The internal challenges of tablet manufacturing basically talks about the processing problems faced due to the improper handling of machinery or excipients used. Produced or compressed tablets can develop certain defects which might appear immediately or only after storage. Following are the ten most common and important internal challenges of tablet manufacturing:
1. Breakage or Capping and Lamination
Capping is the breaking or separation of the top or the bottom of a compressed tablet from its main body. It might happen due to an improper ejection from the tablet die or for some procedural issues in subsequent operations, such as coating, packing, or shipment.
Lamination is another form of breaking, which is the transverse cracking and separation of the compressed tablet into two or more layers. It usually happens when cracks form within the compact tablet body, resulting in the tablet splitting in multiple layers.
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2. Sticking of ingredients over tool surfaces
Sticking is referred to the occurrence of sticking of the compact tablet ingredients on to the tooling surfaces. As it is compacts are repeatedly made in the tooling station, the problem gets even worse when more and more material gets accumulated to that already stuck amount on to the punch surface. The problem tends to be more prevalent on upper punches.
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3. Picking of tablet surfaces
Picking happens when a part of the tablet gets stuck on to the punch surface and eventually gets eroded from the tablet surface. To be more precise, it is product sticking within the letters, logos, or designs on the punch faces.
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4. Mottling or Mottled appearance
This specifically happens with the colored granules tablets, when there is as an uneven distribution of color on a tablet with light and dark areas.
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5. Chipping
Chipping is a very different phenomenon from the ones as mentioned above. It so happens that the compacts, after leaving the press or during subsequent handling and coating operations; are found to have small chips missing from their edges. This is what is known as ‘chipping’, and in addition to the obvious formulation faults, may be caused by compaction conditions which make extremely low mechanical strength, or too brittle tablets.
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6. Binding in the tablet die
This happens when there is an excessive side scraping of the die, along with the high compact ejection forces resulting in the compact edges go rough and scored.
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7. Embossing
It is about the imprinted text or digits, or spur lines on the tablets; being not exactly clear, or appear disfigured.
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8. Low tensile strength
Usually, higher the compaction pressure, denser the compact will be, and hence higher the resulting tensile strength of the compact. So obviously, too low a compaction pressure is responsible for a low tensile strength or “soft” and crumbly compacts.
Other probable reasons for low tensile strength are excessive coverage of the granulation by a lubricant, like a stearate, reducing the potential to form strong interparticle bonds; and the weakening of the intergranular bonds by air entrapment, even when this is not sufficient to cause capping.
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9. Weight variation
Weight non-uniformity is usually due to poor die filling. This might happen due to either poor quality granule, or due to inadequate filling mechanisms on the compression machine. The weight inequality may include too large or too fine size or contain a large proportion of fine materials, or incorrect lubrication or components with widely differing densities or sizes, and so on.
If the reason is poor granule flow, then the addition of glidants like silica or talc, can be used for rectification. As it is some particles happen to acquire a frictional electrostatic charge, that again might be sufficient to impede die filling. Talc (at up to 1%) or sodium lauryl sulphate (at up to 2%) are substances which have shown proven results when used to reduce this charging and which also have lubricating and anti-adherent properties. Lubricants like magnesium stearate, might at times promote granule flow, depending upon the level at which they are used, considering the fact that higher levels tend to impede flow.
Occasionally, with high-weight tablets, more uniform weight and improved appearance can be obtained by slowing the machine speed so allowing more time for die-cavity filling.
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10. Double Impression
A double impression involves only lower punches that have a monogram or other engraving on them. The punch can make double impressions on a tablet surface during the ejection process. This can be avoided by incorporating antiturning devices for the punches.
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