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RGLAX PHARMARglax Coat

ECMS

Enteric coat, methacrylic second bond

Second bond methacrylic enteric system for Mesalamine.

Application

Methacrylic base enteric coating on a second bond, formulated for Mesalamine enteric tablets where release has to be held until a defined point in the intestinal tract.

Formulated for

  • Mesalamine

How it runs

Hold the cool enteric band through the whole stage. The second bond is doing the work of holding release until a defined point in the tract, so dissolution testing rather than appearance is what tells you the coat is right.

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
ECMS
Coating system
Enteric Coating System
Process base
Non-aqueous (solvent)
Finish
Enteric film, delayed release
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 ECMS

Why is ECMS described as a second bond?

The second bond holds release until a defined point in the intestinal tract, which is what Mesalamine needs. A standard gastro resistant film releases too early for that product.

How do we confirm the coat is right?

By dissolution testing rather than appearance. A Mesalamine coat that looks correct can still release at the wrong point, so the dissolution profile is the acceptance criterion.