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    • 1. 发明申请
    • A METHOD OF PRODUCING FAST DISSOLVING TABLETS
    • 生产快速溶解片的方法
    • WO2008120181A2
    • 2008-10-09
    • PCT/IE2008/000036
    • 2008-04-03
    • ROYAL COLLEGE OF SURGEONS IN IRELANDRAMTOOLA, ZebunnissaPABARI, RiteshKELLY, John
    • RAMTOOLA, ZebunnissaPABARI, RiteshKELLY, John
    • A61K9/00A61K9/20
    • A61K9/2018A61K9/0056A61K9/1635A61K9/2009A61K9/2013A61K9/2027A61K9/2054A61K9/2081A61K9/2095A61K9/5026
    • A method of producing a fast-melt tablet comprises the steps of forming a mixture of components, the mixture comprising at least one fast dissolving sugar alcohol, at least one disintegrant or osmotic agent, and at least one an active component, blending the mixture for a period of time, and directly compressing the blended mixture at a compression force of typically between 5 and 2OkN to form the fast-melt tablet. The process of the invention does not involve any granulation step, thereby making the process more energy efficient and cost effective. The fast dissolving sugar alcohol is selected from the group comprising: mannitol; sorbitol; erythritol; xylitol; lactose; dextrose; and sucrose, and comprises at least 50%, preferably at least 60%, and more preferably at least 70%, of the tablet (w/w). The active component is suitably provided in the form of microparticles or microcapsules having an average diameter of less than 125 microns. Also described are directly compressed fast dissolving type tablets obtainable by the process of the invention. The tablets typically are flat-faced.
    • 制备快速熔融片剂的方法包括以下步骤:形成组分的混合物,所述混合物包含至少一种快速溶解糖醇,至少一种崩解剂或渗透剂和至少一种活性组分,将该混合物混合 一段时间,并以通常在5至20kN之间的压缩力直接压缩混合的混合物以形成快速熔融的片剂。 本发明的方法不涉及任何造粒步骤,从而使得该方法更节能和成本有效。 快溶糖醇选自:甘露醇; 山梨糖醇; 赤藓糖醇; 木糖醇; 乳糖; 葡萄糖; 和蔗糖,并且包含片剂(w / w)的至少50%,优选至少60%,更优选至少70%。 活性组分合适地以平均直径小于125微米的微粒或微胶囊的形式提供。 还描述了通过本发明的方法可获得的直接压缩的快速溶解型片剂。 平板电脑通常是平面的。