Coating of pellets with micronized ethylcellulose particles by a dry powder coating technique.

摘要

Pellets were coated with ethylcellulose powder to achieve extended release. The film forming ability of ethylcellulose powder and the effect of formulation factors (plasticizer type and concentration) and curing conditions (curing temperature and time) were investigated. The coating formulation was divided into two components consisting of a powder mixture (polymer plus talc) and a mixture of liquid materials (plasticizer plus binder solution), which were sprayed separately into the coating chamber of a fluidized bed coater (Glatt GPCG-1, Wurster insert). The coated pellets were oven-cured under different conditions (60-80 degrees C, 2-24 h) without and with humidity (100% relative humidity). Propranolol hydrochloride was used as a model drug, and drug release was studied in 0.1 N HCl at 37 degrees C (USP XXV paddle method). Despite the high glass transition temperature of ethylcellulose (133.4 degrees C), micronized ethylcellulose powder can be used for dry powder coating by adjusting the coating temperature, amount and type of plasticizer applied, and curing conditions. 40% plasticizer and a curing step (80 degrees C, 24 h) were required to achieve complete coalescence of the polymer particles and extended drug release of coated pellets. Although ethylcellulose-coated pellets had an uneven surface, extended drug release could be obtained with coating level of 15%. Because of its high glass transition temperature, ethylcellulose-coated pellets showed unchanged drug release profiles upon storage at room temperature for 3 years.