ArticleEuropean journal of hospital pharmacy : science and practice2025
Stability study of topotecan in ophthalmic prefilled syringes for intravitreal delivery.
Article in European journal of hospital pharmacy : science and practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
2 citing papers in PubMed.
- In Vitro Stability and Preclinical Safety Evaluation of High-Dose Intravitreal Topotecan in Rabbits: Impact of Dose and Concentration.Ophthalmology science · 2026Article
- Assessment of leachables in hospital pharmacy compounded topotecan conditioned in common off-label syringes for intravitreal use.Scientific reports · 2025Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIntravitreal and intracameral administration of melphalan and topotecan (TPT) has shown its efficacy in the treatment of retinoblastoma over the last few years. Due to rapid hydrolysis, melphalan must be administered within the hour following reconstitution. With improved stability at room temperature and reduced ocular toxicity, TPT seems to be a promising candidate for production of prefilled syringes in terms of safety and efficiency of preparation and treatment administration. Due to the lack of TPT stability data, the stability of TPT at 20 µg/mL and 200 µg/mL in prefilled syringes was evaluated in three different storage conditions.
methodsThe stability of TPT in prefilled syringes was assessed via reversed-phase liquid chromatography coupled to a diode array detector analytical platform. The physicochemical stability of TPT in prefilled syringes in both concentrations, stored at 30±2°C with a relative humidity (RH) of 65±5%, 5±3°C, and -20±5°C, was evaluated over 12 months including visual inspection and pH measurement.
resultsTPT solution in syringes at 20 µg/mL and 200 µg/mL was stable at 5±3°C and -20±5°C for up to 12 months, with no precipitate and no significant change in pH and concentration. A TPT-related degradant, 8-methoxy-TPT, was detected at <0.5% only in 30±2°C (65±5% RH) after 3 months.
conclusionThis study demonstrated that TPT solutions at 20 µg/mL and 200 µg/mL conditioned in BBraun Omnifix syringes could be stored at 5±3°C for 12 months for safe and secure administration to patients.
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