Tablet weight variation, causes

The most common problem manifested due to poor flow property is the variation in fill weight. This problem is much more serious in the case of DC excipients, but coprocessed excipients are devoid of this effect, when compared with the physical mixture of their parent excipients. This is because of the impregnation of one particle into the matrix of another, which reduces the rough particle surfaces and creates a near-optimal size distribution, causing better flow properties. Tablets prepared with M80K, a coprocessed cellulose powder with CSD, showed lesser weight variation than those prepared with Avicel (43). 

Control charts are an excellent analysis tool to both monitor and improve in-process performance during process development and later during production, where it is desired to follow process characteristics over time within batches or runs. The most common examples of tablet process characteristics that are measured in-process are weight, thickness, and hardness. The parameters measured need to be controllable so that adjustments can be made. During the initial runs, it is desirable to limit process adjustments to a minimum to observe the process in its natural state. Any adjustments made should be recorded and explained. Out-oflimit results should never be removed prior to performing a process capability analysis. If special cause variation is detected, then process improvements should be made to eliminate the special cause variation. 

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