ORODISPERSIBLE PHARMACEUTICAL COMPOSITION FOR ORAL, OROMUCOSAL OR SUB-LINGUAL ADMINISTRATION OF AGOMELATIN

摘要

A coated solid orodispersible pharmaceutical composition comprises a central core or a central layer containing agomelatine and excipients allowing the orodispersible formulation to be obtained, and an orodispersible coating. Independent claims are also included for the following: (1) preparing the composition involving mixing constituents of the core and then compressing by direct compression, and then mixing the constituents of the coating layer, where the coating is carried out by compression of the resulting powder mixture around the cores; and (2) manufacturing a coating for the coated solid orodispersible composition involving disintegrating the composition in the mouth in less than 3 minutes (preferably less than 1 minute), where citric acid is mixed with granules consisting of lactose and starch dried by co-atomization. ACTIVITY : Antidepressant; Hypnotic; Cardiovascular-Gen.; Gastrointestinal-Gen.; Muscular-Gen.; CNS-Gen.; Immunomodulator; Eating-Disorders-Gen; Anabolic; Anorectic. No biological data is given. MECHANISM OF ACTION : 5-Hydroxytryptamine-2c receptor antagonist; Melatoninergic system receptor agonist.