For a start check the very detailed paper regarding this subject by
Vooren. It can be found at
http://www.ualberta.ca/~csps/JPPS5(2)/L.Vooren/tablet.htm
In answer to the question is it difficult to meet--the answer as always
is "it depends".
Break lines are a nuisance because they are a source of tabletting
problems such as sticking and pitting. Therefore many companies,
particularly when there was no requirement for testing, would have a
very small breakline---almost cosmetic. If that is what you have then
you will have a very serious problem and will probably need to buy new
punches. If you have a good fairly deep breakline then there should not
be a problem.
An additional point---one idea to improve the breakability of a poor
breakline would be to put one on both sides of the tablet if there was
currently only on one side. It appears that this will be considered a
type two variation by the regulatory authorities!!!!!!
Hope that helps,
Regards,
Dr. Malcolm S.F. Ross
Director of Research and Development [Special Projects]
Polpharma
Starogard-Gdanski
POLAND
malcolm.ross@polpharma-group.com
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