Diketopiperazine microparticles with defined specific surface areas
Disclosed herein are diketopiperazine microparticles having a specific surface area of less than about 67 m 2 /g. The diketopiperazine microparticle can be fumaryl diketopiperazine and can comprise a drug such as insulin.
1. A method of treating diabetes in a patient in need thereof comprising administering by inhalation a dry powder comprising precipitated crystalline microparticles of a diketopiperazine and insulin or an analog or active fragment thereof, the microparticles having a specific surface area of about 40 m 2 /g to 67 m 2 /g.
2. The method of claim 1 , wherein the diketopiperazine is of the formula 3,6-bis(N—X-4-aminobutyl)-2,5-diketopiperazine, wherein X is selected from the group consisting of fumaryl, succinyl, maleyl, and glutaryl.
3. The method of claim 2 , wherein X is fumaryl.
4. The method of claim 1 , wherein said diabetes comprises diabetes type 1.
5. The method of claim 1 , wherein said diabetes comprises diabetes type 2.
6. The method of claim 4 , wherein said type 1 diabetes comprises honeymoon phase or post-honeymoon phase.
7. The method of claim 6 , wherein said type 1 diabetes comprises honeymoon phase.
8. The method of claim 6 , wherein said type 1 diabetes comprises post-honeymoon phase.
9. The method of claim 1 , wherein said precipitated crystalline microparticles are precipitated with an acetic acid feed solution.
10. The method of claim 9 , wherein said acetic acid feed solution further comprises polysorbate 80.