23 November 2023

Improving quality in continuous manufacturing

A recent scientific publication by universities and laboratories in The Netherlands, Belgium, and Germany investigated the impact of material properties and process parameters on tablet quality in a continuous direct compression line using the SOTAX AT50.

The SOTAX AT50 can be integrated online with different brands of tablet presses for 100% unattended operation – or can be deployed “at line” running stand-alone. It was chosen for the study because of its superior ability to reliably align a great variety of differently shaped tablets. Knowing that repeatable tablet alignment is the basis for accurate dimensional measurements and tablet hardness, the AT50 was used to analyze tablet crushing strength, tablet dimensions (thickness, width, length/diameter), and mass (as part of determining the porosity of the compacts).

The study showed how material properties and process parameters can play a crucial role in the optimization of CDC processes (Continuous Direct Compression). Findings of the study can contribute to the speed and quality of formulation development.

"Impact of material properties and process parameters on tablet quality in a continuous direct compression line"

Published 15 June 2023
Powder Technology, Elsevier

Abstract:
"The current paper shows how excipient properties impact the process parameters and the final tablet properties in a fully integrated continuous direct compression line. Blend properties of low-dose (1% w/w) and high-dose (40% w/w) paracetamol formulations were evaluated and linked to the blending and tableting performance via multivariate models (Partial Least Squares analysis, PLS). Feeding behavior was analyzed separately, as the amount of active pharmaceutical ingredient (API) that ended into tablets was driven by random fluctuations in the API feeding behavior. [...]"

Do you want to learn more about how automation can help with in-process control (IPC) of the physical parameters of your dosage form? Then get in touch with your local contact.