Adrenaline pharmaceutical 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-11439605-B2
Publication Date
2022-09-13
Expiration Date
Abstract
An adrenaline pharmaceutical solution including at least: adrenaline or a pharmaceutically-acceptable salt thereof; vitamin E TPGS; a chelating agent; a solvent. The method also relates to its use in the treatment of anaphylactic shocks, cardiac arrests, asthma and cardiocirculatory distresses. The method also concerns an injection kit including an injection device and this pharmaceutical solution.
Core Innovation
The invention relates to an adrenaline pharmaceutical solution comprising adrenaline (epinephrine) or a pharmaceutically-acceptable salt thereof, D-alpha-tocopheryl polyethylene glycol succinate (vitamin E TPGS), a chelating agent, and a solvent. The formulation is stabilized by the combination of vitamin E TPGS with a chelating agent, with explicit avoidance of sulphite-type antioxidants.
The disclosed solution is intended for parenteral/intramuscular pharmaceutical use and includes options for pharmaceutically-acceptable adrenaline salts, pH, and optional buffer, tonicity, and excipients. The disclosed scope includes adrenaline salts such as tartrate and hydrochloride, and chelating agents such as disodium EDTA.
Stability is demonstrated by comparative stability experiments across nineteen solution variants, with measurements including appearance, pH, and purity loss via HPLC/UV under storage conditions at 25°C, 40°C, and 60°C. The claimed combinations are reported to maintain limpid/colorless appearance and near-constant pH with low purity loss relative to solutions lacking antioxidants or using alternative antioxidants, including vitamin E TPGS without chelator and sulphites and other antioxidants combined with EDTA.
Claims Coverage
The independent claim is directed to a stabilized adrenaline pharmaceutical solution comprising adrenaline or a pharmaceutically-acceptable salt, vitamin E TPGS, a chelating agent, and a solvent, with inventive features centered on the specific antioxidant/chelator combination for stabilization. Dependent claims further refine the formulation by specifying quantitative composition aspects, pH range constraints, alternative chelating agents, therapeutic uses, and an injection kit format with a needleless pyrotechnic cartridge device.
Adrenaline plus vitamin E TPGS plus chelating agent in a solvent
An adrenaline pharmaceutical solution comprising at least adrenaline or a pharmaceutically-acceptable salt thereof, D-alpha-tocopheryl polyethylene glycol succinate (vitamin E TPGS), a chelating agent, and a solvent.
Defined composition amounts for adrenaline, vitamin E TPGS, and chelating agent
A pharmaceutical solution in which defined mg-per-mL ranges are specified for adrenaline or a pharmaceutically-acceptable salt, vitamin E TPGS, and the chelating agent, with the remainder solvent to a total volume of 1 mL.
pH between 2.2 and 5
A pharmaceutical solution whose pH is between 2.2 and 5.
Chelating agent selected from named EDTA variants
A pharmaceutical solution in which the chelating agent is one of disodium EDTA, ethylenediaminetetraacetic acid, or disodium calcium ethylenediaminetetraacetate.
Use for specific therapeutic conditions
A pharmaceutical solution for treating anaphylactic shock, cardiac arrest, asthma, and cardiocirculatory distress.
Injection kit with a needleless pyrotechnic cartridge device
An injection kit in which the injection device is a needleless injection device using a pyrotechnic cartridge.
Overall, the claim set focuses on a stabilized adrenaline pharmaceutical solution defined by the combination of vitamin E TPGS and a chelating agent in a solvent, with refinements including defined composition ranges, an acidic pH range between 2.2 and 5, specified chelating-agent options, therapeutic use for particular clinical conditions, and an injection kit including a needleless injection device with a pyrotechnic cartridge.
Stated Advantages
Maintains limpid/colorless appearance.
Maintains near-constant pH.
Shows low purity loss relative to variants lacking the claimed antioxidant/chelator combinations.
Avoids sulphite-type antioxidants.
Documented Applications
Treatment of anaphylactic shock, cardiac arrest, asthma, and cardiocirculatory distress.
Parenteral/intramuscular injection as a pharmaceutical solution format.
Use in an injection kit employing a needleless injection device with a pyrotechnic cartridge.
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