Sustained release formulation containing dfmo

Details Sustained release formulation containing dfmo Sustained release formulation containing dfmo

A - Human Necessities

61

K

A61K 31/195 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 9/24 (2006.01) A61K 9/28 (2006.01) A61K 9/50 (2006.01) A61K 9/52 (2006.01) A61K 31/198 (2006.01)

Patent

CA 2241896

Preparations comprising a capsule, tablet or other dosage form containing a core of different types of DFMO are provided. These preparations are capable of providing for the direct and constant delivery of DFMO to the entire GI tract or just the colon and rectum. The DFMO-containing granules include granules specially formulated to achieve rapid DFMO release, and granules formulated to achieve slower DFMO release and/or granules formulated for gastric, enteric or colorectal release. Methods of using the preparations to flood the GI tract with relatively constant levels of DFMO may thus be provided. The ratio of the (+) to the (-)-enantiomeric forms of DFMO in the granules will be controlled so as to enhance the pharmacological profile and reduce toxicity of the preparation relative to racemic DFMO. Preparations and methods for achieving systemic delivery as well as direct colon delivery of DFMO are also described.

L'invention concerne des préparations comprenant une gélule, un comprimé ou une autre forme galénique contenant un noyau de différents types de DFMO. Ces préparations permettent l'apport direct et constant de DFMO à la totalité du tractus digestif ou bien uniquement au côlon et au rectum. Les granules contenant de la DFMO englobent des granules spécialement formulés pour assurer une libération rapide de DFMO, et des granules formulés pour assurer une libération plus lente de DFMO et/ou des granules formulés en vue d'une libération gastrique, entérique ou colo-rectale. Il est ainsi possible de proposer des méthodes d'utilisation de ces préparations pour inonder le tractus digestif de concentrations relativement constantes de DFMO. Le rapport des formes énantiomériques (+) aux formes énantiomériques (-) de DFMO dans les granules va être modulé de manière à améliorer le profil pharmacologique et réduire la toxicité de la préparation par rapport à la DFMO racémique. L'invention concerne également des préparations et des méthodes pour assurer l'apport systémique ainsi que l'apport direct au côlon de DFMO.

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