Development of a ready-to-use glucose-calcium infusion fluid for premature neonates

Objective: Premature neonates are considered a population at risk for infections because their immune system is not fully developed. Practically all neonates with a birth weight less than 1800 gram start with parenteral nutrition. One of the products that is used in our hospital is a glucose-calcium infusion. Until recently this infusion was prepared on the ward. Several papers describe substantial microbial contamination when parenteral solutions are prepared on the ward. We developed a ready-to-use glucose-calcium infusion to minimize the microbial contamination and to promote patient safety. Design and methods: A glucose-calcium solution for infusion was formulated and packed in glass and polypropene containers. A validation batch was subjected to quality control and shelf-life testing. Because of the extensive experience with both glucose and calciumgluconate in parenteral solutions and their known stability, a limited sampling plan was adopted for shelf-life stability testing. After introduction, the product was evaluated for its efficacy and safety by retrospective evaluation of biochemical parameters of fourteen neonates. Results: Just after production and six months thereafter the solution for infusion complies with all pharmacopoeial requirements. The clinical evaluation showed serum calcium and glucose concentrations to be within the required range. No infusion-related adverse events were reported. The product in glass contained as much aluminium as the solution prepared on the ward while the product in polypropylene contained less than 10 μg/l aluminium. Conclusion: The glucose-calcium infusion in polypropene has some advantages compared to the previous situation: a decrease in aluminium contamination, in microbial risks and in costs combined with the desired clinical effect without any infusion-related adverse events