Can we reprocess/reowork on coated tablet after crushing them. kindly provide guidance guideline if any.
You can reprocess/rework film-coated tablets by crushing them to remove the film coating. Film coating is very light in weight and hence gets removed easily with the help of air current.
It is impossible or difficult to reprocess/rework sugar-coated tablets. Sugar coating can be removed by washing the tablets with water several times, and then drying the core tablets. The core tablets then should be crushed and reprocessed.
Before reprocessing the crushed tablets, the granular powder (crushed tablets) should be analyzed for the active ingredients and accordingly, those should be compensated. Before coating, the core tablets should be analyzed as per specification and if found meeting the specification, they should be taken for re-coating.
Delayed/modified released OR Enteric-coated tablets should be carefully reprocessed to ensure that the drug release profile is satisfactory as per the finished product specification.
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