PMID- 11411897
OWN - NLM
STAT- MEDLINE
DCOM- 20011025
LR  - 20190921
IS  - 0363-9045 (Print)
IS  - 0363-9045 (Linking)
VI  - 27
IP  - 4
DP  - 2001 Apr
TI  - The development of a blend-sampling technique to assess the uniformity of a 
      powder mixture.
PG  - 297-307
AB  - 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.
FAU - Garcia, T P
AU  - Garcia TP
AD  - Pfizer, Incorporated, Eastern Point Road, Groton, CT 06340, USA.
FAU - Wilkinson, S J
AU  - Wilkinson SJ
FAU - Scott, J F
AU  - Scott JF
LA  - eng
PT  - Journal Article
PL  - England
TA  - Drug Dev Ind Pharm
JT  - Drug development and industrial pharmacy
JID - 7802620
RN  - 0 (Pharmaceutical Preparations)
RN  - 0 (Powders)
RN  - 0 (Tablets)
SB  - IM
MH  - Bias
MH  - *Chemistry, Pharmaceutical
MH  - Pharmaceutical Preparations/analysis/standards
MH  - Powders/analysis/*standards
MH  - Quality Control
MH  - Reproducibility of Results
MH  - Tablets/analysis/*standards
EDAT- 2001/06/20 10:00
MHDA- 2001/10/26 10:01
CRDT- 2001/06/20 10:00
PHST- 2001/06/20 10:00 [pubmed]
PHST- 2001/10/26 10:01 [medline]
PHST- 2001/06/20 10:00 [entrez]
AID - 10.1081/ddc-100103729 [doi]
PST - ppublish
SO  - Drug Dev Ind Pharm. 2001 Apr;27(4):297-307. doi: 10.1081/ddc-100103729.