Stability studies of two compounded solutions potentially used in tumor lysis syndrome

Abstract

Objective

The aim of the study was to determine the stability of two non-commercially produced solutions: 1.68% sodium bicarbonate in 5% glucose (BIC solution) and 1.6% calcium chloride in 0.9% sodium chloride (CAL solution), which can be used to treat tumor lysis syndrome. One of the ways to treat the tumor lysis syndrome is to irrigate patients, alkalinize the urine through the supply of BIC solution or continuous hemodialysis with regional citrate anticoagulation, using a CAL solution.

Method

The study took place in two independent hospital pharmacies. Fifty samples of each solution were prepared under aseptic conditions, then the concentration of sodium and calcium ions was determined and microbiological purity tests were carried out. The tests were performed on the day of sample preparation and after seven days of storage at 4 ± 1℃.

Results

The obtained results showed that applied preparation method was precise and accuracy. The average concentration of sodium ions in BIC solutions ranged from 187.7 to 185.26 mmol/L on 1st and 7th day, respectively. The average concentration of calcium ions in CAL solution ranged from 68.92 to 68.80 mmol/L on 1st and 7th day, respectively. None of the samples were microbiologically contaminated.

Conclusion

Studied solutions for infusion were characterized by good chemical and microbiological stability when prepared in a clean room and stored at 4 ± 1℃.

Keywords

Tumor lysis syndrome hospital medications automated compounding drug stability

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References

Gupta

Moore

. Tumor lysis syndrome. JAMA Oncol 2018; 4: 895–895.

Mirrakhimov

Voore

Khan

et al.

Tumor lysis syndrome: a clinical review. World J Crit Care Med 2015; 4: 130–138.

Wilson

Berns

. Onco-nephrology: tumor lysis syndrome. Clin J Am Soc Nephrol 2012; 7: 1730–1739.

Jones

Will

Jackson

et al.

Guidelines for the management of tumour lysis syndrome in adults and children with haematological malignancies on behalf of the British Committee for Standards in Haematology. Br J Haematol 2015; 169: 661–671.

Rampello

Fricia

Malaguarnera

. The management of tumor lysis syndrome. Nat Clin Pract Oncol 2006; 3: 438–447.

Belay

Yirdaw

Enawgaw

. Tumor lysis syndrome in patients with hematological malignancies. J Oncol 2017; 2017: 9684909–9684909.

Pranav

Poojitha

Natraj

et al.

Impact of dialysis requirement on outcomes in tumor lysis syndrome. Nephrology 2017; 22: 85–88.

Oudemans-van Straaten Heleen

John

Kellum et al.

Clinical review: anticoagulation for continuous renal replacement therapy – heparin or citrate?

Crit Care 2011; 15: 202–211.

Davenport

Tolwani

. Citrate anticoagulation for continuous renal replacement therapy (CRRT) in patients with acute kidney injury admitted to the intensive care unit. Clin Kidney J 2009; 2: 439–447.

10.

Ermer

Miller

JH McB

. Method validation in pharmaceutical analysis. A guide to best practice, Weinheim: WILEY-VCH Verlag GmbH & Co. KGaA, 2005. p.11.