COSMETICS & PERSONAL CARE
Shin-Etsu
Tokyo, Japan · Producing pharmaceutical excipients since 1962
The cellulose ether standard for oral solid dose.
Almost every oral solid dosage form built in the last forty years has a Shin-Etsu decision somewhere in it: the hypromellose in the film coat, the matrix polymer controlling release, the disintegrant preventing capping, or the enteric polymer deciding where in the gastrointestinal tract the drug is released.
Shin-Etsu Chemical began producing pharmaceutical excipients in 1962 and has developed the substitution chemistry of cellulose ethers further than any other manufacturer. The result is a portfolio where a formulator can move between coating, matrix, disintegration, enteric protection and bioavailability enhancement without leaving one polymer family.
- Cosmetics & Personal Care
Over 400 mineral salts and more than 7,000 specifications. The specification count is the more meaningful number: it is the measure of how far a grade can be tailored.
ABOUT THIS PRINCIPAL
Sixty years of substitution chemistry.
Shin-Etsu's excipient business is built on control of a single chemistry taken to an unusual level of precision. Hypromellose is not one material: methoxy and hydroxypropoxy substitution levels, viscosity grade, and particle size distribution together determine whether a polymer coats, gels, disintegrates, or protects. Shin-Etsu segments its grades along all of those axes and specifies them tightly enough that a formulation developed at laboratory scale behaves the same way in production.
Regulated grades are manufactured at Naoetsu in Japan, covering METOLOSE, METOLOSE SR, PHARMACOAT, L-HPC, HPMCP and Shin-Etsu AQOAT, and at Wiesbaden in Germany, covering the TYLOPUR and TYLOPUR SR ranges. Both operate under GMP.
The enteric and bioavailability portfolio is where the science is most differentiated. HPMCP has been in use as an enteric coating since 1971. Shin-Etsu AQOAT, a hypromellose acetate succinate, was approved as a pharmaceutical excipient in Japan in 1987, listed in USP/NF in 2005, in JP in 2012, and in EP in 2024. It functions both as an enteric coating and as a solid dispersion carrier for poorly soluble drugs.
AQOAT is the rare excipient that solves two different problems with the same polymer: delayed release, and the amorphous stabilisation of a poorly soluble molecule.
ADCHEM distributes the Shin-Etsu pharmaceutical excipient range with formulation and troubleshooting support from our own laboratories, covering grade selection, coating trials, and matrix release profiling.
FEATURED TECHNOLOGY
Four areas where the chemistry earns its position.
Most Shin-Etsu projects fall into one of the following four technical problems.
Coating
Film coating and moisture protection
PHARMACOAT low viscosity hypromellose grades give reproducible film formation, adhesion, and moisture barrier without the mechanical brittleness of higher viscosity polymers.
Release Control
Hydrophilic matrix systems
METOLOSE SR carries tighter specifications than standard grades because matrix release depends on hydration rate and gel strength. It is designed exclusively for the hydrophilic matrix system, the simplest sustained release architecture available.
Enteric Protection
pH-targeted delayed release
HPMCP dissolves in the pH 5 to 5.5 region, tunable by phthalyl content across the HP-50 and HP-55 grades. Shin-Etsu AQOAT extends the range across nine grades with dissolution thresholds from approximately pH 5.5 to 6.5.
Bio Availability
Amorphous solid dispersion
AQOAT is widely used as a carrier for solid dispersions to enhance the solubility of poorly soluble drugs, processed by spray drying or hot melt extrusion. It is a bioavailability tool, not only a coating.
Portfolio
The Shin-Etsu excipient portfolio.
Grade selection is driven by dosage form, release target, and process. The ranges below cover the majority of oral solid dose requirements.
PHARMACOAT
What it is
Hypromellose, low viscosity coating grades, USP
Primary Use
Aqueous and organic film coating, moisture protection, seal coating
METOLOSE
What it is
Hypromellose and methylcellulose across a wide viscosity range, USP / EP / JP
Primary Use
Binder, film former, thickener, and viscosity modifier across solid and liquid dosage forms
METOLOSE SR
What it is
Hypromellose grades with tightened substitution and particle specifications for matrix release
Primary Use
Sustained release hydrophilic matrix tablets, by direct compression or wet granulation
L-HPC
What it is
Low-substituted hydroxypropyl cellulose; swells in water without dissolving
Primary Use
Disintegrant and dry binder; capping prevention, direct compression, wet granulation
HPMCP HP-50
What it is
Hypromellose phthalate with lower phthalyl content, dissolving at the lower end of the enteric range
Primary Use
Enteric coating where earlier release in the small intestine is required
HPMCP HP-55
What it is
Hypromellose phthalate, the more widely used enteric grade
Primary Use
Gastro-resistant coating, protection of acid-labile drugs and of gastric mucosa
Shin-Etsu AQOAT AS-L
What it is
Hypromellose acetate succinate, low grade; dissolution from approximately pH 5.5
Primary Use
Enteric coating and solid dispersion carrier for earlier release profiles
Shin-Etsu AQOAT AS-M
What it is
Hypromellose acetate succinate, medium grade; dissolution from approximately pH 6.0
Primary Use
Enteric coating and amorphous solid dispersion, the most widely used AQOAT grade
Shin-Etsu AQOAT AS-H
What it is
Hypromellose acetate succinate, high grade; dissolution from approximately pH 6.5
Primary Use
Distal delayed release and solid dispersion where later release is targeted
AQOAT particle grades (F / MP / G)
What it is
Fine, medium and granular particle size variants of each AQOAT substitution grade
Primary Use
Fine for fully neutralised aqueous coating and spray drying, granular for organic solution and hot melt extrusion
SmartEx
What it is
Co-processed excipient system for orally disintegrating tablets
Primary Use
ODT formats requiring rapid disintegration with acceptable tablet hardness
TYLOPUR and TYLOPUR SR
What it is
Cellulose ether ranges manufactured at Wiesbaden, Germany
Primary Use
Coating, binding and sustained release, with European manufacture where that is a supply requirement
APPLICATION AREAS
Where Shin-Etsu excipients perform.
