Berggren J, Alderborn G
Department of Pharmacy, Uppsala University, Box 580, SE-751 23 Uppsala, Sweden.
Int J Pharm. 2001 Oct 4;227(1-2):81-96. doi: 10.1016/s0378-5173(01)00787-6.
The purpose of this study was to investigate the effect of drying rate during static drying on certain physical properties of pellets. Pellets were prepared from microcrystalline cellulose by granulation with different agglomeration liquids (various ethanol/water ratios) and thereafter dried without agitation at different drying rates. The dry pellets were characterised with respect to their shape, porosity, and compression shear strength and the tensile strength of tablets formed from pellets with low and high drying rates was determined. Drying of the pellets occurred at a falling rate and the reduction in liquid content with time obeyed a first order type of relationship. An increased drying rate did not affect the shape and surface texture of the dried pellets and did not cause them to fracture. However, the drying conditions did affect pellet porosity, with an increased drying rate resulting in more porous pellets. Through a relationship with pellet porosity, the drying rate also affected the deformability of the pellets (as assessed from Kawakita 1/b values) and their ability to form tablets. Owing to a strong effect of porosity on pellet compactability, marked changes in tablet tensile strength with variations in drying rate may be obtained.
本研究的目的是调查静态干燥过程中的干燥速率对微丸某些物理性质的影响。采用微晶纤维素,通过使用不同的团聚液(不同乙醇/水比例)制粒来制备微丸,然后在无搅拌的情况下以不同干燥速率进行干燥。对干燥后的微丸的形状、孔隙率、压缩剪切强度进行了表征,并测定了由干燥速率低和高的微丸制成的片剂的拉伸强度。微丸的干燥以降速方式进行,液体含量随时间的减少遵循一级关系类型。干燥速率的增加不会影响干燥后微丸的形状和表面质地,也不会导致其破裂。然而,干燥条件确实会影响微丸的孔隙率,干燥速率增加会导致微丸的孔隙率更高。通过与微丸孔隙率的关系,干燥速率还会影响微丸的可变形性(根据河合1/b值评估)及其压片能力。由于孔隙率对微丸可压性有很强的影响,干燥速率变化时片剂拉伸强度可能会有显著变化。