Matrix mesalamine extended release minitablets and its process thereof

    公开(公告)号:US11975011B2

    公开(公告)日:2024-05-07

    申请号:US17517353

    申请日:2021-11-02

    摘要: Compositions for development of matrix type extended release mesalamine minitablets without use of any modified release coating, comprising a) mesalamine or its prodrug or derivatives thereof having a weight percentage in a range of 65-85 weight percentage with respect to the composition; b) at least one intragranular excipient having a weight percentage in a range of 3.5-22.5 weight percentage with respect to the composition; c) at least one binder having a weight percentage in a range of 2-6.5 weight percent with respect to the composition; and d) at least one extra granular excipient having a weight percentage in a range of 2-5 weight percentage with respect to the composition such that largest dimension in the minitablet is range of 1.00 mm to 2.8 mm. In another aspect of the present disclosure provides for a process of preparation of composition.

    ENTERIC COATED TABLET
    6.
    发明公开

    公开(公告)号:US20230372250A1

    公开(公告)日:2023-11-23

    申请号:US18363001

    申请日:2023-08-01

    发明人: Akio RYU Miyako OSADA

    IPC分类号: A61K9/28 A61K31/606

    摘要: To provide an enteric coated tablet containing a large amount of medicinal ingredient and having sufficient impact resistance, without forming a thick enteric coating layer.
    The enteric coated tablet contains (A) a core tablet containing a medicinal ingredient and having a weight of 1,000 mg or more; (B) a coating layer containing a water-soluble polymer applied onto the surface of the core tablet; and (C) an enteric coating layer dissolving at pH 7 or higher which is applied onto the surface of the coating layer containing a water-soluble polymer, wherein the sum of the polymer amount of the coating layer (B) and the polymer amount of the coating layer (C) is 10 to 18 mg/cm2, the polymer amount of the coating layer (B) is 6 to 12 mg/cm2, and the polymer amount of the coating layer (C) is 3 to 6 mg/cm2.