12. April 2017

Abstract A new institutional clinical trial assessed the improvement of sleep disorders in 40 children with autism treated by immediate release melatonin formulation in different regimens (0.5 mg, 2 mg, and 6 mg daily) for one month. The objectives of present study were to (i) prepare low dose melatonin hard capsules for pediatric use controlled by two complementary methods and (ii) carry out a stability study in order to determine an use-by-date. Validation of preparation process was claimed...