Extended release composition containing tramadol

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/22 (2006.01) A61K 9/50 (2006.01) A61K 31/137 (2006.01)

Patent

CA 2495463

The present invention relates to a once daily extended release pharmaceutical preparation of Tramadol or its acceptable pharmaceutical salts. The preparation provides, effective blood concentration for a period of about 24 hours with reduced peak concentrations. It is characterized that effective Tramadol levels appear within the first hours after administration, the time to maximal Tramadol content Tmax is at least 10 hours and the peak Tramadol concentration is less than three times the concentration obtained after 24 hours of said administration.

L'invention concerne une préparation pharmaceutique à libération modifiée à dose unique par jour contenant du Tramadol ou ses sels acceptables sur le plan pharmaceutique. Cette préparation procure une concentration sanguine effective sur environ 24 heures avec des pics de concentration réduits. Elle est caractérisée en ce que les taux de Tramadol effectifs se produisent dans les premières heures après l'administration, en ce que le rapport temps/teneur de Tramadol maximale T¿max? est d'au moins 10 heures, et en ce que la concentration de pointe de Tramadol est trois fois inférieure à la concentration obtenue après 24 heures de l'administration.

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