We have a problem with Diltiazem 60 tablets. We have the Dissolution profile of Diltiazem tablet cores according to the USP monograph (Diltiazem Hydrochloride Tablets). Tablet cores passed the mentioned criteria in USP but Their film-coated tablets have an increased dissolution profile so they did not pass USP acceptance criteria.
Any experience or any comment about it?
Hitesh Chavda
Dear Fahimeh Zamani,
Despite the fact that a number of variables might be at play, the coating process parameters have a more significant impact on tablet core behavior than the coating itself.
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