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Claims for Patent: 8,778,403

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Claims for Patent: 8,778,403

Title:Diketopiperazine microparticles with defined specific surface areas
Abstract: Disclosed herein are diketopiperazine microparticles having a specific surface area of less than about 67 m.sup.2/g. The diketopiperazine microparticle can be fumaryl diketopiperazine and can comprise a drug such as insulin.
Inventor(s): Grant; Marshall L. (Newtown, CT), Stowell; Grayson W. (Gaylordsville, CT), Menkin; Paul (Branford, CT)
Assignee: Mannkind Corporation (Valencia, CA)
Application Number:14/017,143
Patent Claims: 1. A method of delivering an active agent to a patient in need thereof comprising administering a dry powder comprising microparticles of a diketopiperazine, the microparticles having a specific surface area of about 40 m.sup.2/g to 67 m.sup.2/g, the microparticles having been loaded with a drug or active agent, by inhalation of said dry powder by said patient.

2. The method of claim 1, wherein the active agent is an endocrine hormone selected from the group consisting of insulin, parathyroid hormone, calcitonin, glucagon, glucagon-like peptide-1, oxyntomodulin, and an analog or active fragment of said endocrine hormone.

3. The method of claim 1, wherein the patient has been diagnosed with diabetes.

4. The method of claim 1, wherein said diketopiperazine is 2,5-diketo-3,6-bis(N-fumaryl-4-amino-butyl)piperazine.

5. An inhalation system comprising a breath powered inhaler and a dry powder comprising microparticles of a diketopiperazine, the microparticles having a specific surface area of about 40 m.sup.2/g to 67 m.sup.2/g.

6. The inhalation system of claim 5, wherein said diketopiperazine is 2,5-diketo-3,6-bis(N-fumaryl-4-amino-butyl)piperazine.

7. The inhalation system of claim 5 wherein said dry powder is provided in a unit dose cartridge.

8. The inhalation system of claim 5 wherein said dry powder is provided prefilled in the inhaler.

9. The inhalation system of claim 5 wherein said inhaler has a resistance to flow of about 0.065 ( kPa)/liter per minute to 0.200 ( kPa)/liter per minute.

10. The inhalation system of claim 5 wherein said inhaler has a flow path passing through an area of powder containment and a flow path bypassing said area of powder containment, wherein in use 10-70% of the total flow existing the inhaler passes through said area of powder containment and 90-30% of the total flow existing the inhaler bypasses said area of powder containment.

11. The inhalation system of claim 10, said inhaler having a mouthpiece, wherein said flow through the powder containment area and said flow bypassing the powder containment area combine prior to exiting the mouthpiece.

12. The inhalation system of claim 5 comprising 1 to 30 mg of said dry powder.

13. The inhalation system of claim 12, wherein greater than 75% of the powder is dispensed when the flow rate through the inhaler is from 7 to 70 liters per minute.

14. The inhalation system of claim 13 wherein greater than 85% of the powder is dispensed.

15. The inhalation system of claim 5 wherein respirable fraction/fill is greater than 40%.

16. The inhalation system of claim 15 wherein respirable fraction/fill is greater than 50%.

17. The inhalation system of claim 15 wherein respirable fraction/fill is greater than 60%.

18. A method of delivering an active agent to a patient in need thereof comprising administering a dry powder using the inhalation system of claim 5, the microparticles having been loaded with a drug or active agent.

19. The inhalation system of claim 5 wherein the active agent comprises an endocrine hormone selected from the group consisting of insulin, parathyroid hormone, calcitonin, glucagon, glucagon-like peptide-1, oxyntomodulin, an analog or active fragment of said endocrine hormone.

20. The inhalation system of claim 5 wherein the active agent comprises insulin.
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