Dry powder treprostinil for the treatment of pulmonary hypertension
A dry powder inhalation treatment for pulmonary arterial hypertension includes a dose of dry particles comprising greater than 25 micrograms of treprostinil enclosed in a capsule. The dry particles can include treprostinil, a wetting agent, a hydrophobicity modifying agent, a pH modifying agent and a buffer. A method of treating a patient having pulmonary arterial hypertension includes providing a patient a dry powder inhaler, providing the patient at least one capsule for use in the dry powder inhaler, the capsule including at least 25 micrograms of treprostinil.
1. A dry powder treatment for treating pulmonary arterial hypertension, comprising:
a dose of dry powder particles comprising treprostinil or a pharmaceutically acceptable salt thereof, and an excipient matrix;
wherein the dry powder particles are formed from a solution comprising a pH modifying agent and a bulking agent;
wherein the dry powder particles are filled into one or more dosage units configured to be inserted into a dry powder inhaler for administration to a patient;
wherein the one or more dosage units include a total predetermined amount of the treprostinil or the pharmaceutically acceptable salt thereof in the range of 100 μg to 350 μg.
2. The dry powder treatment of claim 1 , wherein each of the one or more dosage units contains treprostinil or the pharmaceutically acceptable salt thereof in an amount of 50 μg to 220 μg.
3. The dry powder treatment of claim 2 , wherein each of the one or more dosage units contains treprostinil or the pharmaceutically acceptable salt thereof in an amount of 50 μg to 110 μg.
4. The dry powder treatment of claim 3 , wherein each of the one or more dosage units contains treprostinil or the pharmaceutically acceptable salt thereof in an amount of 100 μg to 220 μg.
5. The dry powder treatment of claim 1 , wherein each of the one or more dosage units contains 2.5 mg to 15 mg of the dry powder particles.
6. The dry powder treatment of claim 1 , wherein each of the one or more dosage units contains greater than or equal to 15 mg of the dry powder particles.
7. The dry powder treatment of claim 1 , wherein the dry powder particles comprise about 0.53% by weight treprostinil or the pharmaceutically acceptable salt thereof.
8. The dry powder treatment of claim 1 , wherein the dry powder particles comprise about 1.06% by weight treprostinil or the pharmaceutically acceptable salt thereof.
9. The dry powder treatment of claim 1 , wherein the dry powder particles have a mass median aerodynamic diameter (MMAD) from 1 μm to 5 μm.
10. The dry powder treatment of claim 9 , wherein the dry powder particles have a MMAD of 3 μm or less.
11. The dry powder treatment of claim 1 , wherein the solution further comprises one or more of a wetting agent, a hydrophobicity modifier, and a buffer.
12. The dry powder treatment of claim 1 , wherein the excipient matrix comprises trehalose, L-leucine, polysorbate 80, sodium citrate, and sodium chloride.
13. The dry powder treatment of claim 1 , wherein the dry powder particles are dried to less than 5 percent water content.
14. The dry powder treatment of claim 13 , wherein the dry powder particles are dried to less than 2 percent water content.
15. The dry powder treatment of claim 1 , wherein the dose of dry powder particles is packaged in a closeable container having a cap.
16. The dry powder treatment of claim 1 , wherein the one or more dosage units comprises one or more capsules.
17. The dry powder treatment of claim 16 , wherein each of the one or more capsules contains an amount of the dry powder particles that is configured to be administered to the patient over one to two breaths using the dry powder inhaler.
18. The dry powder treatment of claim 17 , wherein the dry powder particles comprise about 0.5% by weight treprostinil or the pharmaceutically acceptable salt thereof, and wherein each of the one or more capsules contains 50 μg to 220 μg treprostinil or the pharmaceutically acceptable salt thereof.
19. The dry powder treatment of claim 17 , wherein the dry powder particles comprise about 1% by weight treprostinil or the pharmaceutically acceptable salt thereof, and wherein each of the one or more capsules contains 50 μg to 220 μg treprostinil or the pharmaceutically acceptable salt thereof.
20. The dry powder treatment of claim 1 , wherein the dry powder particles are formed having a predetermined size range.
21. The dry powder treatment of claim 1 , wherein the dry powder particles comprise particles that are substantially uniform in shape.