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Evaluation of Powder Mixing Capability

Alternative assessment of blend homogeneity with tablet content uniformity testing

Bojana Rihtaršič¹, Rok Dreu², Janez Kerč³

¹ Lek Pharmaceuticals d.d., Quality Unit, Ljubljana, Slovenia
² University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia
³ Lek Pharmaceuticals d. d., Sandoz Development Center Slovenia, Ljubljana, Slovenia

Batch homogeneity of powder mixtures is a challenging part in the production of solid dosage forms. The method for demonstrating that the active pharmaceutical ingredient is uniformly distributed across the whole batch has to be reliable and simple for routine production. It is well known that sampling of a powder mixture e. g. using a sampling thief can not always give representative data due to impacts of specific physical properties of the formulation of the obtained sample. A case study is presented showing that powder mixture homogeneity can be efficiently demonstrated by content uniformity analysis of tablets when the results are weight corrected. It has been demonstrated that there are big differences between weight corrected content uniformity results of tablets and blend uniformity results. With statistical methods it has been demonstrated that the weight corrected tablet content uniformity results obtained from stratified sampling locations during compression process is a reliable option for blend uniformity assessment.