STABILITY OF CAFFEINE ORAL FORMULATIONS FOR NEONATAL USE

The stability of an oral formulation of 10 mg/ml caffeine citrate (equ ivalent to 5.03 mg/ml caffeine free base), which was preserved with po tassium sorbate, was assessed at a range of temperatures. There was no appreciable change in pH or caffeine content over 1 year, even at sto rage temperatures of 32 degrees C and 45 degrees C. A batch-to-batch d ifference in the stability of potassium sorbate was detected, with los ses over 1 year of 2% and 11% for two batches at 25 degrees C and 10% and 30%, respectively, at 45 degrees C. The formulation complied with the Antimicrobial Preservative Efficacy test of the British Pharmacopo eia throughout a period of storage at 25 degrees C for 1 year. There w as no detectable benefit to preservative efficacy by adding 20% w/v so rbitol as an osmotic agent. The formula with no sorbitol may be prefer able due to the potential for sorbitol to cause gastrointestinal upset . A shelflife of 1 year at room temperature is feasible. The additiona l precaution of limiting the in-use storage life to 1 month after open ing is recommended to ensure acceptable microbiological quality.