Claims for Patent: 8,734,845

Summary for Patent: 8,734,845

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:	13/377,682
Patent Claims:	1. Diketopiperazine microparticles having a specific surface area of from about 35 m.sup.2/g to about 67 m.sup.2/g. 2. The diketopiperazine microparticles according to claim 1, wherein said microparticles comprise a drug or active agent. 3. The diketopiperazine microparticles according to claim 2, wherein said specific surface area is less than about 62 m.sup.2/g. 4. The diketopiperazine microparticles according to claim 3, wherein said drug or active agent is a peptide or protein. 5. The diketopiperazine microparticles according to claim 4, wherein said peptide is an endocrine hormone. 6. The diketopiperazine microparticles according to claim 5, wherein said endocrine hormone is insulin, parathyroid hormone, calcitonin, glucagon, glucagon-like peptide 1, oxyntomodulin, an analog or active fragment of said endocrine hormone. 7. The diketopiperazine microparticles according to claim 1, wherein said diketopiperazine is fumaryl diketopiperazine. 8. The diketopiperazine microparticles of claim 6 in a dry powder form. 9. The diketopiperazine microparticles of claim 6 wherein said endocrine hormone is insulin or an analog or active fragment thereof. 10. The diketopiperazine microparticles of claim 6 wherein said endocrine hormone is glucagon-like peptide 1 or an analog or active fragment thereof. 11. The diketopiperazine microparticles of claim 1 having a specific surface area of from about 45 m.sup.2/g to about 67 m.sup.2/g. 12. The diketopiperazine microparticles of claim 1 having a specific surface area of from about 35 m.sup.2/g to about 56 m.sup.2/g. 13. The diketopiperazine microparticles of claim 1 having a specific surface area of from about 45 m.sup.2/g to about 56 m.sup.2/g. 14. The diketopiperazine microparticles of claim 9 wherein said endocrine hormone is insulin. 15. The diketopiperazine microparticles of claim 14 wherein the microparticles are about 10-15% insulin by weight. 16. The diketopiperazine microparticles of claim 5, wherein said endocrine hormone is an exendin. 17. The diketopiperazine microparticles of claim 14 wherein the microparticles comprise 3-4 U/mg insulin. 18. The diketopiperazine microparticles of claim 15 wherein the microparticles are about 11% insulin. 19. The diketopiperazine microparticles of claim 2 wherein said drug or active agent comprises about 0.01% to about 20% of the weight of the microparticles. 20. A dry powder comprising the diketopiperazine microparticles of claim 19.

Details for Patent 8,734,845

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2029-06-12