Garg, Vivek ORCID: https://orcid.org/0000-0002-8515-4759, Deng, Tong ORCID: https://orcid.org/0000-0003-4117-4317, Sousa, Lucas Massaro and Bradley, Michael (2024) Evaluation of segregation of pharmaceutical formulations in direct compression process. In: 11th International Conference on Conveying and Handling of Particulate Solids, 2nd -4th Sep., 2024, Edinburgh. (In Press)

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Abstract

The phenomenon of powder segregation during the direct compression process can pose a significant challenge in controlling of content uniformity in blended powders, particularly when the powder exhibits characteristics of being free-flowing or easily flowing. Evaluating the level of segregation in powders at early formulation stage faces a significant challenge due to the scarcity of available samples. The utilisation of small bench-scale testers for an advanced segregation evaluation can provide valuable insights for making formulation decisions and recommendations for operational parameters in a process that has not been extensively studied previously. This study utilized a total of eight formulations, each consisting of a combination of two co-processed excipients blended with one active pharmaceutical ingredient at varying concentrations. The objective of the study was to investigate the phenomenon of segregation using two different types of bench-scale testers, namely the air-induced segregation tester and the surface rolling segregation tester. Additionally, a pilot simulation process rig was employed to conduct a comparative analysis. The findings indicate that the assessment of segregation on bench-scale testers can effectively serve as an indicator of the level of segregation within a blend for a process, if the segregation intensity does not exceed 20%. The comparison also demonstrates that both the bench-scale testers exhibit a strong correlation with the process rig, indicating that any segregation tester can be utilised autonomously for the purpose of evaluation. The study investigated the use of a linear regression model to predict segregation in the process.

Item Type:	Conference or Conference Paper (Paper)
Uncontrolled Keywords:	segregation in process; formulated powders; bench-scale testers; harshness factors; linear regression model
Subjects:	Q Science > Q Science (General) T Technology > T Technology (General)
Faculty / School / Research Centre / Research Group:	Faculty of Engineering & Science Faculty of Engineering & Science > Medway Centre for Pharmaceutical Science > Pharmaceutical and Medicinal Science Research Group Faculty of Engineering & Science > Medway School of Pharmacy Faculty of Engineering & Science > School of Engineering (ENG) Faculty of Engineering & Science > Wolfson Centre for Bulk Solids Handling Technology
Last Modified:	02 Jul 2024 16:03
URI:	http://gala.gre.ac.uk/id/eprint/47541

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