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Rational estimation of the optimum amount of non-fibrous disintegrant applying percolation theory for binary fast disintegrating formulation

Krausbauer, Etienne and Puchkov, Maxim and Betz, Gabriele and Leuenberger, Hans. (2008) Rational estimation of the optimum amount of non-fibrous disintegrant applying percolation theory for binary fast disintegrating formulation. Journal of pharmaceutical sciences, Vol. 97, H. 1. S. 529-541.

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Official URL: http://edoc.unibas.ch/dok/A5248841

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Abstract

The purpose of this study was to propose a method of determining the exact value of disintegrant ratio in a binary drug-disintegrant compacted mixture for a minimum disintegration time in the case of spherical particles. Disintegration is a limiting factor in dissolution process of compact for low water soluble active ingredients. As disintegration time is shortest at a certain ratio of disintegrant, a calculation of this value is important for solid dosage from design to enhance disintegration and dissolution process. According to percolation theory, a minimum disintegration time corresponds to the formation of a continuous water-conducting cluster through the entire tablet. The critical volumetric ratio at which the cluster is formed is named percolation threshold and has the value of 0.16 for random close packed (RCP) sphere systems. RCP systems where chosen as the best model for compacts consisting of spherical particles. Two cases for water diffusion through the tablet were identified, according to geometrical considerations between disintegrant And drug particles. These cases determine if disintegrant particles can have a contact between each other within the compact and thus if porosity and disintegrant volume are included in the continuous cluster. An equation for both cases is presented in the form of piecewise function to determine the minimal disintegrant volumetric ratio for a binary drug/disintegrant compact in order to achieve a minimum disintegration time. Disintegration tests were performed with tablets at different ratios of modified corn starch mixed with caffeine or paracetamol powders. Estimated and experimental optimal ratio were compared showing coefficient R-2=0.96. (C) 2007 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:529-541, 2008.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Pharmazeutische Technologie (Huwyler)
UniBasel Contributors:Puchkov, Maxim
Item Type:Article, refereed
Bibsysno:Link to catalogue
Publisher:American Pharmaceutical Association
ISSN:0022-3549
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:14 Sep 2012 07:14
Deposited On:22 Mar 2012 13:16

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