The development of a blend-sampling technique to assess the uniformity of a powder mixture.
This article discusses the challenges overcome during the development of a blend-sampling technique and the successful validation of the blending operation for a tablet dosage form containing 2% active ingredient. Content uniformity results are discussedfor three pilot-scale (15-kg) and seven commercial-scale (150-kg) batches of tablets. Blend and core content uniformity data from the pilot-scale batches were acceptable. For the initial commercial-scale batches, although the tablet core content uniformity data were acceptable, the blend uniformity results were poor. The blend data for these batches had very high mean values, but acceptable relative standard deviations (RSDs). This suggested that the drug was being preferentially sampled by the thief but in a consistent, reproducible manner. Extensive testing was performed on a commercial-scale development batch to identify potential causes of sampling error. The results of this testing helped define the blend-sampling technique and strategy used to validate the mixing operation.
Garcia
T P
TP
Pfizer, Incorporated, Eastern Point Road, Groton, CT 06340, USA.
Wilkinson
S J
SJ
Scott
J F
JF
D015982:Bias; D002626:Chemistry, Pharmaceutical; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000592:standards; D011208:Powders / Q000032:analysis / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results; D013607:Tablets / Q000032:analysis / Q000592:standards*
D004364:Pharmaceutical Preparations; D011208:Powders; D013607:Tablets