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共处理辅料乳糖:一项比较研究。

Cellactose a co-processed excipient: a comparison study.

作者信息

Arida Adi I, Al-Tabakha Moawia M

机构信息

Faculty of Pharmacy, Philadelphia University, Amman, Jordan.

出版信息

Pharm Dev Technol. 2008;13(2):165-75. doi: 10.1080/10837450701831294.

DOI:10.1080/10837450701831294
PMID:18379907
Abstract

This article describes the differences in compaction properties between microcrystalline cellulose (MCC) and alpha-lactose monohydrate physical mixture, and microcrystalline cellulose co-processed with alpha-lactose monohydrate (Cellactose). The different compaction parameters are not only compared for the pure materials but also for the lubricated powders with magnesium stearate. Magnesium stearate does not facilitate the densification of either the physical mixture or Cellactose during compaction. The difference in tablet relaxation of the physical mixture and Cellactose indicates that the negative effect of the lubricant on the interparticle bonding of Cellactose particles is smaller than the physical mixture particles because after compaction, the structure in the Cellactose tablet is completely different from that in the physical mixture tablet. However, a larger increase in tablet relaxation at a high compression speed was found for both Cellactose and the physical mixture at different lubricant concentrations: 1.0% and 0.0%. Accordingly, the decrease in tablet strength was larger for the physical mixture tablets than for the Cellactose tablets when lubrication was applied. The examination of the tablet strengths of tablets compressed from physical mixtures of different ratios of alpha-lactose monohydrate and MCC proved the positive effect of cellulose on the tensile strength of tablets. Co-processing of MCC with alpha-lactose monohydrate showed extra contribution on the tablet strength of a physical mixture with the same mixing ratio. This extra contribution of Cellactose was attributed only to the interfacial attraction of the particles.

摘要

本文描述了微晶纤维素(MCC)与α-乳糖一水合物物理混合物,以及与α-乳糖一水合物共处理的微晶纤维素(Cellactose)之间的压实特性差异。不仅比较了纯物料的不同压实参数,还比较了添加硬脂酸镁的润滑粉末的压实参数。硬脂酸镁在压实过程中不利于物理混合物或Cellactose的致密化。物理混合物和Cellactose片剂松弛度的差异表明,润滑剂对Cellactose颗粒间键合的负面影响小于物理混合物颗粒,因为压实后,Cellactose片剂中的结构与物理混合物片剂中的结构完全不同。然而,在不同润滑剂浓度(1.0%和0.0%)下,Cellactose和物理混合物在高压缩速度下片剂松弛度的增加都更大。因此,施加润滑时,物理混合物片剂的片剂强度下降幅度大于Cellactose片剂。对由不同比例的α-乳糖一水合物和MCC的物理混合物压制而成的片剂的片剂强度进行检测,证明了纤维素对片剂拉伸强度的积极作用。MCC与α-乳糖一水合物的共处理对相同混合比例的物理混合物的片剂强度有额外贡献。Cellactose的这种额外贡献仅归因于颗粒的界面吸引力。

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引用本文的文献

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Pharmaceutics. 2021 Sep 16;13(9):1486. doi: 10.3390/pharmaceutics13091486.
2
Critical Tools in Tableting Research: Using Compaction Simulator and Quality by Design (QbD) to Evaluate Lubricants' Effect in Direct Compressible Formulation.压片研究中的关键工具:使用压缩模拟器和质量源于设计(QbD)来评估润滑剂在直接压片配方中的效果。
AAPS PharmSciTech. 2021 May 11;22(4):151. doi: 10.1208/s12249-021-02004-y.
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Performance Evaluation of a Novel Biosourced Co-Processed Excipient in Direct Compression and Drug Release.
新型生物源共处理辅料在直接压片和药物释放方面的性能评估
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