College of Pharmacy, The University of Iowa, Iowa City, IA, USA.
Int J Pharm. 2011 Sep 15;416(1):120-8. doi: 10.1016/j.ijpharm.2011.06.017. Epub 2011 Jun 17.
The powder flow and tableting properties of novel silicified microcrystalline cellulose II (SMCCII) were evaluated and compared with current silicified cellulosic I excipients such as ProSolv(®) SMCC50 and ProSolv(®) SMCC90. This excipient was prepared by coprocessing cellulose II and silicon dioxide (SiO(2)) at a 95:5 ratio by spray drying. The novel SMCCII yielded more benefits in terms of functionality as compared with the parent cellulose II material. SMCCII had higher bulk and tap densities, better powder packing ability, reduced porosity, increased surface area, and increased flowability. This silicified excipient had the highest brittleness behavior as given by the Heckel, Leuenberger and brittle fracture index analyses. The mechanical properties of SMCCII, such as toughness and Young's modulus were comparable to those of commercial products. SMCCII was the least sensitive material to magnesium stearate, and blending time or reprocessing did not affect its compactibility. It also provided for the fastest compact disintegration and release of griseofulvin. This new material has the potential for use as a direct compression excipient.
新型硅化微晶纤维素 II（SMCCII）的粉末流动性能和压片特性得到了评估，并与当前的硅化纤维素 I 赋形剂如 ProSolv® SMCC50 和 ProSolv® SMCC90 进行了比较。这种赋形剂是通过喷雾干燥以 95:5 的比例共加工纤维素 II 和二氧化硅（SiO2）制备的。与母体纤维素 II 材料相比，新型 SMCCII 在功能方面具有更多优势。SMCCII 的堆积密度和振实密度更高，粉末填充能力更好，孔隙率更低，比表面积更大，流动性更好。新型硅化赋形剂在 Heckel、Leuenberger 和脆性断裂指数分析中表现出最高的脆性行为。SMCCII 的机械性能，如韧性和杨氏模量与商业产品相当。SMCCII 对硬脂酸镁的敏感性最低，混合时间或再加工不会影响其可压缩性。它还为灰黄霉素最快的压缩崩解和释放提供了条件。这种新材料有可能用作直接压片赋形剂。
