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RGLAX PHARMARglax Coat

Tablet coating defects and what causes them

What each defect looks like and what usually sits behind it. The correction depends on your core, your equipment and your batch, so it is settled at trial rather than prescribed here.

Logo bridging

The film lifts out of an embossed logo or break line and spans across it, so the debossing goes shallow or disappears.

What usually sits behind it

  • Film applied beyond the build-up the debossing can carry
  • A film with high internal stress as it dries
  • Shallow or steeply cut debossing on the punch

An extra white grade reaches full cover at a lower build-up, so there is less film sitting over the logo by the time the core is hidden.

Picking and sticking

Tablets adhere to each other or to the pan, and fragments of film or core pull away, leaving pitted faces.

What usually sits behind it

  • The bed is wetter than the drying can carry
  • Spray rate ahead of inlet temperature and air volume
  • A tacky film at the bed temperature being run
  • A hygroscopic active pulling moisture in before coating even starts

Where the trouble starts on the press rather than in the pan, the moisture is in the powder and an adsorbent addresses it earlier than any coating change can.

Grades that bear on this

Orange peel and roughness

A dimpled, matt surface rather than a smooth gloss, most visible under raking light.

What usually sits behind it

  • Droplets drying before they spread and coalesce
  • Spray too far from the bed, or atomising air too high
  • Inlet temperature high for the dispersion being sprayed

Colour variation

Shade differs tablet to tablet within a batch, or between batches that were meant to match.

What usually sits behind it

  • Uneven distribution of the dispersion across the bed
  • Pigment settling in the dispersion during a long run
  • Comparing shade under a different light source from the one it was approved under

Metallic pigments shift more than conventional ones between daylight and tube light, so the inspection light has to be fixed before the shade is judged.

Loss of gastro resistance

An enteric batch that looks correct fails the acid stage, releasing before it should.

What usually sits behind it

  • Bed temperature run above the band the enteric polymer tolerates, softening the film
  • Insufficient film continuity over edges and debossing
  • Enteric layer applied straight onto an acid labile core without a seal coat

The enteric band sits at 30 to 32 degrees at the bed against a 45 to 50 degree inlet, well below the film coating band, and that gap is the reason.

Moisture driven instability

Coated tablets pass release but drift on stability. Colour changes, assay falls, or degradation products rise.

What usually sits behind it

  • A film that covers but does not act as a barrier
  • A long open hold between coating and blistering
  • A core that was already carrying moisture before the coat went on

Colour drift on early stability pulls is usually the first visible sign, ahead of any change in assay.

Dissolution failure after coating

An uncoated core that met specification falls outside it once coated, or disintegration time lengthens.

What usually sits behind it

  • Film build-up beyond what the release profile allows
  • A film chosen for appearance on a core where dissolution is the constraint
  • A core that was already marginal before the coat was applied

Running into one of these on a batch? Send us the core and the symptom and we will work back from there.