Pemetrexed formulations
AssigneeEagle Pharmaceuticals, Inc.
InventorsFeng-Jing CHEN, Steven L. KRILL
Life of this patent
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Abstract
The present invention is directed to pemetrexed formulations comprising a non-aqueous solvent that remains stable after dilution for at least about 48 hours when stored at 2° C. to 8° C. The present invention is also directed to pemetrexed formulations comprising a non-aqueous solvent that remains stable for at least about 24 months when stored at 2° C. to 8° C.
Claims29
A pharmaceutical composition comprising:
- a) pemetrexed and
- b) a non-aqueous solvent present at less than 0.30 mL/mL;
- wherein upon dilution with a pharmaceutically acceptable diluent to an initial dosage concentration of pemetrexed, the composition comprises at least 90% of the initial dosage concentration of pemetrexed after storage at a temperature of 2° C. to 8° C. for at least 12 hours.
The pharmaceutical formulation of claim 8 wherein the non-aqueous solvent is propylene glycol. The pharmaceutical formulation of claim 9 wherein propylene glycol is present at 250 μL/mL.
A pharmaceutical composition comprising
- a) 25 mg/mL pemetrexed, and
- b) propylene glycol at 250 μL/mL
- c) water
- wherein upon dilution with a pharmaceutically acceptable diluent to an initial dosage concentration of pemetrexed, the composition comprises at least 90% of the initial dosage concentration of pemetrexed after storage at a temperature of 2° C. to 8° C. for at least 24 hours.
A pharmaceutical composition comprising:
- a) pemetrexed at an initial concentration of 10 to 50 mg/mL and
- b) a non-aqueous solvent present at less than 0.30 mL/mL,
- wherein the composition comprises at least 90% of the initial pemetrexed concentration after storage at a temperature of 2° C. to 8° C. for at least 12 months.
A pharmaceutical composition comprising
- a) an initial pemetrexed concentration of 25 mg/mL,
- b) propylene glycol at 250 μL/mL, and
- c) water;
- wherein the composition comprises at least 90% of the initial pemetrexed concentration after storage at a temperature of 2° C. to 8° C. for at least 12 months.
Dependencies are inferred from the claim text.