Method for drug formulation and a pharmaceutical composition
    62.
    发明授权
    Method for drug formulation and a pharmaceutical composition 失效
    药物制剂的方法和药物组合物

    公开(公告)号:US5476667A

    公开(公告)日:1995-12-19

    申请号:US39175

    申请日:1993-04-16

    CPC分类号: A61K9/1641 A61K9/1694

    摘要: A melt granulating method for the production of pellets (spheres) which contain a therapeutically active substance of high-dosage type. The method is characterized by: (i) mechanically working a mixture which contains (a) the active substance in cohesive form and (b) a binder (melting point 40.degree. C.-100.degree. C.) while supplying sufficient energy for the binder to melt and to form spherical overwetted pellets; (ii) adding further cohesive substance, while maintaining the mechanical working; (iii) interrupting the mechanical working and supply of energy and cohesive substance when the desired mean particle size of dry pellets (spheres) has been achieved; and (iv) removing the smallest and largest particles and dividing the remaining pellets into dosage batches. A novel pharmaceutical composition containing a dosage of 300-500 mg of pellets is obtainable from this process.

    摘要翻译: PCT No.PCT / SE91 / 00690 Sec。 371日期:1993年04月16日 102(e)日期1993年4月16日PCT 1991年10月15日PCT PCT。 公开号WO92 / 06679 日期:1992年4月30日。一种用于生产含有高剂量治疗活性物质的丸粒(球)的熔体造粒方法。 该方法的特征在于:(i)机械加工包含(a)活性物质以粘结形式和(b)粘合剂(熔点为40℃-100℃)的混合物,同时为粘合剂提供足够的能量 熔化并形成球形过湿颗粒; (ii)在保持机械加工的同时加入更多的粘性物质; (iii)当达到所需的干颗粒(球体)平均颗粒尺寸时,中断机械加工和能量供应和粘性物质; 和(iv)除去最小和最大的颗粒,并将剩余的颗粒分成剂量批料。 从该方法可获得含有300-500mg粒料剂量的新型药物组合物。