Pharmaceutically acceptable ready-to-use ferric carboxymaltose compositions
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.
1 . A pharmaceutical product comprising a sealed container and further comprising a pharmaceutically suitable ready-to-use ferric carboxymaltose premix composition in the sealed container,
the pharmaceutically suitable ready-to-use ferric carboxymaltose premix composition comprising water, sodium chloride, and ferric carboxymaltose in an amount that comprises about 2.0 mg to about 4.0 mg elemental iron/mL of the composition,
wherein the pharmaceutically suitable ready-to-use ferric carboxymaltose premix composition does not contain any buffering agent,
wherein the pharmaceutically suitable ready-to-use ferric carboxymaltose premix composition is stable in the sealed container at room-temperature (RT) for at least one month.
2 . The pharmaceutical product of claim 1 , wherein the pharmaceutically suitable ready-to-use ferric carboxymaltose premix composition is suitable for parenteral administration.
3 . The pharmaceutical product of claim 1 , wherein the sealed container comprises a flexible bag.
4 . The pharmaceutical product of claim 1 , wherein the sealed container contains a unit dosage form of the ready-to-use ferric carboxymaltose premix composition which is about 250 mL and comprises an amount of the ferric carboxymaltose that comprises about 100 mg to about 1000 mg elemental iron.
5 . The pharmaceutical product of claim 1 , wherein the sealed container contains a unit dosage form of the ready-to-use ferric carboxymaltose premix composition which is about 50 mL and comprises an amount of the ferric carboxymaltose that comprises about 100 mg elemental iron.
6 . The pharmaceutical product of claim 1 , wherein the sodium chloride is about 0.9% of the composition.
7 . The pharmaceutical product of claim 1 , wherein the ferric carboxymaltose has a particle size distribution z-average of about 22 nm to about 28 nm.
8 . The pharmaceutical product of claim 1 , wherein the pharmaceutically suitable ready-to-use ferric carboxymaltose premix composition has been aseptically filled into the container and has not been subjected to terminal sterilization in the container.