Hovione FarmaCiencia S.A., Lisboa, Portugal.
Hovione FarmaCiencia S.A., Lisboa, Portugal.
J Pharm Sci. 2020 Aug;109(8):2536-2543. doi: 10.1016/j.xphs.2020.05.004. Epub 2020 May 19.
An approximate analytical solution to Johanson's rolling theory is derived. It is shown that the solution yields a single dimensionless parameter invariant in process scale-up or equipment transfer, which relates the densification factor with process parameters (roll force and gap), geometric parameters (roll diameter and width) and material properties. It is shown that, to a first approximation, the model prediction does not depend on the nip angle evading the need to powder rheometry measurements such as wall friction and internal shear angle. The model is benchmarked against data obtained from pilot-scale roller compactors from different manufacturers as well as literature data from Nesarikar. The model yields good ribbon density predictions even when calibrating material properties from uniaxial die compression.
约翰森滚动理论的近似解析解。结果表明,该解产生了一个无量纲参数,在过程放大或设备转移过程中保持不变,该参数将致密化因子与工艺参数(辊压力和间隙)、几何参数(辊直径和宽度)和材料性能相关联。结果表明,在第一近似中,模型预测不依赖于消除需要粉末流变测量(如壁摩擦和内部剪切角)的咬入角。该模型通过来自不同制造商的中试辊式压片机以及来自 Nesarikar 的文献数据进行了基准测试。即使从单轴模压缩中校准材料性能,该模型也能很好地预测条带密度。