Stability of concentrated solutions of isosorbide dinitrate in syringes for administration in the Intensive Care Unit

Hecq JD , Lardinois B, Dimitrio A, Bihin B, Jamart J, Soumoy L, Galanti L Drug Stability Research Group. CHU UCL Namur, Belgique

Background

In order to avoid fluid overload, the use of more concentrated drug solutions in intensive care units is common.

Purpose

Quantifying the physicochemical stability of concentrated solution of isosorbide dinitrate in polypropylene syringe during 28 days at 5 ± 3°C with protection from light.

Material and methods

Five syringes of 50 ml, containing 0.60 mg/ml of isosorbide dinitrate in 0.9 % NaCl were prepared and stored at 5 ± 3°C with protection from light during 28 days. Immediately after preparation and periodically during the storage, isosorbide dinitrate concentrations were measured by an ultra performance liquid chromatography (UPLC). Spectrophotometric absorbance at different wavelengths, pH measurement, visual and microscopic observations were also performed.

Results

All solutions were physicochemically stable during the whole period storage at 5 ± 3°C: no color change, turbidity, precipitation or opacity, no significant pH variations or optic densities were observed in the solutions. 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 28 days.

Conclusions

Solutions of isosorbide dinitrate 0.60 mg/ml in syringe of 0.9 % NaCl are physically and chemically stable for at least 28 days when stored in syringes at 5 ± 3°C with protection from light and may be prepared in advanced by a Centralized IntraVenous Admixture Service (CIVA).

References

Closset M, Hecq JD, Soumoy L, Simar J, Gonzalez E, Charlet L, Declave C, Gillet P, Galanti L. Physical stability of highly concentrated injectable drugs solutions used in intensive care units. Ann Pharm Fr. 2017 Feb 13. pii: S0003-4509(16)30055-4. doi: 10.1016/j.pharma.2016.12.004

Key words: Isosorbide dinitrate infusions – - Ultra performance liquid chromatography – physicochemical stability – CIVA – intensive care units.

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