A correction factor for bridging compaction simulator and different roller compactors

Abstract

Roller compaction (RC) is an important dry granulation technique. Since pilot and commercial scale roller compactors, which operate continuously on a large scale, usually require kilograms of material per run, formulation and process development directly on such roller compactors is not practical. In contrast, a compaction simulator (CS) can produce ribblets, also known as “slugs”, using only a few grams of material with sinusoidal displacement profile replicating the motion of a specific point on the roll surface. Thus, it is possible to develop RC formulation and process in laboratory using a CS-based material-sparing approach. However, because of the inherently different configurations for applying pressure between die compression and roll compression, translating uniaxial pressure from CS experiments to roll pressure during RC is often unreliable, leading to significant uncertainties in the critical quality attributes of ribbons, such as ribbon solid fraction (or porosity) and mechanical strength. The objective of this study was to identify a correction factor (Kp = uniaxial die compression pressure/roll pressure), by correlating the compressibility profiles from CS and a roller compactor of interest, to enable more reliable process translation from CS to roller compactor. In this study, a Kp value of 0.5 was determined for Alexanderwerk WP120 and validated for Gerteis Mini-Pactor and Bepex Pharmapactor. This value may serve as a starting point for translating the optimal compaction pressure identified based on CS investigation to common roller compactors, requiring only minor adjustments to attain optimal RC process parameters (i.e., roll force and roll gap) for a chosen roller compactor.

Materials

Vivapur® 102 microcrystalline cellulose (MCC, PH102), purchased from JRS Pharma GmbH & Co. KG (Rosenberg, Germany), was used as the model material in this study.

Die compaction using Styl’One

A compaction simulator (Styl’One Evolution, Medelpharm, Beynost, France) equipped with ROCO™ (Roller Compactor) module was used to prepare rectangular MCC PH102 ribblets, each weighing approximately 300 mg. The ROCOTM module was used to simulate the Alexanderwerk WP120 roller compactor. Compaction experiments were performed over pressures ranging from 15 to 200 MPa using rectangular flat-faced punches (16 x 9 mm). Two experimental schemes were used: 1) varying roll speed (3.4, 8, and 12 rpm) at …

Read more

Yiwang Guo, Neha Singh, Pratap Kasina, Bindhu Gururajan, Changquan Calvin Sun, A correction factor for bridging compaction simulator and different roller compactors, International Journal of Pharmaceutics, Volume 702, 2026, 127244, ISSN 0378-5173,
https://doi.org/10.1016/j.ijpharm.2026.127244.