期刊
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY
卷 46, 期 5, 页码 775-787出版社
TAYLOR & FRANCIS LTD
DOI: 10.1080/03639045.2020.1753063
关键词
Tamping-pin capsule filling; lactose-based formulations; material characterization; process optimization; continuous manufacturing
资金
- Austrian COMET Program under Austrian Federal Ministry of Transport, Innovation and Technology (bmvit)
- Austrian Federal Ministry of Economy, Family and Youth (bmwfj)
- State of Styria (Styrian Funding Agency SFG)
We studied three lactose-based formulations in terms of bulk powder properties and capsule-filling behavior in a tamping-pin capsule filling system, to which several mechanical adaptions were made for process optimization in light of future continuous production. The model formulations were thoroughly characterized and filled into size 1 capsules according a well-defined design of experiments (DoE). Overall, the three entirely different formulations were successfully filled within the selected design space. The fill weight and fill weight variability can be adjusted by fine-tuning the process settings, like the pin immersion depth and the maximum compaction pressure (pneumatic or spring-controlled), and by using the appropriate powder bed height and mechanical adaptions. This study demonstrated that selection of process parameters and mechanical adaptions could enhance the filling performance, especially in continuous production, since they reduce the powder volume in the process. Moreover, we showed that a tamping-pin system is capable of successfully filling a broad range of powders with various material characteristics and can potentially be used in a continuous production mode.
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