Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
AAPS PharmSciTech. 2013 Mar;14(1):234-44. doi: 10.1208/s12249-012-9910-4. Epub 2012 Dec 21.
Blending of powders is a crucial step in the production of pharmaceutical solid dosage forms. The active pharmaceutical ingredient (API) is often a powder that is blended with other powders (excipients) in order to produce tablets. The blending efficiency is influenced by several external factors, such as the desired degree of homogeneity and the required blending time, which mainly depend on the properties of the blended materials and on the geometry of the blender. This experimental study investigates the mixing behavior of acetyl salicylic acid as an API and α-lactose monohydrate as an excipient for different filling orders and filling levels in a blender. A multiple near-infrared probe setup on a laboratory-scale blender is used to observe the powder composition quasi-simultaneously and in-line in up to six different positions of the blender. Partial least squares regression modeling was used for a quantitative analysis of the powder compositions in the different measurement positions. The end point for the investigated mixtures and measurement positions was determined via moving block standard deviation. Observing blending in different positions helped to detect good and poor mixing positions inside the blender that are affected by convective and diffusive mixing.
粉末混合是制药固体制剂生产中的关键步骤。原料药（API）通常是一种粉末，需要与其他粉末（辅料）混合以生产片剂。混合效率受到几个外部因素的影响，例如所需的均匀度和所需的混合时间，这些主要取决于混合材料的性质和混合器的几何形状。本实验研究了不同填充顺序和填充水平下作为 API 的乙酰水杨酸和作为辅料的 α-乳糖一水合物在混合器中的混合行为。在实验室规模的混合器上使用多个近红外探针设置，可以在混合器的多达六个不同位置准同时在线观察粉末成分。偏最小二乘回归建模用于对不同测量位置的粉末成分进行定量分析。通过移动块标准偏差确定了所研究混合物和测量位置的终点。在不同位置观察混合有助于检测到混合器内部受对流和扩散混合影响的良好和不良混合位置。
