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Process intensification of pharmaceutical powder blending at commercial throughputs by utilizing semi-continuous mini-blending

By Maarten Jaspers1; Florian Tegel2; Timo P. Roelofs1; Fabian Starsich2; Yunfei Li Song3; Bernhard Meir2; Richard Elkes3; Bastiaan H.J. Dickhoff1

1. DFE Pharma 2. Gericke AG 3. GSK

Published on

Abstract

Process intensification involves the miniaturization of equipment while retaining process throughput and performance. The pharmaceutical industry can benefit from this approach especially during drug product development, where the availability of active pharmaceutical ingredients (API) is often limited. It reduces the need for process scale up, as equipment used during product development and commercial production is identical. However, applications of process intensification for processing pharmaceutical powders are limited so far. Here we show that semi-continuous mini-blending can be utilized for process intensification of blending of API and excipients. Uniform blending at commercially relevant throughputs was achieved through mini-blends with a volume of less than ten liters. Our results demonstrate that blending speed, cycle time and blender fill level can be optimized without compromising blending performance. Acceptable blend uniformity is obtained over a broad range of operating parameters, by choosing the right excipients. The optimized throughput of the mini-blending process is in line with the desired throughput of a commercial Continuous Direct Compression (CDC) process.

Journal

International Journal of Pharmaceutics: X

DOI

10.1016/j.ijpx.2024.100264

Type of publication

Peer-reviewed journal

Affiliations

  • DFE Pharma, Klever Strasse 187, 47568 Goch, Germany
  • Gericke AG, Althardstrasse 120, CH-8105 Regensdorf, Switzerland
  • GSK, Park Road, Ware SG12 0DP, UK

Article Classification

Peer-Reviewed Journal

Classification Areas

  • API

Tags