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聚乙二醇6000物理性质对熔融制粒法制备微丸的影响。

Effects of physical properties of PEG 6000 on pellets produced by melt pelletization.

作者信息

Wong T W, Wan L S, Heng P W

机构信息

Department of Pharmacy, National University of Singapore, Singapore.

出版信息

Pharm Dev Technol. 1999 Aug;4(3):449-56. doi: 10.1081/pdt-100101381.

Abstract

This study examined the effects of polyethylene glycol (PEG) binders of different physical forms and from different commercial sources on size and size distribution of pellets produced. The meltable binders used were PEG 6000 in the form of flakes, and coarse and fine powders, and melt pelletization using lactose 450 M was carried out in an 8-liter high-shear mixer. Binder particle size, molecular weight, tack, and viscosity were determined. The results showed that the size and size distribution of the pellets obtained could not be explained by the binder particle size. The size and size distribution of the pellets were related to the tack and viscosity of the molten binders. PEGs used were labeled as the same nominal molecular weight grade, although their determined molecular weights could be quite different. Differences in tack and viscosity of the molten binders were associated with determined molecular weight of the binders. The melt pelletization process is sensitive to tack and viscosity of the molten binders. When different PEG brands of the same nominal molecular weight or different batches of the same brand are used in melt pelletization, it is important to characterize the tack and viscosity of the binders used. The effects of the physical form of binders on the pellet quality appear to be less important when compared to the influences of tack and viscosity of the molten binder.

摘要

本研究考察了不同物理形态、来自不同商业来源的聚乙二醇(PEG)粘合剂对所制备颗粒的尺寸和尺寸分布的影响。所使用的可熔性粘合剂为片状、粗粉和细粉形式的PEG 6000,并在一台8升高剪切混合器中使用乳糖450 M进行熔融造粒。测定了粘合剂的粒径、分子量、粘性和粘度。结果表明,所获得颗粒的尺寸和尺寸分布无法用粘合剂粒径来解释。颗粒的尺寸和尺寸分布与熔融粘合剂的粘性和粘度有关。所用的PEG虽标记为相同的标称分子量等级,但其测定的分子量可能有很大差异。熔融粘合剂粘性和粘度的差异与所测定的粘合剂分子量有关。熔融造粒过程对熔融粘合剂的粘性和粘度很敏感。当在熔融造粒中使用相同标称分子量的不同PEG品牌或同一品牌的不同批次时,表征所用粘合剂的粘性和粘度很重要。与熔融粘合剂的粘性和粘度的影响相比,粘合剂物理形态对颗粒质量的影响似乎不那么重要。

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