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RGLAX PHARMARglax Coat

ECM-RP347

Enteric coat, methacrylic base, non-aqueous

Solvent base methacrylic enteric film for the Pantoprazole group.

Application

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.

Formulated for

  • Pantoprazole group

How it runs

Lay SC-401 down first as a transparent seal, then apply the enteric film over it. The enteric stage runs cool throughout, around 30 to 32 degrees at the bed against a 45 to 50 degree inlet, because a hot bed softens the polymer and the finished film loses gastro resistance. Non-aqueous, so solvent handling applies to the functional stage.

Build-up and solids are fixed at trial.

The polymer

Methacrylic acid copolymer (methacrylic base, acrylic enteric polymer)

Methacrylic acid copolymers stay intact in the stomach and dissolve once pH rises in the intestine. They carry most of the enteric range because they can be applied from either a solvent or a water base, which lets the same polymer family serve cores that can and cannot tolerate an aqueous process.

Part of the Enteric Coating System range.

Product code
ECM-RP347
Coating system
Enteric Coating System
Process base
Non-aqueous (solvent)
Finish
Enteric film, gastro resistant
Supply form
Ready-mix, dispersed on site

How the coat sits on the tablet

Enteric filmMethacrylic, phthalate or CAPSeal coatSC-401, isolates the coreTablet coreCompressed active and excipientsCross-section, not to scale
An enteric system is two layers, not one. The seal isolates an acid labile core, the enteric film holds through the stomach and releases as pH rises.

Starting parameters

Rglax Coat enteric coating

Bed temperature is held low through the functional layer, which protects the polymer film. Settings are indicative and confirmed against your core during trials.

Coating equipmentConventional coater12 inch panAuto coater24 inch panConventional coater36 inch panAuto coater48 inch pan
Pan speed (rpm)18 to 2010 to 148 to 123 to 5
Tablet charge (kg)0.5 to 13 to 540 to 50100 to 130
Tablet bed temp (°C)30 to 3230 to 3230 to 3230 to 32
Inlet temp (°C)45 to 5045 to 5045 to 5045 to 50

Common questions about ECM-RP347

Does ECM-RP347 need a seal coat underneath?

Yes for the Pantoprazole group. Lay SC-401 down first as a transparent seal, then apply the enteric film over it. The seal isolates the acid labile core from the enteric polymer and gives the functional layer an even surface to build on.

Can it run on a 24 inch conventional coater?

Yes. At 24 inch the pan runs at 10 to 14 rpm with a 3 to 5 kg charge. Hold the bed at 30 to 32 degrees against a 45 to 50 degree inlet, the same as every other grade in the enteric range.

Is it aqueous or solvent based?

Solvent based. It is a methacrylic film applied from a non-aqueous system, so solvent handling and area classification apply to the enteric stage. Where your core allows a water base process, ECM-RP348 is the aqueous equivalent.