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使用反向旋转双螺杆挤出机对液体进行封装。

Encapsulation of liquids using a counter rotating twin screw extruder.

作者信息

Tackenberg Markus W, Krauss Ralph, Marmann Andreas, Thommes Markus, Schuchmann Heike P, Kleinebudde Peter

机构信息

Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Duesseldorf, Germany; Institute of Process Engineering in Life Sciences, Section I: Food Process Engineering, Karlsruhe Institute of Technology, Karlsruhe, Germany.

HB-Feinmechanik GmbH & Co. KG, Metten, Germany.

出版信息

Eur J Pharm Biopharm. 2015 Jan;89:9-17. doi: 10.1016/j.ejpb.2014.11.017. Epub 2014 Nov 25.

Abstract

Until now extrusion is not applied for pharmaceutical encapsulation processes, whereas extrusion is widely used for encapsulation of flavours within food applications. Based on previous mixing studies, a hot melt counter-rotating extrusion process for encapsulation of liquid active pharmaceutical ingredients (APIs) was investigated. The mixing ratio of maltodextrin to sucrose as matrix material was adapted in first extrusion trials. Then the number of die holes was investigated to decrease expansion and agglutination of extrudates to a minimum. At a screw speed of 180 min(-1) the product temperature was decreased below 142 °C, resulting in extrudates of cylindrical shape with a crystalline content of 9-16%. Volatile orange terpenes and the nonvolatile α-tocopherol were chosen as model APIs. Design of experiments were performed to investigate the influences of barrel temperature, powder feed rate, and API content on the API retentions. A maximum of 9.2% α-tocopherol was encapsulated, while the orange terpene encapsulation rate decreased to 6.0% due to evaporation after leaving the die. During 12 weeks of storage re-crystallization of sucrose occurred; however, the encapsulated orange terpene amount remained unchanged.

摘要

到目前为止,挤出工艺尚未应用于药物包封过程,而挤出工艺在食品应用中广泛用于香料包封。基于之前的混合研究,对用于液体活性药物成分(API)包封的热熔反向旋转挤出工艺进行了研究。在首次挤出试验中调整了作为基质材料的麦芽糊精与蔗糖的混合比例。然后研究了模孔数量,以将挤出物的膨胀和凝集降至最低。在螺杆转速为180分钟⁻¹时,产品温度降至142℃以下,得到圆柱形挤出物,结晶含量为9 - 16%。选择挥发性橙萜和非挥发性α-生育酚作为模型API。进行实验设计以研究料筒温度、粉末进料速率和API含量对API保留率的影响。最多包封了9.2%的α-生育酚,而橙萜的包封率在离开模头后由于蒸发降至6.0%。在储存12周期间,蔗糖发生了重结晶;然而,包封的橙萜量保持不变。

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