Comparative studies with Kollicoat MAE 30 D and Kollicoat MAE 30 DP in aqueous spray dispersions and enteric coatings on highly swellable caffeine cores.
A film formulation containing Kollicoat MAE 30 D, Kollidon 30, Sicovit Rot 30, titanium dioxide, talc, and a plasticizer for the aqueous manufacture of 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 MAE 30 DP and Eudragit L 30 D-55. The coagulations occurring with all three film latices can be attributed to the presence of Kollidon 30 together with certain excipients. Preparations with Kollidon 30, but without color pigments, showed no tendency to coagulate. The advantage of propylene glycol (PG) compared to other plasticizers such as triethyl citrate (TEC) is that no coagulations occurred, even in the presence of Kollidon 30 and color pigments. Among the Kollidon 30-free film formulations examined, a plasticizer content 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 by prolonged stirring of the pigment suspension. The resistance can be further 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 this study.
Dangel
C
C
Fachhochschule, Pharmatechnik Department, Sigmaringen, Germany.
Schepky
G
G
Reich
H B
HB
Kolter
K
K
D002110:Caffeine / Q000494:pharmacology; D000697:Central Nervous System Stimulants / Q000494:pharmacology; D002626:Chemistry, Pharmaceutical; D010539:Permeability; D010860:Pigments, Biological; D010968:Plasticizers / Q000737:chemistry*; D011109:Polymethacrylic Acids / Q000493:pharmacokinetics*; D013270:Stomach / Q000737:chemistry; D013608:Tablets, Enteric-Coated
D000697:Central Nervous System Stimulants; D010860:Pigments, Biological; D010968:Plasticizers; D011109:Polymethacrylic Acids; D013608:Tablets, Enteric-Coated; C117135:kollicoat MAE 30 D; D002110:Caffeine