Poloni, Lorenzo, Lubej, Martin, Palanisamy, Arnesh and Gururajan, Bindhu (2023) INDUSTRIAL CASE STUDY ON APPLICATION OF ROLLER COMPACTION MODELLING FOR SCALE UP AND TECHNOLOGY TRANSFER. Pharmaceutical research.

Abstract

Dry granulation of pharmaceutical powders by the roller compaction process is gaining increasing popularity in the pharmaceutical industry for its simplicity, cost, potential stability benefits and continuous processing options. The Johanson model for dry granulation process by roller compaction is well established in the scientific literature. Its applicability and limitations have been demonstrated. In this work we focus on the application of the model in an industrial environment and highlights how the application of roller compaction modelling in combination with experimental data can guide the successful scale up and equipment transfer. This work is focused on how the model can inform the DoE design and decision-making process to set parameters and choose operating ranges.

In this work, the pilot phase data (Bepex with roll width 30 cm without vacuum de-aeration) was used to model the roller compaction force range on a commercial scale (Bepex with roll width 50 cm with vacuum de-aeration) using the relationship between Pmax and porosity. The predictions helped to establish a good roller compaction process parameter range with wider range for roller compaction force and roll gap, which enabled the production of tablets without work hardening effects and good tablet quality, meeting all the in-process control specifications resulting in free-flowing and compactible granules. These granules ensure that there are no tablet defects such as capping, lamination and sticking. This work demonstrates potential applicability of mechanistic modelling using Johanson model for scale-up from lab scale to commercial roller compaction process settings.

Item Type:	Article
Keywords:	Roller compaction; Modelling and Simulation; Pharmaceutical development; Material Science
Date Deposited:	25 Oct 2023 12:15
Last Modified:	25 Oct 2023 12:15
URI:	https://oak.novartis.com/id/eprint/49832