A novel technique for imaging film coating defects in the film-core interface and surface of coated tablets.

摘要

Confocal laser scanning microscopy (CLSM) was introduced and examined as a novel technique for imaging film-core interface and surface defects of film-coated tablets. Tablets of acetylsalicylic acid, microcrystalline cellulose (MCC) and lactose monohydrate were film-coated with aqueous hydroxypropyl methylcellulose using an instrumented side-vented pan coater. The film coatings were applied using 100- and 500-kPa spraying air pressures. The CLSM images of the coating surface were compared with surface roughness measurements using a laser profilometer and an optical roughness analyzer. The spraying air pressure affected the film-core interface and the occurrence of coating defects. With the lower spraying pressure the aqueous coating solution penetrated into the tablet core, the core components migrated to the coating layer, and the film coating surface was clearly rougher compared to the higher spraying pressure. Storage at 25 degrees C/60% RH or 40 degrees C/75% RH for 3 months expanded the MCC-containing tablet core impaired the film structure and increased the film roughness. Based on the present results, CLSM is an effective tool for imaging film-core interface and surface defects of film-coated tablets. The CLSM images are supported by the results obtained with the other surface roughness measuring techniques.