Dry powder inhaler and system for drug delivery
Inventors
Smutney, Chad C. • Kinsey, P. Spencer • Sahi, Carl R. • Adamo, Benoit • Polidoro, John M.
Assignees
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Publication Number
US-12447293-B2
Publication Date
2025-10-21
Expiration Date
Abstract
A breath-powered, dry powder inhaler, a cartridge, and a pulmonary drug delivery system are provided.
Core Innovation
The patent describes control of FDKP isomers and how isomer content affects aerodynamic performance of inhalable dry powders and microparticles. It relates differences in solubility between cis and trans FDKP isomers to selective precipitation of the less soluble trans isomer, thereby raising the trans isomer content. The resulting isomer content is characterized and linked to particle properties and inhaler-system performance parameters.
The document explains that trans FDKP isomer content is associated with respirable fraction and deagglomeration, and that these outcomes connect to aerodynamic and flow-related measurements. Reported characterization includes specific surface area, rugosity, Carr’s index, particle size, emitted particle size via laser diffraction, airflow and resistance in a dry powder inhaler, and respirable fraction using an Andersen cascade impactor.
In addition, the patent describes delivery system embodiments that include dry powders containing a vasoactive agent, including vasoactive intestinal peptide, combined with diketopiperazine-related components. The claimed dry powder is characterized by a rugosity of about 11 to about 16 and is evaluated in dry powder inhaler systems.
Claims Coverage
The independent claim set is anchored by a dry powder inhaler claim, with dependent claims refining the structural configuration and powder or formulation constraints. The coverage emphasizes a mouthpiece-driven open/loading to closed/dosing reconfiguration of rigid container and lid parts, combined with specified dry powder properties and vasoactive agent content.
Mouthpiece-actuated container motion with open loading and closed dosing positions
A dry powder inhaler having a sled or slide tray, a mouthpiece, and a cartridge with a container, a lid, and at least one inlet opening and at least one outlet opening, where movement of the mouthpiece actuates movement of the container relative to the lid from a powder containment position to a dosing position, and the inhaler is configured to attain an open or container loading position and a closed or dosing position.
Rigid container and lid driven by mouthpiece movement
The container and the lid are both rigid parts, and the mouthpiece actuates the sled or slide tray during movement between the open position and the closed position, or from the closed position to the open position.
Dry powder with vasoactive agent and specified rugosity
The container includes a dry powder including a vasoactive agent, and the dry powder has a rugosity of about 11 to about 16.
Vasoactive intestinal peptide as the vasoactive agent
The dry powder inhaler includes a vasoactive agent that is a vasoactive intestinal peptide.
Diketopiperazine in the dry powder formulation
A dry powder formulation that contains a diketopiperazine.
Mouthpiece internal volume threshold
A mouthpiece whose internal volume from the first inlet port to the exit port is greater than 0.2 cubic centimeters.
Hinge mechanism including gear or rack and pinion
A hinge mechanism that includes a gear or a rack and pinion mechanism.
Housing openings for ambient air entry
A housing with one or more openings that let ambient air enter an interior compartment.
Across the independent coverage, the main inventive concept is a mouthpiece-driven mechanism that reconfigures a cartridge container relative to a rigid lid between powder containment and dosing positions, coordinated with sled or slide tray actuation and cartridge inlet and outlet openings. Dependent coverage further narrows the vasoactive agent, includes diketopiperazine formulations, constrains powder rugosity, adds a mouthpiece internal volume threshold, specifies hinge actuation using gear or rack and pinion, and includes ambient air entry openings.
Stated Advantages
Improved respirable fraction.
Improved deagglomeration.
Improved aerodynamic performance of inhalable dry powders and microparticles.
Fluidize, deagglomerate, and consistently discharge cohesive powders by balancing cartridge and inhaler airflow.
Improved aerodynamic performance metrics such as respirable fraction (RF/fill).
Documented Applications
Breath-powered dry powder inhaler for delivery of a dry powder including a vasoactive agent.
Dry powder inhaler formulations including diketopiperazine microparticles, including fumaryl diketopiperazine (FDKP), across multiple active agents.
Inhalable dry powders and microparticles delivered using a dry powder inhaler, including insulin-loaded FDKP microparticles and dry powder formulations including vasoactive intestinal peptide.
Delivery systems employing dry powders with specified isomer-content and diketopiperazine-related components, evaluated via inhaler-system performance and Andersen cascade impactor respirable fraction.
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