Stabilization and sustained-release effect of misoprostol with methacrylate copolymer.

The use of ammonio methacrylate copolymer (Eudrgit RS, RL) to form a sustained-release solid dispersion of Misoprostol can improve and enhance two important physical and chemical properties of Misoprostol. First, the solid dispersion matrix formed by the copolymer can protect Misoprostol from being degraded by water so that its stability is improved. Second, Misoprostol can be slowly released by diffusion from the copolymer matrix. Accelerated stability studies of Misoprostol-Eudragit solid dispersion after storing at various temperatures for different time periods were carried out. According to high performance liquid chromatography (HPLC) analyses, the stability of Misoprostol in a series of Eudragit appeared significantly improved at different ratios. The Misoprostol-Eudragit dispersion can be used in a powder form, filled in capsules, or compressed into tablets. The dissolution profiles of Misoprostol-Eudragit solid dispersion and its tablets in water, pH 1. 2, 4.5 and 6.8, dissolution media show that this stable solid dispersion is a sustained-release type.