Purpose

Direct compression (DC) remains the most preferred technique to produce tablets, and its effectiveness is directly influenced by raw material attributes. Therefore, the selection of specific grades of excipients to achieve desirable powder flow and compression properties is of importance. Shifting toward continuous manufacturing requires even more enhanced performance, quality, and consistency directly from the starting ingredients. Starch, as a well-known excipient with good compression characteristics in its native state, is poorly flowing and highly sensitive to lubrication. The objective of this study was to characterize the flow properties of different starch products and investigate the suitability of modified starch products for continuous manufacturing.

Methods

The proposed methodology included techniques to characterize material flow properties and their feeding performance in a loss-in-weight feeder. Principal component analysis (PCA) was then applied to project material properties onto reduced dimensions and compare the flow behavior of starch products with other common excipients.

Results

A newly developed starch product, StarTab®, was characterized and compared with two other starch products in terms of their flow behavior. StarTab showed desirable flowability and packing behavior, demonstrated by shear cell and compressibility results. During feeder refill studies, StarTab exhibited a low total deviation of material fed in excess of setpoint compared with the other two starch products. Additionally, it was observed that StarTab flow behavior was not sensitive to its moisture level.

Conclusions

StarTab showed suitable characteristics compared with other starch products making it a potential candidate to design and develop pharmaceutical continuous direct compression (PCDC) formulations.

中文翻译：

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连续直接压缩生产线中作为候选赋形剂的淀粉产品

目的

直接压片（DC）仍然是生产片剂的最优选技术，其有效性直接受到原材料属性的影响。因此，选择特定等级的赋形剂以实现所需的粉末流动性和压缩性质是重要的。转向连续生产需要直接从起始原料中获得更高的性能，质量和一致性。淀粉作为一种众所周知的赋形剂，在其原始状态下具有良好的压缩特性，其流动性差且对润滑高度敏感。这项研究的目的是表征不同淀粉产品的流动特性，并研究改性淀粉产品在连续生产中的适用性。

方法

拟议的方法包括在失重式给料机中表征物料流动特性及其给料性能的技术。然后应用主成分分析（PCA）将材料特性投影到缩小的尺寸上，并将淀粉产品与其他常见的赋形剂的流动行为进行比较。

结果

对新开发的淀粉产品StarTab®进行了表征，并将其与其他两种淀粉产品的流动性能进行了比较。StarTab表现出理想的流动性和堆积行为，通过剪切池和可压缩性结果证明。在进料器补充研究中，与其他两种淀粉产品相比，StarTab的进料超出设定值的总偏差很小。此外，观察到StarTab的流动行为对其水分含量不敏感。

结论

与其他淀粉产品相比，StarTab具有合适的特性，使其成为设计和开发药物连续直接压缩（PCDC）配方的潜在候选者。