Drug mixing and delivery system and method
Inventors
Buchine, Brent A. • Standley, Adam R. • Stepanian, Christopher J.
Assignees
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Abstract
The present disclosure provides methods of preparing a medical solution. In some aspects, the medical solution can be prepared from mixing a first liquid with a second liquid or mixing a solid component with a liquid in an autoinjector. In some aspects, the heat released from the mixing can promote solubility of a dry medicament in the solution.
Core Innovation
The invention relates to an autoinjector that includes a dry chamber comprising a dry epinephrine composition and a wet chamber comprising a liquid acid composition. The dry chamber is sealed from the wet chamber prior to activation, and activation results in mixing the liquid acid composition from the wet chamber with the dry epinephrine composition from the dry chamber. This arrangement enables preparation of an epinephrine-containing medical solution by mixing the separated dry and liquid components.
The dry epinephrine composition is described as epinephrine free base or epinephrine salts, including epinephrine free base and epinephrine salts selected from maleate, malate, fumarate, tartrate, bitartrate, borate, hydrochloride, and related forms. The liquid acid composition is described as a liquid acid suitable to mix with the dry epinephrine composition after activation.
Mixing activation is associated with dissolution or reconstitution of the epinephrine component using heat generated from mixing, including exothermic acid/base neutralization. The disclosure further describes using a pH-optimized acid and, optionally, a pH adjusting solution or buffer to support reconstitution.
Claims Coverage
The independent claim is an autoinjector with a sealed dry chamber holding a dry epinephrine composition and a sealed wet chamber holding a liquid acid composition, where activation mixes the separated components. The dependent claim set refines the epinephrine form and characterizes the liquid acid composition, including by specific acid species and pH constraints.
Sealed dry and wet chamber mixing in an autoinjector
An autoinjector comprising a dry chamber comprising a dry epinephrine composition and a wet chamber comprising a liquid acid composition, wherein the dry chamber is sealed from the wet chamber prior to activation, and activation of the autoinjector results in mixing of the liquid acid composition from the wet chamber with the dry epinephrine composition from the dry chamber.
Dry epinephrine composition as epinephrine free base
The autoinjector wherein the dry epinephrine is epinephrine free base.
Stereospecific L-epinephrine free base
The autoinjector wherein the epinephrine free base is L-epinephrine free base.
Liquid acid containing a specified acid species
The autoinjector wherein the liquid acid composition contains HCl, phosphoric acid, or sulfuric acid.
Liquid acid pH range of 0.1 to 6.0
The autoinjector wherein its liquid acid composition has a pH within the range of 0.1 to 6.0.
Epinephrine salt selected from specified anion forms
The autoinjector wherein the epinephrine salt is selected from maleate, malate, fumarate, tartrate, bitartrate, sulfate, hydrochloride, and borate.
Across the claim set, the core inventive structure is the autoinjector with a sealed dry chamber containing a dry epinephrine composition and a sealed wet chamber containing a liquid acid composition, with activation causing mixing of the separated components. Dependent features further specify epinephrine form, including L-epinephrine free base, and constrain the liquid acid by named acid species and pH, while also specifying possible epinephrine salt anion forms.
Stated Advantages
Improved stability of dry formulations with quantified potency/chiral purity retention after temperature exposure.
Documented Applications
Provision of an epinephrine-containing medical solution using an autoinjector by mixing a liquid acid composition with a dry epinephrine composition after activation.
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