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Details for Patent: 8,785,396

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Details for Patent: 8,785,396

Title:Method and composition for treating migraines
Abstract: A method for treating migraines is disclosed. The method utilizes a rapid drug delivery system which prevents deactivation or degradation of the active agent, including small molecules and peptides being administered to a patient in need of treatment. In particular, the drug delivery system is designed for inhalation for delivery of drugs to the pulmonary circulation in a rapid and therapeutically effective manner.
Inventor(s): Leone-Bay; Andrea (Ridgefield, CT), Stowell; Grayson W. (Gaylordsville, CT), Guarneri; Joseph J. (Stamford, CT), Carlson; Dawn M. (New Milford, CT), Grant; Marshall (Newtown, CT), Smutney; Chad C. (Watertown, CT)
Assignee: Mannkind Corporation (Valencia, CA)
Filing Date:Nov 09, 2011
Application Number:13/293,017
Claims:1. A pharmaceutical composition comprising bis-3,6-[(N-fumaryl-4-aminobutyl)]-2,5-diketopiperazine or a salt thereof, 1-50 mg of sumatriptan or rizatriptan, and an aliphatic amino acid selected from the group consisting of alanine, glycine, leucine, isoleucine, norleucine, and serine, wherein said aliphatic amino acid is about 0.5% to about 30% by weight of the composition.

2. The pharmaceutical composition of claim 1, comprising bis -3,6[(N-fumaryl-4-aminobutyl)]-2,5-diketopiperazine and sumatriptan in a dry powder form.

3. The pharmaceutical composition of claim 2, wherein the composition is inhalable.

4. The pharmaceutical composition of claim 3, wherein the composition further comprises an excipient.

5. The pharmaceutical composition of claim 2, wherein the dry powder comprises microparticles, wherein from about 35% to about 75% of said microparticles have an aerodynamic diameter of less than 5.8 .mu.m.

6. The pharmaceutical composition of claim 1, wherein the composition further comprises L-leucine.

7. The pharmaceutical composition of claim 1, wherein the aliphatic amino acid is alanine.

8. The pharmaceutical composition of claim 1, wherein the aliphatic amino acid is glycine.

9. The pharmaceutical composition of claim 1, wherein the aliphatic amino acid is isoleucine.

10. The pharmaceutical composition of claim 1, wherein the aliphatic amino acid is norleucine.

11. The pharmaceutical composition of claim 1, wherein the aliphatic amino acid is serine.

12. The pharmaceutical composition of claim 1, comprising bis -3,6[(N-fumaryl-4-aminobutyl)]-2,5-diketopiperazine and rizatriptan in a dry powder form.

13. A method of treating a migraine comprising: providing a patient with migraine symptoms an inhaler comprising the pharmaceutical composition of claim 1 in a dry powder form comprising bis-3,6[(N-fumaryl-4-aminobutyl)]-2,5-diketopiperazine, the aliphatic amino acid and 1-50 mg of sumatriptan or rizatriptan; wherein the aliphatic amino acid is L-leucine and wherein a therapeutically effective amount of said dry powder composition is administered to said patient by oral inhalation.
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