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

J Oncol Pharm Pract. 2019 Sep;25(6):1434-1438. doi: 10.1177/1078155219840421. Epub 2019 Apr 2.

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; automated compounding; drug stability; hospital medications.

MeSH terms

  • Calcium Chloride / chemistry*
  • Drug Compounding
  • Drug Contamination
  • Drug Stability
  • Glucose / chemistry*
  • Humans
  • Infusions, Parenteral
  • Pharmaceutical Solutions
  • Sodium Bicarbonate / chemistry*
  • Sodium Chloride / chemistry*
  • Solutions
  • Tumor Lysis Syndrome / drug therapy

Substances

  • Pharmaceutical Solutions
  • Solutions
  • Sodium Chloride
  • Sodium Bicarbonate
  • Glucose
  • Calcium Chloride