涂覆eudragit®s100丙烯酸聚合物的软硬胶囊缓释系统的研究

L. A. Soares, E. Crema
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引用次数: 2

摘要

本研究的目的是评估使用聚合物Eudragit®S100的回肠结肠活性成分释放的ph依赖系统。在标准化的实验条件下,采用喷淋床对棕榈油软胶囊和谷氨酰胺硬胶囊进行包衣。用卡尺测量棕榈油和谷氨酰胺胶囊的高度和直径。分析了以下变量:胶囊包衣过程中使用的Eudragit®S100分散量、喷嘴气压、喷嘴气流速率、喷淋床包衣过程的喷淋速率和温度。Eudragit®S100分散配方,由赢创工业公司注册为Quickstart®,经修改后用于制备肠溶涂层。结果表明,喷淋床涂层工艺的适宜温度为50℃,每cm2胶囊0.2 mL 6.5% Eudragit®S100涂层在pH 6.8下耐涂60分钟。研究结果证明了Eudragit®S100在修饰涂层和制备软硬胶囊缓释系统中的应用,从而实现了活性成分的回肠释放。
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Study of a delayed-release system for hard and soft capsules coated with eudragit® s100 acrylic polymers
The objective of this study was to evaluate a pH-dependent system of ileocolonic release of active ingredients using the polymer Eudragit® S100. A spouted bed was used in the coating process of soft capsules containing palm oil and of hard capsules containing glutamine under standardised experimental conditions. The height and diameter of the palm oil and glutamine capsules were measured using a calliper. The following variables were analysed: Eudragit® S100 dispersion amount used in the capsule coating process, nozzle air pressure, nozzle air flow rate, spray rate and temperature of the spouted bed coating process. The Eudragit® S100 dispersion formulation, trademarked as Quickstart® by Evonik Industries, was used with modifications to prepare the enteric coating. The results showed that the adequate temperature for the spouted bed coating process was 50°C and that 0.2 mL of 6.5% Eudragit® S100 coating per cm2 capsule was resistant for 60 minutes at pH 6.8. The findings demonstrate the pharmaceutical application of Eudragit® S100 in the modification of the coating and the preparation of a delayed-release system of hard and soft capsules, thus enabling ileal release of active ingredients.
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