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一系列孔隙率的微丸的压片行为——两种不同成分微丸之间的比较

Tabletting behaviour of pellets of a series of porosities--a comparisonbetween pellets of two different compositions.

作者信息

Nicklasson F, Johansson B, Alderborn G

机构信息

Department of Pharmacy, Uppsala University, Box 580, S-751 23 Uppsala, Sweden.

出版信息

Eur J Pharm Sci. 1999 Apr;8(1):11-7. doi: 10.1016/s0928-0987(98)00056-6.

DOI:10.1016/s0928-0987(98)00056-6
PMID:10072474
Abstract

The tabletting behaviour of pellets prepared from a 4:1 mixture of dicalcium phosphate dihydrate (DCP) and microcrystalline cellulose (MCC) was studied and compared with the tabletting behaviour of pellets made solely from microcrystalline cellulose (results from an earlier study by Johansson et al.). A series of pellets with porosities in the range 26-55% were prepared and tabletted at applied pressures of 25-200 MPa. Tablets were also formed from lubricated pellets. The degree of compression during compaction was calculated, and the porosity and tensile strength of the tablets and their permeability to air flow were determined. The porosity of the pellets was found to significantly affect the tabletting behaviour of the DCP/MCC pellets. However, the relationship between pellet porosity and tablet data for the DCP/MCC pellets was different from that for the MCC pellets. The DCP/MCC pellets were generally less prone to a reduction in volume during tabletting, and the pore structure of the DCP/MCC tablets was more closed. It was concluded that the DCP/MCC pellets were more rigid and underwent a different mode of deformation during tabletting than the MCC pellets. This mode of deformation was characterised by a more limited bulk deformation and a more extensive surface deformation at the pellet surfaces. The DCP/MCC pellets tended to give tablets of a lower mechanical strength. They were also less sensitive to lubrication in terms of their compactability, which may be explained either by less surface coverage by the lubricant before compression or rupture of the lubricant film during compression caused by the more extensive surface deformation of DCP/MCC pellets.

摘要

研究了由二水磷酸氢钙(DCP)和微晶纤维素(MCC)按4:1混合物制备的微丸的压片行为,并与仅由微晶纤维素制成的微丸的压片行为进行了比较(Johansson等人早期研究的结果)。制备了一系列孔隙率在26%-55%范围内的微丸,并在25-200MPa的外加压力下压片。还由润滑后的微丸制成片剂。计算了压片过程中的压缩程度,并测定了片剂的孔隙率、拉伸强度及其对气流的渗透性。发现微丸的孔隙率对DCP/MCC微丸的压片行为有显著影响。然而,DCP/MCC微丸的微丸孔隙率与片剂数据之间的关系与MCC微丸不同。DCP/MCC微丸在压片过程中通常不太容易发生体积减小,并且DCP/MCC片剂的孔结构更封闭。得出的结论是,DCP/MCC微丸比MCC微丸更坚硬,并且在压片过程中经历了不同的变形模式。这种变形模式的特点是在微丸表面有更有限的整体变形和更广泛的表面变形。DCP/MCC微丸倾向于得到机械强度较低的片剂。它们在可压性方面对润滑也不太敏感,这可能是由于压缩前润滑剂的表面覆盖较少,或者是由于DCP/MCC微丸更广泛的表面变形导致压缩过程中润滑剂膜破裂。

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