In the new tablet friability General chapter which is harmonized in the Pharmacopoeias, the following statement is present:
“If tablet size or shape causes irregular tumbling, adjust the drum base so that the base forms an angle of about 10° with the horizontal and the tablets no longer bind together when lying next to each other, which prevents them from falling freely.”
However, I saw in the old European pharmacopoeia (5.0) and in catalogs of friability apparatus manufacturers that the 10° angle is used for all tablets whose diameter is 13 mm or larger
European pharmacopoeia (5.0):
“For tablets having a diameter of 13 mm or greater, problems of reproducibility may be encountered due to frequent irregular tumbling. In such cases, adjust the drum so that the tablets may fall freely and do not bind together when lying next to each other, adjusting the drum so that the axis forms a 10° angle with the base is usually satisfactory.”
My questions are:
1- If we use the 10° angle for all tablets whose diameter is 13 mm or larger , does this ensure compliance with the harmonized pharmacopoeial requirement ?
2- If we use the 10° angle with all tablets sizes , is this considered a violation to the harmonized pharmacopoeial requirements (my knowledge is that the target is that tablets fall freely during the test and so there is no violation in using 10° angle with all tablet sizes) ?
Thanks a lot