Enteric, delayed release
Phthalate base polymer
Also written as HPMC phthalate, phthalate enteric polymer.
Written by the Rglax Pharma technical team, who formulate and manufacture every grade named on this guide at our WHO-GMP works in Tahliwal, Una (drug manufacturing licence NNZ/23/238). Reviewed 3 September 2026. Licences and certificates.
What it is
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.
What it does in the film
A phthalate base gives a delayed release film whose dissolution behaviour differs from a methacrylic one even where both are described as enteric. The release point is governed by the polymer rather than by the build-up.
When to choose it
Where the product has been developed on a phthalate base, most commonly Duloxetine in our range. A profile developed on one enteric polymer does not carry across to another, so this is not a grade to substitute into an existing product.
How it runs on the coater
Enteric band throughout. Confirm both the acid stage and the buffer stage on the first trial batch rather than assuming a profile from another enteric product.
- Role
- Enteric, delayed release
- Also called
- HPMC phthalate, phthalate enteric polymer
- Grades on this base
- 1
- Systems
- Enteric coating
- Made at
- Plot No. 30, Industrial Area Tahliwal, Himachal Pradesh, India
Grades built on phthalate base polymer
What each grade on this base is for, and the actives it was formulated against. The process parameters are on each grade page.
Enteric coat, phthalate base
Phthalate base enteric system for Duloxetine enteric tablets.
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.
- Base ·
- Non-aqueous (solvent)
- Finish ·
- Enteric film, gastro resistant
- Formulated against ·
- Duloxetine
Read next
- Why an enteric coat runs cooler than a film coatThe two bands in our parameter tables are not a preference. They come from what the polymer does at temperature, and running the wrong one costs gastro resistance.
- Enteric Coating SystemDelayed release polymers on methacrylic, phthalate and CAP bases for aqueous or organic processing.
- Coating defects, and what causes themThe faults a film shows when the polymer is run outside its band, traced back to cause.
- Coating glossaryBuild-up, bed temperature, coalescence and the rest of the vocabulary this guide uses.
References
- FDA Inactive Ingredient Database
Maximum potency per dosage unit for each excipient in an approved US product.
- European Pharmacopoeia, EDQM
Excipient monographs, including the identity and purity tests a European buyer specifies against.
- USP-NF excipient monographs
The National Formulary monographs that US and Canadian specifications are written to.
- IPEC excipient GMP guide
The good manufacturing practice framework an excipient supplier is audited against.
Process bands quoted on this page are the ones our grades were developed on at Tahliwal. Confirm them on your own coater; a monograph describes the polymer, not your pan.
The other polymers
- Enteric, delayed releaseMethacrylic acid copolymermethacrylic base, acrylic enteric polymer
- Enteric, delayed releaseCellulose acetate phthalateCAP, CAP base
- Immediate release film, seal, sugar filmHypromelloseHPMC, hydroxypropyl methylcellulose
- Moisture barrier, immediate releasePolyvinyl alcoholPVA
- Enteric and moisture barrier film, glazingShellaclac resin, pharmaceutical glaze, E904
Films built on this polymer
Metallic gold film coat
Metallic blue DB3012
Aqueous colour film coat
Extra white film coat