Pharmaceutical compositions for clinical nutrition
AssigneesBaxter International Inc., Baxter Healthcare S.A.
InventorsZouaoui Bourezg, Cyrille Pousset
Life of this patent
Estimating the term…
Abstract
The present disclosure relates to a pharmaceutical composition for providing phosphorus to an adult or pediatric patient, wherein the composition is an aqueous solution of sodium glycerophosphate which by virtue of an improved process for producing the active pharmaceutical ingredient and the pharmaceutical composition is characterized by a low amount of free phosphate, a low amount of SGP-related substances and by a low amount of aluminum. The pharmaceutical composition is used in clinical nutrition, preferably in the preparation of nutritional formulations by compounding. The compositions can further be used for preventing or correcting phosphorus deficiency (hyperphosphatemia) in said adult or pediatric patients.
Claims27
A pharmaceutical composition comprising sodium glycerophosphate (SGP) in a concentration of from about 0.5 mmol/mL to about 30.0 mmol/mL, wherein
- (a) the amount of free phosphate is below 5% (w/w) of the total phosphate,
- (b) the total amount of SGP related substances is below 15% (w/w) of the total phosphate, and
- (c) the amount of aluminum is below 500 ppb.
A sodium glycerophosphate (SGP) drug product, wherein
- (a) the amount of free phosphate in the drug product is not more than 5% (w/w) of the total phosphate,
- (b) the total amount of SGP-related substances in the drug product is not more than 15% (w/w) of the total phosphate, and
- (c) the amount of aluminum in the drug product is not more than 500 ppb.
Dependencies are inferred from the claim text.