Optimizing pediatric melatonin therapy through semi solid extrusion of tailored dosage forms

Pediatric drug therapy lacks suitable individualized dosage forms, and semi-solid extrusion (SSE) is a promising compounding technology for producing patient-specific formulations. Melatonin was formulated in three dosage forms: CuraBlend® gel tablets (1% and 2.5% w/w), anhydrous troches (1% w/w) and orodispersible films (ODFs; 0.25% w/w). Each dosage form was produced in various sizes, giving target doses of 0.81-12.5 mg. The formulations were evaluated for content uniformity, 3-month stability and in vitro dissolution, and their solid state was characterized by differential scanning calorimetry (DSC). All printed tablets, and ODFs met pharmacopoeia requirements for mass and content uniformity, and stable assay results over three months. ODFs showed almost 100% release within 3 minutes. Melatonin formulations achieved over 70-90% drug release within 60 minutes depending on PS80 concentration, and the 2.5% melatonin formulations exceeded 90% release. 1% of melatonin in troche demonstrated complete drug release within 10 minutes. DSC showed that melatonin's melting peak at 117°C was absent in most formulations, suggesting dissolution of the drug in the excipient bases. SSE compounding platform enables the accurate, reproducible compounding of pediatric melatonin dosage forms in both development and hospital settings.