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