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Table 1 Class of excipients in pediatric oral liquid medicines and compliance status

From: Prevalence of ethanol and other potentially harmful excipients in pediatric oral medicines: survey of community pharmacies in a Nigerian City

Class of excipients

Excipient

Frequency of use (n = 67)

Concentration in leaflet

Score ratea

ADI

Compliance status

Coloring agents/dyes

Tartrazine

1

Not stated

0/1

25 mg/kg

Cannot be determined

Sunset yellow

8

Not stated

0/8

0.3 mg/kg

Cannot be determined

Preservatives

Methylparaben

Proplyparaben

11

(As parabens)

0.045–0.18%

0.011–0.02%

3/11

5 mg/kg

Appropriate

Sodium Benzoate

10

0.8% w/v

2/10

10 mg/kg

Appropriate

Solvents/co-solvents

Ethanol

42

1–90% v/v

26/42

5 g/day

Inappropriate

Propylene Glycol

7

Not stated

0/7

10 mg/kg

Cannot be determined

Surfactants

Polysorbate 80

2

Not stated

0/2

10 mg/kg

Cannot be determined

Sweetners

Aspartame

2

0.03 g/5 ml

2/2

< 10 mg/kg

Appropriate

Saccharin Sodium

6

5 mg/5 ml

1/6

2.5 mg/kg

Too high for infants

Sorbitol

8

1 g–1.06 g/5 ml

2/8

0.3 mg/kg

Too high for infants and neonates

Sucrose

11

1.7 g–3.7 g/5 ml

5/11

< 25 g/day

Too high for infants and neonates when added to sugar from foods

  1. aScore rates = the number of formulations that stated the concentration of that excipient out of all the formulations containing the excipient e.g. 42 formulations contained ethanol but only 26 stated the concentration, so score rate for ethanol was 26/42