Formulation comprising histone deacetylase inhibitors

Details Formulation comprising histone deacetylase inhibitors Formulation comprising histone deacetylase inhibitors

A - Human Necessities

61

K

A61K 9/50 (2006.01) A61K 45/08 (2006.01)

Patent

CA 2564877

The present invention relates to an orally available galenics formulation of Valproic Acid or derivatives thereof exhibiting a specific bi-phasic pharmacokinetic profile optimized for maximum inhibition of histone deacetylases in a therapeutic setting. This specific galenics formulation is designed for the treatment of malignant diseases and diseases associated with hypoacetylation of histones or in which induction of hyperacetylation has a beneficial effect, e.g., by induction of differentiation and/or apoptosis. Due to the bi-phasic release pattern the resulting pharmacokinetic profile is able to inhibit HDAC target enzymes most efficiently and to subsequently induce histone hyperacetylation in a rapid as well as a long-lasting fashion. This profile secures the efficient modulation of a desired target gene expression profile which contributes to the therapeutic benefit.

La présente invention concerne une formulation galénique pour voie orale d'acide valproïque ou de dérivés de ce dernier, présentant un profil pharmacocinétique biphasique spécifique optimisé pour l'inhibition maximale d'histone désacétylases dans un cadre thérapeutique. Cette formulation galénique spécifique est destinée à traiter des maladies malignes et des maladies associées à l'hypoacétylation d'histones ou dans lesquelles l'induction de l'hyperacétylation a un effet bénéfique, p. ex. par induction de la différentiation et/ou de l'apoptose. Grâce au modèle de libération biphasique, le profil pharmacocinétique obtenu est capable d'inhiber des enzymes cibles HDAC de manière plus efficace et d'induire, par la suite, l'hyperacétylation d'histones d'une manière rapide et durable. Ce profil assure la modulation efficace d'un profil d'expression de gènes cibles souhaité qui contribue au bénéfice thérapeutique.

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