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

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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.