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流化床包衣机的改造及其对丸芯包衣过程影响的研究。

Fluid-bed coater modifications and study of their influence on the coating process of pellets.

机构信息

Faculty of Pharmacy, University of Ljubljana, Aškercˇeva, Ljubljana, Slovenia.

出版信息

Drug Dev Ind Pharm. 2012 Apr;38(4):501-11. doi: 10.3109/03639045.2011.617754. Epub 2011 Oct 1.

Abstract

OBJECTIVE

In this study, different modifications of bottom spray fluid-bed coater with draft tube inserted were characterized and evaluated.

MATERIALS AND METHODS

After coating the neutral pellets with polymeric solution comprising coloring agent pellet batches were characterized for coating variation, yield and degree of agglomeration.

RESULTS

Funnel-shaped distribution plate was found to improve process yield and decrease the degree of agglomeration at selected values of process parameters, whereas coating uniformity was worse in all cases when compared to conventional Wurster chamber. Results of the coating chamber with the swirl airflow generator indicate more uniform deposition of the coating material and in some cases an improved process yield and decreased formation of agglomerates when compared to conventional Wurster chamber. In series of experiments using Wurster chamber, having tangentially oriented air intake slots, which enabled introduction of air above the distribution plate, coating layer was more uniformly deposited on the pellet cores and formation of agglomerates was lower compared to the results obtained in a conventional Wurster coating chamber.

CONCLUSION

Modifications of Wurster coating process by introducing swirling air motion within the draft tube or by introduction of air above the distribution plate have at selected values of process parameters resulted in reduced per-particle coating variation, degree of agglomeration and improved process yield.

摘要

目的

本研究对带导流管的底喷流化床的不同改进形式进行了特征描述和评估。

材料和方法

在将中性丸剂用包含着色剂的聚合物溶液包衣后,对丸剂批次的包衣变化、收率和团聚程度进行了特征描述。

结果

在选定的工艺参数值下,锥形分布板可提高工艺收率并降低团聚程度,而与传统的 Wurster 室相比,所有情况下的包衣均匀度都较差。采用旋流空气发生器的包衣室的结果表明,与传统的 Wurster 室相比,包衣材料的沉积更均匀,在某些情况下,工艺收率提高,团聚体形成减少。在使用具有切向进气槽的 Wurster 室进行的一系列实验中,空气可以从分布板上方引入,与在传统的 Wurster 包衣室中获得的结果相比,包衣层更均匀地沉积在丸芯上,团聚体的形成减少。

结论

通过在导流管内引入旋流空气运动或在分布板上方引入空气对 Wurster 包衣工艺进行改进,在选定的工艺参数值下,可降低每丸的包衣变化、团聚程度并提高工艺收率。

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