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Evaluation of segregation of pharmaceutical formulations in direct compression process

Evaluation of segregation of pharmaceutical formulations in direct compression process

Garg, Vivek ORCID: 0000-0002-8515-4759 , Deng, Tong ORCID: 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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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

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