PREGABALIN SUSTAINED RELEASE COMPOSITION AND METHOD FOR PREPARING THE SAME

    公开(公告)号:US20210369621A1

    公开(公告)日:2021-12-02

    申请号:US16618756

    申请日:2019-06-12

    IPC分类号: A61K9/20 A61K31/197

    摘要: The present application relates to a pregabalin sustained release composition, comprising: (a) an active ingredient; (b) a matrix-forming agent; (c) a swelling agent; (d) a gelling agent; and optionally a filler. The pregabalin sustained release composition provided in the present application can rapidly swell in volume when exposed to aqueous medium until exceeding the diameter of human gastric pyloric (13 mm). It thereby prolongs the gastric emptying time to increase the retention time of pregabalin in the stomach and enhances absorption of pregabalin in the small intestine and ascending colon. Moreover, the pregabalin sustained release composition provided herein achieves a sustained release for 24 h, which allows QD (once a day) administration, reduces administration number, and improves patient compliance.