Preservative-free treprostinil formulations and methods and devices for use with same
This invention provides for a unit dosage form of treprostinil at a dosage of between 0.1 mg/mL and 25 mg/mL in a sterile fluid composition formulated for subcutaneous or intravenous injection, which composition does not comprise an antimicrobial preservative, and methods of reducing irritation, inflammation or a combination thereof at a site of subcutaneous or intravenous infusion of treprostinil in a subject in need thereof.
1. A unit dosage form of treprostinil in a sterile fluid composition formulated for subcutaneous or intravenous injection, 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 unit dosage form of claim 1 , wherein said composition provides for a maximal volume of injection which does not exceed 10 mL for single use.
3. The unit dosage form of claim 1 , wherein the pH of the composition is from 6.5 to 6.7.
4. The unit dosage form of claim 1 , wherein the composition further comprises dextrose or glycerol.
5. The unit dosage form of claim 1 , wherein the composition does not comprise cresols, phenols, parabens, or benzyl alcohol.
6. A method of reducing pain at a site of subcutaneous or intravenous infusion of treprostinil in a subject in need thereof, wherein said subject is administered the unit dosage form of claim 1 .
7. A method of reducing irritation, inflammation or a combination thereof at a site of subcutaneous or intravenous infusion of treprostinil in a subject in need thereof, wherein said subject is administered the unit dosage form of claim 1 .