Shelf life after opening of prescription medicines and supplements with Vitamin D 3 for paediatric use

Abstract

Objectives The aim of this study was to evaluate the effect of storage conditions on the shelf life of liquid pharmaceuticals with Vitamin D3 in order to determine appropriate storage conditions and shelf life after the product has been opened. Manufacturers rarely specify the shelf life after products have been opened, which leads to a controversial debate among medical professionals regarding the safety of products after opening and optimal storage conditions and considerably different recommendations to the public. Methods Effect of storage conditions on the shelf life was evaluated by comparing the isothermal stability of Vitamin D 3 in three prescription and three non-prescription medicines at different temperatures (4°C, 25°C and 40°C) using stability-indicating high performance liquid chromatography assay. Results Most of the examined preparations had a higher Vitamin D 3 content than the label claim when the products were first opened, presumably to compensate for loss during production and storage. An association was observed between the initial Vitamin D 3 content and its stability in the preparations. The Vitamin D 3 overage in liquid prescription medicines guaranteed its content >90% of the amount claimed on the label for at least 1 year when stored at 25°C and for 4 months at 40°C. All tested preparations are consumed when used as recommended over this period. Since some manufacturers recommend storage below room temperature, redefining the storage conditions is of practical significance. Conclusions The shelf life after opening examined prescription medicines containing Vitamin D 3 as their main active ingredient is at least 1 year at room temperature.