A novel amylose corn-starch dispersion as an aqueous film coating for tablets.

A novel aqueous coating dispersion of amylose-rich corn starch (Hylon VII) was evaluated in an aqueous film-coating process of tablets using an instrumented laboratory-scale pan-coating apparatus. The influence of two independent process variables, the coating temperature and the atomizing air pressure, on the properties of the coated tablets were investigated. The preuse stability of aqueous coating dispersion (i.e., amylose corn-starch precipitate) was studied using a powder X-ray diffraction (XRD) technique. The crystallinity of amylose starch in the coating dispersion was found to increase slightly during 9 months of storage (in a refrigerator 6 +/- 2 degrees C). The film coatings of an aqueous amylose-rich starch dispersion were successfully applied onto tablets without any significant drawbacks, such as nozzle blockage or related problems. It was found that the temperature in the coating pan had a significant influence on the film surface roughness, mechanical strength, and drug release in vitro. When the lowest coating temperature (30 degrees C) was used, rougher film coatings were obtained due to overwetting. At higher temperatures (up to 50-60 degrees C), lower surface roughness and higher mechanical strength values for the coated tablets were obtained. With the present amylose starch dispersion, the atomizing air pressure had a minor influence on the quality of the coating. Under appropriate coating conditions, a smooth tablet film coating was produced with this new, natural, and inexpensive amylose starch dispersion.