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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