Rahman Md A, Ali J
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, (Hamdard University), New Delhi-110 062, India.
Indian J Pharm Sci. 2008 Jul-Aug;70(4):477-81. doi: 10.4103/0250-474X.44597.
The multiparticulate formulation of sodium para aminosalicylate for oral administration was developed by extrusion spheronization technique. Microcrystalline cellulose was used as filler in concentration of 14.4% w/w. Pellets were coated with Eudragit L 30 D-55 using fluidized bed processor. Different weight gains of acrylic polymer were applied onto the pellets and evaluated for in vitro dissolution behavior in 0.1 N HCl for two hours and then media was changed to phosphate buffer pH 6.8. A 60% w/w coating level of Eudragit L30 D 55 has produced the most acceptable results against the gastric attack. 3% Seal coat of HPMC E5 was also applied in order to protect the drug from migration into the Eudragit coat and film coat was applied in order to prevent aggregation of pellets in the dissolution media. Morphological characteristics of developed pellets were also investigated by scanning electron microscopy and found to be smooth and spherical. Developed system was found to be suitable for the delivery of Sod PAS in to intestinal region.
对氨基水杨酸钠口服多颗粒制剂采用挤出滚圆技术制备。微晶纤维素用作填充剂，浓度为14.4%（w/w）。使用流化床处理器用Eudragit L 30 D-55对丸粒进行包衣。将不同重量增加量的丙烯酸聚合物应用于丸粒，并在0.1 N HCl中评估其两小时的体外溶出行为，然后将介质更换为pH 6.8的磷酸盐缓冲液。Eudragit L30 D 55的60%（w/w）包衣水平对胃酸攻击产生了最可接受的结果。还应用了3%的羟丙甲纤维素E5密封包衣，以保护药物不迁移到Eudragit包衣中，并应用薄膜包衣以防止丸粒在溶出介质中聚集。通过扫描电子显微镜研究了所制备丸粒的形态特征，发现其光滑且呈球形。所开发的系统被发现适用于将对氨基水杨酸钠递送至肠道区域。
