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Claims for Patent: 9,192,675

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Claims for Patent: 9,192,675

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. (Poughquag, NY), Somerville; Karla (Corona, CA)
Assignee: ManKind Corporation (Valencia, CA)
Application Number:13/954,731
Patent Claims: 1. A drug delivery system comprising an inhaler, a powder container, comprising fumaryl diketopiperazine (FDKP) microparticles comprising a trans-FDKP isomer content of about 45% to about 65% and a drug, wherein the aerodynamic performance of the microparticles is improved as compared to fumaryl diketopiperazine microparticles having a trans isomer content outside of said trans isomer content of about 45% to about 65%; and wherein in use about 10% to 70% of an air flow exiting the inhaler and entering a user passes through the powder container and about 90% to 30% of said air flow bypasses the powder container.

2. The drug delivery system of claim 1 wherein the FDKP microparticles have a trans-FDKP isomer content of about 45% to about 56%.

3. The drug delivery system of claim 1 wherein said powder container comprises a unit dose cartridge.

4. The drug delivery system of claim 1 wherein the FDKP microparticles comprise a drug comprising insulin, GLP-1, heparin, calcitonin, felbamate, parathyroid hormone and fragments thereof, oxyntomodulin, growth hormone, erythropoietin, AZT, DDI, G-CSF, lamotrigine, chorionic gonadotropin releasing factor, luteinizing releasing hormone, .beta.-galactosidase or Argatroban.

5. The drug delivery system of claim 1 having a resistance to flow of about 0.065 to about 0.200 ( kPa)/liter per minute.

6. The drug delivery system of claim 4 wherein the drug is insulin.

7. The drug delivery system of claim 6 wherein the insulin content of the FDKP microparticles is about 3 to about 4 U/mg.

8. A method of treating an insulin-related disorder comprising providing, for self-administration, the drug delivery system of claim 1 to administer insulin to a person in need thereof.

9. A drug delivery system comprising an inhaler, a powder container comprising 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% and the aerodynamic performance of the microparticles is improved as compared to fumaryl diketopiperazine microparticles having a trans isomer content outside of said trans isomer content of about 45% to about 65%; and wherein in use about 10% to 70% of an air flow exiting the inhaler and entering a user passes through the powder container and about 90% to 30% of said air flow bypasses the powder container.

10. The drug delivery system of claim 9 comprising FDKP microparticles having a trans-FDKP isomer content of about 50% to about 63%.

11. The drug delivery system of claim 9 comprising FDKP microparticles having a trans-FDKP isomer content of about 45% to about 56%.

12. The drug delivery system of claim 9 having a resistance to flow of approximately 0.065 to about 0.200 (IkPa)/liter per minute.

13. The drug delivery system of claim 1 wherein the FDKP microparticles are prepared by a process comprising recrystallizing FDKP from a solvent, then forming microparticles, wherein the trans-FDKP content of the microparticles is about 45% to about 65%.

14. The drug delivery system of claim 13 wherein the FDKP microparticles have a trans-FDKP isomer content of about 50% to about 65%.

15. The drug delivery system of claim 13 wherein the FDKP microparticles have a trans-FDKP isomer content of about 54% to about 65%.

16. The drug delivery system of claim 4 having a manufacturing specification in a range of about 53% to about 63% trans-FDKP isomer content, based upon the total content of FDKP.

17. The drug delivery system of claim 15 wherein the FDKP microparticles have a trans-FDKP isomer content of about 54% to about 63%.

18. The drug delivery system of claim 17 wherein the FDKP microparticles have a trans-FDKP isomer content of about 54% to about 56%.
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