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RGLAX PHARMARglax Coat

ECM-RP348

Enteric coat, methacrylic base, aqueous

Water base methacrylic enteric film for Diclofenac and Serratiopeptidase.

Application

Methacrylic base enteric coating for an aqueous process, formulated for Diclofenac and Serratiopeptidase enteric tablets. It takes solvent handling out of the enteric stage wherever the core allows a water base process.

Formulated for

  • Diclofenac
  • Serratiopeptidase

How it runs

The same cool band applies, around 30 to 32 degrees at the bed with a 45 to 50 degree inlet. A water base takes solvent handling out of the enteric stage, but drying at that low a bed temperature is slower, so plan for a longer stage rather than pushing the spray rate.

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-RP348
Coating system
Enteric Coating System
Process base
Aqueous
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-RP348

Which actives is ECM-RP348 formulated for?

Diclofenac and Serratiopeptidase enteric tablets. It is a methacrylic base film, the same polymer family as ECM-RP347, applied from water rather than solvent.

How does it differ from EC714?

Both are formulated for the same actives by different polymer routes. ECM-RP348 is methacrylic, EC714 is cellulose acetate phthalate. Choose EC714 where a CAP film is named in your filing, otherwise the aqueous methacrylic route is simpler to run.

Is the aqueous route slower?

The stage takes longer. Bed temperature still has to sit at 30 to 32 degrees to protect the polymer film, and drying water at that temperature is slower than drying solvent, so plan for a longer stage rather than pushing the spray rate.