Physico-chemical stability of valproate sodium in polypropylene syringe for administration in the Intensive Care Unit

B. Lardinois, A. Baltzis, M. Braibant, M. Godet, J. Jamart, B. Bihin, L. Soumoy, L. Galanti, J-D. Hecq Drug Stability Research Group, CHU UCL Namur, Yvoir, Belgique

Background

The intensive Care Unit (ICU) use drug solutions within higher concentration to avoid fluid overload.

Purpose

To evaluate the physico-chemical stability of concentrated solution of valproate sodium in polypropylene syringe during 30 days at 5 ± 3°C.

Material and methods

Five syringes of 50 ml, containing 20.0 mg/ml of valproate sodium in 0.9 % NaCl were prepared and stored at 5 ± 3°C during 30 days. Immediately after preparation and periodically during the storage, valproate concentrations was measured by a high-performance liquid chromatography (HPLC). Spectrophotometric absorbance at different wavelengths, pH measurement and microscopic observations were also performed.

Results

All solutions were physically stable during the whole period storage at 5 ± 3°C: no color change, turbidity, precipitation or opacity at visual observation. No significant pH variations or optic densities were observed. Any crystals were seen by microscopic analysis. Solutions are considered chemically stable as the lower limit of the 95 % unilateral confidence interval on the mean remained above 90 % of the initial concentration for at least 30 days.

Conclusions

Solutions of valproate sodium 20.0 mg/ml in syringe of 0.9 % NaCl are physically and chemically stable for at least 30 days when stored in syringes at 5 ± 3°C and may be prepared in advanced by a CIVA.

Discussion forum

GERPAC provides for its members a discussion forum specifically devoted to technology in hospital pharmacy

Access forum

GERPAC
Association Loi 1901
Siège social : Chez Jean-Yves Jomier / 8ter rue Léon Bussat, 64000 PAU
Immatriculation formation N° 72 64 035 30 64
Contact us Legal notes - Management of personal data