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Table 4 Quantitative analysis of potentially harmful excipient exposure

From: Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan

Excipients Number of neonates quantitative data available PMA at dose (weeks) Weight at dose (g) Daily PHE Dose (mg/kg/day) Number of neonates exceed ADI (%)a Missing of quantitative information ADI for human Reference no.
Median (range) Median (range) Median (range) Products Neonates Prescriptions
Aspartame 0 5 13 13 FDA: 50 mg/kg/day
EMA: 40 mg/kg/day (do not apply to
infants below 12 weeks of age)
[24, 25, 27]
Ethanol 1 32.4 1290.0 1.6 0 5 130 192 6 mg/kg/day [15]
Benzalkonium chloride 0 2 3 3 0.1 mg/kg for food residual [28]
Benzyl alcohol 100 34.9 (23.3–71.1) 1808 (486–6665) 0.3 (0.0–48.8) 10 (10%) 0 0 0 5 mg/kg [29, 30]
Parabens 13 30.4 (24.4–42.0) 1101 (410–3102) 0.03 (0.02–0.50) 0 (0%) 4 81 91 10 mg/kg/day [31]
Polysorbate 80 90 34.0 (23.3–55.9) 1646 (487–4175) 1.2 (0.006–31.1) 38 (42.2%) 5 11 11 2 mg (<  1 month)
2–6 mg (<  6 months)
[32]
Propylene glycol 39 35.3 (23.7–55.7) 1984 (486–4175) 46.0 (0.04–257.4) 37 (94.9%) 2 28 28 34 mg/kg/day
1 mg/kg/day (<  1 month)
1–50 mg/kg/day (>  1 month)
[33, 34]
Saccharin sodium 0 5 63 70 15 mg/kg/day [31]
Sodium benzoate 0 6 153 208 5 mg/kg/day [29]
Sorbitol 23 35.0 (24.4–40.6) 2098 (410–3716) 8.4 (0.2–13.9) 9 (39.1%) 2 159 136 10 mg/kg/day [35]
  1. anumber of neonates exceeding ADI criteria for humans; PHE potentially harmful excipient, PMA postmenstrual age, ADI acceptable daily intake, FDA U.S. Food and Drug Administration, EMA European Medicines Agency