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Formulation, stability testing, and analytical characterization of melatonin-based preparation for clinical trial
Samira Filali1,2, Charlotte Bergamelli1, Mamadou Lamine Tall1
1Service pharmaceutique, Plateforme FRIPHARM, Groupement Hospitalier Edouard Herriot, 5 Place d'Arsonval, F-69437 Lyon Cedex 03, France.
Journal of Pharmaceutical Analysis
|February 7, 2018
Summary
This study developed stable, low-dose melatonin capsules for children with autism, demonstrating their quality and suitability for clinical trials. Melatonin hard capsules proved stable for 18 months, aiding pediatric sleep disorder treatment.
Area of Science:
- Pharmaceutical Sciences
- Pediatric Medicine
- Neuroscience
Background:
- Sleep disorders are common in children with autism spectrum disorder (ASD).
- Melatonin is a potential treatment, but low-dose formulations for pediatric use require careful preparation and stability assessment.
- Clinical trials necessitate reliable methods for quality control of pharmaceutical preparations.
Purpose of the Study:
- To prepare and characterize low-dose melatonin hard capsules for pediatric use.
- To validate analytical methods for quality control, including mass uniformity and content analysis.
- To conduct a stability study to establish a use-by-date for the melatonin capsules.
Main Methods:
- Preparation of melatonin hard capsules (0.5 mg, 2 mg, 6 mg) with microcrystalline cellulose.
- Quality control using mass uniformity, attenuated total reflectance Fourier transformed infrared (ATR-FTIR) spectroscopy, and high-performance liquid chromatography (HPLC).
- Forced degradation studies and stability testing according to European Pharmacopoeia standards over 18 months.
Main Results:
- Manual preparation yielded hard capsules with validated mass uniformity.
- ATR-FTIR effectively identified and quantified melatonin and excipients.
- HPLC analysis showed high absolute melatonin content (93.6%±4.1% for 0.5 mg, 98.7%±6.9% for 6 mg).
- Melatonin capsules demonstrated good stability over 18 months, meeting dissolution and stability requirements.
- Forced degradation studies confirmed method capability with a low risk of false negatives.
Conclusions:
- Low-dose melatonin hard capsules for pediatric use can be reliably prepared and are stable for at least 18 months.
- ATR-FTIR is a viable alternative to HPLC for quality control of melatonin capsules.
- The developed formulation and quality control methods support the use of melatonin in clinical trials for children with autism and sleep disorders.
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