Stability studies of etoposide as syringes for intrathecal administration and syringes for pediatric oral administration

Jonathan Hua; Chloé Renon; Rachel Jaud; Geoffroy Denniel; Romain Paoli-Lombardo; Pascal Rathelot; Patrice Vanelle; Christophe Curti; Bertrand Pourroy

doi:10.1177/10781552261452549

May 19, 2026Journal of Oncology Pharmacy Practice

Stability studies of etoposide as syringes for intrathecal administration and syringes for pediatric oral administration

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Key Points

To determine the physicochemical and microbiological stability of etoposide compounded into syringes for pediatric oral and intrathecal administration under various storage conditions.
Validated an HPLC-UV assay to measure etoposide concentrations and degradation products alongside microbiological and endotoxin assays.
Assessed pH, particulate matter, leachables, preservative efficacy, and benzaldehyde content in 10 mg/mL oral solutions (normal saline and 5% dextrose) and 0.1 mg/mL intrathecal solutions (normal saline).
Tested formulations stored at 25°C with 60% relative humidity and under refrigerated conditions (2–8°C) across Luer-Lock and NRFit syringe systems.
Oral etoposide (10 mg/mL) in both normal saline and 5% dextrose remained stable for 15 days at 25°C/60% RH and for 90 days at 2–8°C.
Intrathecal etoposide (0.1 mg/mL) packaged in Luer-Lock syringes remained stable for 2 days at 25°C/60% RH and 14 days at 2–8°C.
Intrathecal etoposide (0.1 mg/mL) packaged in NRFit syringes maintained chemical stability for 14 days at both 25°C/60% RH and 2–8°C.

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Implication

Stability study demonstrates extended shelf life of compounded oral and intrathecal etoposide syringes, indicating container type critically influences drug safety and quality.

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Hua et al. (2026) studied this question.

synapsesocial.com/papers/6a7eea0ecb17bc2d1d0d2d41 https://doi.org/10.1177/10781552261452549

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Stability studies of etoposide as syringes for intrathecal administration and syringes for pediatric oral administration

Key Points

No abstract yet

Implication

Discussion

Cite This Study

Stability studies of etoposide as syringes for intrathecal administration and syringes for pediatric oral administration

Key Points

No abstract yet

Implication

Discussion

Cite This Study

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