Abstract

Plasticizers are added to the polymer coating of sustained-release granules to improve the mechanical properties of the coating shell. The present investigation evaluated the influence of different plasticizer/polymer combinations on theophylline (TH) release from pellets coated with latex aqueous dispersions of ethylcellulose (EC) or acrylic polymers (ACR). The plasticizers, present in the coating films in amounts ranging from 8 to 30%, were acetylated monoglycerides (AMG), diethyl phthalate (DEP), dibutyl phthalate (DBP) and dibutyl sebacate (DBS). The release profiles of TH from the coated pellets were influenced by the type and amount of plasticizer and of coating material, and by the ratio polymer-plasticizer. For both types of coating, the drug release rate decreased with increasing plasticizer content. A correlation was found between the permeability coefficients (Pwv) to water vapour of free films, having the same composition as those used for coating, and drug release.

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