Copyright © 2021 pubrica. All rights reserved 1

Reasons behind the Production of Defected

Tablets through Various Processes

Dr. Nancy Agnes, Head, Technical Operations, Pubrica, sales@pubrica.com

Keywords: Compression, Defects, Disease,

Pharmaceutics, Tablet

I. 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. 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. Other issues include Poor quality

of raw materials, formation of too many fines in the

milling process, defects in formulation process. bad

compressibility and flow of the powder (Rajani et al.,

2018).

II. 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).

Figure 1 : Capping defect (Rana & Kumar,

2013)

III. 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. 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).

IV. 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

Copyright © 2021 pubrica. All rights reserved 2

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. 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 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. 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).

V. 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).

Copyright © 2021 pubrica. All rights reserved 3

VI. 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. 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. 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.

REFERENCES

1. Chattoraj, S., Daugherity, P., McDermott, T.,

Olsofsky, A., Roth, W.J. & Tobyn, M. (2018).

Sticking and Picking in Pharmaceutical Tablet

Compression: An IQ Consortium Review.

Journal of Pharmaceutical Sciences. [Online].

107 (9). pp. 2267–2282. Available from:

https://linkinghub.elsevier.com/retrieve/pii/S002

2354918302922.

2. Jonathan Gaik (2018). Tablets and capsules

Soild doed Digest. [Online]. Available from:

https://www.tabletscapsules.com/enews_tc/2018/

issues/tcnews_11_26_18question.html.

3. pharmaguideline (2017). Different Types of

Defects of Tablets. [Online]. 2017. Available

from:

https://www.pharmaguideline.com/2017/09/diffe

rent-types-of-defects-of-tablets.html.

4. Rajani, C., Kumar, D.D., Jaya, D. & Kumar, J.A.

(2018). Effects of granule particle size and

lubricant concentration on tablet hardness

containing large concentration of polymers.

Brazilian Journal of Pharmaceutical Sciences.

[Online]. 53 (3). Available from:

http://www.scielo.br/scielo.php?script=sci_arttex

t&pid=S1984-

82502017000300617&lng=en&tlng=en.

5. Rana, A.S. & Kumar, S.L.H. (2013).

Manufacturing defects of tablets-a review.

Journal of Drug Delivery and Therapeutics.

[Online]. 3 (6). pp. 200–206. Available from:

http://jddtonline.info/index.php/jddt/article/view/

722.