How do we perform content uniformity for tablet’s break-score validation?
If we use USP <905>, the test should be done to 10 tablets or 10 divided tablets?
For example, for tablet with break score that allowed to split the tablet to 2 parts. We should perform the test to10 tablets (20 divided tablets) or 10 divided tablets (from 5 tablets)?
Thanks in advance.
As per USFDA’s “Tablet Scoring: Nomenclature, labeling and data for evolution” (draft guide), “the split tablet portions should meet the same finished-product testing requirements as for a whole-tablet product with equivalent strength. The assessment should be undertaken on both tablets that are split nonmechanically (by hand) and tablets that are split mechanically (with a tablet splitter)…”