Preservative-free treprostinil devices
Embodiments include a system including a sealed prefilled drug-reservoir. The drug-reservoir may include a unit dosage of treprostinil in a sterile fluid composition. The composition may not include an antimicrobial preservative. The treprostinil may be present at a dosage of between 0.1 mg/mL and 25 mg/mL. In addition, the treprostinil may be treprostinil sodium Furthermore, the composition may include sodium chloride. The composition may also include a sodium ion from sodium chloride in a concentration from 3000 to 4500 ppm. The composition may not include metacresol.
1. A system comprising a sealed prefilled drug-reservoir containing a unit dosage form of treprostinil in a sterile fluid composition, wherein:
said composition does not comprise an antimicrobial preservative,
said treprostinil is present at a dosage of between 0.1 mg/mL and 25 mg/mL,
said treprostinil is treprostinil sodium,
said composition comprises sodium chloride,
the composition comprises a sodium ion from sodium chloride in a concentration from 3000 to 4500 ppm, and
said composition does not comprise metacresol.
2. The system of claim 1 , wherein the system is a selectively activatable patch-pump assembly.
3. The system of claim 2 , wherein the selectively activatable patch-pump assembly does not comprise a user programmable pump.
4. The system of claim 1 , wherein the system is an automatic injection device.
5. The system of claim 1 , wherein the volume of the sterile fluid composition does not exceed 10 mL.
6. The system of claim 1 , wherein the volume of the sterile fluid composition does not exceed 8 mL.
7. The system of claim 1 , wherein the volume of the sterile fluid composition does not exceed 5 mL.
8. The system of claim 1 , wherein the volume of the sterile fluid composition does not exceed 2.5 mL.
9. The system of claim 1 , wherein the volume of the sterile fluid composition does not exceed 1 mL.
10. The system of claim 1 , wherein the system is configured to deliver treprostinil at a rate of 0.5 to 25 mg per day.
11. The system of claim 1 , wherein the system is configured to deliver treprostinil at a rate of 0.1 to 25 mg per day.
12. The system of claim 1 , wherein the system is formulated for subcutaneous or intravenous injection.
13. The system of claim 1 , wherein the sealed prefilled drug-reservoir comprises cyclic olefin polymer.
14. The system of claim 1 , wherein the pH of the composition is from 6.5 to 6.7.
15. The system of claim 1 , wherein the composition further comprises dextrose or glycerol.
16. The system of claim 1 , wherein the composition does not comprise cresols, phenols, parabens, or benzyl alcohol.