Podczeck F, Blackwell S, Gold M, Newton J M
Department of Pharmaceutics, The School of Pharmacy, University of London, 29/39 Brunswick Square, London, UK.
Int J Pharm. 1999 Oct 15;188(1):59-69. doi: 10.1016/s0378-5173(99)00208-2.
Four different granule size fractions of Sorbitol instant(R) were filled into hard gelatine capsules on a tamp filling (Bosch) and a dosator nozzle machine (Zanasi) to allow comparison of the filling principles. An acceptable filling performance was always achieved and was independent of the machine type employed. Tamp filling was found to be slightly better for the coarser granule size fractions, because it does not seem to rely on a firm plug formation. A direct relationship between the angle of internal flow (Varthalis and Pilpel, 1976) and the coefficient of fill weight variation was found for both systems. Using the dosator nozzle machine, the plug formed was always denser than the maximum bulk density, whereas on the tamp filling machine for smallest granule size the maximum plug density could not be achieved with the settings employed. The results suggest that in situations where a low plug density is an essential prerequisite for drug dissolution and bioavailability the tamp filling machine appears the more suitable filling principle. However, if a greater extent of compression is required in order to fill large dose drugs or to use a smaller capsule size, the dosator nozzle principle might work more successfully for granules.
将山梨醇速溶（R）的四种不同粒度级分分别装填到硬明胶胶囊中，使用捣实填充机（博世）和定量给料喷嘴机（扎纳西），以比较填充原理。始终能获得可接受的填充性能，且与所使用的机器类型无关。发现捣实填充对于较粗粒度级分稍好一些，因为它似乎不依赖于形成紧实的药栓。对于这两种系统，均发现内部流动角（瓦尔萨利斯和皮尔佩尔，1976年）与装量差异系数之间存在直接关系。使用定量给料喷嘴机时，形成的药栓总是比最大堆密度更密实，而在捣实填充机上，对于最小粒度级分，在所采用的设置下无法达到最大药栓密度。结果表明，在低药栓密度是药物溶解和生物利用度的必要前提的情况下，捣实填充机似乎是更合适的填充原理。然而，如果为了装填大剂量药物或使用较小胶囊尺寸而需要更大程度的压缩，那么定量给料喷嘴原理对于颗粒可能更有效。
