Pharmaceutical compositions comprising desglymidodrine as an...

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A61K 9/00 (2006.01) A61K 9/127 (2006.01) A61K 9/20 (2006.01) A61K 9/24 (2006.01) A61K 9/28 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01) A61K 9/70 (2006.01) A61K 31/137 (2006.01) A61K 47/18 (2006.01)

Patent

CA 2409950

Novel pharmaceutical compositions comprising desglymidodrine or a pharmaceutically acceptable salt thereof as an active drug substance. Desglymidodrine is the active metabolite of the prodrug midodrine. The pharmaceutical composition may be presented in a suitable dosage form for oral, parenteral, mucosal, nasal, sublingual, buccal, topical, vaginal, rectalor, ocular etc. administration. A pharmaceutical composition of the invention may be in the form of an immediate and/or modified release composition or it may be designed to release the active drug substance, desglymidodrine, in a relatively fast manner in order to enable a relatively fast onset of the therapeutical effect. The compositions have a suitable shelf- life, i.e. the desglymidodrine contained in the composition is not subject to a significant degradation under storage conditions normally acceptable for pharmaceuticals. Also disclosed is a method for treating animals such as, e.g. mammals and humans with a novel pharmaceutical composition comprising desglymidodrine. Furthermore, is disclosed a novel use of desglymidodrine in the treatment of septic shock and to a method for treating mammals (e.g. humans) suffering from septic shock with a sufficient amount of desglymidodrine.

Nouvelles compositions pharmaceutiques comprenant du desglymidodrine ou un sel pharmaceutiquement acceptable de celui-ci en tant que substance médicamenteuse active. Le desglymidodrine est un métabolite actif du promédicament midodrine. La composition pharmaceutique peut se présenter selon une posologie acceptable pour l'administration orale, parentérale, mucosale, nasale, sublinguale, buccale, topique, vaginale, rectale, oculaire, etc. Une composition pharmaceutique de l'invention peut avoir la forme d'une composition à libération immédiate et/ou modifiée ou être destinée à libérer la substance médicamenteuse active, le desglymidodrine, de façon relativement rapide afin de permettre à l'effet thérapeutique de se manifester assez rapidement. Les compositions ont une durée de conservation appropriée, c'est-à-dire que le desglymidodrine contenu dans la composition n'est pas sujet à une dégradation sensible lors du stockage dans des conditions normalement acceptables pour les produits pharmaceutiques. L'invention concerne aussi un procédé pour traiter des animaux tels que les mammifères et les humains avec une nouvelle composition pharmaceutique comprenant du desglymidodrine. Elle concerne aussi un nouveau procédé d'utilisation du desglymidodrine dans le traitement du choc septique et un procédé pour traiter des mammifères (tels que les humains) souffrant du choc septique avec une quantité suffisante de desglymidodrine.

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