Reasons behind the production of defected tablets through various processes – Pubrica

Tablets are produced by mixing excipients and active pharmaceutical ingredient (API). The powder mixture is then compressed and a tablet in a solid form is obtained. A good tablet is free from any sort of defects (pharmaguideline, 2017). Common issues faced in the product development processes of tablets are as weight variation, hardness, friability, picking, laminating, mottling, sticking, capping, chipping, and double press or impression (Jonathan Gaik, 2018). Among these mentioned defects laminating/capping, hardness, and picking/sticking are the three most commonly encountered issues faced in the production process of making tablets. Generally, these defects stem from various issues in production process with unit upstream, tablet press, compression failure, and prevention of proper ejection of the product if it is too wet or too dry.

1. Capping

Capping phenomena occurs when there is fracture at the top of the tablet. The top layer gets separated and detached from the solid tablet body. This issue generally arises when air is trapped in the tablets powder material during the compression stage. Capping can also stem from the issue of failure of compression of the formulation because of accumulation of powder fines (Jonathan Gaik, 2018).

II. Lamination

The term lamination is used when a split occurs anywhere in the tablet other than the top layer. Usually, lamination defect is similar to capping and caused by the same issues. Nevertheless, it is essential to diagnose the issue of lamination in a proper manner. Often, lamination occurs due to over compression of the tablets.

III. Sticking and Picking

The defect of sticking happens when the formulation granules stick to the face of the press punch. Quite differently, picking defect occurs when the mixture granules stick on the design embossing of the punch tip such as in logos or lettering. Both picking and sticking result in the production of defective tablets. In quality control of the tablets, generally a visual inspection is carried out to identify picking and sticking. When, the batch of the product reach the compression stage, the skilled operator should efficiently adjust the press to comply with the product’s characteristic designs. The quality of the product is majorly affected by the tablet’s press setup, operation, tooling, and maintenance. There may be cases when the granules are not completely dried, in other words they may be hard and dry on the outside but wet and moist inside. This scenario in turn seriously affects the tablet’s quality.

IV. Tablet Hardness

Another issue arising in tablet production process is the variation in the hardness of the tablets. A soft tablet tends to cause a range of issues not only in the press process but also in the consistency of the product. A soft tablet can lead to product recall due to poor film coating process and packaging of the product (Rajani et al., 2018).

Conclusion:

Tablet manufacture is shown significantly increase the likelihood of tablet defects through breakage of tablets. Increasing tablet tensile strength provides some resistance to defects upon impact. The remedies are change the solvent system, change the binder, reduce drying temperature and use a smaller particle size, improperly mixed dye especially during direct compression.

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