a Chemical Engineering Department, School of Engineering , University of Jordan , Amman , Jordan.
b The Jordanian Pharmaceutical Manufacturing Co , Naor , Jordan.
Drug Dev Ind Pharm. 2018 Dec;44(12):2038-2047. doi: 10.1080/03639045.2018.1508224. Epub 2018 Sep 5.
Roller compaction was used to prepare a direct-compressed lactose excipient using crystalline α-lactose monohydrate. The effect of various roller compaction process parameters (compaction pressure, compaction repetition, and speed ratio) on the characteristics of compacted α-lactose monohydrate was investigated. Results were compared with data obtained using industrial spray-dried lactose and lactose samples with different degrees of crystallinity. XRPD analysis revealed that roller compaction reduced the crystallinity of α-lactose monohydrate, and the resulting material is similar to spray-dried lactose in behavior as a direct compression excipient. Roller compaction introduced desirable characteristics to the raw α-lactose monohydrate by inducing changes in crystallinity and particle morphology. Scanning electron microscopy results indicated that the compaction process converted some of the original torpedo-shaped crystals of α-lactose monohydrate into a more cylindrical shape with rounded edges. Compaction pressure and repetition of compaction have a significant effect on the modification of the crystallinity of the processed, raw α-lactose monohydrate.
滚压法被用于制备使用结晶α-乳糖一水合物的直接压片乳糖赋形剂。研究了各种滚压工艺参数（压缩压力、压缩重复次数和速比）对压缩α-乳糖一水合物特性的影响。结果与使用工业喷雾干燥乳糖和不同结晶度的乳糖样品获得的数据进行了比较。XRPD 分析表明，滚压降低了α-乳糖一水合物的结晶度，所得材料在作为直接压片赋形剂的行为上类似于喷雾干燥乳糖。滚压通过诱导结晶度和颗粒形态的变化，为原始α-乳糖一水合物带来了理想的特性。扫描电子显微镜结果表明，压缩过程将一些原始的鱼雷形α-乳糖一水合物晶体转化为具有圆形边缘的更圆柱形形状。压缩压力和压缩重复次数对加工后的原始α-乳糖一水合物结晶度的改性有显著影响。
