Properties of Aqueous, Plastic Izer-Containing Ethyl Cellulose Dispersions and Prepared Films in Respect to the Production of oral Extended Release Formulations

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Abstract
Plasticized aqueous ethyl cellulose (EC) dispersions (AquacoatR ECD-30) are incompatible with concentrated electrolytes but stable with nonelectrolytes. The minimum film formation temperature (MFT) decreases with increasing plasticizer content, from 81°C to about 30°C with 20% dibutyl sebacate (DBS) in the resulting film. The plasticiser has to penetrate completely into the EC particles before film formation to obtain optimal plastification, the lowest film formation temperature and high permeability of the resulting film. This takes more than 5 hours with 20% DBS. Films prepared from plasticized dispersion with short standing times show craters of former plasticizer droplets. With increasing plasticizer content the sticking point of the films decreases. The plasticizer induce a high water absorption of the films: more than 30% with 23–26% DBS or diethyl phthalate (DEP). DBS is hardly released from the films within 5 hours, in contrast to DEP. Thus, the absorbed water is completely swelling water in case of DBS and partially also substitution water in case of DEP. The films squeeze out cetylalcohol (CA) and also sodium lauryl sulfate (NaLS) during storage, this may change the permeability of the films. EC contains a small amount of carboxylic groups which explains the pH dependent release of drugs from pellets coated with aqueous EC dispersions.