Objectives This study was conducted to investigate the microbial contamination of caffeine citrate 10 mg/mL oral solution (CCOS) during a simulated in-use test in a clinical environment.
Methods A real-time in-use simulation study was conducted in a neonatal intensive care unit at a UK National Health Service hospital. Following the simulation, samples of the product were taken and assessed for microbiological contamination.
Results This study shows that CCOS does not comply with the European Pharmacopoeia (Ph Eur) Specification for Preservative Efficacy. However, it shows that the in-use contamination of the product in a clinical environment remained within the Ph Eur General Text (5.1.4) Specification for the Microbiological Quality of Non-Sterile Pharmaceutical Preparations.
Discussion There is a requirement for medicines to be developed and formulated specifically for paediatric use. This requires that excipients should be kept to a minimum. CCOS has been specifically developed to treat apnoea of prematurity in neonates. This product does not contain antimicrobial preservatives. It is produced as a terminally sterilised solution to enable an appropriate shelf-life. CCOS is currently marketed as a unit dose product, and once opened has an immediate-use, single-patient requirement. This gives CCOS an expensive unit cost. A suitable in-use shelf-life would reduce unit dose costs.
Conclusions The evidence from this study would suggest that CCOS, a product specifically formulated for use in neonates without antimicrobial preservatives, can safely be assigned a 7-day room temperature in-use shelf-life.
- microbiological control
- pharmaceutical excipients
- shelf life
- storage conditions
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