Solid Fraction Data and Its Importance in Pharmaceuticals

Sponsored byMicromeritics Instrument Corporation2017年2月14日

干燥的颗粒在制药行业中用于通过增加颗粒粒径来改善粉末流量。这是通过使用辊压力机来完成的，该滚筒可以配置为不同的颗粒尺寸和质量。

滚子压实对颗粒的特性及其对片剂生产的适用性有重大影响¹。The technique involves pressing powders together under high pressure to produce larger granules. Two pressure rollers squeeze the powder to make a ribbon of material of uniform thickness and density, which is then passed through a low-shear mill. The method is used widely in drug manufacture to produce solid dosage forms of high quality.

该过程

Regulating roller compaction is essential to control granule properties. Maintaining a uniform density across the ribbon allows granulates with a more uniform particle size to be produced. Altering limits, such as the feed-in speed of the powder, the speed of the roller itself and the nip angle of the rollers to the ribbon, also allows the granulates properties to be fine-tuned. In this way, the granules can then control other product properties such as porosity, flowability, homogeneity, compactability and compressibility in the final product. These factors are essential as they influence dissolution profiles, disintegration times, and hardness of the final solid dosage form.

Measuring density

控制roller compaction，需要精确的产品进行准确的测量。相对密度或固体分数是一个关键的控制参数，它决定了滚子压缩机中速度，压缩和NIP角的最佳设置。使用固体分数数据可以从批处理到批处理，以及具有设计和所需性能的最终产品。由于材料具有不规则的结构和孔隙，因此很难实现体积和密度的准确测量。需要三个不同的多孔材料密度定义，每种都需要不同的技术进行测量²。

当测量体积排除颗粒内的孔和散装材料中颗粒之间的空间时，获得了绝对密度。yabo214气体平均计，是最快，最准确的技术，因为氦气迅速而彻底地填充了最小的孔隙空间。该方法可以用于所有形状和大小的固体，并且该技术被认为是获得体积和密度最可靠的一种。
包络或散装密度包括体积测量中的孔隙空间。这里的方法利用自由流动的干粉作为位移介质。然后可以通过将色带的包膜密度除以颗粒的绝对密度来计算固体分数。
Tap density is obtained from filling a container with the test material and vibrating it so that the particles settle into the best packing arrangement. The measurement depends upon particle size distribution and shape as well as the technique.

密度测量技术

Micromeritics has two automated helium pycnometers instrument ranges (GeoPyc and AccuPyc) to determine each of the three different types of density. The GeoPyc range measures envelope density using Dry Flo, a quasi-fluid composed of small, rigid spheres with a high degree of flowability. The sample is placed in a bed of Dry Flo which is then agitated. The Dry Flo particles form an 'envelope' around the sample; and are designed to conform closely to the surface of the object but not invade its孔隙空间。Geopyc 1365是该范围内的最新微型仪器。借助智能触摸屏用于控制和报告功能，该仪器还可以提供水龙头密度测量值³。

ACCUPYC II级计提供高速和高精度的绝对密度测量值。该仪器旨在为所有对温度敏感的样品提供温度稳定性和准确的温度控制。这很重要，因为尽管气体平衡法提供了可靠的密度测量值，但温度可能会对体积（扩展）产生重大影响并影响准确的密度测定。Accupyc II TEC提供了15-36⁰C的温度稳定性和准确的温度控制（可调节0.1⁰C）。

Conclusion

气体平衡仪的微密度范围允许可靠，准确地控制滚筒压实过程。每个范围旨在为制药科学家提供测量一系列基本参数并密切控制其压实操作的能力⁴。

参考和进一步阅读

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引用

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APA
Micromeritics Instrument Corporation。（2021年8月4日）。固体分数数据及其在药品中的重要性。azom。于2023年2月9日从//www.washintong.com/article.aspx?articleId=13573检索。
MLA
Micromeritics Instrument Corporation。“固体分数数据及其在药品中的重要性”。AZoM。09 February 2023. .
Chicago
Micromeritics Instrument Corporation。“固体分数数据及其在药品中的重要性”。azom。//www.washintong.com/article.aspx?articleId=13573。（2023年2月9日访问）。
Harvard
Micromeritics Instrument Corporation。2021。Solid Fraction Data and Its Importance in Pharmaceuticals。Azom，2023年2月9日，//www.washintong.com/article.aspx?articleId=13573。