Coating the Pantoprazole group
Pantoprazole sodium
The problem
Pantoprazole is acid labile. It degrades in stomach acid, so the tablet has to reach the intestine intact. It is also sensitive to the enteric polymer itself, which means an enteric film applied straight onto the core creates its own problem while solving another.
The sequence
- 01Apply SC-401 as a transparent seal coat first. Keep it thin. Its job is to isolate the core from the enteric polymer, not to cover.
- 02Apply ECM-RP347 over the seal. It is a methacrylic base enteric film from a non-aqueous system, formulated for this group.
- 03Hold the enteric stage on the cool band throughout, 30 to 32 degrees at the tablet bed against a 45 to 50 degree inlet.
- 04Confirm both stages of dissolution on the first trial batch, the acid stage the film must survive and the buffer stage in which it must release.
What to watch for
A batch that looks correct can still fail the acid stage. The usual causes are a bed run warmer than the band allows, which softens the polymer, or incomplete film continuity over edges and debossing. Appearance is not the acceptance criterion here, dissolution is.
This note describes the sequence, not measured results. Build-up, dispersion solids and dissolution figures depend on your core and your equipment and are fixed during trials at your plant.