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RGLAX PHARMARglax Coat

EC714

Enteric coat, CAP base

Cellulose acetate phthalate enteric film for Diclofenac and Serratiopeptidase.

Application

CAP base enteric coating material for Diclofenac and Serratiopeptidase enteric tablets. It is the alternative polymer route to ECM-RP348 where a CAP film is specified.

Formulated for

  • Diclofenac
  • Serratiopeptidase

How it runs

The same cool enteric band as the methacrylic grades. Choose it over ECM-RP348 where a CAP film is specified in your filing, since the two are formulated for the same actives by different polymer routes.

Build-up and solids are fixed at trial.

The polymer

Cellulose acetate phthalate (CAP, CAP base)

CAP is the older of the enteric polymers and is still named in many filings. Where your dossier specifies a CAP film, the methacrylic route is not a substitution you can make without a change control, which is why we hold a CAP grade for the same actives.

Part of the Enteric Coating System range.

Product code
EC714
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 EC714

When should EC714 be chosen over ECM-RP348?

When a CAP film is specified in your filing. Both grades are formulated for Diclofenac and Serratiopeptidase enteric tablets, but EC714 builds the film on cellulose acetate phthalate rather than a methacrylic polymer.

What temperature does it run at?

The standard enteric band. Bed at 30 to 32 degrees, inlet at 45 to 50, across every pan size from 12 to 48 inch.