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Preventing Off-weight Tablets
Weight is a crucial parameter of any finished drug tablet, whether prescription, over-the-counter, or nutritional supplement. Overweight tablets can result in too much of an ingredient, which may lead to a harmful effect. But tablets that are too light are also problematic because they may not offer enough of a particular ingredient to bring about an intended therapeutic benefit. A manufacturer’s goal should be two-fold: do not produce off-weight tablets in the first place, and catch and reject them, accurately and reliably, if they are produced. The best ways to prevent the manufacturing of off-weight tablets begin before product is loaded into the hopper—through comprehensive operator training, diligent and rigorous preventive maintenance, and regularly scheduled calibration of the press and its subassemblies.
The importance of training cannot be overstated. Companies should have standard operating procedures (SOPs) and ensure that operators follow the SOPs. A tablet-press vendor should be able to demonstrate and confer comprehensive knowledge of their technology and of how it can be used to manufacture tablets of optimal quality.
A press vendor can provide training specific to understanding the feeder and optimizing its use, because the feeder has a direct correlation to maintaining acceptable tablet weights. Users should also understand and use the relationship between feeder speeds and consistent die filling.
Maintenance and calibration
A force-based relative standard deviation should be used as an indicator of consistent tablet weights. Given the correlation between force and final tablet weight, this statistic allows an operator, with a quick glance, to determine how consistently they are compressing tablets. Many modern presses calculate this figure for the user, further streamlining the ability to quickly analyze results in real time.
Seek outside help
Matt Bundenthal is direct sales and communications manager at Fette Compacting America.
For further information on this topic, read the January 2014 issue of Pharmaceutical Technology for the full article, “Battling Off-Weight Tablets.”