Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
Drug Dev Ind Pharm. 2013 Feb;39(2):252-8. doi: 10.3109/03639045.2012.672424. Epub 2012 Apr 12.
Excipient selection is key to product development because it affects their processability and physical properties, which ultimately affect the quality attributes of the pharmaceutical product.
To study how the flowability of lubricated formulations affects acetaminophen (APAP) homogeneity.
The formulations studied here contain one of two types of cellulose (Avicel 102 or Ceollus KG-802), one of three grades of Mallinckrodt APAP (fine, semi-fine, or micronized), lactose (Fast-Flo) and magnesium stearate. These components are mixed in a 300-liter bin blender. Blend flowability is assessed with the Gravitational Displacement Rheometer. APAP homogeneity is assessed with off-line NIR.
Excluding blends dominated by segregation, there is a trend between APAP homogeneity and blend flow index. Blend flowability is affected by the type of microcrystalline cellulose and by the APAP grade.
The preliminary results suggest that the methodology used in this paper is adequate to study of the effect of blend flow index on APAP homogeneity.
赋形剂的选择是产品开发的关键，因为它会影响其加工性能和物理性质，而这些性质最终会影响药物产品的质量属性。
研究润滑配方的流动性如何影响对乙酰氨基酚（APAP）的均一性。
这里研究的配方含有两种纤维素（Avicel 102 或 Ceollus KG-802）中的一种、三种美仑尼克德（Mallinckrodt）APAP 等级（细粉、中粉或微粉）中的一种、乳糖（Fast-Flo）和硬脂酸镁。这些成分在 300 升桶式混合机中混合。使用重力置换流变仪评估混合的流动性。使用离线近红外（NIR）评估 APAP 的均一性。
排除由分离主导的混合物，APAP 的均一性和混合流动指数之间存在趋势。混合的流动性受到微晶纤维素的类型和 APAP 等级的影响。
初步结果表明，本文中使用的方法足以研究混合流动指数对 APAP 均一性的影响。
