Wax beads as cushioning agents during the compression of coated diltiazem pelletsWax beads as cushioning agents during the compression of coated diltiazem pellets
Faculty of Pharmaceutical, Biomedical and Veterinary Sciences. Pharmacy
European journal of pharmaceutical sciences. - Amsterdam, 1993, currens
17(2002):3, p. 145-151
Placebo particles were mixed with film-coated diltiazem pellets to evaluate them as cushioning agents during tabletting in order to protect the film coat from damage. The cushioning properties of α-lactose monohydrate granules, microcrystalline cellulose pellets and wax/starch beads were evaluated by comparing the dissolution profile of the coated pellets before and after compression (compression force 10 kN). Only the tablet formulations containing wax/starch beads provided protection to the film coat. However, the dissolution rate of tablets formulated with waxy maltodextrin/paraffinic wax placebo beads was too slow as the tablets did not disintegrate. Adding 50% (w/w) drum-dried corn starch/Explotab®/paraffinic wax beads to the formulation was the optimal amount of cushioning beads to provide sufficient protection for the film coat and yield disintegrating tablets. Using a compression simulator, the effect of precompression force and compression time on the dissolution rate was found to be insignificant. The diametral crushing strength of tablets containing 50% (w/w) drum-dried corn starch/Explotab®/paraffinic wax beads was about 25.0 N (±0.3 N), with a friability of 0.4% (±0.04%). This study demonstrates that adding deformable wax pellets minimizes the damage to film-coated pellets during compression.