Stability study of four vitamin formulations for parenteral nutrition in neonatology

P. Rault1, B. Le Dare1, M. Ropert2, P-Y. Donnio3, S. Cammas-Marion1, P-N. Boivin1, M-A. Lester1 1 Pharmacy department, Rennes University Hospital, Rennes, France
2 Laboratory of biochemistry and toxicology, Rennes University Hospital, Rennes, France
3 Laboratory of bacteriology and hospital hygiene, Rennes University Hospital, Rennes, France
4 National School of Chemistry, Rennes, France

Following the IGAS report no. 2014-168R, the modalities of supplementation of nutrient mixtures were reviewed with the hospital neonatal service. Production of vitamin mixtures with lipids and trace elements, adaptable to preterm babies’ weights was expressed. Four kinds of syringes formulation were proposed during a multidisciplinary meeting: vitamins and trace elements (VO), and vitamins and lipids (VL) at three concentrations (117, 148 and 162 mg/ml).

The aim of this study was to show a 15 days stability for these 4 formulations.

Three batches of vitamin syringes were prepared: one VO batch and two VL batches at 2 levels of concentrations. These preparations have been stored between +4°C and +8°C and away from light. The physical parameters evaluated were: osmolality, pH, zeta potential (PZ), dynamic light scattering (DLS) and macroscopic appearance. According to European Pharmacopoeia (9th edition), sterility tests by membrane filtration were achieved in different culture media. The dosages to demonstrate the chemical stability are in progress.

The highest osmolality variation was 2.3% and 0.5 unit for pH. PZ measures demonstrate the stability of particulate dispersion in the three batches. For the VO syringes, PZ varies from -44 ± 5 mV at D0 to -36 ± 6 mV at D15. For VL syringes, the average PZ is equal to -44 ± 7 mV with a maximum variation of 2mV over 15 days. DLS measures showed no significant differences between particle sizes, the largest diameter is 280 nm. All the sterility tests were in accordance with the European Pharmacopoeia.

These results allow us to establish a 15 days of physical stability for these preparations. This expiration date must be confirmed with the chemical stability results.

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