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压片时送料器对片剂强度的影响。

Effect of force feeder on tablet strength during compression.

机构信息

Bristol-Myers Squibb, Co., One Squibb Dr., PO Box 191, New Brunswick, NJ 08903-0191, United States.

出版信息

Int J Pharm. 2010 Nov 30;401(1-2):7-15. doi: 10.1016/j.ijpharm.2010.08.027. Epub 2010 Sep 9.

Abstract

Mechanical strength of tablets is an important quality attribute, which depends on both formulation and process. In this study, the effect of process variables during compression on tablet tensile strength and tabletability (the ratio of tensile strength to compression pressure) was investigated using a model formulation. Increase in turret and force feeder speeds reduced tablet tensile strength and tabletability. Turret speed affected tabletability through changes in dwell time under the compression cam and the kinetics of consolidation of granules in the die cavity. The effect of force feeder was attributed to the shearing of the granulation, leading to its over-lubrication. A dimensionless equation was derived to estimate total shear imparted by the force feeder on the granulation in terms of a shear number. Scale-independence of the relationship of tabletability with the shear number was explored on a 6-station Korsch press, a 16-station Betapress, and a 35-station Korsch XL-400 press. The use of this relationship, the exact nature of which may be formulation dependent, during tablet development is expected to provide guidance to the scale-up and interchangeability of tablet presses.

摘要

片剂的机械强度是一个重要的质量属性,它取决于配方和工艺。在这项研究中,使用模型配方研究了压缩过程中工艺变量对片剂拉伸强度和可压性(拉伸强度与压缩压力的比值)的影响。转塔和送料器速度的增加降低了片剂的拉伸强度和可压性。转塔速度通过改变压缩凸轮下的停留时间和模腔中颗粒的固结动力学来影响可压性。送料器的作用归因于对造粒的剪切,导致其过度润滑。推导出了一个无量纲方程,以剪切数的形式来估算送料器对造粒施加的总剪切。在 6 工位 Korsch 压片机、16 工位 Betapress 和 35 工位 Korsch XL-400 压片机上,探索了可压性与剪切数之间的关系与剪切数的比例无关性。在片剂开发过程中使用这种关系(其确切性质可能取决于配方),有望为片剂压片机的放大和互换性提供指导。

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