Romidepsin formulations and uses thereof

Abstract

Provided herein are liquid concentrate formulations of romidepsin. Also provided are methods for producing these formulations and uses thereof. In one embodiment, the formulation comprises romidepsin, polyethylene glycol, etanol and a citrate buffer. In another embodiment, the formulation comprises romidepsin, polyethylene glycol, etanol and an acetate buffer.

1 . A formulation comprising romidepsin in a concentration of 1 mg/mL to 10 mg/mL and a citrate buffer. 
     
     
         2 . The formulation of  claim 1 , further comprising propylene glycol (PG) and ethanol (EtOH). 
     
     
         3 . The formulation of  claim 2 , wherein the ratio of PG, EtOH and the citrate buffer is 70% of PG, 20% of EtOH, and 10% of the citrate buffer. 
     
     
         4 . The formulation of  claim 3 , wherein a pH of the solution is in a range of 3.0 and 6.0. 
     
     
         5 . The formulation of  claim 4 , wherein the pH is 4.5. 
     
     
         6 . The formulation of  claim 1 , wherein the concentration of romidepsin is 5 mg/mL. 
     
     
         7 . A formulation comprising romidepsin in a concentration of 1 mg/mL to 10 mg/mL and an acetate buffer. 
     
     
         8 . The formulation of  claim 7 , further comprising propylene glycol (PG) and ethanol (EtOH). 
     
     
         9 . The formulation of  claim 8 , wherein the ratio of PG, EtOH and the acetate buffer is 30% of PG, 30% of EtOH, and 40% of the acetate buffer. 
     
     
         10 . The formulation of  claim 9 , wherein a pH of the solution is in a range of 2.0 and 6.0. 
     
     
         11 . The formulation of  claim 10 , wherein the pH is 4.0. 
     
     
         12 . The formulation of  claim 1 , wherein the formulation is a unit dosage form. 
     
     
         13 . The formulation of  claim 7 , wherein the formulation is a unit dosage form. 
     
     
         14 . The formulation of  claim 12 , wherein the amount of romidepsin is about 2 to about 20 mg per vial. 
     
     
         15 . The formulation of  claim 13 , wherein the amount of romidepsin is about 2 to about 20 mg per vial. 
     
     
         16 . A method of treating cancer comprising administering to a subject the formulation of  claim 1 . 
     
     
         17 . A method of treating cancer comprising administering to a subject the formulation of  claim 7 .