Pharmaceutically acceptable ready-to-use ferric carboxymaltose compositions
Inventors
Chaubal, Mahesh V • Mantei, Jason Robert • Parker, Kelly Ann
Assignees
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Publication Number
US-12721859-B1
Publication Date
2026-09-01
Expiration Date
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.
Core Innovation
The invention is a pharmaceutical product comprising a sealed container holding a ready-to-use ferric carboxymaltose premix composition. The composition comprises water, sodium chloride, and ferric carboxymaltose at about 2.0 to about 4.0 mg elemental iron/mL, contains no buffering agent, and remains stable in the sealed container at room temperature for at least one month.
The described problem includes increased particle size and possible precipitation when ferric carboxymaltose formulations undergo direct terminal sterilization. The ready-to-use premix is presented for parenteral infusion without further dilution, improving workflow and reducing preparation-related medication errors. The relevant claims also describe a flexible bag and aseptic filling without terminal sterilization in the container.
Claims Coverage
The provided claims identify one independent claim covering a sealed-container pharmaceutical product and its ready-to-use ferric carboxymaltose premix composition, reciting one inventive feature.
Sealed-container ferric carboxymaltose premix
A pharmaceutical product comprising a sealed container with a ready-to-use ferric carboxymaltose premix composition comprising water, sodium chloride, and ferric carboxymaltose at about 2.0 mg to about 4.0 mg elemental iron/mL. The composition contains no buffering agent and is stable in the sealed container at room temperature for at least one month.
The independent claim centers on the sealed, room-temperature-stable, ready-to-use premix composition. The supplied dependent claim elements further specify parenteral suitability, a flexible bag, dosage and particle-size constraints, and aseptic filling without terminal sterilization.
Stated Advantages
The ready-to-use premix is presented as improving workflow and reducing preparation-related medication errors.
Documented Applications
The premix is suitable for parenteral administration and is presented for parenteral infusion without further dilution.
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