The formulation and stability of a unit-dose oral vitamin K1 preparation.

A unit-dose oral vitamin K1 solution (1 mg ml-1) was developed for administration to neonates as prophylaxis against early haemorrhagic disease of the new-born. Previously, a multidose oral-drop solution was prepared from sterile ampoules of vitamin K1 injection (10 mg ml-1). The unit-dose preparation enabled accurate and convenient dose delivery and was more economical than the multidose solution. Furthermore, the preparation of sterile, single-dose units enabled the elimination of potentially harmful preservatives from the formulation. The unit-dose preparation was shown to be stable for 6 months under refrigerated storage conditions.