection platform, the company develops and manufactures fast-acting treatments for life-threatening situations such as epilepsy, adrenal crisis, and anaphylaxis. Crossject conducts advanced regulatory development, clinical validation, and large-scale industrialization to deliver innovative therapies for global markets, with an emphasis on simplicity, reliability, and patient usability.
Crossject is a specialty pharmaceutical company focused on drug-device combination products for emergency medicine. Leveraging a proprietary needle-free auto-injection platform, the company develops and manufactures fast-acting treatments for life-threatening situations such as epilepsy, adrenal crisis, and anaphylaxis. Crossject conducts advanced regulatory development, clinical validation, and large-scale industrialization to deliver innovative therapies for global markets, with an emphasis on simplicity, reliability, and patient usability.
Publication Number
US-10456355-B1
Publication Date
2019-10-29
Expiration Date
Abstract
A pharmaceutical hydrocortisone solution including at least hydrocortisone or a pharmaceutically-acceptable salt thereof, rongalite, disodium EDTA, and a solvent. Also relates to its use in the treatment of acute adrenal insufficiency and asthma. Also relates to an injection kit including an injection device and this pharmaceutical solution.
Core Innovation
The invention relates to a parenteral hydrocortisone injection solution that comprises hydrocortisone or a pharmaceutically-acceptable salt thereof, rongalite, disodium EDTA, and a solvent. The disclosed concept replaces formaldehyde sodium bisulfite with a two-antioxidant system of rongalite and disodium ethylenediaminetetraacetic acid to stabilize hydrocortisone and limit impurities.
The disclosed pharmaceutical hydrocortisone solution includes pharmaceutically-acceptable hydrocortisone salt forms, including hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydrocortisone hydrogen succinate, hydrocortisone butyrate, and hydrocortisone acetate. Optional buffers include sodium phosphate and sodium dihydrogen phosphate, with a pH in the range of about 7 to 9, preferably 7.5 to 8.5.
The document describes an injection solution for use in acute adrenal insufficiency and asthma, and further describes an injection kit that includes a needleless automatic injection device with a pyrotechnic cartridge device. Experimental evaluation under forced storage conditions using HPLC reports lower impurity sums, fewer and/or no impurities above specified thresholds, and better stability over time for the rongalite and disodium EDTA approach.
Claims Coverage
The partial document contains one independent claim defining a pharmaceutical hydrocortisone solution. The claim set is structured around an inventive hydrocortisone stabilization system comprising rongalite plus disodium EDTA in a solvent, with dependent claims refining salt form, pH, composition ranges, preparation, parenteral route, and an injection kit.
Hydrocortisone solution stabilized by rongalite and disodium EDTA
A pharmaceutical hydrocortisone solution comprising hydrocortisone or a pharmaceutically-acceptable salt thereof, rongalite, disodium ethylenediaminetetraacetic acid, and a solvent.
Selected hydrocortisone salt forms in the rongalite/EDTA solution
The pharmaceutical solution includes a pharmaceutically-acceptable salt form of hydrocortisone selected from hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydrocortisone hydrogen succinate, hydrocortisone butyrate, and hydrocortisone acetate.
pH range constraint for the hydrocortisone rongalite/EDTA solution
The pharmaceutical solution has a pH between 7 and 9.
Quantitative composition ranges per 200 mL for the hydrocortisone rongalite/EDTA solution
The pharmaceutical solution includes specified quantitative amounts per 200 mL for hydrocortisone or a pharmaceutically-acceptable salt, rongalite, disodium EDTA, and an injectable preparation solvent.
Stirring-based preparation with optional filtration for the hydrocortisone solution
A method for preparing a pharmaceutical solution by stirring a solvent, rongalite, and disodium EDTA, adding hydrocortisone or a pharmaceutically acceptable salt under stirring, and optionally filtering the resulting pharmaceutical solution.
Parenteral administration route for the hydrocortisone solution
The pharmaceutical solution is administered via a parenteral route.
Injection kit with needleless pyrotechnic cartridge device
An injection kit is described that includes a needleless automatic injection device with a pyrotechnic cartridge device.
The inventive concept centers on a hydrocortisone pharmaceutical solution defined by hydrocortisone or a pharmaceutically-acceptable salt, rongalite, disodium EDTA, and a solvent. Coverage is further characterized by selected hydrocortisone salt forms, a pH range, quantitative composition constraints per 200 mL, stirring-based preparation with optional filtration, parenteral use, and an injection kit including a needleless pyrotechnic cartridge device.
Stated Advantages
Stabilizes hydrocortisone.
Limits impurities.
Lower impurity sums and fewer and/or no impurities above specified thresholds compared to comparative antioxidants.
Better stability over time.
Documented Applications
Treatment of acute adrenal insufficiency.
Treatment of asthma.
An injection kit use with a needleless automatic injection device having a pyrotechnic cartridge device.
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