A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies

Sleep disorders in children can negatively impact their development and quality of life. While melatonin is commonly used to manage these issues, there are no FDA-approved formulations specifically designed for children, and traditional tablet forms can be challenging for these patients. This study aims to develop a patient-friendly melatonin syrup formulation suitable for personalized pediatric therapies. Each teaspoon contains 1.0 mg of melatonin, allowing for flexible and precise dosing customized to individual patient needs. Melatonin content was quantified using a reversed-phase HPLC method with UV/Visible detector (HPLC-UV/Vis) ifadesi ‘with UV/Visible detector (HPLC-UV/Vis) that was developed and validated in line with ICH Q2(R1), demonstrating selectivity, linearity (1.0–30.0 μg/mL; R²=0.999), and intra- and inter-day accuracy and precision within 2%. Stability studies demonstrated that the syrup remains stable and retains its potency for at least seven days at room temperature. This syrup formulation enhances palatability and ease of administration, potentially improving therapeutic outcomes in children with sleep disorders through personalized treatment approaches. The syrup can be easily prepared using commercially available melatonin tablets in hospital pharmacies or home settings, using safe pediatric excipients.