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Rglax Pharma

Coating defect

Loss of gastro resistance

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

Written by the Rglax Pharma technical team, who formulate and manufacture every grade named on this guide at our WHO-GMP works in Tahliwal, Una (drug manufacturing licence NNZ/23/238). Reviewed 3 September 2026. Licences and certificates.

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

Worth knowing

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.

Every cause above is a process parameter, not a property of the material. If you are seeing loss of gastro resistance on a grade of ours, send us the run conditions and a retained sample and we will work back from them — start at the contact page.

A heap of fine white powder
Loss of gastro resistance, as it appears on a coated tablet. Illustration, not a photograph of production material.

Grades formulated against it

Where loss of gastro resistance is the problem the grade was made for

  • Transparent seal coat and pre-coat

    Clear sub-coat laid down before an enteric layer on acid labile cores.

    Transparent layer seal coat or pre-coat applied ahead of an enteric coat, specified for the Pantoprazole group. It isolates the core from the enteric polymer and gives the functional layer a uniform surface to build on.

    Base ·
    Aqueous or non-aqueous
    Finish ·
    Transparent
    Formulated against ·
    Pantoprazole group
  • Enteric coat, methacrylic base, non-aqueous

    Solvent base methacrylic enteric film for the Pantoprazole group.

    Methacrylic base enteric coating applied from a non-aqueous system, formulated for the Pantoprazole group and other dissolution critical enteric tablets. It runs best over a transparent seal coat such as SC-401, which protects the acid labile core.

    Base ·
    Non-aqueous (solvent)
    Finish ·
    Enteric film, gastro resistant
    Formulated against ·
    Pantoprazole group
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