Influence of API particle size and shape on flow and process induced attrition in a continuous direct compression work stream

制药业目前正在经历口服固体剂型制造路线的范式转变。从历史上看，该行业使用批量工艺进行压片，这通常涉及许多离散的单元工艺（例如混合，造粒，碾磨和压实）。在这些工序之间可能存在间隙和物料夹持。近年来，有一个显著的迁移向连续制造的利用。连续处理的一个结果是，输入粒子的属性对过程的实现变得更加重要。确保材料具有适合通过重量损失（LIW）给料机以受控方式进入连续搅拌器的特性是至关重要的。此外，由于颗粒性质直接影响该工艺重现性和有效地提供合适的最终剂型的能力，因此必须了解和/或控制过程中材料性质的任何变化。目的是通过实验研究，在连续的直接压缩工作流程中，具有不同形态性质的原料药颗粒的流动（喂料器效率）和磨损行为。BMS还拥有一项专有技术，即协同处理技术，该技术可以改善材料的流动特性，并且可能是实现连续直接压缩的有益技术。

The pharmaceutical industry is currently undergoing a paradigm shift with respect to manufacturing routes for oral solid dosage forms. Historically, the industry has utilised batch processes for tableting which have typically involved numerous, discrete, unit processes in trains (e.g. blending, granulation, milling and compaction). There may be gaps and material holds between these processes. In recent years, there has been a notable migration towards the utilisation of continuous manufacturing. One consequence of continuous processing is that the input particle properties become significantly more important to enablement of the process. Ensuring that a material has properties which are suitable for feeding via a Loss in Weight (LIW) feeder in a controlled manner into a continuous blender are critical. Additionally, as the particle properties directly influence the ability of the process to reproducibly and efficiently deliver a suitable final dosage form, any change in the properties of the material during the process must be understood and/or controlled. The objective is to study experimentally, the flow (feeder efficacy) and attrition behaviour of API particles with varying morphological nature within a continuous direct compression work stream. BMS also has a proprietary technology, co-processing, which improves the flow properties of materials, and may be a beneficial technology in enabling continuous direct compression.