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Administration of melatonin mixed with soft food and liquids for children with neurodevelopmental difficulties
1Department of Pharmaceutics, The School of Pharmacy, University of London, London, UK.
Insights
Melatonin capsules can be safely mixed with various foods and drinks for children. This study confirms melatonin stability in common vehicles for up to 6 hours, ensuring reliable medication for pediatric neurodevelopmental disorders.
Area of Science:
- Pharmacology and Pharmaceutical Sciences
- Pediatric Medicine
- Neurodevelopmental Disorders
Background:
- Children often struggle to swallow medication capsules, necessitating alternative administration methods.
- Melatonin is frequently used in pediatric populations, particularly for sleep disturbances associated with neurodevelopmental disorders.
- Ensuring medication stability when mixed with food or drink is crucial for accurate dosing and therapeutic efficacy.
Purpose of the Study:
- To assess the compatibility and short-term stability of melatonin capsules when mixed with common foods and liquids.
- To develop and validate analytical methods for quantifying melatonin and its degradation products in various administration vehicles.
- To determine if mixing melatonin capsules with specified vehicles compromises drug integrity for up to 6 hours.
Main Methods:
- Melatonin capsules were mixed with water, orange juice, semi-skimmed milk, strawberry yogurt, and strawberry jam.
- Extraction of melatonin from these mixtures was performed, followed by analysis using a validated analytical assay.
- Stability was assessed by monitoring for drug degradation over a 6-hour period at room temperature.
Main Results:
- High recovery rates of melatonin were achieved from all tested administration vehicles, ranging from 89% to 111%.
- Melatonin demonstrated excellent stability in water, orange juice, milk, yogurt, and jam for up to 6 hours.
- No significant degradation peaks of melatonin were observed in any of the tested mixtures within the 6-hour timeframe.
Conclusions:
- Melatonin capsules are compatible with a range of common liquids and foodstuffs, allowing for flexible administration in children.
- The stability of melatonin in these vehicles ensures that its therapeutic efficacy is maintained for at least 6 hours.
- These findings support the use of mixed melatonin in pediatric trials, such as the Use of Melatonin in Children with Neurodevelopmental Disorders and Impaired Sleep study, without compromising drug integrity.
Abstract:
It is sometimes necessary for the contents of medication capsules to be mixed with certain foods and drinks because children are not always able to swallow the capsules. The compatibility and short-term stability (6h) of melatonin capsules mixed in a variety of liquids and foodstuffs (water, orange juice, semi-skimmed milk, strawberry yogurt, and strawberry jam) were analyzed for degradation. Extraction of melatonin from these common administration vehicles and an analytical assay for the drug and its potential degradation products were developed and validated. The results showed good recovery of melatonin from low- and high-strength capsules for all administration vehicles (between 89% minimum and 111% maximum). The drug was found to be stable in the common liquids and foods tested for up to 6 hours at room temperature (no degradation peak); hence it is unlikely to compromise the results of the Use of Melatonin in Children with Neurodevelopmental Disorders and Impaired Sleep trial.
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