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    • 4. 发明授权
    • Tablet excipient
    • 片剂赋形剂
    • US08871270B2
    • 2014-10-28
    • US10888360
    • 2004-07-09
    • Yeli ZhangChaodong XiaoWolfgang BindzusVincent Green
    • Yeli ZhangChaodong XiaoWolfgang BindzusVincent Green
    • A61K9/14A61K47/36A61K9/20
    • A61K47/36A61K9/2059H01L27/3276H01L51/524H01L51/5246
    • This invention relates to a composition comprising physically modified, partially pregelatinized starch, which is useful as a multi-functional excipient for solid dosage forms, a method of making such composition, and solid dosage forms prepared using the composition. Such composition is characterized by a predominance of particles having both birefringent and non-birefringent portions, a sedimentation volume of between 1.5 and 9 ml/g, and a cold water solubility of between 1 and 8%. This free-flowing starch may have an average particle size greater than 30 μm, and a moisture content of between 5 and 12% by weight. The 500 mg placebo tablet prepared from such composition at 13 kN using a manual tablet press equipped with a 1.11 cm ( 7/16″) standard concave punches has a crushing strength of at least 160 Newtons, and a disintegration time of no more than 10 minutes.
    • 本发明涉及包含物理修饰的部分预胶化淀粉的组合物,其可用作固体剂型的多功能赋形剂,制备该组合物的方法,以及使用该组合物制备的固体剂型。 这种组合物的特征在于具有双折射和非双折射部分的颗粒,沉淀体积为1.5至9ml / g,冷水溶解度为1至8%的颗粒为主。 这种自由流动的淀粉可以具有大于30μm的平均粒度和5至12重量%的水分含量。 使用配备有1.11cm(7/16“)标准凹形冲头的手动压片机以13kN由这种组合物制备的500mg安慰剂片具有至少160牛顿的破碎强度,并且崩解时间不超过10 分钟。
    • 5. 发明申请
    • Tablet excipient
    • 片剂赋形剂
    • US20060008521A1
    • 2006-01-12
    • US10888360
    • 2004-07-09
    • Yeli ZhangChaodong XiaoWolfgang BindzusVincent Green
    • Yeli ZhangChaodong XiaoWolfgang BindzusVincent Green
    • A61K9/20
    • A61K47/36A61K9/2059H01L27/3276H01L51/524H01L51/5246
    • This invention relates to a composition comprising physically modified, partially pregelatinized starch, which is useful as a multi-functional excipient for solid dosage forms, a method of making such composition, and solid dosage forms prepared using the composition. Such composition is characterized by a predominance of particles having both birefringent and non-birefringent portions, a sedimentation volume of between 1.5 and 9 ml/g, and a cold water solubility of between 1 and 8%. This free-flowing starch may have an average particle size greater than 30 μm, and a moisture content of between 5 and 12% by weight. The 500 mg placebo tablet prepared from such composition at 13 kN using a manual tablet press equipped with a 1.11 cm ( 7/16″) standard concave punches has a crushing strength of at least 160 Newtons, and a disintegration time of no more than 10 minutes.
    • 本发明涉及包含物理修饰的部分预胶化淀粉的组合物,其可用作固体剂型的多功能赋形剂,制备该组合物的方法,以及使用该组合物制备的固体剂型。 这种组合物的特征在于具有双折射和非双折射部分的颗粒,沉淀体积为1.5至9ml / g,冷水溶解度为1至8%的颗粒为主。 这种自由流动的淀粉可以具有大于30μm的平均粒度,并且水分含量在5至12重量%之间。 使用配备有1.11cm(7/16“)标准凹形冲头的手动压片机,以13kN由这种组合物制备的500mg安慰剂片具有至少160牛顿的破碎强度,并且崩解时间不超过 10分钟。