ETHYL CELLULOSE

PRODUCTIONPrepared by agitating alkali cellulose with ethyl chloride et 60C for several hours.

R(ONa) + C2H5Cl ------- R-O-C2H5

STRUCTURE:

NONPROPRIETARY NAMES

BP: Ethylcellulose

PhEur: Ethylcellulosum

USPNF: Ethylcellulose

SYNONYMS

Aquacoat ECD;

Aqualon; E462;

Ethocel;

Surelease

CHEMICAL NAME AND CAS REGISTRY NUMBER

Cellulose ethyl ether [9004-57-3]

FUNCTIONAL CATEGORY:

Coating agent; flavoring fixative; tablet binder; tablet filler; viscosity-increasing agent.

HISTORY

Ethyl cellulose was first developed in Germany in 1912; it did not make its appearance in country till 1916 and 1917 when patents were issued.

Its manufacture remained static, however until as late as 1935, when the Hercules Powder company began working with it.

Two years later the Dow Chemical Company began manufacturing ethyl cellulose under the trade name of Ethocel

PROPERTIESDESCRIPTION: tasteless, free-flowing, white to light tancolored powders

SOLUBILITY:

Insoluble in water, glycerin and propylene glycol and soluble in some organic solvents such as alcohol, ether, ketone, ester, aromatic hydrocarbon.

STABLITY:

Stable against light, heat, oxygen, wetness and alkali, dilute acid and salting liquid.

It undergoes oxidative degradation in the presence of sunlight or UV light at elevated temperatures. Use of antioxidant and chemical additives that absorb light in the 230–340nm range can prevent it.

COMPATIBLE WITH:

Many celluloses, resin and nearly all plasticizers.

INCOMPATIBLE WITH:

Incompatible with paraffin wax and microcrystalline wax.

MOISTURE CONTENT:

It absorbs very little water from humid air or during immersion, and that small amount evaporates readily

OTHER PROPERTIES:

Density-0.4 g/cm3

Specific gravity- 1.07- 1.18,

Glass Transition Temperature-129–1338C(26)

Non flammable, Flexible

ETHYL CELLULOSE PLASTICS

Thermoplastics,

Toughest,

Lightest ,

Ease of molding,

light weight,

good dielectric strength,

Retention of flexibility over a wide range of temp.

SAFETYNontoxic, Non allergenic and Nonirritating material.

Because ethyl cellulose is not metabolized

it is not recommended for parenteral products; parenteral use may be harmful to the kidneys.

As ethylcellulose is not considered to be a health hazard, the WHO has not specified an acceptable daily intake.(29)

LD50 (rabbit, skin): >5 g/kg(30)

LD50 (rat, oral): >5 g/kg

USESTablet adhesive and thin film coating material.Retarding agent for aggregate for various types of pills.As microcapsule materialDispersing agent, stabilizer and water retention agent.Widely used in paints for various products, such as wooden products (furnitures), metal surfaces, paper, rubber, thermoplastic products and integrated circuits

HANDLING PRECAUTIONSIt is important to prevent fine dust clouds of ethyl cellulose from reaching potentially explosive levels in the air.

Ethyl cellulose is combustible.

Ethyl cellulose powder may be an irritant to the

eyes and eye protection should be worn.

REGULATORY STATUSGRAS listed. Accepted for use as a food additive in Europe.

Included in the FDA Inactive Ingredients Guide (oral capsules, suspensions and tablets; topical emulsions and vaginal preparations).

Included in non-parenteral medicines licensed in

Europe. Included in the Canadian List of Acceptable Non-medicinal Ingredients.