Investigation to find out the Root Cause for Presence of Broken Tablet in the Marketed Blister Pack

Abstract

The main objective of this study was to find out the root cause for broken tablet and black spots on tablets in primary pack of the marketed product containing Diclofenac sodium 50 mg and Paracetamol500 mg. In this study, we took tablets of same batch in which broken tablet (Batch A) was found and another batch (Batch B) from the same company was procured (for investigation) and they were evaluated for parameters like appearance, weight variation, hardness and friability. The results of (Batch A) and (Batch B) showed that weight variation, Friability was within limit according to Indian pharmacopeia, Hardness of both batcheswas found to be 9 kg.Based on the investigation, it was concluded that there was no formulation defect in the Batch-A tablets.Breakage of the tablet at the edge must be due to somephysical damage or some other reason. This wasconcluded from results of friability, weight variation andhardness tests. Appearance of black color spots on thetablet surface was not due to formulation problem. Itmay be due to instrumental problems like excessive useof oil- Based Lubricants etc. Finally to sum up, it isrecommended to carry out 100% tablet inspection beforeprimary packing activity which shall avoid defectivetablets getting packed into blister. Broken tablet found in the (Batch A) was due to some physical damage or any other reason during shipping and storage. Black colour spots found on the surface of the tablet may be due excessive usage of oil lubricants, more amount fines in the powder blend.