Storage-stable ready-to-use injectable formulations of Trabectedin
Ready-to-use liquid parenteral formulations are provided that include trabectedin, at least one of a pharmaceutically acceptable solvent, and at least one pharmaceutically acceptable excipient or adjuvant.
1 . A ready-to-use liquid parenteral formulation, comprising trabectedin, at least one of a pharmaceutically acceptable solvent, and at least one pharmaceutically acceptable excipient or adjuvant.
2 . The formulation of claim 1 , wherein the pharmaceutically acceptable excipient or adjuvant comprises a pH adjuster selected from the group consisting of Orthophosphoric acid and Potassium hydroxide.
3 . The formulation of claim 1 , having a concentration of trabectedin of less than 10 mg/ml.
4 . The formulation of claim 1 , having a concentration of Trabectedin of less than 7 mg/ml.
5 . The formulation of claim 1 , having a concentration of Trabectedin of less than 5 mg/ml.
6 . The formulation of claim 1 , having a concentration of Trabectedin of less than 3 mg/ml.
7 . The formulation of claim 1 , having a concentration of Trabectedin of about 0.5 mg/ml.
8 . The formulation of claim 1 , having a concentration of Trabectedin of from about 0.001 w/v to about 0.1 w/v.
9 . The formulation of claim 1 , having a concentration of Trabectedin of from about 0.04 w/v to about 0.08 w/v.
10 . The formulation of claim 1 , having a concentration of Trabectedin of about 0.05 w/v.
11 . The formulation of claim 1 , wherein at least 90% purity of the trabectedin is retained after storage for 12 months at 5° C.±3° C.
12 . The formulation of claim 1 , having a pH from about 4 to about 9.
13 . The formulation of claim 1 , having a pH from about 5 to about 8.
14 . The formulation of claim 1 , having a pH from about 6.5 to about 7.3.
15 . The formulation of claim 1 , wherein the solvent comprises ethanol.
16 . A single dose vial of ready-to-use liquid parenteral formulation, comprising trabectedin, ethanol, sterile water for injection, wherein the formulation has a pH about 6.5 to about 7.3.
17 . The formulation of claim 16 , comprising a pharmaceutically acceptable stabilizing agent.
18 . The formulation of claim 17 , wherein the pharmaceutically acceptable stabilizing agent comprises glycine.
19 . The formulation of claim 17 , wherein the pharmaceutically acceptable stabilizing agent comprises about 125 ml glycine.
20 . The formulation of claim 16 , wherein 100% purity of the trabectedin is retained after storage for 30 days.