Method and composition for treating migraines
View Patent ↗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.
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 μm.
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.