COMPOSITION COMPRISING A (METH)ACRYLATE COPOLYMER, AN ALKALI OR AMMONIUM SALT OF A SATURATED ALIPHATIC MONOCARBOXYLIC ACID AND SPECIFIC GLIDANTS

The invention refers to a composition, suitable as coating or binding agent for pharmaceutically, nutraceutically or cosmetically active ingredients, comprising the following components: a) at least one (meth)acrylate copolymer a), comprising polymerized units of 5 to 25 % by weight of methacrylic a...

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Hauptverfasser: NIEPOTH Peter, ROTH Erna, GÜTTLER Lisa, ENGEL Andrea, KLOSENDORF Andreas
Format: Patent
Sprache:eng ; spa
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Zusammenfassung:The invention refers to a composition, suitable as coating or binding agent for pharmaceutically, nutraceutically or cosmetically active ingredients, comprising the following components: a) at least one (meth)acrylate copolymer a), comprising polymerized units of 5 to 25 % by weight of methacrylic acid and 75 to 95 % by weight of C1- to C4-alkylesters of methacrylic acid and/or C1- to C4-alkylesters of acrylic acid, and b) 1 to 25 % by weight, based on the total weight of at least one (meth)acrylate copolymer a), of an alkali or ammonium salt of a saturated aliphatic monocarboxylic acid having 10 to 30 carbon atoms, and c) or d) or both c) and d) c) 2 to 25 % by weight, based on the total weight of a), of at least one compound selected from glyceryl tristearate, hydroxypropyl methylcellulose, glyceryl behenate, and glyceryl monostearate and/or d) 25 to 90 % by weight, based on the total weight of a), of at least one compound selected from talc, rice hulls in powder form, magnesium stearate, corn starch, and microcrystalline cellulose. Furthermore, the present invention refers to an aqueous dispersion, comprising water and 5 to 50 % by weight of the composition according to the present invention as well as a dosage form, comprising a pharmaceutically, nutraceutically or cosmetically active ingredient and a polymeric coating or a polymeric matrix, wherein the polymeric coating or the polymeric matrix comprises the composition according to the present invention. Finally, the present invention pertains to the use of a composition according to the present invention as a coating or binding agent for pharmaceutically, nutraceutically or cosmetically active ingredients. La invención se refiere a una composición, adecuada como agente de recubrimiento o aglutinante de ingredientes farmacéutica, nutracéutica o cosméticamente activos, que comprende los siguientes componentes: a) al menos un copolímero de (met)acrilato a), que comprende unidades polimerizadas del 5 al 25 % en peso de ácido metacrílico y del 75 al 95 % en peso de ésteres alquílicos C1 a C4 de ácido metacrílico y/o alquilésteres C1 a C4 del ácido acrílico, y b) del 1 al 25 % en peso, basado en el peso total de al menos un copolímero de (met)acrilato a), de una sal alcalina o amónica de un ácido monocarboxílico alifático saturado que tiene 10 a 30 átomos de carbono, y c) o d) o ambos c) y d) c) del 2 al 25 % en peso, basado en el peso total de a), de al menos un compuesto seleccionado entre triestearato d