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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.
- 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).
- 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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