E-DRUG: Splitting of FDC tablets (2)
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Further to Chengetanai T. Mangoro's enquiry:
Even if a tablet is intended to be homogenous, there may be a problem with
content uniformity of divided tablets, and especially when one or more of
the actives is present at a low dose.
At TGA our view was that, if a manufacturer wanted to recommend a dose that required a tablet to be divided, then (1) the tablet had to have a score line and (2) the manufacturer had to demonstrate that dividing tablets produced an accurate dose.
Some tablets crumble rather than break cleanly. Without a score line,
the possibility of poor dose uniformity is much greater.
regards
Susan Walters
Retired regulator
Australia
susanw@netspeed.com.au