Stable pharmaceutical formulation

A - Human Necessities – 61 – K

Patent

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A61K 9/00 (2006.01)

Patent

CA 2532337

The invention concerns a pharmaceutical composition in gelatine capsule form, comprising (a) an active core composition comprising at least one pharmaceutically active compound and optionally conventional pharmaceutical adjuvants, (b) at least one quenching protective layer, positioned between said active core composition and the inner surface of the gelatine capsule shell, which comprises at least one quenching agent, the quenching agent being able to chemically bind volatile impurities initiating the cross-linking of gelatine by a substantially irreversible chemical reaction after said impurities have been released by either adjuvants and/or active compound(s) of said active core composition and (c) a gelatine capsule shell wrapping said active core composition including any adjuvant material and any quenching layer added to the active core composition. Such a composition has improved stability on storage.

L'invention concerne une composition pharmaceutique sous forme de capsules en gélatine, la composition comprenant (a) un noyau en composition active constitué d'au moins un composé pharmaceutiquement actif et d'adjuvants pharmaceutiques classiques optionnels, (b) d'au moins une couche protectrice de désactivation située entre le noyau en composition active et la surface interne de l'enveloppe de la capsule en gélatine, la couche de désactivation étant constituée d'au moins un agent désactivant susceptible de se lier chimiquement aux impuretés volatiles qui initient la réticulation croisée de la gélatine par une réaction chimique sensiblement irréversible lorsque ces impuretés sont libérées par les adjuvants et/ou par les composés actifs faisant partie du noyau constitué d'une composition active ; et (c) une enveloppe en gélatine de la capsule qui enrobe la composition active dont est constitué le noyau, y compris les adjuvants éventuels ou une couche de désactivation éventuelle ajoutée à la composition active dont est constitué le noyau. Cette composition a une stabilité accrue pendant le stockage.

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