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自由流动和粘性药物粉末的辊压比较研究。

A comparative study of roll compaction of free-flowing and cohesive pharmaceutical powders.

机构信息

School of Chemical Engineering, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.

出版信息

Int J Pharm. 2012 May 30;428(1-2):39-47. doi: 10.1016/j.ijpharm.2012.02.033. Epub 2012 Feb 28.

Abstract

Roll compaction is widely adopted as a dry granulation method in the pharmaceutical industry. The roll compaction behaviour of feed powders is primarily governed by two parameters: the maximum pressure and the nip angle. Although the maximum pressure can be measured directly using pressure sensors fitted in the rolls, it is not a trivial task to determine the nip angle, which is a measure of the size of the compaction zone and hence the degree of compression. Thus a robust approach based upon the calculation of the pressure gradient, which can be obtained directly from experiments using an instrumented roll compactor, was developed. It has been shown that the resulting nip angles are comparable to those obtained using the methods reported in literature. Nevertheless, the proposed approach has distinctive advantages including (1) it is based on the intrinsic features of slip and no-slip interactions between the powder and roll surface and (2) it is not necessary to carry out wall friction measurements that involve plates that may not be representative of the roll compactor in terms of the surface topography and surface energy. The method was evaluated by investigating the effect of roll speed for two pharmaceutical excipients with distinctive material properties: microcrystalline cellulose (MCC) and di-calcium phosphate dihydrate (DCPD). It was found that the maximum pressure and nip angle for DCPD, which is a cohesive powder, decrease sharply with increasing roll speed whereas they are essentially independent of roll speed for MCC, which is an easy flowing powder. The roll compaction behaviour of MCC-DCPD mixtures with various compositions was also investigated in order to evaluate the effect of flowability. It was found that the nip angle and maximum pressure generally increased with improved flowability of the feed powders.

摘要

辊压是制药工业中广泛采用的干法造粒方法。粉末的辊压行为主要由两个参数决定:最大压力和辊隙角。虽然可以使用安装在轧辊上的压力传感器直接测量最大压力,但确定辊隙角并非易事,辊隙角是压缩区域大小的度量,也是压缩程度的度量。因此,开发了一种基于压力梯度计算的稳健方法,该方法可以使用装有仪器的辊式压实机直接从实验中获得。已经表明,得到的辊隙角与使用文献中报道的方法得到的辊隙角相当。然而,所提出的方法具有明显的优势,包括(1)它基于粉末与轧辊表面之间滑动和不滑动相互作用的固有特征,(2)不需要进行壁面摩擦测量,因为这些测量涉及的平板可能与轧辊式压实机在表面形貌和表面能方面不具有代表性。该方法通过研究两种具有不同材料特性的药用辅料(微晶纤维素(MCC)和二水磷酸二钙(DCPD))的辊速对辊压的影响进行了评估。结果发现,对于粘性粉末 DCPD,最大压力和辊隙角随辊速的增加而急剧下降,而对于易于流动的粉末 MCC,它们基本上与辊速无关。还研究了具有不同组成的 MCC-DCPD 混合物的辊压行为,以评估流动性的影响。结果发现,随着进料粉末流动性的提高,辊隙角和最大压力通常会增加。

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