Development and process scaling of repeat mini-blending as a complementary approach to deliver continuous direct compression

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Prostredny, Martin and Jolliffe, Hikaru Graeme and Elkes, Richard and Maqsood, Khalid and Song, Yunfei li and Reynolds, Gavin and Meir, Bernhard and Robertson, John (2024) Development and process scaling of repeat mini-blending as a complementary approach to deliver continuous direct compression. Powder Technology, 448. 120224. ISSN 0032-5910 (https://doi.org/10.1016/j.powtec.2024.120224)

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Abstract

Process integration efforts in the pharmaceutical industry have led to an increased interest in Direct Compression, including Continuous Direct Compression. Accurate scale-up of powder blending and prediction of blend Critical Quality Attributes (CQAs) is key. The present work takes a modified approach for blend CQA characterisation in a high-shear semi-continuous blender (originally developed for low-shear batch blenders), and combines it with a blend content uniformity model (developed for high-shear continuous blenders) to characterise content uniformity responses of a high-shear semi-continuous blender (Gericke GBM-10-P Mini Blender). Blend content uniformity assessed across process conditions and formulations shows that for a given formulation one set of model parameters can be regressed for all datapoints, allowing insight to be transferred between blender scales and types. This infers that lab-scale low-shear batch blenders can be used to predict the content uniformity response of the high-shear semi-continuous blender, minimising materials consumption and experimental burden.

ORCID iDs

Prostredny, Martin ORCID logoORCID: https://orcid.org/0000-0001-5326-2408, Jolliffe, Hikaru Graeme, Elkes, Richard, Maqsood, Khalid, Song, Yunfei li, Reynolds, Gavin, Meir, Bernhard and Robertson, John ORCID logoORCID: https://orcid.org/0000-0002-2191-1319;
CORE (COnnecting REpositories)