Stabilized aqueous leucovorin calcium compositions

Details Stabilized aqueous leucovorin calcium compositions Stabilized aqueous leucovorin calcium compositions

A - Human Necessities

61

K

167/219

A61K 31/33 (2006.01) A61K 31/505 (2006.01) A61K 47/12 (2006.01)

Patent

CA 2002642

ABSTRACT OF THE DISCLOSURE A laucovorin composition having improved properties is provided by an aqueous, isotonic, sterile leucovorin calcium solution having a pH in the range 6. 5-8 . 5 and containing as a buffer therein sodium citrats dihydrate in the amount in the range 1 mg - 3 2 mg/mL, the leuco- vorin composition containing leucovorin calcium pentahy- drate in the amount 6. 35 mg/mL, equivalent to 5 mg/mL leucovorin content. A preferred starile, aqueous leuco- vorin solution in accordance which this invention con- tains 6.35 mg/mL leucovorin oalcium pentahydrate, 22 mg/mL sodium citrate dihydrate, the remainder being sterile water. The pH of this solution is adjusted to 8.1 ? 0.1 with 1N NaOH solution and/or 1N citric acid solution.

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