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Pregabalin-containing high-swelling controlled release triple tablets

机译:含普瑞巴林的高膨胀控释三联片剂

摘要

A controlled release triple tablet containing pregabalin suitable for once daily administration is disclosed. A multilayer tablet according to the present invention is a multilayer tablet comprising pregabalin or a pharmaceutically acceptable salt thereof as a main component, which comprises an upper layer and a lower layer containing a swellable polymer, and a medium transfer agent. And an intermediate layer disposed between the upper layer and the lower layer, wherein the multilayer tablet swells to 250% or more of the initial volume when 2 hours have elapsed since contact with a water-soluble medium . In addition, the method for producing a multilayer tablet according to the present invention comprises: (i) a mixture of upper and lower layers comprising a mixture of pregabalin or a pharmaceutically acceptable salt thereof and a swellable polymer, or granules obtained by granulating the mixture. Manufacturing a tablet, and (ii) manufacturing a tablet for an intermediate layer comprising a mixture of pregabalin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable salt thereof and a vehicle transfer agent, or granules obtained by granulating the mixture. And (iii) tableting the tableted product in the step (i) and the tableted product in the step (ii) to produce a triple tablet. [Selected figure] Figure 3
机译:公开了一种含有普瑞巴林的控释三重片剂,适用于每日一次给药。根据本发明的多层片剂是包含普瑞巴林或其药学上可接受的盐作为主要成分的多层片剂,其包含上层和下层,所述上层和下层包含可溶胀的聚合物以及介质转移剂。以及设置在上层和下层之间的中间层,其中当自与水溶性介质接触以来经过2小时时,多层片剂溶胀至初始体积的250%或更多。另外,根据本发明的多层片剂的生产方法包括:(i)上层和下层的混合物,所述上层和下层包含普瑞巴林或其药学上可接受的盐和可溶胀聚合物的混合物,或通过将所述混合物制粒而获得的颗粒。 。制造片剂,和(ii)制造用于中间层的片剂,该中间层包含普瑞巴林或其药学上可接受的盐和其药学上可接受的盐与媒介物转移剂的混合物,或通过将混合物制粒获得的颗粒。并且(iii)将步骤(i)中的片剂产品压片并且将步骤(ii)中的片剂产品压片以制备三重片剂。 [选定图]图3

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