Food additives Europe numbers: E462
Functional Category:
Cating agent; flavoring agent; tablet binder; tablet filler; viscosityincreasing agent
Applications in Pharmaceutical Formulation:
Coating agent; flavoring agent; tablet binder; tablet filler; viscosityincreasing agent
Description
Ethylcellulose is a tasteless, free-flowing, white to light tan-colored powder.
Stability and Storage Conditions
Ethylcellulose is a stable, slightly hygroscopic material. It is chemically resistant to alkalis, both dilute and concentrated, and to salt solutions, although it is more sensitive to acidic materials than are cellulose esters. Ethylcellulose is subject to oxidative degradation in the presence of sunlight or UV light at elevated temperatures. This may be prevented by the use of antioxidant and chemical additives that absorb light in the 230–340 nm range. Ethylcellulose should be stored at a temperature not exceeding 328C (908F) in a dry area away from all sources of heat. It should not be stored next to peroxides or other oxidizing agents.
Incompatibilities
Incompatible with paraffin wax and microcrystalline wax.
Safety
Ethylcellulose is widely used in oral and topical pharmaceutical formulations. It is also used in food products. Ethylcellulose is not metabolized following oral consumption and is therefore a noncalorific substance. Because ethylcellulose is not metabolized it is not recommended for parenteral products; parenteral use may be harmful to the kidneys. Ethylcellulose is generally regarded as a nontoxic, nonallergenic, and nonirritating material. As ethylcellulose is not considered to be a health hazard, the WHO has not specified an acceptable daily intake.(29) The highest reported level used in an oral product is 308.8 mg in an oral sustained release tablet.