Dry powder formulations and methods of use
The subject technology relates generally to pulmonary delivery of NSAIDs, such as aspirin.
1. A dry powder formulation for treating or reducing risk of a thromboembolic event in a subject in need thereof, the formulation suitable for delivery from within a dry powder inhaler, the formulation comprising a pharmaceutically acceptable excipient and 95% or more by weight of acetylsalicylic acid or a pharmaceutically acceptable salt thereof, the formulation having a volume median geometric diameter (VMGD) of from about 1 μm to about 5 μm and a mass median aerodynamic diameter (MMAD) of less than 5 μm, and wherein said formulation delivers at least 50% of the administered acetylsalicylic acid to systemic circulation of the subject within about 15 minutes of administering to the subject by inhalation.
2. The formulation of claim 1 , which delivers at least 60% of the administered acetylsalicylic acid to systemic circulation of the subject within about 15 minutes of administering to the subject by inhalation.
3. The formulation of claim 1 , which delivers at least 70% of the administered acetylsalicylic acid to systemic circulation of the subject within about 15 minutes of administering to the subject by inhalation.
4. The formulation of claim 1 , which delivers at least 80% of the administered acetylsalicylic acid to systemic circulation of the subject within about 15 minutes of administering to the subject by inhalation.
5. The formulation of claim 1 , which has a median geometric diameter of from about 1.7 μm to about 2.7 μm.
6. The formulation of claim 1 , comprising particles to inhibit aggregation.
7. A dry powder formulation for treating or reducing risk of a thromboembolic event in a subject in need thereof, the formulation suitable for delivery from within a dry powder inhaler, the formulation comprising a pharmaceutically acceptable excipient and 95% or more by weight of acetylsalicylic acid or a pharmaceutically acceptable salt thereof, the formulation having a VMGD of less than 5 μm, and an MMAD of from about 1 μm to about 5 μm, and wherein said formulation delivers at least 50% of the administered acetylsalicylic acid to systemic circulation of the subject within about 15 minutes of administering to the subject by inhalation.
8. The formulation of claim 7 , which delivers at least 60% of the administered acetylsalicylic acid to systemic circulation of the subject with within about 15 minutes of administering to the subject by inhalation.
9. The formulation of claim 7 , which delivers at least 70% of the administered acetylsalicylic acid to systemic circulation of the subject with within about 15 minutes of administering to the subject by inhalation.
10. The formulation of claim 7 , which delivers at least 80% of the administered acetylsalicylic acid to systemic circulation of the subject with within about 15 minutes of administering to the subject by inhalation.
11. The formulation of claim 7 , which has a median geometric diameter of from about 1.7 μm to about 2.7 μm.
12. The formulation of claim 7 , which comprises an excipient which is neither sodium citrate nor maltodextrin.
13. The formulation of claim 12 , wherein the acetylsalicylic acid is the sole non-steroidal anti-inflammatory in the formulation.
14. The formulation of claim 7 , comprising particles to inhibit aggregation.