Solid pharmaceutical composition for buccal administration of agomelatine

    公开(公告)号:NZ601713A

    公开(公告)日:2014-01-31

    申请号:NZ60171312

    申请日:2012-08-08

    Applicant: SERVIER LAB

    Abstract: ABSTRACT - 601713 The disclosure relates to a solid buccal pharmaceutical composition intended for systemic action, which is a tablet to be sucked, a pastille to be sucked, a lozenge to be sucked, or a solid obtained by hot-melt extrusion or injection-moulding, comprising agomelatine or one of its hydrates, complexes, co-crystals, crystalline forms, addition salts with a pharmaceutically acceptable acid or base, and one or more excipients selected from diluents, binders, flow agents, lubricants, coating agents, plasticisers, flavourings, counter-irritants and sweeteners, characterised in that it makes it possible to obtain a release time of the active ingredient comprised between 3 and 30 minutes and an absolute bioavailability greater than 25%. These compositions have a slow erosion release of agomelatine and are suitable for the treatment of major depression, seasonal affective disorder, generalized anxiety disorder, obsessional compulsive disorder, bipolar disorders, sleep disorders, cardiovascular pathologies, pathologies of the digestive system, insomnia and fatigue due to jet-lag, appetite disorders and obesity, and any pathology associated with deregulation of circadian rhythms.

    3.
    发明专利
    未知

    公开(公告)号:BR102012020320A2

    公开(公告)日:2013-10-29

    申请号:BR102012020320

    申请日:2012-08-09

    Applicant: SERVIER LAB

    Abstract: Solid oral composition comprises agomelatine or its hydrate, complexes, co-crystals, crystalline forms, addition salts with an acid or a base, and one or more excipients comprising diluents, binders, flowing agents, lubricants, coating agents, plasticizers, flavors, anti-irritants or sweeteners, where the composition has: an absolute bioavailability of greater than 25%; and a bioavailability greater than that obtained for an orodispersible tablet with an oromucosal absorption containing the active principle agomelatine under the same form and at the same dosage. ACTIVITY : Antidepressant; Tranquilizer; Neuroleptic; Hypnotic; Cardiovascular-Gen.; Gastrointestinal-Gen.; CNS-Gen.; Muscular-Gen.; Anorectic. MECHANISM OF ACTION : None given.

    COMPOSICION FARMACEUTICA ORODISPERSABLE DE AGOMELATINA PARA ADMINISTRACION OROMUCOSAL O SUBLINGUAL

    公开(公告)号:PE20071030A1

    公开(公告)日:2007-11-17

    申请号:PE2006001582

    申请日:2006-12-11

    Applicant: SERVIER LAB

    Abstract: REFERIDA A UNA COMPOSICION FARMACEUTICA SOLIDA RECUBIERTA ORODISPERSABLE DE N-[2-(7-METOXI-1-NAFTIL)ETIL]ACETAMIDA (AGOMELATINA) QUE COMPRENDE a) UN NUCLEO CENTRAL O UNA CAPA CENTRAL CONTENIENDO AGOMELATINA Y EXCIPIENTES Y b) UNA CUBIERTA ORODISPENSABLE, DONDE LA AGOMELATINA SE ENCUENTRA ENTRE 0,2% A 5% DE PESO DE AGOMELATINA EN RELACION AL PESO TOTAL DE LA COMPOSICION. LA AGOMELATINA ES OBTENIDA COMO FORMA CRISTALINA II; EL NUCLEO O CAPA CENTRAL COMPRENDE UN DILUYENTE TAL COMO LACTOSA Y ALMIDON, Y UN AGENTE DESINTEGRANTE. LA CUBIERTA ORODISPERSABLE COMPRENDE UN AGENTE DESENSIBILIZANTE TAL COMO EL ACIDO CITRICO. TAMBIEN ESTA REFERIDA A UN PROCEDIMIENTO DE PREPARACION COMPRENDIDO POR LA MEZCLA DE LOS CONSTITUYENTES DEL NUCLEO Y LUEGO LA COMPRESION DIRECTA DE LOS MISMOS, LUEGO LOS CONSTITUYENTES DE LA CAPA DE COBERTURA SON MEZCLADOS Y LA COBERTURA SE REALIZA POR COMPRESION ALREDEDOR DE LOS NUCLEOS. DICHA COMPOSICION SE PUEDE ADMINISTRAR POR VIA ORAL, OROMUCOSAL O VIA SUBLINGUAL

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