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Statistical analysis of tablet breakability methods

Lieven Van Vooren, Bart De Spiegeleer UGent, T Thonissen, Philippe Joye UGent, J Van Durme and Guido Slegers UGent (2002) JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES. 5(2). p.190-198
abstract
Purpose: Using a model tablet, the influence of breakability methodology on mass uniformity of half- and quarter-tablets as well as the comparison of different data acquisition and evaluation approaches were investigated. Moreover, different breakability evaluation criteria were compared based upon distribution as well as distribution-free models. Methods: A cross-scored tablet, i.e. having two break-marks, was broken by different methods by different persons, and the masses determined for the whole (unbroken) tablets, the half- tablets and quarter-tablets. Results: Beside the possible interaction between the methodology and the person breaking the tablets, the major factor significantly influencing the mass uniformity of broken tablets is the breakability methodology. The best results, i.e. smallest loss and smallest variability, are obtained when the breaking force applied by the thumbs is directed towards the score side of the tablet, i.e. by "opening" the score. Using our model tablet, significant differences between the different evaluation criteria are observed, with the USP/NF approach being best in line with the detailed analysis of all broken tablets. Conclusions: Assuming that for this model tablet the variance is a linear function of the break-line length, the standard deviation of quarter-tablets is theoretically calculated to be 0.87 times the standard deviation of the half- tablets. As the absolute standard deviation, expressed in mass units, will thus remain approximately identical, the relative standard deviation will nearly double as the mean mass of the quarter-tablets will be half of the mean mass of the half- tablets. This was experimentally confirmed.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
journal title
JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES
J. Pharm. Pharm. Sci.
volume
5
issue
2
pages
190 - 198
Web of Science type
Article
Web of Science id
000177552100010
JCR category
PHARMACOLOGY & PHARMACY
JCR impact factor
1.515 (2002)
JCR rank
96/186 (2002)
JCR quartile
3 (2002)
ISSN
1482-1826
language
English
UGent publication?
yes
classification
A1
id
321922
handle
http://hdl.handle.net/1854/LU-321922
date created
2005-10-17 12:03:00
date last changed
2016-03-23 09:17:55
@article{321922,
  abstract     = {Purpose: Using a model tablet, the influence of breakability methodology on mass uniformity of half- and quarter-tablets as well as the comparison of different data acquisition and evaluation approaches were investigated. Moreover, different breakability evaluation criteria were compared based upon distribution as well as distribution-free models.
Methods: A cross-scored tablet, i.e. having two break-marks, was broken by different methods by different persons, and the masses determined for the whole (unbroken) tablets, the half- tablets and quarter-tablets.
Results: Beside the possible interaction between the methodology and the person breaking the tablets, the major factor significantly influencing the mass uniformity of broken tablets is the breakability methodology. The best results, i.e. smallest loss and smallest variability, are obtained when the breaking force applied by the thumbs is directed towards the score side of the tablet, i.e. by {\textacutedbl}opening{\textacutedbl} the score. Using our model tablet, significant differences between the different evaluation criteria are observed, with the USP/NF approach being best in line with the detailed analysis of all broken tablets.
Conclusions: Assuming that for this model tablet the variance is a linear function of the break-line length, the standard deviation of quarter-tablets is theoretically calculated to be 0.87 times the standard deviation of the half- tablets. As the absolute standard deviation, expressed in mass units, will thus remain approximately identical, the relative standard deviation will nearly double as the mean mass of the quarter-tablets will be half of the mean mass of the half- tablets. This was experimentally confirmed.},
  author       = {Van Vooren, Lieven and De Spiegeleer, Bart and Thonissen, T and Joye, Philippe and Van Durme, J and Slegers, Guido},
  issn         = {1482-1826},
  journal      = {JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES},
  language     = {eng},
  number       = {2},
  pages        = {190--198},
  title        = {Statistical analysis of tablet breakability methods},
  volume       = {5},
  year         = {2002},
}

Chicago
Van Vooren, Lieven, Bart De Spiegeleer, T Thonissen, Philippe Joye, J Van Durme, and Guido Slegers. 2002. “Statistical Analysis of Tablet Breakability Methods.” Journal of Pharmacy and Pharmaceutical Sciences 5 (2): 190–198.
APA
Van Vooren, Lieven, De Spiegeleer, B., Thonissen, T., Joye, P., Van Durme, J., & Slegers, G. (2002). Statistical analysis of tablet breakability methods. JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES, 5(2), 190–198.
Vancouver
1.
Van Vooren L, De Spiegeleer B, Thonissen T, Joye P, Van Durme J, Slegers G. Statistical analysis of tablet breakability methods. JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES. 2002;5(2):190–8.
MLA
Van Vooren, Lieven, Bart De Spiegeleer, T Thonissen, et al. “Statistical Analysis of Tablet Breakability Methods.” JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES 5.2 (2002): 190–198. Print.