Comparative studies with Kollicoat MAE 30 D and Kollicoat MAE 30 DP in aqueous spray dispersions and enteric coatings on highly swellable caffeine cores
C. Dangel et al., Comparative studies with Kollicoat MAE 30 D and Kollicoat MAE 30 DP in aqueous spray dispersions and enteric coatings on highly swellable caffeine cores, DRUG DEV IN, 26(4), 2000, pp. 415-421
A film formulation containing Kollicoat MAE 30 D, Kollidon 30, Sicovit Rot
30, titanium dioxide, talc, and a plasticizer for the aqueous manufacture o
f enteric coatings was studied for the coagulations occurring with certain
plasticizers and for differences in resistance on highly swellable caffeine
cores. Also included in these investigations were the latices Kollicoat MA
E 30 DP and Eudragit L 30 D-55. The coagulations occurring with all three f
ilm latices can be attributed to the presence of Kollidon 30 together with
certain excipients. Preparations with Kollidon 30 but without color pigment
s, showed no tendency to coagulate. The advantage of propylene glycol (PG)
compared To other plasticizers such as triethyl citrate (TEC) is that no co
agulations occurred, even in the presence of Kollidon 30 and color pigments
. Among the Kollidon 30-free film formulations examined a plasticizer conte
nt of 10-15% PG or TEC gave the best results. Optimal pigment distribution
in the coat originally produced by Kollidon 30 can optionally be achieved b
y prolonged stirring of the pigment suspension. The resistance can be furth
er improved by inclusion of a subcoating with Kollidon VA 64. Kollicoat MAE
30 D and MAE 30 DP and Eudragit L 30 D-55 showed identical behavior in thi
s study.