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) | |
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 | |
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) | |
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] |