A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/20 (2006.01)
Patent
CA 2548615
Non-tabletted, individually dosed administration forms comprising a composition of at least one pharmaceutically active substance dissolved or dispersed within a matrix material comprising a mixture of at least 0,2% by weight of a gelatine, at least one stabilising agent and at least one water- soluble alcohol and/or water as a solvent, which composition is plastic at elevated temperature, characterised in that : the stabilising agent is selected from the group consisting of (i) esters of glycerine and fatty acids; (ii) products resulting from the alcoholysis / esterification reaction of such esters of glycerine and fatty acids with polyethylenglycols; and, in that the stabilising agent has a melting point in the range of 42~ C to 63~ C, in that water is present in an amount not greater than 46% by weight of the composition.
L'invention porte sur des formes posologiques individuelles masticables pas en comprimés dont la composition comporte au moins un principe actif dissous ou dispersé dans une matrice comprenant: un mélange d'au moins 0,2% en poids d'une gélatine, au moins un agent stabilisateur, et au moins un alcool hydrosoluble et/ou de l'eau comme solvant. Ladite composition, plastique aux températures élevées, se caractérise en ce que: l'agent stabilisateur est choisi parmi (i) des esters de glycérine et des acides gras, et (ii) des produits résultant de la réaction d'alcoolyse/estérification desdits esters et acides avec des polyéthylènglycols, en ce que l'agent stabilisateur présente un point de fusion compris entre 42° C et 63° C, et en ce que la teneur en eau ne dépasse pas 46% en poids de la composition.
Fabregas Vidal Jose Luis
Garcia Gonzalez Nuria
Guiro Coll Pere
Masso Carbonell Antoni
Almirall Prodesfarma Sa
Blake Cassels & Graydon Llp
Laboratorios Almirall S.a.
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