Characterising the disintegration properties of tablets in opaque media using texture analysis.

Autor: Scheuerle RL; Department of Chemical Engineering and Biotechnology, BioScience Engineering Research Group, University of Cambridge, New Museums Site, Pembroke Street, Cambridge CB2 3RA, United Kingdom. Electronic address: rs765@cam.ac.uk., Gerrard SE; Department of Chemical Engineering and Biotechnology, BioScience Engineering Research Group, University of Cambridge, New Museums Site, Pembroke Street, Cambridge CB2 3RA, United Kingdom., Kendall RA; University College London, School of Pharmacy, Department of Pharmaceutics, London WC1N 1AX, United Kingdom., Tuleu C; University College London, School of Pharmacy, Department of Pharmaceutics, London WC1N 1AX, United Kingdom., Slater NK; Department of Chemical Engineering and Biotechnology, BioScience Engineering Research Group, University of Cambridge, New Museums Site, Pembroke Street, Cambridge CB2 3RA, United Kingdom., Mahbubani KT; Department of Chemical Engineering and Biotechnology, BioScience Engineering Research Group, University of Cambridge, New Museums Site, Pembroke Street, Cambridge CB2 3RA, United Kingdom.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2015; Vol. 486 (1-2), pp. 136-43. Date of Electronic Publication: 2015 Mar 16.
DOI: 10.1016/j.ijpharm.2015.03.023
Abstrakt: Tablet disintegration characterisation is used in pharmaceutical research, development, and quality control. Standard methods used to characterise tablet disintegration are often dependent on visual observation in measurement of disintegration times. This presents a challenge for disintegration studies of tablets in opaque, physiologically relevant media that could be useful for tablet formulation optimisation. This study has explored an application of texture analysis disintegration testing, a non-visual, quantitative means of determining tablet disintegration end point, by analysing the disintegration behaviour of two tablet formulations in opaque media. In this study, the disintegration behaviour of one tablet formulation manufactured in-house, and Sybedia Flashtab placebo tablets in water, bovine, and human milk were characterised. A novel method is presented to characterise the disintegration process and to quantify the disintegration end points of the tablets in various media using load data generated by a texture analyser probe. The disintegration times in the different media were found to be statistically different (P<0.0001) from one another for both tablet formulations using one-way ANOVA. Using the Tukey post-hoc test, the Sybedia Flashtab placebo tablets were found not to have statistically significant disintegration times from each other in human versus bovine milk (adjusted P value 0.1685).
(Copyright © 2015 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: