Ready to use injectable formulations of Micafungin Sodium
The present application provides method for formulating and corresponding a ready-to-use liquid injectable parenteral pharmaceutical composition, comprising Micafungin sodium and a first excipient and/or pharmaceutically acceptable second excipient.
1 . A ready-to-use liquid injectable parenteral formulation, comprising micafungin sodium and at least a first pharmaceutically acceptable first excipient.
2 . The formulation of claim 1 , wherein the pharmaceutically acceptable first excipient is selected from the group consisting of polysaccharides, disaccharides, and a combination thereof.
3 . The formulation of claim 1 , wherein the first excipient comprises a polysaccharide selected from a group consisting of lactose, maltose, and sucrose.
4 . The formulation of claim 1 , comprising a second pharmaceutically acceptable excipient selected from a group consisting of sodium metabisulfite, sodium thiosulfate, methionine, ascorbic acid, and butylated hydroxytoluene.
5 . The formulation of claim 1 , wherein the formulation further comprises one or more additional pharmaceutically acceptable excipients selected from a group consisting of one or more preservatives, polymers, pH adjusting agents, surfactants, chelating agents, dispersing agents, binding agents, tonicity modifying agents, and antioxidants.
6 . The formulation of claim 1 , wherein the formulation further comprises at least one pharmaceutically acceptable pH adjusting agent selected from a group consisting of sodium hydroxide, hydrochloric acid, acetic acid, phosphoric acid, succinic acid, potassium hydroxide, and ammonium hydroxide.
7 . The formulation of claim 1 , wherein the formulation further comprises at least one pharmaceutically acceptable vehicle selected from a group consisting of 0.9% NaCl, sterile water for injection, dextrose, and lactated ringer solution.
8 . The formulation of claim 1 , wherein formulation may be in the form of clear injectable solution, suspension, or emulsion.
9 . The formulation of claim 1 , having a concentration of Micafungin of less than 50 mg/ml.
10 . The formulation of claim 1 , wherein at least 90% potency of the micafungin sodium is retained after storage for 6 months at about 0° C. to about 40° C. temperature and 60% relative humidity.