Pharmaceutical Composition Containing Dabigatran Etexilate And Preparation Method Thereof

    公开(公告)号:US20230310401A1

    公开(公告)日:2023-10-05

    申请号:US18207751

    申请日:2023-06-09

    IPC分类号: A61K31/4439 A61K9/16

    摘要: Disclosed is a pharmaceutical composition containing dabigatran etexilate and a preparation method thereof. The pharmaceutical composition comprises a pharmaceutically active ingredient, dabigatran etexilate and/or dabigatran etexilate mesylate, an amphiphilic polymer of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, and a hydrophilic polymer of polyoxyethylene-polyoxypropylene glycol block copolymer. The mass percentage of the active pharmaceutical ingredient in the pharmaceutical composition is 5 wt % to 60 wt %; the mass percentage of the amphiphilic polymer in the pharmaceutical composition is 3 wt % to 40 wt %; and the mass percentage of the hydrophilic polymer in the pharmaceutical composition is 10 wt % to 90 wt %. The pharmaceutical composition not only increases the bioavailability of the pharmaceutically active ingredient, but also reduces absorption variability, and provides a more stable concentration of dabigatran in plasma, thereby reducing adverse side effects.

    CONTROLLED-RELEASE SYSTEM OF ACTIVE PHARMACEUTICAL INGREDIENT AND PREPARATION METHOD THEREFOR

    公开(公告)号:US20210169811A1

    公开(公告)日:2021-06-10

    申请号:US17101706

    申请日:2020-11-23

    摘要: Disclosed are a controlled-release dosage form with an absorption window in the upper gastrointestinal tract and a preparation method therefor, wherein the controlled-release dosage form comprises a controlled-release platform and a retention platform. The controlled-release platform is a pharmaceutical composition comprising a tablet core and a coating membrane; and the retention platform holds the controlled-release platform in the oral cavity. The operation steps of the controlled-release dosage form are as follows: placing the controlled-release platform in the retention platform, and fixing the retention platform on matching teeth in the oral cavity; taking out the controlled-release dosage form after 4-24 hours and replacing same with a new controlled-release platform; and re-fixing the retention platform on the matching teeth in the oral cavity to achieve the sustained and stable release of drugs.