Spray-drying composition containing an adrenaline receptor modulator

A stable amorphous powder composition of epinephrine with maltodextrin carrier addresses the instability and convenience issues of current auto-injectors, enhancing shelf life and bioavailability for transmucosal delivery.

JP2026519542APending Publication Date: 2026-06-16OREXO AB

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
OREXO AB
Filing Date
2024-05-31
Publication Date
2026-06-16

AI Technical Summary

Technical Problem

Current epinephrine auto-injectors are inconvenient for self-administration, chemically unstable, and have limited shelf life, leading to waste and reduced bioavailability due to instability and formulation challenges in transmucosal delivery systems.

Method used

A stable, amorphous single-particle powder composition of epinephrine or its salt, formulated with maltodextrin as a carrier, providing rapid absorption and improved bioavailability through spray-drying, suitable for transmucosal delivery.

Benefits of technology

The composition exhibits enhanced physical and chemical stability, allowing for extended shelf life and rapid pharmacological effects with minimal adverse events, improving patient compliance and reducing waste.

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Abstract

The present invention provides a pharmaceutically acceptable composition in the form of a solid amorphous single-particle powder, comprising a mixture of (a) a pharmacologically effective dose of an adrenergic receptor modulator or a pharmaceutically acceptable salt thereof, and (b) a pharmaceutically acceptable carrier material comprising maltodextrin, wherein the solid composition exhibits a pH of about 4.5 to about 8.0 when dissolved in an aqueous medium. The composition is suitable for transmucosal drug delivery, for example, nasal delivery, and can be loaded into a single-use nasal applicator. The composition may further comprise a disaccharide, such as lactose or trehalose, which may be prepared by spray drying and spray-dried together with the active ingredient and maltodextrin. The composition may further comprise one or more alkylsaccharides. Preferred alkylsaccharides include sucrose esters such as sucrose monolaurate. A preferred adrenergic receptor modulator is epinephrine (adrenaline). Therefore, the composition is particularly useful in the treatment of allergic reactions, including anaphylaxis.
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