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Claims for Patent: 8,912,193

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Claims for Patent: 8,912,193

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), Overfield; Dennis (Fairfield, CT), Kraft; Kelly S. (Poughqaug, NY), Somerville; Karla (Corona, CA)
Assignee: MannKind Corporation (Valencia, CA)
Application Number:13/921,104
Patent Claims: 1. Fumaryl diketopiperazine (FDKP) microparticles comprising a trans-FDKP isomer content of about 45% to about 63%.

2. The FDKP microparticles of claim 1 having a trans-FDKP isomer content of about 52% to about 63%.

3. The FDKP microparticles of claim 1 having a trans-FDKP isomer content of about 50% to about 56%.

4. The FDKP microparticles of claim 1 having a trans-FDKP isomer content of about 54% to about 56%.

5. The FDKP microparticles of claim 1 wherein the FDKP microparticles comprise a drug.

6. The FDKP microparticles of claim 5 having a trans-FDKP isomer content of about 50% to about 56%.

7. The FDKP microparticles of claim 5 wherein the drug is insulin.

8. The microparticles of claim 7 wherein the insulin content is about 3 to about 4 U/mg.

9. A dry powder comprising the microparticles of claim 1.

10. The dry powder of claim 9, wherein the microparticles have a trans-FDKP isomer content of about 53% to about 63%.

11. A method of treating diabetes comprising administering the microparticles of claim 7 to a person in need thereof.

12. FDKP microparticles having improved aerodynamic performance that have been prepared by a process comprising: determining the trans-FDKP isomer content; wherein the microparticles have a trans-FDKP isomer content of about 45% to about 65%.

13. The FDKP microparticles of claim 12 having a trans-FDKP isomer content of about 50% to about 63%.

14. The FDKP microparticles of claim 12 having a trans-FDKP isomer content of about 54% to about 56%.

15. An FDKP composition comprising a trans isomer content of about 45% to about 56%.

16. Microparticles comprising the FDKP composition of claim 15.

17. The FDKP microparticles of claim 16, wherein the trans-FDKP content of the microparticles is about 45% to about 54%.

18. The FDKP microparticles of claim 16 having a trans-FDKP isomer content of about 50% to about 56%.

19. The FDKP microparticles of claim 16 having a trans-FDKP isomer content of about 53% to about 56%.

20. The FDKP microparticles of claim 5 having a manufacturing specification in a range of about 53% to about 63% trans-FDKP isomer content, based upon the total content of FDKP.

21. The method of claim 11 wherein said microparticles are administered using 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 (IkPa)/liter per minute.
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