PROCESSO PARA O FABRICO DE UMA PREPARACAO DE TRAMADOL DE LIBERTACAO SUSTENTADA COM UM PERFIL DE LIBERTACAO ESTAVEL EM ARMAZENAMENTO SEM CURA DO PRODUTO REVESTIDO

摘要

Production of an orally administered retard preparation containing tramadol (I) (or its salt) involves forming a coating with an aqueous ethyl cellulose (EC) dispersion containing at least one lipophilic diester plasticizer (II) (derived from a 6-40C aliphatic or aromatic dicarboxylic acid and a 1-8C aliphatic alcohol) and drying the coating at the usual temperature. This gives a storage-stable release profile, and release is optionally accelerated (without affecting the stability of the profile) by tempering above 35 degrees C. An Independent claim is included for a preparation obtained by the process, having a coalescent EC coating.