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Study of radial die-wall pressure during high speed tableting: effect of formulation variables.
Drug Dev Ind Pharm. 2012 May; 38(5):623-34.DD

Abstract

With high-speed compaction cycles as applied in pharmaceutical industrial presses, robust tools like radial die-wall pressure (RDWP) are required to monitor the deformation behavior of formulations under pressure and to avoid common problems such as capping. In this study, the effects of common formulation factors such as lubricant, binder, and drug loading on RDW were investigated. Compaction simulation using Presster™ was applied for five pharmaceutical fillers with different compaction behaviors. Two lubricants, two binders and paracetamol as a model drug were used. Residual die-wall (RDP) and other compaction parameters were measured. Lubricant reduced RDP for fillers with plastic/brittle behavior(s), (p < 0.05), while increased RDP for fillers with plastic/elastic behavior, (p < 0.05), leading to higher tendency for capping in the later fillers. Binder reduced RDP for the fillers, (p < 0.05), hence, decreased capping probability. By increasing drug loading for fillers with plastic/elastic behavior(s), RDP was increased, (p = 0.00001), leading to capping, especially at high compaction pressure and speed. Die-wall instrumentation was useful in investigating formulation variables and detecting capping during high speed tableting.

Authors+Show Affiliations

Department of Pharmaceutical Sciences, Industrial Pharmacy Research Group, University of Basel, Switzerland.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21988183

Citation

Abdel-Hamid, Sameh, et al. "Study of Radial Die-wall Pressure During High Speed Tableting: Effect of Formulation Variables." Drug Development and Industrial Pharmacy, vol. 38, no. 5, 2012, pp. 623-34.
Abdel-Hamid S, Koziolek M, Betz G. Study of radial die-wall pressure during high speed tableting: effect of formulation variables. Drug Dev Ind Pharm. 2012;38(5):623-34.
Abdel-Hamid, S., Koziolek, M., & Betz, G. (2012). Study of radial die-wall pressure during high speed tableting: effect of formulation variables. Drug Development and Industrial Pharmacy, 38(5), 623-34. https://doi.org/10.3109/03639045.2011.621431
Abdel-Hamid S, Koziolek M, Betz G. Study of Radial Die-wall Pressure During High Speed Tableting: Effect of Formulation Variables. Drug Dev Ind Pharm. 2012;38(5):623-34. PubMed PMID: 21988183.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Study of radial die-wall pressure during high speed tableting: effect of formulation variables. AU - Abdel-Hamid,Sameh, AU - Koziolek,Mirko, AU - Betz,Gabriele, Y1 - 2011/10/11/ PY - 2011/10/13/entrez PY - 2011/10/13/pubmed PY - 2012/7/18/medline SP - 623 EP - 34 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 38 IS - 5 N2 - With high-speed compaction cycles as applied in pharmaceutical industrial presses, robust tools like radial die-wall pressure (RDWP) are required to monitor the deformation behavior of formulations under pressure and to avoid common problems such as capping. In this study, the effects of common formulation factors such as lubricant, binder, and drug loading on RDW were investigated. Compaction simulation using Presster™ was applied for five pharmaceutical fillers with different compaction behaviors. Two lubricants, two binders and paracetamol as a model drug were used. Residual die-wall (RDP) and other compaction parameters were measured. Lubricant reduced RDP for fillers with plastic/brittle behavior(s), (p < 0.05), while increased RDP for fillers with plastic/elastic behavior, (p < 0.05), leading to higher tendency for capping in the later fillers. Binder reduced RDP for the fillers, (p < 0.05), hence, decreased capping probability. By increasing drug loading for fillers with plastic/elastic behavior(s), RDP was increased, (p = 0.00001), leading to capping, especially at high compaction pressure and speed. Die-wall instrumentation was useful in investigating formulation variables and detecting capping during high speed tableting. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/21988183/Study_of_radial_die_wall_pressure_during_high_speed_tableting:_effect_of_formulation_variables_ L2 - https://www.tandfonline.com/doi/full/10.3109/03639045.2011.621431 DB - PRIME DP - Unbound Medicine ER -