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Claims for Patent: 8,636,001

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Claims for Patent: 8,636,001

Title:Dry powder inhaler and system for drug delivery
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 and glucagon-like peptide 1 for the treatment of diabetes and/or obesity. The dry powder inhaler is compact; can be provided in various shapes and sizes, colors, and comprises a housing, a mouthpiece, a cartridge placement area, and a mechanism for opening and closing the medicament cartridge. The device is easy to manufacture, provides a pre-metered single unit dose, it is relatively easy to use, and can be reusable or disposable.
Inventor(s): Smutney; Chad C. (Watertown, CT), Kinsey; P. Spencer (Sandy Hook, CT), Sahi; Carl R. (Coventry, CT), Adamo; Benoit (Mount Kisco, NY), Polidoro; John M. (Coventry, CT), McLean; Scott (Waterbury, CT), Overfileld; Dennis (Fairfield, CT), Bryant; Anthony (Stratford, CT), He; Tom (Valencia, CA), Mann; Alfred (Valencia, CA)
Assignee: Mannkind Corporation (Valencia, CA)
Application Number:12/484,129
Patent Claims: 1. An inhalation system for delivering a dry powder medicament to a pulmonary tract, comprising a dry powder inhaler configured to have at least two inlet apertures, wherein a first inlet aperture is in communication with a first air flow pathway and a second inlet aperture is in communication with a second air flow pathway, and the first airflow pathway and the second airflow pathway converge in a substantially perpendicular manner during an inhalation maneuver, and wherein said inhalation system has a total resistance to flow in a dosing configuration ranging in value from 0.065 to about 0.200 ( kPa)/liter per minute.

2. The inhalation system of claim 1, further comprising an enclosure for containing the dry powder medicament for inhalation.

3. The inhalation system of claim 2, wherein the enclosure comprises a cartridge.

4. The inhalation system of claim 2, wherein the enclosure has an internal volume configured to contain the dry powder medicament and having at least one inlet port to allow flow into the enclosure, and at least one dispensing port to allow flow out of the enclosure; said at least one inlet port is configured to direct at least a portion of the flow entering the at least one inlet port at the at least one dispensing port within the enclosure in response to a pressure differential.

5. The inhalation system of claim 3, wherein the cartridge comprises a cartridge top and a cartridge bottom, wherein the cartridge top and the container are configurable to attain a containment position and a dosing or dispensing position.

6. The inhalation system of claim 1, wherein the dry powder inhaler comprises a mouthpiece and moveable member.

7. The inhalation system of claim 6, further comprising a housing.

8. The inhalation system of claim 7, wherein the mouthpiece comprises a flow conduit having a first inlet port in fluid communication with ambient air, a second inlet port in fluid communication with the cartridge; and an outlet port.

9. The inhalation system of claim 6, wherein the moveable member comprises a sled, a slide tray, or a carriage.

10. The inhalation system of claim 1, wherein the total resistance to flow is relatively constant across a pressure differential range between 0.5 kPa and 7 kPa.

11. The dry powder inhalation system of claim 1 further comprising a mouthpiece and a container to enclose the dry powder medicament wherein the dry powder medicament comprises diketopiperazine particles; wherein in use at a pressure differential of 4 kPa, the diketopiperazine particles emitted from the mouthpiece have a volumetric median geometric diameter of less than 7 .mu.m as measured by geometric size distribution analysis.

12. The dry powder inhalation system of claim 11, wherein the diketopiperizine particles have a Carr's index of 16 to 50.

13. The dry powder inhalation system of claim 11, wherein the diketopiperizine particles are composed of fumaryl diketopiperazine (FDKP) crystals wherein the ratio of FDKP isomers is in the range of 50% to 65% trans:cis.

14. The dry powder inhalation system of claim 11, wherein the diketopiperizine particles are composed of FDKP crystals having a specific surface area ranging from 45 to 65 cm.sup.2/g.

15. An inhalation system for delivering a dry powder medicament to a patient, comprising an inhaler comprising a container mounting area configured to receive a container, and a mouthpiece having at least two inlet apertures and at least one exit aperture; wherein a first inlet aperture of the at least two inlet apertures is in fluid communication with the container area, and a second inlet aperture of the at least two inlet apertures is in fluid communication with the at least one exit aperture via a flow path configured to bypass the container area and wherein the first inlet aperture and the second inlet aperture include flows that converge in a substantially perpendicular manner; wherein the flow path configured to bypass the container area delivers 30% to 90% of a total flow going through the inhaler during an inhalation.

16. The inhalation system of claim 15, further comprising a container comprising a dry powder medicament mounted to the container area.

17. The inhalation system of claim 16, wherein 10% to 70% of the flow entering the inhaler transits through the container prior to merging with the flow path.

18. An inhalation system for delivering a dry powder medicament to a patient, comprising a dry powder inhaler comprising a container region and a container; said dry powder inhaler and container combined are configured to have rigid flow conduits in a dosing configuration and a plurality of structural regions that provide a mechanisms for powder de-agglomeration of the inhalation system in use; wherein at least one of the plurality of mechanisms for de-agglomeration is an agglomerate size exclusion aperture in the container region having a smallest dimension less than 3 mm; said container comprising a top wherein the top and container are moveable relative to one another by a translational motion.

19. An inhalation system for delivering a dry powder medicament to a patient, comprising a dry powder inhaler comprising a mouthpiece and a container; said dry powder inhaler and container combined are configured to have rigid flow conduits in a dosing configuration and a plurality of structural regions that provide a mechanisms for powder de-agglomeration of the inhalation system in use; wherein at least one of the plurality of mechanisms for de-agglomeration is an air conduit configured in the mouthpiece which directs flow at an exit aperture in fluid communication with the container, said container comprising a top wherein the top and container are moveable relative to one another by a translational motion.

20. The inhalation system of claim 18 or 19, wherein the container further comprises one of the mechanisms for de-agglomeration which is a cup-like structure configured to guide a flow entering the container to lift and circulate a powder medicament prior to exiting the container.

21. The inhalation system of claim 20, wherein the cup-like structure has one or more radii configured to prevent flow stagnation.
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