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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 excipientsExcipientFrequency of use (n = 67)Concentration in leafletScore rateaADICompliance status
Coloring agents/dyesTartrazine1Not stated0/125 mg/kgCannot be determined
Sunset yellow8Not stated0/80.3 mg/kgCannot be determined
PreservativesMethylparaben
Proplyparaben
11
(As parabens)
0.045–0.18%
0.011–0.02%
3/115 mg/kgAppropriate
Sodium Benzoate100.8% w/v2/1010 mg/kgAppropriate
Solvents/co-solventsEthanol421–90% v/v26/425 g/dayInappropriate
Propylene Glycol7Not stated0/710 mg/kgCannot be determined
SurfactantsPolysorbate 802Not stated0/210 mg/kgCannot be determined
SweetnersAspartame20.03 g/5 ml2/2< 10 mg/kgAppropriate
Saccharin Sodium65 mg/5 ml1/62.5 mg/kgToo high for infants
Sorbitol81 g–1.06 g/5 ml2/80.3 mg/kgToo high for infants and neonates
Sucrose111.7 g–3.7 g/5 ml5/11< 25 g/dayToo 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