SHINETSU CHEMICAL CO., JAPAN

Shin-Etsu, founded in Japan in 1926, has grown to become the world’s largest producer of methylcellulose and hypromellose. The company’s speciality products include film coating materials, binders, water soluble cellulose ethers and their derivatives, sustained-release agents and enteric coating materials. As part of their expansion strategy, they acquired the cellulose business unit of the Swiss based company, Clariant.

The company’s Naoetsu plant fully implements the Shin-Etsu ‘six sigma’ activities and pursues the principle of ‘total quality control’. Their speciality chemicals research centre proactively works on new applications for existing products and on development of innovative products to meet the customer’s ever growing needs.

Shin-Etsu’s corporate symbol, ‘memorable glow’ is representative of their abidance to advanced technology, top quality, dynamism, high spirits and flexibility, all of which are activated by the light source at the centre, and today, this company has made themselves indispensible in the development of successful and new generation formulations.

Pharmacoat
Hypromellose USP/NF, EP, JP

Pharmacoat is a low viscosity hydroxypropyl methylcellulose polymer which is easy to use as a film coating material and gives an excellent finish to the final product. It is versatile and suitable for many applications in the design of film coated tablet formulations.

This product is also effective as a binder since it does not interact with drugs, has superior stability and is non-ionic in character.

 GradeSubstitution TypeLabeled Viscosity (mPa¥s)*
6033
64529104.5
Pharmacoat 606 6
615 15
904 2208 4

Note: * 2 wt.% aqueous solution at 20oC according to the USP measuring method.
Pharmacoat 904 is especially useful as a binder for sugar coating.

METOLOSE®
Hypromellose USP/NF, EP, JP and
Methylcellulose USP/NF, EP, JP

Metolose is a non-ionic, water soluble cellulose ether derived from highly purified natural pulp by initial treatment with caustic soda to obtain alkali-cellulose, followed by etherification with methyl chloride or with the combination of methyl chloride and propylene oxide.

It can be used as a binder for solid dosage forms and enjoys a variety of properties such as water retention, thickening, sustained-release, protective colloid.

Metolose consists of methylcellulose and three substitution types of hypromellose each available in several grades of differing viscosity. Shin-Etsu also manufactures Metolose SR grades specifically for use in hydrophilic sustained-release matrix systems.

 TypeViscosity Grade* (mPa¥s)Substitution TypeMethoxy
Content(%)
Hydroxypropoxy
Content(%)
SM 4,15,25,100,400
1500,4000
(Methylcellulose)26.0-33.0-
Metolose60SH 50,4000,10000291028.0-30.07.0-12.0
65SH 50,400,4000 290627.0-30.04.0-7.5
90SH4000,15000,100000 220819.0-24.04.0-12.0

Note: * 2 wt.% aqueous solution at 20oC according to the USP measuring method.

METOLOSE – SR®
Hypromellose USP/NF, EP, JP

Metolose SR is designed exclusively for a hydrophilic matrix agent. It has tighter specifications compared to the regular Metolose grades.
The hydrophilic matrix system is the simplest sustained-release technology for oral dosage forms, consisting essentially of a drug and a water-soluble, highly viscous polymer.
Metolose SR has a high level of consistency in its product quality.

 TypeViscosity Grade* (mPa¥s)Substitution TypeMethoxy
Content(%)
Hydroxypropoxy
Content(%)
Particle size(%)
100SR
Metolose SR90SH4000SR220822.0-24.08.0-12.0150 m on
less than 5.0%
15000SR
100000SR

Note: * 2 wt.% aqueous solution at 20oC according to the USP measuring method.
The degree of substitution and powder properties (i.e.; particle size, etc.) of Metolose SR grades are controlled to a limited range which is suitable for sustained release preparations from the view point of functionality and processability.
Metolose SR grades are suitable for direct compression and wet granulation.

L-HPC
Low-substituted Hydroxypropyl Cellulose USP/NF, JP

LHPC is a low-substituted hydroxypropyl ether of cellulose. It is non-ionic, less reactive to active ingredients, insoluble in water and alcohol but swells in water by holding water molecules around hydroxypropyl groups that are distributed on the cellulose backbone. L-HPC is widely used as a dual-functionality excipient (binder-disintegrant) for tablets, granules or other pharmaceutical solid dosage forms depending on its particle size and substituent content. Tablets containing L-HPC disintegrate into very fine individual particles thus resulting in rapid drug dissolution.

ShinEtsu has also launched new ‘L-HPC NBD’ grades with different particle morphology that are designed to significantly improve binding capability.

LH series

GradeParticle appearanceCharacteristicsHydroxypropoxy content(%)Mean particle size(ƒÊm)90% cumulated particle size(ƒÊmTypical application
LH-1Most fibrousHighly anti-capping effect1155175Direct compression, Wet granulation (anti-capping)
LH-21Moderately fibrousRegular grade1145135Direct compression, Wet granulation
LH-22Moderately fibrousHigh swelling speed845135Direct compression, Wet granulation (sometimes better disintegration)
LH-B1Non fibrous/High densityHighly swelling force1155125Fluid-bed granulation, direct compression for high-load formulation
LH-31MicronizedHigh binding strength112070Pellet extrusion, layering
LH-32MicronizedHigh binding strength82070Pellet extrusion, layering

NBD series
GradeParticle appearanceCharacteristicsHydroxypropoxy content(%)Mean particle size(ƒÊm)90% cumulated particle size(ƒÊm)Typical application
NBD-022Short fiber (uniformlyHigh swelling speed845100Oral disintegrating tablet, Direct compression
NBD-021Short fiber (uniformly)Regular garde1145100Direct compression, Wet granulation
NBD-020Short fiber (uniformly)High binding strength1445100Wet granulation

HPMCP
Hypromellose Phthalate USP/NF, EP, JP

This product is a monophthalic acid ester of hypromellose, widely used a solvent-based enteric coating agent to protect drugs from gastric degradation or to protect the gastric mucosa from irritant drugs. Its threshold pH value for rapid disintegration can be controlled by varying the phthalyl content.

 GradeNominal Phthalyl
Content
pH SolubilityLabeled Viscosity (cSt)*
5024%≤5.055
HPMCP5540
55S31% ≥ 5.5170

Note: * 10 wt.% in a mixture of equal weights of Methanol and Methylene Chloride according to the USP/NF measuring method.

SHIN-ETSU AQOAT®
Hypromellose Acetate Succinate USP/NF, JPE

This excipient is a novel, enteric coating polymer manufactured from highly purified pulp involving introduction of acetyl and succinoyl groups into the hydroxyl backbone of hypromellose.

The characteristics of ‘Shin-Etsu AQOAT’ allow its use in different coating techniques such as aqueous, solvent based, ammonia neutralization and dry / deposition coating. It is also recommended in solid dispersions to enhance the bioavailability of poorly soluble drugs as well as in the design of controlled-release dosage forms for targeting drug release to specific gastrointestinal sites.

Various grades of ‘Shin-Etsu AQOAT’ are available which differ in chemical substitution levels and particle sizes.