FDA Wants To Make It Safer To Split Tablets

FDA Wants To Make It Safer To Split Tablets

August 31st, 2011 // 12:55 pm @

The practice of splitting tablets is nothing new. Countless people do so every day to save money or adjust dosages, but how does one know that each half – or portion – contains the needed amount of medication? Just because a tablet is scored – which is industry-speak for visible markings on the tablet coating – is not a guarantee that patients will get what they need.

Following a pair of meetings by its Drug Safety Oversight Board over the past two years, the agency conducted internal research on tablet splitting and found, in some cases, possible safety issues, especially when tablets are not scored or evaluated for splitting. These include variations in tablet content; weight; disintegration; dissolution, which affects absorption in the body, and stability.


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And so the FDA has issued a guidance for drugmakers on data needed for applications to support scored tablets. Such as? The dosage amount meant to be achieved after splitting the tablet should not be below the minimum therapeutic dose indicated on approved labeling. And modified release tablets in which the control of drug release can be compromised by splitting should not be scored.

Also, generic drugmakers must ensure their tablets follow the same scoring as reference-listed drugs, or brand-name meds. Why? The consistency would allow patients to switch between the different products without fear of receiving an improper dose. And as the FDA noted, consistent scoring ensures that neither a generic or a brand-name med has an advantage in the marketplace.

Source: Pharmalot


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