Method and compositions for dissolving or solubilizing therapeutic agents
Inventors
Standley, Adam R. • Nellaiappan, Kaliappanadar • Buchine, Brent A.
Assignees
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Publication Number
US-11246842-B2
Publication Date
2022-02-15
Expiration Date
Abstract
The invention provides pharmaceutical compositions comprising a dry medicament. The dry medicaments can be rapidly dissolved, solubilized, and/or reconstituted to deliver to a subject. The present invention provides methods of preparing a medical solution. The medical solution can be prepared from mixing the pharmaceutical composition as described herein with a first liquid.
Core Innovation
The invention provides an autoinjector comprising a dry pharmaceutical composition that includes a mixture of a therapeutically effective amount of a dry epinephrine and one or more dry pH adjusting agents. The dry epinephrine and the one or more dry pH adjusting agents are located in a first chamber, while the autoinjector includes a second chamber comprising a first liquid.
The first liquid is an acid aqueous solution having a pH from 0.1 to 6.0, and the dry epinephrine and the dry pH adjusting agents are in different particles. When mixed with the first liquid, the dry epinephrine particles dissolve faster than the one or more dry pH adjusting agent particles, enabling the pH to change into a physiologically acceptable pH range after mixing.
The disclosed system is implemented in autoinjector formats having separate dry and liquid chambers and provides quick single-stage mixing prior to injection. The pH adjusting agent is described as a dry pH optimizing agent capable of buffering pH drift during reconstitution, and the dissolution behavior is tuned by relationships of particle size and/or coated particles.
Claims Coverage
The provided independent claim coverage is focused on an autoinjector structure and its differential dissolution behavior between dry epinephrine and dry pH adjusting agents when mixed with an acidic aqueous first liquid (pH 0.1 to 6.0). The independent claim includes three core inventive features and is further refined by dependent claims.
Dry epinephrine and dry pH adjusting agents in separate chambers
An autoinjector comprising a dry pharmaceutical composition that comprises a mixture of a therapeutically effective amount of a dry epinephrine and one or more dry pH adjusting agents, wherein the dry epinephrine and one or more dry pH adjusting agents are located in a first chamber of the autoinjector, and the autoinjector comprises a second chamber comprising a first liquid.
Acid aqueous first liquid with defined pH
The autoinjector wherein the first liquid is an acid aqueous solution having a pH from 0.1 to 6.0.
Different particles with faster epinephrine dissolution
The autoinjector wherein the dry epinephrine and the one or more dry pH adjusting agents are in different particles, and wherein the dry epinephrine particles dissolve faster than the one or more dry pH adjusting agent particles when mixed with the first liquid.
Overall, the claim set centers on an autoinjector where a dry epinephrine component and one or more dry pH adjusting agents are separately stored and then mixed with an acidic aqueous first liquid of pH 0.1 to 6.0 such that the dry epinephrine dissolves faster than the pH adjusting agent particles.
Stated Advantages
Rapid reconstitution into an injection-ready solution by mixing the dry pharmaceutical composition with an acidic aqueous solution.
Enablement of pH change into a physiologically acceptable pH range through differential dissolution and pH buffering.
Improved stability and chiral purity under temperature exposure.
Documented Applications
Use in medical devices including autoinjectors and prefilled syringes configured with separate dry and liquid chambers to enable quick single-stage mixing prior to injection.
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