Dry powder formulations for inhalation
A respirable dry powder including acetylsalicylic acid in particles has a mass median aerodynamic diameter (MMAD) within a range of about 0.5 μm to about 10 μm. The respirable dry powder may contain a pharmaceutically acceptable excipient, such as a phospholipid, in an amount ranging from about 0.1% (w/w) to about 10% (w/w) of the particles.
1. A drug delivery system comprising a dry powder, the dry powder comprising a non-steroidal anti-inflammatory drug (NSAID), a pharmaceutically acceptable excipient and having an emitted dose from 70% to 95%;
wherein
the NSAID is 50% w/w or more of the dry powder,
the pharmaceutically acceptable excipient is 0.01% w/w to 10% w/w of the dry powder, and
the dry powder has a particle size distribution with a DV50 in a range of 3 μm to 6.7 μm and a DV10 in a range of 0.9 μm to 3.3 μm.
2. The drug delivery system according to claim 1 , wherein the emitted dose is from 75% to 95%.
3. The drug delivery drug delivery system according to claim 1 , wherein the NSAID is a salicylate.
4. The drug delivery system according to claim 1 , wherein the NSAID is acetylsalicylic acid or a pharmaceutically acceptable salt thereof.
5. The drug delivery system according to claim 1 , wherein the dry powder has a mass median aerodynamic diameter (MMAD) within a range of about 0.5 μm to about 10 μm.
6. The drug delivery system according to claim 1 , wherein the NSAID is 90% (w/w) or more of the dry powder.
7. The drug delivery system according to claim 1 , wherein the pharmaceutically acceptable excipient is 0.01% (w/w) to 4% (w/w) of the dry powder.
8. The drug delivery system according to claim 1 , wherein the pharmaceutically acceptable excipient comprises one or more surfactants.
9. The drug delivery system according to claim 1 , wherein the pharmaceutically acceptable excipient comprises one or more phospholipids.
10. The drug delivery system according to claim 1 , further comprising a dry powder inhaler,
wherein the dry powder inhaler comprises a mouthpiece, a reservoir for receiving the respirable dry powder, and an actuation member for making available the respirable dry powder.
11. The drug delivery system according to claim 1 , wherein the NSAID is present in a dose of less than 81 mg.
12. The drug delivery system according to claim 1 , wherein the dry powder further comprises clopidogrel.
13. The drug delivery system according to claim 5 , wherein the MMAD varies less than about 30% after the dry powder is stored at 30° C. at 65% relative humidity for about 4 weeks.
14. The drug delivery system according to claim 5 , wherein the MMAD varies less than about 30% after the dry powder is stored at 50° C. at 75% relative humidity for about 2 weeks.
15. The drug delivery system according to claim 5 , wherein the MMAD varies less than about 10% after the dry powder is stored at 50° C. for about 5 days.
16. A method of preventing or treating a thromboembolic event in a subject in need thereof using the drug delivery system of claim 1 .