Abstract
To study the excipients exposure among neonates in a neonatal intensive care unit. Prospective observational study was conducted from January, 2017 to June, 2019. Details of administered drugs were collected from the hospital case files. List of excipients of formulations and their quantities were collected from package insert leaflets or by contacting the manufacturers. Excipients were grouped into four categories based on available safety data. Calculated daily exposures to the excipients (mg/kg/day) were compared with adult acceptable daily intake. More than half of the included 746 neonates were exposed to harmful excipients. 12.3% and 12.7% of neonates received higher than acceptable daily intake of sodium metabisulphite and sunset yellow FCF, respectively. There is a high risk of exposure of neonates to harmful excipients, and clinicians need to be aware of this during neonatal care.
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