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

制药行业目前正在经历口服固体剂型生产路线的范式转变。在历史上，该行业一直使用分批工艺进行压片，其通常涉及多个离散的系列单元工艺（例如混合、制粒、研磨和压实）。这些过程之间可能存在间隙和材料保持。近年来，有一个显着的迁移到利用连续制造。连续处理的一个结果是输入颗粒性质对于实现该过程变得显著更重要。确保材料具有适合于通过失重（LIW）进料器以受控方式进料到连续混合器中的性质是至关重要的。此外，由于颗粒性质直接影响该方法可重复且有效地递送合适的最终剂型的能力，因此必须理解和/或控制该方法期间材料性质的任何变化。目的是通过实验研究连续直接压缩工作流中具有不同形态性质的API颗粒的流动（进料器功效）和磨损行为。BMS还拥有一项专有技术，即共处理，它可以改善材料的流动性能，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.