A research on market complaint product: Detailed investigation and a report on broken film coated tablet inside an intact blister pack

Aim of present study was to determine the causes of a broken film coated tablet with black spots and a twisted tablet in blister pack of marketed product containing aceclofenac and paracetamol. Tablets of the complaint batch (batch No.22) and another batch (batch No.49) manufactured at the same facility of the company were procured and evaluated to find out the reasons. Physical appearance of these batches showed differences in colour which might be owing to the variations in concentration of dyes or improper spraying process. Although, both the batches passed weight variation test, but batch No.22 could not pass the friability test which might be due to low moisture contents in the granules. Hardness varied between two batches with an average of 2.2 kg/cm2. It was concluded that presence of broken tablet might be due to the high compaction forces or improper handling during loading-unloading into the automatic coating pan.