ABSTRACT
We use a variety of experimental results to illustrate issues and challenges involved in the sampling and characterization of pharmaceutical mixtures. Accurate and reliable characterization of granular mixtures is hindered by both the complexity of granular systems and the lack of validated and reliable sampling technology and techniques. Both sampling tools and sampling protocols are critically important for accurate characterization. Using cohesive and free-flowing powders and four thief probe designs, we reveal a large potential for extremely misleading results as well as severe disturbance of the granular bed. We also discuss results from several experiments designed to test the validity of various sampling protocols by varying parameters such as sampling location and frequency of sampling. These experiments illustrate the importance of effective sampling procedures to achieve the best and most efficient results.
Subject(s)
Powders , Technology, PharmaceuticalABSTRACT
The roles of blender rotational speed and blender discharge on the homogeneity of free-flowing art sand and of a cohesive placebo formulation were investigated in the tote blender. For three practical operating speeds, 6, 10, and 14 RPM, spanning the entire range of commercial equipment, the homogeneity of the free-flowing mixture was independent of rotational speed and blender size. On the other hand, the homogeneity of the cohesive pharmaceutical powder mixture was dependent on vessel rotational speed in a complex fashion, with 10 RPM producing a better final mixture than either 5 or 15 RPM. The homogeneity of the free-flowing sand mixture was preserved when discharged into a vertical bin, while the homogeneity of the fine pharmaceutical powder mixture significantly improved after discharge from the tote blender.
