Stimulated by Pharma 4.0, the pharmaceutical industry is changing from batch-wise to continuous manufacturing. Therefore, individual processing steps such as blending of the active pharmaceutical ingredient (API) with excipients have to be re-designed to continuous operations. In this study, batch and continuous powder blending are directly compared for API with three different excipients with varying material properties. Content uniformity analysis of the blends shows that the continuous process results in more homogeneous blends for all excipients, independent of API dosage. The type of excipient used, however does impact the consistency of the continuous blending process over time. The results presented here reveal the impact of the physical material properties of excipients on blending with API in batch and continuous processes. (c) 2021 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/). Stimulated by Pharma 4.0, the pharmaceutical industry is changing from batch-wise to continuous manufacturing. Therefore, individual processing steps such as blending of the active pharmaceutical ingredient (API) with excipients have to be re-designed to continuous operations. In this study, batch and continuous powder blending are directly compared for API with three different excipients with varying material properties. Content uniformity analysis of the blends shows that the continuous process results in more homogeneous blends for all excipients, independent of API dosage. The type of excipient used, however does impact the consistency of the continuous blending process over time. The results presented here reveal the impact of the physical material properties of excipients on blending with API in batch and continuous processes. ? 2021 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://

• DFE Pharma
• Gericke AG

• API

1. API
2. continuous manufacturing
3. Excipients
4. Lactose
5. Microcrystalline cellulose
6. Powder flow
7. powder mixing
8. Research Article