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Abstract
The objectives of the present study are to investigate the effect of plasticizer type and level on the curing of cellulose acetate phthalate (CAP) coated beads with and without the presence of humidity. Theophylline beads were coated in a fluidized-bed with CAP dispersion (Aquacoat® CPD) plasticized by a water-insoluble plasticizer, diethyl phthalate (DEP), or a water-soluble plasticizer, triethyl citrate (TEC), at various levels. The coated beads were cured at a heat-only condition (50°C for 24 hr) and a heat-humidity condition (50°C/75%RH for 24 hr). Rapid drug release in the acidic media was found for both heat-only and heat-humidity cured beads when plasticizer was not used in the coating dispersion, indicating that the heat-humidity curing is ineffective without the presence of plasticizers. When plasticizer was incorporated in the coating formulations, heat-humidity curing effectively improved the acid resistance of the coated films at all plasticizer levels investigated. The minimum plasticizer level required to obtain enteric release profiles for heat-humidity cured beads coated at an outlet coating temperature of 46°C was 15%. This limit was further decreased when the beads were coated at a lower temperature due to a less plasticizer loss at the lower coating temperature. Between the two plasticizers, less TEC was lost during the coating process, and TEC was more effective compared to DEP with regards to heat-humidity curing at the 10% plasticizer level. The enteric release profiles were reproducible following a 7-day drying period at 40°C for all heat-humidity cured beads that had initially passed the enteric release dissolution test. The rapid leaching of TEC and DEP into the acidic media during the dissolution test did not impair the integrity of the heat-humidity cured films.