Department of Pharmaceutics, University of Bonn, Gerhard-Domagk-Str.3, 53121 Bonn, Germany.
Department of Pharmaceutics, University of Bonn, Gerhard-Domagk-Str.3, 53121 Bonn, Germany.
Int J Pharm. 2020 Dec 15;591:119941. doi: 10.1016/j.ijpharm.2020.119941. Epub 2020 Oct 14.
Melt granules of DI-CAFOS® A12 and 15% (w/w) Kolliphor® P407 were manufactured in a twin-screw granulator (TSG) at five different conditions (screw speed and throughput varied) and compared to granules manufactured in a high-shear granulator (HSG) (rotation speed of chopper/impeller and granulation time varied). Evaluated granules characteristics were process yield, particle-size distribution (PSD), particle morphology, flowability, porosity, specific surface area (SSA), tabletability, compressibility and binder distribution. Compared to TSG, granules produced from HSG were more spherical in shape with lower porosity, smaller mean particle size and a superior flowability. Granules made by TSG showed a more elongated structure, higher porosity and larger mean particle size with smaller SSA instead. Concerning the compression process of granules, tablets made of TSG granules exhibited a higher tabletability compared to HSG granules, whereas the compressibility remained similar. In the case of the TSG granules, energy-dispersive-X-ray (EDX) measurements of the tablet surface indicated an enhanced homogenous binder distribution. Additionally, the EDX-analyses determined that more binder was available between the individual particles, resulting in a stronger bonding.
DI-CAFOS® A12 熔融颗粒和 15%（w/w）Kolliphor® P407 颗粒在双螺杆造粒机（TSG）中于五种不同条件下（螺杆速度和吞吐量不同）制造，并与在高剪切造粒机（HSG）中制造的颗粒（搅拌器/叶轮的转速和制粒时间不同）进行比较。评估的颗粒特性包括工艺收率、粒度分布（PSD）、颗粒形态、流动性、孔隙率、比表面积（SSA）、可压性、可压缩性和粘合剂分布。与 TSG 相比，HSG 生产的颗粒形状更球形，孔隙率更低，平均粒径更小，流动性更好。TSG 生产的颗粒呈更细长的结构，孔隙率更高，平均粒径更大，SSA 更小。关于颗粒的压缩过程，与 HSG 颗粒相比，TSG 颗粒制成的片剂具有更高的可压性，而可压缩性保持相似。在 TSG 颗粒的情况下，片剂表面的能量色散 X 射线（EDX）测量表明，粘合剂的分布更加均匀。此外，EDX 分析确定，在单个颗粒之间有更多的粘合剂可用，从而产生更强的结合。
