Ethyl Cellulose | EC | 9004-57-3

Ethylcellulose (EC), an ethyl ether of cellulose, is a free-flowing, white to light-tan powder prepared from wood pulp or cotton that is used in pharmaceutical manufacturing industries. The European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP) monographs describe EC as partially O-ethylated cellulose. EC with ethoxyl substitution molecular formula is C12H23O6(C12H22O5)nC12H23O5, where n can vary in order to provide a wide variety of molecular weights, which affect its properties. It is insoluble at any pH that occurs in organisms, but it undergoes swelling in the presence of gastric juice. There is very limited data detailing possible side effects of EC, hence it is generally regarded as safe (GRAS) and included in the US Food and Drug Administration (FDA) Inactive Ingredients database as well as in the Canadian List of Acceptable Non-medicinal Ingredients to be utilized in oral capsules, suspensions, tablets, topical emulsions, and vaginal or ocular preparations. In contrast to other polymers which are insoluble in the gastrointestinal tract (e.g., nitrocellulose, cellulose acetate, Eudragit RL, or Eudragit RS), EC is characterized as a non-ionic material, having the advantage of being non-reactive. Moreover, safety data on utilizing cellulose acetate and methacrylic acid copolymers in pediatric preparations are limited, while EC is clinically tested and approved for use in pediatric formulations. EC is also allowed for use in non-parenteral medicines licensed in Europe. The polymer is accepted for use as a food additive because it is a non-calorific and metabolically inert substance following oral consumption. As EC is not considered to be a health hazard, the World Health Organisation (WHO) has not specified its acceptable daily intake. According to the intended use, the commercially available EC can be classified in two categories of products: industrial grade and pharmaceutical grade. For the pharmaceutical grade, the quality standard should meet USP, Ph. Eur., Chinese Pharmacopoeia, and Japanese Pharmacopoeia standards.

Ethylcellulose(EC) is A Pharmaceutical Excipient with Multidirectional Application in Drug Dosage Forms Development.