1. Impact of excipients on batch and continuous powder blending
- Author
-
Bastiaan H.J. Dickhoff, Sri Sharath Kulkarni, Bernhard Meir, Pauline H. M. Janssen, Maarten Jaspers, Mara M.W. van Haandel, and Myrthe T.W. de Wit
- Subjects
Active ingredient ,Materials science ,business.industry ,General Chemical Engineering ,Excipient ,02 engineering and technology ,Continuous manufacturing ,021001 nanoscience & nanotechnology ,020401 chemical engineering ,Homogeneous ,medicine ,0204 chemical engineering ,0210 nano-technology ,Process engineering ,business ,medicine.drug - Abstract
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.
- Published
- 2021
- Full Text
- View/download PDF