Claims for Patent: 8,945,612

Summary for Patent: 8,945,612

Title:	Capsules containing high doses of levodopa for pulmonary use
Abstract:	The present invention provides a capsule containing an inhalable powder composition wherein the composition comprises about 75% by weight or more levodopa, dipalmitoylphosphatidylcholine (DPPC) and a salt characterized by a working density of less than about 100 g/L. The invention further provides a capsule containing an inhalable powder composition wherein the composition comprises about 75% by weight or more levodopa, dipalmitoylphosphatidylcholine (DPPC) and a salt characterized by a working density of less than about 100 g/L wherein the capsule material comprises hydroxypropylmethylcellulose (HPMC) and titanium dioxide.
Inventor(s):	Kee; Kevin D. (Somerville, MA), Penachio; Ernest D. (Haverhill, MA), Kamerkar; Abhijit (Boston, MA), Lipp; Michael M. (Framingham, MA), Batycky; Richard P. (Newton, MA)
Assignee:	Civitas Therapeutics, Inc. (Chelsea, MA)
Application Number:	14/174,179
Patent Claims:	1. A capsule for use in an inhalation device filled with a dry powder comprising levodopa, a salt and a phospholipid and having a working density between about 0.02 to about 0.1 g/cm.sup.3, and containing a capsule shell comprising hydroxypropyl methylcellulose (HPMC) and titanium dioxide, and wherein said capsule emits more powder comprising levodopa upon actuation of the inhalation device as compared to a capsule that comprises HPMC and is free of titanium dioxide; and wherein the capsule comprises from about 80% to about 95% levodopa. 2. The capsule of claim 1, wherein said working density is between about 0.02 g/cm.sup.3 to about 0.05 g/cm.sup.3. 3. The capsule of claim 1, wherein said dry powder comprises from about 2 to about 8% of water by weight. 4. The capsule of claim 3, wherein said dry powder comprises from about 5 to about 6% of water by weight. 5. The capsule of claim 1, wherein said capsule is a 00 size capsule. 6. The capsule of claim 5, wherein said dry powder comprises between about 15 and 50 milligrams of levodopa. 7. The capsule of claim 6, wherein said dry powder comprises between about 25 and 35 milligrams of levodopa. 8. The capsule of claim 1, wherein said salt is sodium chloride. 9. The capsule of claim 1, wherein said phospholipid is dipalmitoylphosphatidylcholine (DPPC). 10. The capsule of claim 1, wherein the dry powder comprises from about 85% to about 95% by weight of levodopa. 11. The capsule of claim 1, wherein a fine particle fraction of the dry powder is about 50% to about 70% of the nominal dose. 12. The capsule of claim 1, wherein the capsule is filled with about 20 milligrams or more of the dry powder. 13. The capsule of claim 1, wherein the capsule is filled with about 30 to about 50 milligrams of dry powder. 14. The capsule of claim 1, wherein the salt is sodium chloride and the phospholipid is DPPC.