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US 2014/0271888 A1Published application
Diketopiperazine microparticles with defined specific surface areas
AssigneeMannKind Corporation
InventorsMarshall L. Grant, Grayson W. Stowell, Paul Menkin
Life of this patent
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Abstract
Disclosed herein are diketopiperazine microparticles having a specific surface area of less than about 67 m2/g. The diketopiperazine microparticle can be fumaryl diketopiperazine and can comprise a drug such as insulin.
Claims21
A method for forming diketopiperazine microparticles comprising:
- a) dissolving a diketopiperazine in a water-based solution;
- b) adding an acid solution to the water-based solution to form a mixture;
- c) adjusting manufacturing conditions to target production microparticles with a specific surface area (SSA) of about 52 m2/g;
- d) precipitating the diketopiperazine microparticles out of the solution by adding aqueous ammonia forming a microparticle suspension, and
- e) collecting the precipitate after washing with deionized water;
- wherein the precipitate comprises FDKP microparticles having a SSA of about 35 m2/g to about 67 m2/g .
3 more elements
A method of forming fumaryl diketopiperazine microparticles with an SSA of about 35 m2/g to about 67 m2/g within a 95% confidence limit comprising, feeding equal masses of about 10.5 wt % acetic acid and about 2.5 wt % fumaryl diketopiperazine solutions at about 14° C. to about 18° C. through a high shear mixer.
Dependencies are inferred from the claim text.