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The use of ethanol in paediatric formulations in New Zealand
Darren Svirskis1, Meiyen Toh, Sanyogita Ram
1School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. d.svirskis@auckland.ac.nz
Insights
Ethanol is present in many children's liquid medicines in New Zealand, with concerningly high concentrations in some. Clearer labelling is needed globally to ensure safe medicine choices for pediatric patients.
Area of Science:
- Pharmaceutical Science
- Paediatric Medicine
- Public Health
Background:
- Ethanol is commonly used in paediatric liquid medicines as a solvent and preservative.
- Safety concerns exist regarding both acute and chronic ethanol exposure in children.
- Cultural and religious factors may preclude ethanol use for some families.
Purpose of the Study:
- To investigate the availability of ethanol-containing medicines for paediatric use in New Zealand.
- To compare findings with international guidelines on ethanol in paediatric medicines.
Main Methods:
- Identification of paediatric liquid medicines available in New Zealand.
- Analysis of ethanol content in identified medicinal products.
Main Results:
- Forty-seven paediatric liquid medicines containing ethanol were identified.
- Ethanol concentrations ranged from 0.6% to 76% v/v.
- Some medicines, like digoxin (10.1-11.4% v/v ethanol), are used in neonates.
Conclusions:
- Stricter guidance is necessary to reduce ethanol use in paediatric medicines, both in New Zealand and globally.
- Full disclosure of ethanol presence and concentration on labels is crucial for informed decision-making by healthcare professionals and patients.
Unlabelled:
Children's right to access safe and effective medicines is recognised globally. Ethanol, used in paediatric liquid formulations as a solvent and preservative, is associated with safety concerns with respect to both acute ingestion and chronic exposure. In addition, families may have cultural or religious values making ethanol use inappropriate when alternatives are available. International guidelines aim to reduce, and if possible eliminate, the use of ethanol in paediatric medicines. Guidelines on labelling vary globally, limiting the ability of health professionals and patients to make informed decisions on appropriate medicines. This study aimed to explore the availability of ethanol-containing medicines for use in the paediatric population in New Zealand and to discuss findings alongside international guidelines. Forty-seven paediatric liquid medicines were identified containing ethanol. The ethanol concentration could be determined in 35 of these medicines and ranged from 0.6 % v/v to an alarming 76 % v/v ethanol. If recommended dosing instructions are followed, the ethanol consumed per dose is not expected to cause acute toxic effects. The medicines identified are indicated for both acute and chronic use, including digoxin (10.1-11.4 % v/v ethanol) which is used in patients of all ages, including preterm neonates.
Conclusion:
Stronger guidance should be provided to reduce the use of ethanol in paediatric medicines, in New Zealand and globally. If ethanol is used, full disclosure of its presence and concentration on the product label is essential to enable prescribers and patients to make informed decisions on the most suitable pharmaceutical formulations.
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Ethers from Alcohols: Alcohol Dehydration and Williamson Ether Synthesis
Ethers can be prepared from organic compounds by various methods. Some of them are discussed below,
Preparation of Ethers by Alcohol Dehydration
In this method, in the presence of protic acids, alcohol dehydrates to produce alkenes and ethers under different conditions. For example, in the presence of sulphuric acid, dehydration of ethanol at 413 K yields ethoxyethane, whereas it yields ethene at 443 K.

