Twenty-nine day study of stability for six different parenteral nutrition mixtures

Aim of the study

Parenteral nutrition is often peri-operative. It can be realized with packages containing different nutrients. Knowledge of the stability of these mixtures is necessary. The aim of this study is to test the stability of six parenteral nutrition mixtures, fitted to different pathologies.

Materials and methods

The mixtures are not supplemented. The packages are made of EVA (Nutripoches NPP235; Pharmacia). They contain (Table) glucose (G50 or G30%: Aguettant and Cooper Lab), amino acids (Hyperamine 25^® B Braun Medical SA), and lipids consisting of medium chain and long chain triglycerides (20% Médialipide^® B Braun Medical SA) or only long chain (20% Intralipide^® Pharmacia). The Central Pharmacy of the hospital fills the packages in a clean room under a laminary horizontal flux hood. The packages are filled with nutrients under nitrogen pressure. Two packages of each type are forwarded by air freight in a cold box to the stability control laboratory within 24 h after manufacture. They are stored in a refrigerator at 4 ± 1°C (circulating air) during 28 days, then 24 h at room temperature. The stability tests are performed at Dl, D3, D7, D10, D14, D21, D28, D28 + 24 h. The tests are: visual macroscopic (with and without homogenization) and microscopic controls (dilution = 1 : 10, increase: × 500 and × 1000), granulometric analysis (Coulter Counter TA II with a 50 μm aperture tube, dilutions = 1 : 100,000 and 1 : 1000), controls of pH, osmolality and conformity to the formulae. Results are given compared to mother emulsions.

Results

There is no macroscopic destabilization from D1 to D29 (no change in the colour or aspect of the mixtures). They are microscopically identical with the D1 mother emulsions. There is neither granulometric destabilization nor break of the emulsion incompatible with a normal therapeutic use. Conformity to the formulae, osmolality and pH are not significantly different from D1 to D29.

Conclusion

All the stability tests comply: the controlled mixtures are stable during a long storage period: 28 days at 4°C temperature, plus 24 h at room temperature.

Table: Contents of the six parenteral nutritions