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Presence of Potentially Harmful Alcohol Excipients in Paediatric Medicine Dispensed in Nairobi

Author: Maureen W Chege , Sylvia A Opanga
Is Part Of: Pharmaceutical Journal of Kenya, Volume 23, No. 4 (2018)
Background: Alcohol, as an excipient in pharmaceutical preparations, serves as a preservative and solvent. It is commonly found in oral and topical formulations, elixirs and spirits. Although it has been widely used in paediatric formulations, its safety in children has not been well characterized though toxicity has been reported.
Objective: The aim of the study was to document the presence and content of alcohol excipients in paediatric drug products dispensed in pharmacies in Nairobi.
Method: A cross sectional study was conducted at seven randomly selected pharmacies in Nairobi. The investigators selected all paediatric products and perused their packages, labels and package inserts for information on presence of alcohol, content, type of alcohol excipients and recommendations for use. The data was entered into Microsoft Excel 2010 worksheet, and descriptively analysed.
Results: Out of 290 products sampled, 87 (30%) were found to have alcohol excipients. Ethanol was the most common type of excipient (46.0%), followed by propylene glycol (27.6%). Syrups had the highest number of products with alcohol (58.6%). Antihistamines recorded the highest number of products with alcohol (39.1%). Most of the products with alcohol were over the counter drugs (79.3%). Of the drugs that contained alcohol, 53% (n=46) were not recommended for use by patients less than 6 years of age. The daily dose of alcohol in the drug with the highest alcohol content was equivalent to 28.8 ml of beer.
Conclusion: Over the counter drugs had more products containing alcohol than the prescription only drugs. Ethanol and propylene glycol were the most commonly used excipients. The propylene glycol content was not stated in all its products. The highest amount of alcohol per daily dose of drugs was equivalent to 28.8 ml of beer. Nearly half of the products were not recommended for children less than 6 years old.

Keywords: Paediatric medicine, Alcohol, Ethanol, Excipient, Propylene glycol
Publisher: The Pharmaceutical Society of Kenya
ISSN: 2411-6386