Stability of all-in-one parenteral nutrition admixtures containing Smoflipid®
Smoflipid® is a lipid emulsion with the particularity of containing ù-3 fatty acids. The purpose of this study is to evaluate the galenic stability of all-in-one parenteral nutrition admixtures containing this lipid emulsion in order to produce these preparations for neonatal intensive care unit.
A retrospective study of the all-in-one parenteral nutrition prescriptions over a period of one month was carried out. Six admixtures containing different concentrations of amino acids (33 - 40 g / L), calcium (6 - 16 mmol / L), phosphate (10 - 23 mmol / L) and lipids (4 - 15 mL per 100 mL of solution) were elaborated. The stability of the emulsion was assessed by visual inspection as well as pH, particle size, osmolarity and zeta potential measurements. These measurements were carried out for 3 days after storage at 2 - 8 ° C and after 24 h at 25 ° C.
No change of color and no sign of creaming or coalescence were observed. The pH (5.8 - 6) and the osmolarity (900 - 1600 mOsm / L) remained stable. The mean diameter of globules was 0.32 ìm. Zeta potential remained stable 4 days (between -32 and -40 mV) for the six tested admixtures.
The results are comparable to those obtained with an emulsion of Médialipide® currently used in our unit. Smoflipid® can be used in the all-in-one parenteral nutrition admixtures. The admixtures can be stored for 3 days between 2 ° C and 8 ° C and remained stable for 24h during the administration at 25°C. A further study is in progress to assess galenic stability at 7 days.