Reasons behind the production of defected tablets through various processes - Pubrica
                     REASONS BEHIND THE  
PRODUCTION OF 
DEFECTED  TABLETS 
THROUGH  VARIOUS 
PROCESSES
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, Pubrica 
 Group: www.pubrica.com
Email: [email protected]
Today's Discussion
Outline
Introduction
Capping  
Laminatio
n
Sticking and 
Picking  Tablet 
Hardness  
Conclusion
Introduction
With increasing number of patients and diseases,
the  need for medicines is growing more than ever.
This has created pressure on the
pharmaceutical  industries to product high quality of 
medicines.
Tablets are a form of medicine which is solid and
is  given as oral dosage.
Tablets are the highest selling dosage form of medicine.
Contd...
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). Contd...
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.
Other issues include Poor quality raw  materials, 
of  formation of too many fines in milling  
tdheefects in formulation process. bad compressibpilriotycess,
and  flow of the powder (Rajani et al., 2018).
Cappin
Capping phenomena occurs when there is fracture at g
 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).
Contd...
Figure : Capping defect
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.
Contd...
As greater compression can cause the  
granules to flatten out and thus prevent them  
from binding together.
Lamination may also occur when fine or light  
particles do not combine, as the particles fail 
 to compress well (Jonathan Gaik, 2018).
Contd...
Contd...

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.
Contd...
However, this method of visual inspection is very  
time-consuming and tends to decrease the overall  
production yield of the tablet.
Unfortunately sometimes many manufacturers have  
no option but to carry out visual detection as a quality  
control measure.
When, the batch  of the product reach the  
 stage, the skilled operator
ceoffmicipernetslysioandjust the shporeuslds to comply with
the  product’s characteristic designs.
Contd...
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.
Contd...
The un dried particles can break open during  
compression and stick to the punch press surfaces  
causing sticking.
In such cases it is essential to keep checking the  
process of drying the granules (Rajani et al., 2018;  
Chattoraj et al., 2018).
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.
Contd...
Mix it properly and reduce size if it is of a larger 
 size to prevent segregation.
Tablets are widely used dosage forms but  
defects in aesthetic appearance may lead to  
rejection of their administration by patient.
Be careful during manufacturing process.
Contd...
The cost vs benefit equation mainly focuses on  
the pharmaceutical innovations which will be an 
 integral part to address this challenge.
The adequacies of drug benefit programs and  
policies that foster investment in newer  
medicines pay way for the new pharmaceutical  
environment.
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