Dry powder inhaler and system for drug delivery
Inventors
Smutney, Chad C. • Kinsey, P. Spencer • Sahi, Carl R. • Adamo, Benoit • Polidoro, John M. • McLean, Scott • Overfield, Dennis • Bryant, Anthony
Assignees
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Publication Number
US-12233206-B2
Publication Date
2025-02-25
Expiration Date
Abstract
A breath-powered, dry powder inhaler, a cartridge, and a pulmonary drug delivery system are provided. The dry powder inhaler can be provided with or without a unit dose cartridge for using with the inhaler. The inhaler and/or cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, peptides and proteins such as insulin, oxyntomodulin and glucagon-like peptide.
Core Innovation
The disclosure describes a breath-powered dry powder inhaler and pulmonary delivery system for delivering a single dose of a dry powder medicament to a pulmonary tract. The system uses diketopiperazine, including 2,5-diketopiperazine and fumaryl diketopiperazine (FDKP), to form cohesive self-assembling microparticles loaded with an active agent.
The inhaler includes a container and a mouthpiece that work together to reconfigure during use, moving from a containment position to a dosing position. In the reconfigured dosing position, the mouthpiece undersurface changes from a first surface flush with the top surface of the container in the containment position to a second surface that is concave or hollow, and the concave or hollow undersurface includes a dispensing port positioned above the top surface.
The disclosure further describes airflow and powder handling concepts to control powder dispersion, including airflow conduit pathways and bypass flow, with deagglomeration of the microparticles. Device designs are evaluated and tuned using flow resistance and mass-flow balance concepts, and delivered powder is characterized using respirable fraction and particle size metrics such as VMAD/VMGD, particle size distributions, and Andersen cascade or laser diffraction.
Claims Coverage
Two independent claims are identified: a single use dry powder inhaler, and an inhalation system for delivering a dry powder medicament to a pulmonary tract. Each independent claim focuses on the combination of a movable container/mouthpiece architecture with mouthpiece undersurface geometry, and one claim further includes dual air flow pathways.
Single use dry powder inhaler with containment-to-dosing reconfiguration
A single use dry powder inhaler comprising a container with top surface and side wings, and a mouthpiece including tracks, an inlet, an outlet and a dispensing port, where the side wings interface with the tracks to allow movement of the container from a containment position to a dosing position, and where the mouthpiece undersurface is flush with the top surface in the containment position and is concave or hollow including the dispensing port above the top surface in the dosing position.
Inhalation system with pulmonary tract delivery and dual air flow pathways
An inhalation system for delivering a dry powder medicament to a pulmonary tract, comprising a container including a top surface, side wings, and a dry powder formulation, and a mouthpiece including tracks, a first inlet, a second inlet, an outlet, an undersurface, and a dispensing port, where the side wings interface with the tracks to allow movement of the container from a containment position to a dosing position, where the undersurface is flush with the top surface in the containment position and is concave or hollow including the dispensing port above the top surface in the dosing position, and where the first inlet communicates with a first air flow pathway and the second inlet communicates with a second air flow pathway.
Across the independent claims, the main inventive focus is the coordinated mechanical and geometrical reconfiguration between containment and dosing positions, achieved by container side wings engaging tracks and a mouthpiece undersurface transitioning from flush to concave or hollow to position the dispensing port above the container. In the pulmonary tract inhalation system, the architecture further includes two inlets communicating with separate air flow pathways to support delivery of a dry powder medicament.
Stated Advantages
Documented Applications
No documented applications found
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