EUDRAGIT® E 100, EUDRAGIT® E PO and EUDRAGIT® E 12,5

The EUDRAGIT® portfolio of functional polymers delivers unrivalled versatility and reliability to help protect your API, boost drug product effectiveness and reduce formulation risk. With a proven record for safe applications that spans more than 60 years backed by monographs across all major pharmacopoeias, they are ideal for use with all oral solid dosage forms including multiparticulates, regular or matrix tablets and hard or soft-gel capsules. EUDRAGIT® polymers are easy to handle and process at any scale, with multiple options available for supply as aqueous dispersions, granules, organic solutions, powders, or ready-to-use powders. EUDRAGIT® polymers are compatible with all relevant process technologies including film coating, melt, wet or dry granulation, hot melt extrusion, micro-encapsulation and spray drying. Furthermore, all of our polymers are manufactured to a consistent high-quality, with established, audited sites helping to provide global supply security.

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1. Commercial form

EUDRAGIT® E 100
Solid substance
EUDRAGIT® E 100 is described in the monographs quoted above.

EUDRAGIT® E PO
Solid substance obtained from EUDRAGIT® E 100.
EUDRAGIT® E PO is described in the Ph. Eur. and JPE monographs quoted above.
The polymer conforms to the USP/NF monograph quoted above.

EUDRAGIT® E 12,5
Solution of EUDRAGIT® E 100 with 12.5 % (w/w) dry substance in a mixture of 60 % (w/w) Isopropyl Alcohol Ph. Eur. / USP and 40 % (w/w) Acetone Ph. Eur. / NF.

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2 Chemical structure

EUDRAGIT® E 100 is a cationic copolymer based on dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate with a ratio of 2:1:1.

The monomers are randomly distributed along the copolymer chain. Based on SEC method the weight average molar mass (Mw) of EUDRAGIT® E 100; EUDRAGIT® E PO and EUDRAGIT® E 12,5 is approximately 47,000 g/mol.

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3 Characters

Description

EUDRAGIT® E 100: colourless to yellow tinged granules with a characteristic amine-like odour.
EUDRAGIT® E PO: white powder with a characteristic amine-like odour.
EUDRAGIT® E 12,5: light yellow liquid of low viscosity, clear to slightly cloudy with a characteristic odour of the solvents.

Solubility

1 g of EUDRAGIT® E 100 or EUDRAGIT® E PO dissolves in 7 g methanol, ethanol, isopropyl alcohol, acetone, ethyl acetate, methylene chloride or 1 N hydrochloric acid to give clear to slightly cloudy solutions. EUDRAGIT® E 12,5 is mixable with these solvents and with petroleum ether in a ratio of 1:1.

The solid substance is practically insoluble in petroleum ether and water. The polymer is precipitated from EUDRAGIT® E 12,5 when mixed with water in a ratio of 1:1.

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4 Tests

Test solution

Either EUDRAGIT® E 12,5 is used for the Test solution, or a corresponding solution of EUDRAGIT® E 100 or EUDRAGIT® E PO: 12.5 % (w/w) dry substance is dissolved in a mixture of 60 % (w/w) isopropyl alcohol and 40 % (w/w) acetone.

Particle size

EUDRAGIT® E PO: Dv50 < 50 μm
The particle size is determined by laser light diffraction according to Ph. Eur. 2.9.31 / light diffraction measurement USP <429>.

Film formation

When the Test solution is poured onto a glass plate, a clear film forms upon evaporation of the solvents.

Dry substance / Residue on evaporation

EUDRAGIT® E 100 / EUDRAGIT® E PO: not less than 98.0 %
The test is performed according to Ph. Eur. 2.2.32 d.
1 g is dried in an oven for 3 hrs at 110°C.

EUDRAGIT® E 12,5: 11.9 – 13.1 %
The test is performed according to Ph. Eur. 2.2.32 d. 20 g quartz sand are mixed with 1 g of the solution and dried in an oven for 5 hrs at 110°C.

Loss on drying

EUDRAGIT® E 100 / EUDRAGIT® E PO: max. 2.0 % according to “Dry substance / Residue on evaporation”.

Assay

Dimethylaminoethyl (DMAE) groups on dry substance (DS): 20.8 – 25.5 %
Alkali value: 162 – 198 mg KOH per g DS

The assay is performed according to Ph. Eur. 2.2.20 “Potentiometric titration” or USP <541>. 0.2 g EUDRAGIT® E 100 / EUDRAGIT® E PO or 1.6 g EUDRAGIT® E 12,5 are dissolved in 96 ml glacial acetic acid and 4 ml water. 0.1 N perchloric acid is used as the titrant. 1 mL of 0.1 N perchloric acid is equivalent to 7.21 mg of dimethylaminoethyl groups.

The alkali value (AV) states how many mg KOH are equivalent to the basic groups contained in 1 g dry substance (DS).

DMAE groups (%) = AV (mg KOH / g DS) . 0.1286

JPE: EUDRAGIT® E 100 / EUDRAGIT® E PO: 4.0 – 6.0 % Nitrogen on dry substance
The test is performed according to JP method “Nitrogen determination”.

Colour

Absorbance (A): max. 0.300
The test is performed according to Ph. Eur. 2.2.25 or USP monograph.
The yellow colour of the test solution is determined against water at 420 nm in a 1 cm cuvette.
Viscosity / Apparent viscosity
3 – 6 mPa . s
The viscosity of the Test solution is determined by means of a Brookfield viscometer (UL adapter / 30 rpm / 20°C).
The test is performed according to Ph. Eur. 2.2.10 or USP <912> method II.

