Stability of Extemporaneously Prepared Acetazolamide Oral Suspensions at Two Temperatures

The Journal of Pediatric Pharmacology and Therapeutics : JPPT : the Official Journal of PPAG
Charlotte GilliumGrégoire Leclair

Abstract

Some drugs need to be compounded by the pharmacist before being administered to the patient. A study was conducted to determine the stability of acetazolamide suspensions in 2 different vehicles (Oral Mix and Oral Mix Sugar Free [SF]) from bulk drug and tablets at 2 different temperatures and in 2 different containers (amber plastic bottles and clear plastic syringes). Acetazolamide suspensions (25 mg/mL) were prepared from bulk drug or tablets. Each suspension, using Oral Mix or Oral Mix SF, was split between 2 types of containers-amber plastic bottles and clear plastic syringes-and stored either at room temperature (23°C-27°C) or under refrigeration (3°C-7°C). Samples were drawn from the suspensions right after preparation and on days 7, 14, 30, 45, 60, 75, and 90. They were then analyzed by high-performance liquid chromatography (HPLC) using a reverse-phase column. A validated stability-indicating HPLC with ultraviolet detection method was developed. A visual inspection and a pH measurement were also completed at each time point. Stability was defined as retention of at least 90% of the initial concentration of acetazolamide suspension. At least 91.2% of the initial acetazolamide concentration in suspensions remained through...Continue Reading

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