Claims for Patent: 10,772,883

Summary for Patent: 10,772,883

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. (Cary, NC), Menkin; Paul (Branford, CT), Freeman, Jr.; John J. (New Fairfield, CT)
Assignee:	MannKind Corporation (Westlake Village, CA)
Application Number:	15/462,559
Patent Claims:	1. A dry powder pharmaceutical composition comprising inhalable 3,6-di(N-fumaryl-4-aminobutyl)-2,5-diketopiperazine microparticles; wherein each of the microparticles has a specific surface area of 35 m.sup.2/g to about 67 m.sup.2/g and comprises an active agent. 2. The dry powder of claim 1, wherein the active agent is vasoactive agent, a neuroactive agent, an immunomodulating agent, a cytotoxic agent, an antibiotic, an antiviral agent, an antigen, and infectious agent, an inflammatory mediator, a hormone, or a cell surface antigen. 3. The dry powder of claim 1, wherein the active agent is a prostaglandin. 4. The dry powder of claim 3, wherein the prostaglandin is PG I.sub.2. 5. The dry powder of claim 1, wherein the active agent is about 0.01% to about 20% of the weight of the microparticles. 6. A dry powder for inhalation comprising microparticles of a diketopiperazine of the formula: ##STR00003## and a prostaglandin; wherein the microparticles have a specific surface area of 35 m.sup.2/g to about 67 m.sup.2/g. 7. The dry powder of claim 6, wherein the prostaglandin is PG I.sub.2 or an analog thereof. 8. A dry powder for inhalation comprising microparticles of a diketopiperazine of the formula: ##STR00004## and granulocyte macrophage colony stimulating factor; wherein the microparticles have a specific surface area of 35 m.sup.2/g to about 67 m.sup.2/g. 9. A dry powder inhaler comprising a dry powder formulation comprising microparticles of a fumaryl diketopiperazine (FDKP) having the formula: ##STR00005## wherein the FDKP microparticles have a specific surface area of 35 m.sup.2/g to about 67 m.sup.2/g and one or more than one active agents. 10. The dry powder inhaler of claim 9, wherein the one or more active agents is a prostaglandin. 11. The dry powder inhaler of claim 10, wherein the one or more active agent prostaglandin PG 12 or an analog thereof. 12. The dry powder inhaler of claim 9 wherein the one or more active agent is granulocyte macrophage colony stimulating factor.