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RGLAX PHARMARglax Coat

ECPT5

Enteric coat, phthalate base

Phthalate base enteric system for Duloxetine enteric tablets.

Application

Phthalate base enteric coating material formulated for Duloxetine enteric tablets, where the release profile is governed by the phthalate polymer rather than a methacrylic film.

Formulated for

  • Duloxetine

How it runs

Runs on the cool enteric band alongside the methacrylic grades. Because release is governed by the phthalate polymer rather than a methacrylic film, confirm both the acid stage and the buffer stage on the first trial batch rather than carrying over a profile from another enteric product.

Build-up and solids are fixed at trial.

The polymer

Phthalate base polymer (HPMC phthalate, phthalate enteric polymer)

A phthalate base governs release differently from a methacrylic film, so a dissolution profile developed on one does not carry across to the other. Confirm the acid stage and the buffer stage on the first trial batch.

Part of the Enteric Coating System range.

Product code
ECPT5
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 ECPT5

What is ECPT5 formulated for?

Duloxetine enteric tablets. Release is governed by a phthalate base polymer rather than a methacrylic film, which is why it is a separate grade rather than a shade of the methacrylic range.

Can a profile from another enteric grade be carried over?

No. Because the polymer differs, confirm both the acid stage and the buffer stage on the first trial batch instead of carrying over a dissolution profile from a methacrylic enteric product.