The objectives of this study are the development and evaluation of modified release multi-particulate drug delivery systems containing a BCS class II drug (meloxicam), formulated as polymer-coated pellets. Inert seeds containing microcrystalline cellulose, lactose monohydrate, and polyvinylpyrrolidone were prepared by extrusion-spheronization. The obtained cores were loaded with meloxicam using the drug layering technique, by spray coating in a fluidized bed with a liquid dispersion of the drug. The resulting drug pellets were film-coated with various polymers (Acryl-EZE^® 93O, Eudragit^® RS 30-D as well as experimental composite obtained by adding Methocel™ E5 Premium LV as pore forming agent to the extended release polymer Eudragit^® RS 30-D). All experimental systems were evaluated by scanning electron microscopy and in vitro release testing, in an attempt to investigate the characteristics of the film coatings and their influence on drug release from the multi-particulate systems. The in vitro release study was performed in two stages, using two media with pH values corresponding to the gastric and intestinal environment (HCl 0.1N, pH = 1.2 for the first two hours of the test and phosphate buffer 50 mM, pH 6.8 for the next 4 h). The in vitro release data have highlighted the impact of the formulation factors on the drug release.

中文翻译：

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美洛昔康对实验性多颗粒聚合物涂层药物递送系统的评估

这项研究的目的是开发和评估含有BCS II类药物（美洛昔康）的调释多颗粒药物递送系统，该系统被配制为聚合物包衣的小丸。通过挤出滚圆法制备含有微晶纤维素，乳糖一水合物和聚乙烯吡咯烷酮的惰性种子。使用药物分层技术，通过在流化床中用药物的液体分散体喷雾包衣，将获得的核心装载美洛昔康。将得到的药物颗粒的薄膜涂覆有各种聚合物（丙烯-EZE ^® 930，尤特奇^® RS 30-d以及实验复合添加的Methocel E5™高级LV作为成孔剂的延长释放聚合物的Eudragit获得^®RS 30-D）。通过扫描电子显微镜和体外释放测试对所有实验系统进行了评估，以试图研究薄膜包衣的特性及其对多颗粒系统药物释放的影响。体外释放研究分两个阶段进行，使用两种介质的pH值分别对应于胃和肠环境（测试的前两个小时为HCl 0.1N，pH = 1.2，磷酸盐缓冲液为50 mM，pH 6.8）。接下来的4小时）。体外释放数据突出了制剂因素对药物释放的影响。