Question
Posted on: October 1 2013Is 5% extra of the active substance weighed for the making of gelules?
In 2011, the pharmaceutical inspection carried out 2 preparations (Gelulen) for control. These preparations were only nipped in accordance with (90.3% of the prescribed dose). When looking at the weighing chips of these preparations we have seen that 5% extra of the active ingredient was weighed. Now we are not doing this anymore, so we think the gelules we are making are not compliant. Is it a standard rule that 5% extra is weighed? For folic acid We do not weigh 10% extra.
Answer
For folic acid, the TMF recommends an overdose of 10%. I did not think for other low dose capsules like hydrocortisone.
It is indeed advisable to apply an overdose of 5% for an amount of active ingredient less than 10 mg.. A ring test written out by the FAMHP has demonstrated this and further research is underway to demonstrate where the possible losses occur?