Stability of an extemporaneous formulation of injectable cholecalciferol
Bertino, J.S.; Reed, M.D.; Lambert, P.W.; Halpin, T.C.
American Journal of Hospital Pharmacy 38(12): 1932-1933
1981
ISSN/ISBN: 0002-9289 PMID: 6275700 Document Number: 181980
THe stability of an extemporaneous formulation of injectable cholecalciferol 40,000 IU/ml was assessed. A preparation of cholecalciferol 40,000 IU/ml in a solution of propylene glycol with ethanol 10% was prepared. The solution was stored at 4 degrees C in 2-ml sterile glass vials protected from light. Cholecalciferol content was measured initially and periodically for 199 days using a high-pressure liquid chromatography technique. A 7.3% loss of cholecalciferol potency from baseline was observed over the 199-day period. In contrast to currently available preparations, this extemporaneous formulation of injectable cholecalciferol potentially offers a versatile dosage form for therapeutic or prophylactic therapy of vitamin D deficiency. It was easily prepared and retained more than 90% potency of cholecalciferol for at least six months. The addition of this formulation to large-volume parenteral or parenteral nutrition solutions is not recommended, however, because compatibility data are not available. In addition, the biological activity of the preparation has not been assessed.