Rowley G, Hawley A R, Dobson C L, Chatham S
School of Health Sciences, University of Sunderland, Tyne & Wear, UK.
Drug Dev Ind Pharm. 1998 Jul;24(7):605-11. doi: 10.3109/03639049809082361.
The rheology and capsule filling properties of molten excipients, Dynafill, Dynasan-114. Lutrol-F68, and polyethylene glycols (PEG) 6000, 8000, 10,000, and 20,000 have been investigated. Lactose (alpha-monohydrate) was selected as a model particulate solid with low solubility in PEG in order to investigate the effects of disperse phase particle size, concentration, and PEG molecular weight on rheology and capsule filling properties of these systems. All excipients behaved as Newtonian fluids between 65 and 90 degrees C, which was chosen as a possible temperature range for liquid filling of hard gelatin capsules. The excipients, apart from Dynasan-114 and PEG 20,000, showed satisfactory capsule filling properties at 70 degrees C using a semi-automatic filling machine. Dynasan-114 (viscosity = 0.012 Pa.s at 70 degrees C) leaked from the seals between the hopper and pump of the filling machine, whereas PEG 20,000 (viscosity = 24 Pa.s at 70 degrees C) showed bridging of the molten polymer between successive capsule bodies during the filling process. The effect of disperse phase (lactose) particle size and concentration, and continuous phase (PEG) molecular weight on the apparent viscosity and filling properties of the non-Newtonian dispersions were investigated at 70 degrees C. Satisfactory filling of the dispersions was achieved at 70 degrees C up to a limiting concentration of disperse phase which was dependent upon disperse phase particle size and continuous phase molecular weight, and corresponded to a pronounced increase in apparent viscosity of the dispersion.
已对熔融辅料Dynafill、Dynasan - 114、Lutrol - F68以及聚乙二醇（PEG）6000、8000、10000和20000的流变学和胶囊填充特性进行了研究。选择乳糖（α - 一水合物）作为在PEG中低溶解度的模型颗粒固体，以研究分散相粒径、浓度和PEG分子量对这些体系流变学和胶囊填充特性的影响。所有辅料在65至90摄氏度之间表现为牛顿流体，该温度范围被选为硬明胶胶囊液体填充的可能温度范围。除Dynasan - 114和PEG 20000外，其他辅料在70摄氏度下使用半自动灌装机显示出令人满意的胶囊填充特性。Dynasan - 114（70摄氏度下粘度 = 0.012 Pa·s）从灌装机料斗和泵之间的密封处泄漏，而PEG 20000（70摄氏度下粘度 = 24 Pa·s）在填充过程中在连续的胶囊体之间表现出熔融聚合物的架桥现象。在70摄氏度下研究了分散相（乳糖）粒径和浓度以及连续相（PEG）分子量对非牛顿分散体表观粘度和填充特性的影响。在70摄氏度下，分散体在分散相的极限浓度以下实现了令人满意的填充，该极限浓度取决于分散相粒径和连续相分子量，并且对应于分散体表观粘度的显著增加。