Viscosity / Kinematic viscosity

JPE: EUDRAGIT® E 100 / EUDRAGIT® E PO: 2.5 – 5.5 mm2 / s
The test is performed according to the JPE monograph.

Refractive index

N_D²⁰: 1.380 – 1.385
The refractive index of the Test solution is determined according to Ph. Eur. 2.2.6.

Relative density

D₂₀²⁰ : 0.811 – 0.821
The relative density of the Test solution is determined according to Ph. Eur. 2.2.5.

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5 Purity

Sulphated ash / Residue on ignition

Max. 0.1 %
The test is performed according to Ph. Eur. 2.4.14 or USP <281>.
1 g EUDRAGIT® E 100, EUDRAGIT® E PO or EUDRAGIT® E 12,5 is used for the test.

Heavy metals

Max. 20 ppm
The test is performed according to Ph. Eur. 2.4.8 method C or USP <231> method II.
1 g EUDRAGIT® E 100, EUDRAGIT® E PO or EUDRAGIT® E 12,5 is used for the test.

Arsenic

JPE: EUDRAGIT® E 100 / EUDRAGIT® E PO: max. 2 ppm
The test is performed according to JP Method 3.
1.0 g EUDRAGIT® E 100 or EUDRAGIT® E PO is used for the test.

Monomers

EUDRAGIT® E 100 / EUDRAGIT® E PO total of monomers: < 2500 ppm
Butyl methacrylate: < 1000 ppm
Methyl methacrylate: < 500 ppm
Dimethylaminoethyl methacrylate: < 1000 ppm

EUDRAGIT® E 12,5: total of monomers max. 0.04 %

The test is performed according to the Ph. Eur., USP/NF or JPE monograph on 1 g
EUDRAGIT® E 100 / EUDRAGIT® E PO or 8 g EUDRAGIT® E 12,5.

Residual Solvents

EUDRAGIT® E 100 / EUDRAGIT® E PO:
Contains small amounts of 2-Propanol with concentration below 0.5 %.
Small amounts of Methanol may be detectable in the product within the minimum stability
period. The concentration remains below 0.1 %.
Small amounts of n-Butanol may be detectable in the product within the minimum stability
period. The concentration remains below 0.5 %.
The test is performed according to Ph. Eur. 2.4.24 sample preparation 2 or USP <467> for
water-insoluble substances.

EUDRAGIT® E 12,5:
The product is a solution of polymer in 2-Propanol and Acetone.

Microbial count

Total aerobic microbial count (TAMC): max. 103 CFU / g
Total combined yeasts and moulds count (TYMC): max. 102 CFU / g
(Acceptance criteria according to Ph. Eur. 5.1.4 / USP <1111>)
The test is performed according to Ph. Eur. 2.6.12 or USP <61>.

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6 Identity testing

First identification

The material must comply with the tests for “Assay” and “Viscosity / Apparent viscosity.”

Second identification

IR spectroscopy on a dry film approx. 15 μm thick. To obtain the film, a few drops of the Test solution are placed on a crystal disc (KBr, NaCl) and dried in vacuo for about 2 hours at 70°C.

The figure on page 5 shows the characteristic bands of the ester groups at 1,150 – 1,190, 1,240 and 1,270cm^-1, as well as the C = O ester vibration at 1,730 cm^-1. In addition, CHX vibrations can be discerned at 1,385, 1,450 – 1,490 and 2,950 cm^-1. The absorptions at 2,770 and 2,820 cm^-1 can be assigned to the dimethylamino groups.

EUDRAGIT® E 100 / EUDRAGIT® E PO / EUDRAGIT® E 12,5

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7 Detection in dosage forms

The dosage forms are extracted using the solvents listed under “Solubility,” if necessary after crushing. Insoluble substances are isolated by filtration or centrifugation. The clear filtrate is boiled down and the residue identified by IR spectroscopy.

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8 Storage

EUDRAGIT® E 100: Protect from warm temperatures (USP, General Notices). Protect from moisture. Any storage between 8°C and 25°C fulfils this requirement. EUDRAGIT® E 100 tends to form lumps at warm temperatures (≥ 30°C). This has no influence on the quality. The lumps are easily broken up again.

EUDRAGIT® E PO: Store at temperatures up to 25°C. Protect from moisture. Any storage between 8°C and 25°C fulfils this requirement. Temperatures above 25°C will cause caking of EUDRAGIT® E PO.

EUDRAGIT® E 12,5: Protect from warm temperatures (USP, General Notices). Store in tightly closed containers.

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9 Stability

Minimum stability dates are given on the product labels and batch-related Certificates of Analysis. Storage Stability data are available upon request.

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This information and all further technical advice are based on our present knowledge and experience. However, it implies no liability or other legal responsibility on our part, including with regard to existing third party intellectual property rights, especially patent rights. In particular, no warranty, whether expressed or implied, or guarantee of product properties in the legal sense is intended or implied. We reserve the right to make any changes according to technological progress or further developments. The customer is not released from the obligation to conduct careful inspection and testing of incoming goods. Performance of the product described herein should be verified by testing, which should be carried out only by qualified experts in the sole responsibility of a customer. Reference to trade names used by other companies is neither a recommendation, nor does it imply that similar products could not be used.

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The name EUDRAGIT® is a protected trademark owned by Evonik Industries or one of its subsidiaries

Evonik Nutrition & Care GmbH
Kirschenallee, 64293 Darmstadt, Germany
PHONE +49 6151 18-4019, FAX +49 6151 18-3520,
[email protected]
www.eudragit.com