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Use of Polymer Mixtures For the Production of Coated Pharmaceutical Formulations and Pharmaceutical Formulation With Mixed Polymeric Coating

机译:聚合物混合物用于制备包衣药物制剂和具有混合聚合物包衣的药物制剂的用途

摘要

The invention relates to the use of mixture of 2 to 60 wt. % of one or more polymers (I) with 40 to 98 wt. % of one or more polymers (II), whereby the polymer (I) is a (meth)acrylate copolymer, containing 90 to 100 wt. % radically polymerised of 40 to 95 wt. % of C1 to C4 alkyl esters of acrylic or methacrylic acid and 5 to 60 wt. % of units of (meth)acrylate monomers with an anionic group with 0 to 10 wt. % of further vinylic polymerisable monomers and polymer(ll) is a vinyl polymer different from polymer (I) or a polysaccharide or a derivative of a polysaccharide, containing 88 to 100 % neutral monomer units and up to 12 wt. % polymerisable monomer units with ionic groups, for production of a coated pharmaceutical formulation, containing an active agent core and a polymeric coating made from the mixture of polymers (I) and (II), characterised in that the glass temperature of polymer (I) is not more than 70° C. and an active agent release profile is achieved, whereby the agent release is delayed with relation to a pharmaceutical formulation with a coating made exclusively of polymer (I), starting with the same pH. The invention further relates to a pharmaceutical formulation with a selected polymer (I).
机译:本发明涉及2至60重量%的混合物的用途。 %的一种或多种具有40至98wt。%的聚合物(I)。 %的一种或多种聚合物(II),其中聚合物(I)是包含90至100重量%的(甲基)丙烯酸酯共聚物。 40〜95wt。%的自由基聚合%。丙烯酸或甲基丙烯酸的C 1 相对于C 4 烷基酯的百分比,以及5至60 wt。具有0至10wt。%的阴离子基团的(甲基)丙烯酸酯单体的单元的%。 %的另外的乙烯基可聚合单体和聚合物(II)是不同于聚合物(I)的乙烯基聚合物或多糖或多糖的衍生物,其包含88至100%的中性单体单元和至多12重量%。 %的具有离子基团的可聚合单体单元,用于生产包含活性剂核心和由聚合物(I)和(II)的混合物制成的聚合物涂层的包衣药物制剂,其特征在于聚合物(I)的玻璃温度相对于具有仅由聚合物(I)制成的涂层的药物制剂,从相同的pH开始,不超过70℃且实现了活性剂释放曲线,从而相对于药物制剂延迟了药物释放。本发明进一步涉及具有选择的聚合物(I)的药物制剂。

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