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Stability for 6 months and accuracy of a specific enteral caffeine base preparation for a multisite clinical trial

Grant Erickson1, Michael McAnulty2, Chelsea Powers2

  • 1National Capital Consortium Neonatal-Perinatal Medicine Fellowship, Uniformed Services University, Bethesda, Maryland, USA.

British Journal of Clinical Pharmacology
|April 11, 2023
PubMed

Insights

This study confirms that enteral caffeine base solutions are stable for up to six months at room temperature. Accurate caffeine concentrations were consistently achieved by multiple research pharmacies for the ICAF study.

Area of Science:

  • Neonatal pharmacology
  • Pharmaceutical stability testing
  • Clinical trial drug preparation

Background:

  • Extemporaneously compounded enteral caffeine base solutions are utilized in neonatal clinical trials, such as the Intermittent Hypoxia and Caffeine in Infants Born Preterm (ICAF) study.
  • Ensuring the stability and accurate concentration of study drugs is critical for the integrity of clinical research involving preterm infants.

Purpose of the Study:

  • To determine the stability of an extemporaneously compounded enteral caffeine base solution over a 6-month storage period.
  • To assess the optimal storage temperature for this specific caffeine preparation.
  • To verify the accuracy of compounded caffeine concentrations across multiple research pharmacies.

Main Methods:

  • Caffeine solutions were prepared and stored under controlled conditions at 4°C and 25°C (room temperature).
  • High-performance liquid chromatography (HPLC) was employed to analyze caffeine concentrations at various time points.
  • Samples from three research pharmacies were analyzed to confirm the accuracy of compounded drug concentrations.

Main Results:

  • Caffeine concentrations remained within 5% of the expected value when stored for up to 6 months at room temperature (25°C).
  • The study demonstrated that multiple research pharmacies could accurately compound the caffeine solutions, meeting required concentration specifications.

Conclusions:

  • Extemporaneously compounded enteral caffeine base solutions exhibit adequate stability for at least 6 months when stored at room temperature.
  • The findings support the reliable use of this preparation in clinical trials, ensuring drug efficacy and participant safety.

Keywords:
HPLCclinical pharmacologydrug analysisdrug informationneonatologypaediatrics

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