Immediate release film coating
PHARMACOAT grades for cosmetic, seal and moisture-barrier coats with predictable spray parameters and low tack.
PHARMACOAT
METOLOSE
Sustained and controlled release
METOLOSE SR hydrophilic matrix systems, the most robust route to a controlled release profile that survives scale-up.
METOLOSE SR
Enteric and delayed release
HPMCP and AQOAT give a tunable dissolution threshold across the physiologically relevant pH range, in aqueous or organic systems.
HPMCP HP-55
AQOAT AS-M
Bioavailability enhancement
AQOAT as an amorphous solid dispersion carrier for BCS class II and IV molecules, via spray drying or hot melt extrusion.
AQOAT
SPRAY DRYING
HME
Disintegration and compression
L-HPC as a multifunctional problem solver for capping, hardness, and disintegration time in direct compression formats.
L-HPC
Orally disintegrating tablets
SmartEx for ODT formats where disintegration speed and tablet robustness are normally in direct conflict.
SMARTEX
DOCUMENTATION TO BE HELD
Regulatory documentation that supports the filing, not just the purchase order.
Shin-Etsu excipients are supplied with the documentation set required for regulatory submission and for supplier qualification: compendial compliance, GMP evidence, impurity and safety declarations, and reference to filed Drug Master Files where applicable. Shin-Etsu also publishes application guides and troubleshooting resources covering tablet defects and enteric coating problems, which shorten development cycles materially.
Product & Quality
- Product specification sheet
- Certificate of Analysis (CoA), batch specific
- Safety Data Sheet (SDS / MSDS)
- Compendial compliance statement against USP/NF, Ph. Eur., JP or BP as applicable
- Analytical methods and method validation summary
- Physical characterisation data: particle size distribution, bulk and tapped density, loss on drying
- Stability data with retest period or shelf life justification
Regulatory filings
- Drug Master File number with Letter of Access
- Certificate of Suitability (CEP / COS) where filed
- Written Confirmation for API import into the European Union
- Manufacturing licence and site registration details
- Open part documentation for inclusion in the applicant’s submission
- Regulatory support commitment for market registration and variations
GMP and quality system
- GMP certificate for the manufacturing site
- Excipient GMP statement aligned to IPEC-PQG or EXCiPACT, for excipient grades
- ISO 9001 certificate
- Quality Agreement
- Change control and prior notification commitment
- Most recent regulatory inspection outcome summary
- Completed supplier questionnaire or audit report
Impurities and biological safety
- Elemental impurities risk assessment (ICH Q3D)
- Residual solvents data (ICH Q3C)
- Genotoxic and mutagenic impurity assessment (ICH M7)
- Nitrosamine risk evaluation
- Related substances and impurity profile with named and characterised impurities
- Microbiological limits and bioburden data
- Bacterial endotoxin data where the grade or route requires it
Origin and declarations
- Manufacturing process flow chart and route of synthesis summary
- Starting material identity and origin statement
- TSE / BSE-free declaration
- GMO-free statement
- Allergen statement
- Residual antibiotic and cross-contamination control statement
- Latex-free and melamine-free statements
- Country of origin declaration
- Halal and Kosher certificates where required by the market
- Packaging and container closure specification
WORKING WITH ADCHEM
What ADCHEM adds to the Shin-Etsu relationship.
DEVELOPMENT SUPPORT
Grade selection against the release target
Hypromellose grade selection is where most oral solid dose projects lose time. We work from the target dissolution profile backwards to viscosity grade and substitution type.
LABORATORY TRIALS
Coating and matrix trials
Our formulation laboratories run coating and matrix trials on the selected grade so the transfer into your production equipment starts from validated parameters.
SUBMISSION-READY
Filing documentation assembly
Compendial statements, DMF references, impurity declarations and GMP evidence compiled into the format your regulatory affairs team needs for submission.
AUTO-ATTACHED VIA COSMO
Full documentation with every sample
Specification, SDS, CoA, compendial statement and applicable declarations dispatched with the sample as standard, via COSMO, our digital platform.
On this page
Quick facts
HQ
Tokyo, Japan
Founded
1962
Manufacturing
Naoetsu, Japan and Wiesbaden, Germany (SE Tylose)
SEGMENT
Cellulose ether excipients for oral solid and oral liquid dosage forms
Compendial Status
USP/NF, EP and JP monograph compliance across the principal ranges
Quality System
GMP manufacture, subject to FDA inspection
Application Support
Published application guides, tablet troubleshooting and enteric coating troubleshooting resources
One polymer family, from the coat to the release profile.
Three ways to start: a sample, a technical data sheet, or a conversation with a specialist who can discuss substitution type and dissolution threshold before discussing quantities.
Request a Sample
Any product in the portfolio
Request Technical Data
Full technical library
Talk to Our Specialist
Someone who knows the chemistry first
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