Wax beads as cushioning agents during the compression of coated diltiazem pellets.
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 alpha-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.
Vergote
G J
GJ
Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, 9000 Ghent, Belgium.
Kiekens
F
F
Vervaet
C
C
Remon
J P
JP
D019245:Compressive Strength; D004110:Diltiazem / Q000737:chemistry* / Q000493:pharmacokinetics; D011109:Polymethacrylic Acids / Q000737:chemistry* / Q000493:pharmacokinetics; D012995:Solubility; D013608:Tablets, Enteric-Coated; D014885:Waxes / Q000737:chemistry* / Q000493:pharmacokinetics
D011109:Polymethacrylic Acids; D013608:Tablets, Enteric-Coated; D014885:Waxes; C038300:methylmethacrylate-methacrylic acid copolymer; D004110:Diltiazem