Abstract
The liquid and solid solution interactions of eight FD&C dyes in 1% concentration with pharmaceutical gelatins and the effects of the dyes on the disintegration behavior of gelatins were observed. In liquid solution by visible region spectroscopy, all FD&C dyes interacted with a type A gelatin. The xanthene dye, FD&C Red No. 3 (erythrosine), interacted to the greatest extent by a combination of ionic, hydrogen, and hydrophobic types of bonds. The FD&C dyes did not appear to interact with a type B gelatin. A method for simulating a gelatin capsule shell wall was devised to examine solid-state interactions by visible and IR-attenuated total reflectance spectroscopy, dye release patterns, and the effect of the dyes on gelatin disintegration. FD&C Red No. 3 and Violet No. 1 in solid solution appeared to interact to a greater extent than the other FD&C dyes. Hydrogen bonding changes in the solid solution films of both gelatins were not observable by IR-attenuated total reflectance spectroscopy until very high (1:10 to 1:5) dye-protein ratios were attained. The same two dyes (FD&C Red No. 3 and Violet No. 1) that showed the greatest spectral changes exhibited the slowest release times from both gelatins at temperatures both below and within the temperature range at which gelatins disintegrate and go into colloidal solution. In simulated gastric fluid USP without pepsin, the FD&C Red No. 3 dye greatly diminished the average disintegration rate of both gelatins. The addition of pepsin essentially eliminated the effect of FD&C Red No. 3 on gelatin disintegration. In simulated intestinal fluid USP without pancreatin, both gelatins disintegrated slower than in simulated gastric fluid without pepsin. FD&C Red No. 3 also had a detrimental effect on gelatin disintegration in simulated intestinal fluid without pancreatin. Pancreatin was not added to the simulated intestinal fluid because of its interference with visualization of disintegration.
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