Development and optimization of a solid dispersion hot-melt fluid bed coating method.

Abstract

A new hot-melt fluid bed coating process has been developed, characterized, and optimized. Polyethylene glycol served as the model coating agent and was charged with substrate into the fluid bed chamber in the solid state. The processing stages included: (A) warm-up, (B) preheating, (C) melting-spreading, and (D) cooling-congealing. A central composite design was utilized to characterize and optimize the process. Substrate porosity and density evaluations were conducted by mercury intrusion. The method proved capable of coating nonpareils from 10 to 35 mesh (0.500 to 2.00 mm) and tablets up to 1 g. The nonpareils were coated as individual particles, while particle sizes significantly smaller than 40 mesh (0.420 mm) tended to agglomerate. The porosity and density values of dissimilar nonpareil batches showed a large degree of variation, affecting the method's reproducibility. Additive coatings were achieved by sequential runs using coating agents of diminishing melting points. The method is a viable alternative to hot-melt spray-coating processes. Organic solvents, spraying equipment, steam jackets, and/or heating tape are eliminated from the process.