Characterization of enteric-coated erythromycin tablets by Raman mapping and its pharmaceutical evaluation

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Analytical Chemistry

Background:

• Enteric coating thickness is a critical quality attribute influencing drug dissolution and in vivo release.
• Raman mapping is a powerful technique for analyzing the spatial distribution of components in pharmaceutical formulations.

Purpose of the Study:

• To characterize and compare the coating formulation, thickness, and uniformity of enteric-coated erythromycin tablets produced by two different processes using Raman mapping.
• To determine the optimal pH for drug release and establish dissolution profiles.
• To evaluate the impact of coating variations on drug release behavior.

Main Methods:

• Raman mapping was employed to analyze the coating characteristics of enteric-coated erythromycin tablets.
• Comparative analysis of coating thickness, uniformity, and formulation between two different coating processes.
• Dissolution testing was performed to determine drug release profiles at varying pH levels.

Main Results:

• Differences in coating thickness and uniformity between the two products led to distinct dissolution behaviors.
• Product A, with a relatively thick outer coating, showed dissolution influenced by the side coating thickness.
• Product B, with a thinner outer coating, exhibited a short cracking time, high dissolution variability, and significant differences in initial drug release.

Conclusions:

• Coating thickness, particularly on the side, is a critical quality attribute affecting enteric-coated erythromycin tablet dissolution.
• Raman mapping is effective in analyzing differences in coating formulations and evaluating pharmaceutical coating processes.
• Understanding coating uniformity is essential for predicting and controlling in vitro and in vivo drug release.