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首页> 外文期刊>International Journal of Pharmaceutics >The evaluation of modified microcrystalline cellulose for the preparation of pellets with high drug loading by extrusion/spheronization.
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The evaluation of modified microcrystalline cellulose for the preparation of pellets with high drug loading by extrusion/spheronization.

机译：对改性微晶纤维素通过挤出/滚圆法制备高载药量药丸的评价。

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摘要

The performance of microcrystalline cellulose (MCC) which had been modified by the inclusion of various levels of sodium carboxymethylcellulose (SCMC) in the wet cake prior to drying, in terms of their ability to form pellets by a standardised extrusion/spheronization process has been assessed. Initial screening of the ability of the modified MCCs to form pellets with an 80% level of lactose as a model drug identified two potential products containing 6 or 8% of SCMC (B 6 and B 8). These two products were compared with a standard grade of MCC (Avicel PH101) in terms of their ability to produce pellets with 80% of model drugs of low (ibuprofen), intermediate (lactose) and high (ascorbic acid) water solubility when subjected to a standardised extrusion/spheronization process. Also assessed was their ability to retain water with applied pressure using a pressure membrane technique and their ability to restrict water migration during extrusion with a ram extruder. The two new types of MCC (B 6 and B 8) were able to form good quality pellets with all three model drugs, whereas Avicel PH101 could not form pellets with this high level of ibuprofen. This improved performance was related to the ability of the new types of MCC to hold higher levels of water within their structure and restrict the migration of water in the wet mass when subjected to pressure applied during the process of preparing the pellets. There is evidence to show that the two new types of MCC can function over a wider range of water contents than Avicel PH101 and that they have an improved performance if the extrusion process is rapid and if, after incorporation of the water into the powder, the sample is stored for some time before extrusion.
机译：评估了通过干燥前在湿饼中加入各种含量的羧甲基纤维素钠（SCMC）改性的微晶纤维素（MCC）的性能，就其通过标准化挤出/滚圆工艺形成颗粒的能力而言。初步筛选了修饰的MCC形成具有80％乳糖水平的小球作为模型药物的能力，确定了两种潜在产品，其中含有6或8％的SCMC（B 6和B 8）。将这两种产品与标准等级的MCC（Avicel PH101）进行比较，得出的结果是，它们在承受80％低（布洛芬），中（乳糖）和高（抗坏血酸）水溶性的模型药物时，能够产生小丸标准化的挤出/滚圆工艺。还评估了它们使用压力膜技术在施加压力的情况下保水的能力，以及在冲压挤出机挤出过程中限制水迁移的能力。两种新型MCC（B 6和B 8）能够与所有三种模型药物一起形成高质量的颗粒，而Avicel PH101不能与这种高水平的布洛芬一起形成颗粒。这种改进的性能与新型MCC在制备颗粒过程中受到压力时能够在其结构内保持较高含量的水并限制湿物料中水的迁移的能力有关。有证据表明，这两种新型的MCC可以比Avicel PH101在更宽的含水量范围内发挥作用，并且如果挤出过程迅速并且在将水掺入粉末中后，它们具有更好的性能。样品在挤出前要保存一段时间。

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