Mazindol ir/sr multilayer tablet and its use for the treatment of attention deficit/hyperactivity disorder (adhd)

Abstract

The present invention relates to a modified-release composition of mazindol and its use in the treatment of attention deficit disorders (ADD) or attention deficit/hyperactivity disorder (ADHD) or related deficit of alertness (i.e., incoercible sleepiness) or decline of vigilance (i.e., daytime somnolence) or excessive daytime sleepiness (e.g., narcolepsy, idiopathic hypersomnia) in particular in children, adolescents and adults.

1 . A mazindol oral pharmaceutical unit dosage form in the form of a multilayer matrix-type tablet comprising:
 at least one immediate-release (IR) layer comprising mazindol and at least one diluent,   at least one sustained-release (SR) layer comprising mazindol and at least one sustained-release, pH-independent and water-insoluble polymer,   for a total amount of mazindol comprised between 1 and 6 mg and a ratio in weight between the IR layers and the SR layers comprised between 40:60 and 80-20 preferably between 50:50 and 70:30, more preferably of 50:50.   
     
     
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