Pharmaceutically acceptable ready-to-use ferric carboxymaltose compositions

Abstract

A pharmaceutical product includes a sealed container and further includes a pharmaceutically suitable ready-to-use ferric carboxymaltose premix composition in the sealed container. The ferric carboxymaltose premix composition contains water, sodium chloride, and ferric carboxymaltose in an amount that includes about 2.0 mg to about 4.0 elemental iron/mL of the composition, preferably about 3.0 mg elemental iron/mL of the composition. The ferric carboxymaltose premix composition is stable in the sealed container at room-temperature (RT) for at least one month. A method of preparing the pharmaceutical product includes: (i) dissolving ferric carboxymaltose in water to form a concentrate; (ii) adjusting the pH of the concentrate to 5.0 to 7.0, preferably about 6.0; (iii) subjecting the pH-adjusted concentrate to addition of thermal energy; (iv) diluting the heat-treated concentrate in the presence of sodium chloride, and adjusting the pH to 5.0 to 7.0, preferably about 6.0, to form the ferric carboxymaltose premix composition; (v) aseptically filling the ferric carboxymaltose premix composition into the container; and (vi) sealing the container.

Dependencies are inferred from the claim text.