采用不同类型的设备和工艺条件通过挤压/滚圆法来制备丸剂。
Preparing of pellets by extrusion/spheronization using different types of equipment and process conditions.
机构信息
Department of Pharmaceutical Technology, University of Szeged , Szeged , Hungary and.
出版信息
Drug Dev Ind Pharm. 2014 Jun;40(6):762-4. doi: 10.3109/03639045.2013.783588. Epub 2013 Apr 18.
INTRODUCTION
The focus of this work was to produce matrix pellets made by extrusion/ spheronization using two types of equipment. The aim was to accomplish the laboratory-scale I process that has been already optimized and accepted with another type of equipment (laboratory-scale II).
METHODS
A matrix pellet formulation consisting of MCC, Eudragit NE 30D and diclofenac sodium was used in the two types of equipment. Physico-chemical parameters and the dissolution profiles of the pellets in phosphate buffer pH 6.8 were compared.
RESULTS
Pellets from both processes were similar in shape and tensile strength. They differed in particle size and dissolution profile. This may be contributed to different spheronization conditions.
简介
本工作的重点是使用两种设备通过挤出/滚圆法制备基质丸。目的是完成已经用另一种设备（实验室规模 II 型）优化并接受的实验室规模 I 过程。
方法
在两种设备中使用包含 MCC、Eudragit NE 30D 和双氯芬酸钠的基质丸配方。比较了丸的物理化学参数和在磷酸盐缓冲液 pH6.8 中的溶出曲线。
结果
两种工艺的丸在形状和拉伸强度方面相似。它们在粒径和溶出曲线方面有所不同。这可能归因于不同的造球条件。
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