Content uniformity as development target for the production of soft capsules

被引：0
|
作者：
Freier, Ruediger [1 ]
机构：
[1] Swiss Caps AG, CH-9533 Kirchberg, Switzerland
来源：
PHARMAZEUTISCHE INDUSTRIE | 2008年 / 70卷 / 05期
关键词：
content uniformity; mass variation; rotary die technology; dosiersystem;
D O I：
暂无
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
The softcaps technology using the rotary die principle provides excellent conditions to meet all requirements for content uniformity. This is mainly achieved by a very high precision in dosing volumes, enabled by construction and special mechanical features. These technical options only can be applied when basic requirements are verified during all development stages in preformulation, analytics and process design. The system landscape SAP/HYDRA enables a continuous workflow across all operational tasks, from generating material specifications, specific instructions, online data notification/verification, batch documentation, batch release and PQR.
引用
收藏
页码：664 / 669
页数：6
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