Background and importance Excipients are essential to improve the quality, stability, bioavailability and patient acceptability of medicines. Most pharmaceutical excipients are recognised as safe. However, there are potentially harmful excipients for vulnerable group of patients, such as children younger than 4 years of age.
Aim and objectives We aimed to assess exposure to potentially harmful excipients for children younger than 4 years and determine if the amount exceeds the acceptable daily intake (ADI) in these patients.
Material and methods A retrospective descriptive study was conducted in neonates and children younger than 4 years of age who received oral medicines during a period of 1 year. According to the literature, propylparaben, propylene glycol, sodium benzoate, sorbitol, ethanol and sulphites were considered as potentially harmful excipients (PHE) for paediatric and neonatal patients. The estimated ADI of each excipient was also established from the literature. The different oral drugs and the total dose received was collected. The information about the amount of studied excipients was not available in the data sheet, so it was necessary for it to be provided by the pharmaceuticals laboratories. Pharmaceutical composition, vaccines and enteral diets were excluded.
Results A total of 609 patients who received 98 different drugs were included. We found that 28.6% (28) of drugs contained at least one excipient studied and 26% of patients were exposed to PHE. We observed that 9 drugs included had sorbitol, 8 had propylparaben, 7 sodium benzoate, 7 propylene glycol, 4 ethanol and 1 had sulphites.
The ADI was exceeded in 26 cases of the 158 patients that had been exposed to PHE. According to these results, the ADI of sodium benzoate was exceeded in 34.6% of patients, sorbitol in 34.6%, sulphites in 11.5%, ethanol in 11.5% and propylene glycol in 7.6%. Propylparaben ADI was not exceeded in any case.
The ADI was exceeded in six drugs of the total products analysed: calcium phosphate solution, potassium bicarbonate tablets, rifampicin suspension, domperidone suspension, clonazepam and diazepam solution.
Conclusion and relevance The percentage of patients who exceeded the ADI of the PHE was low, although the ADI should not be exceeded in any case. Quantitative information about excipients should be available to health professionals in order to take into account excipient issues when selecting medicines for this vulnerable group.
References and/or acknowledgements No conflict of interest.
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