Dry powder drug delivery system and methods
Inventors
Smutney, Chad C. • Adamo, Benoit • Laurenzi, Brendan F. • Kinsey, P. Spencer
Assignees
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Publication Number
US-12128173-B2
Publication Date
2024-10-29
Expiration Date
Abstract
A pulmonary drug delivery system is disclosed, including a breath-powered, dry powder inhaler, with or without a cartridge for delivering a dry powder formulation. The inhaler and cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, small organic molecules, peptides and proteins, including, hormones such as insulin and glucagon-like peptide 1 for the treatment of disease and disorders, for example, diseases and disorders, including endocrine disease such as diabetes and/or obesity.
Core Innovation
The disclosed invention relates to a dry powder inhalation system that includes a dry powder for oral inhalation and a dry powder inhaler. The dry powder inhaler comprises a mouthpiece, a cartridge having a powder container with a lid, and at least two rigid air conduits, and in a dosing configuration one rigid air conduit includes a deflector or stem protruding from an undersurface of the lid facing an internal volume of the powder container.
In the dosing configuration, the deflector or stem directs airflow into the powder container along a pathway that is substantially U-shaped. The airflow is directed from a direction parallel to the mouthpiece to a substantially downward direction to a direction substantially parallel to the mouthpiece through the dry powder to a direction substantially perpendicular to the mouthpiece to exit the powder container. In a containment configuration, the dry powder is sealed from the at least two rigid air conduits and from the deflector or stem.
The powder container includes a first vertical wall and a second vertical wall parallel and opposed, and in the dosing configuration the deflector or stem is disposed between the first vertical wall and the second vertical wall. The system is further characterized as using a high resistance dry powder inhaler, and the disclosed payload can include peptide, polypeptide, or fragments thereof, and can include small organic molecules and nucleic acid molecules. Example therapeutic peptide/protein agents include insulin, glucagon, glucagon-like peptide-1, parathyroid hormone, deoxyribonuclease, oxytocin, oxyntomodulin, peptide YY, and an exendin, or fragments thereof.
Claims Coverage
The partial content identifies three independent claims. The main inventive features focus on the rigid air-conduit and lid-mounted deflector or stem cartridge architecture with a substantially U-shaped airflow pathway and sealing in a containment configuration, with additional limitations on high resistance inhaler form and container geometry.
Substantially U-shaped airflow pathway using lid-mounted deflector or stem
In a dosing configuration, one rigid air conduit includes a deflector or stem protruding from an undersurface of the lid facing an internal volume of the powder container and configured to direct airflow into the powder container along a pathway that is substantially U-shaped.
Containment sealing from rigid air conduits and deflector or stem
In a containment configuration, the dry powder is sealed from the at least two rigid air conduits and from the deflector or stem.
Deflector or stem disposed between parallel opposed vertical walls of the powder container
The powder container includes a first vertical wall and a second vertical wall parallel and opposed, and in the dosing configuration the deflector or stem is disposed between the first vertical wall and the second vertical wall.
High resistance dry powder inhaler
A dry powder inhalation system comprises a dose of a dry powder medication and a high resistance dry powder inhaler.
Specific medication identities for dry powder medication
The dry powder comprises insulin, glucagon, glucagon-like peptide-1, parathyroid hormone, deoxyribonuclease, oxytocin, oxyntomodulin, peptide YY, an exendin, or fragments thereof.
Claim coverage is concentrated on an inhaler architecture that uses a lid-mounted deflector or stem in a dosing configuration to impose a substantially U-shaped airflow pathway through dry powder, while sealing the dry powder from the conduits and deflector or stem in a containment configuration. Additional scope includes opposed vertical wall placement, a high resistance dry powder inhaler, and specified peptide or protein therapeutics or fragments thereof.
Stated Advantages
Improved cartridge emptying efficiency.
Improved respirable fraction of emitted particles.
Improved de-agglomeration performance.
Improved systemic exposure/bioavailability for FDKP and insulin with DPI systems versus MEDTONE.
Documented Applications
In vitro evaluation of dry powder inhaler systems delivering FDKP diketopiperazine powders and insulin/FDKP formulations.
In vivo pharmacokinetic evaluation in healthy volunteers of DPI systems delivering FDKP and insulin/FDKP formulations, including systemic exposure metrics and bioavailability comparisons versus MEDTONE.
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