June surprises !
As I told you, June will be full of surprises !
Surprise number 1: Tablets
Yes, we are pressing tabs again, first batch has been made, using a two-Dimensional horizontal mixer, not the best variance for sure for a first batch and first trial, but the results are okish, we will be using a 3D mixer for next batchs, and we expect the next batchs to be way more precise and accurate.
The most important thing, is that every batch will have a multi tabs testing prior selling, and this is what we've done:
On the tadalafil:
First let me say that I applaud you for doing 5-unit tests to look at the dose-to-dose variability. Performing such analyses is a positive contribution toward harm reduction, and other suppliers should follow this practice as well, if they are not already.
One of the very specific ways that doing these multi-unit tests helps in harm reduction is by finding out whether the dose variability in a batch is acceptable from the perspective of dose safety. While having this information available allows potential buyers to determine whether or not the risk is acceptable to them, true harm reduction would be to not allow a batch that has tablets overdosed by 156% to be put on the market. Note that I said a 156% overdose, meaning the 38.39 mg tablet is 256% of the 15 mg target.
A 156% overdose is massive. I'll leave it to those with more medical expertise in the dangers of a potential tadalafil overdose to contribute, if they desire, but I do not consider it something to be just casually mentioned without taking mitigation action.
Another important point is that there are guaranteed to be other tablets in the production batch with GREATER THAN a 156% overdose. What are the chances that, of the entire production run, the one (of five) sampled for analysis was the most overdosed tablet? Effectively 0 chance. It's certainly not the most overdosed, and there's no way to know what the limit might be. There could be a 200% overdose, or 250%, or greater. Without knowing the causal mechanism for how the overdose happened, there's no way to know how bad things could be.
I know it would be a substantial cost to scrap the production run in the service of harm reduction. However, to help, from a business perspective, you would not necessarily need to trash the entire batch. Talk with your formulators and process engineers about reprocessing the material. Grind the entire batch, add more tablet compaction excipients, mix thoroughly, and perform compaction again to get 10mg or 5mg tablets. The dose consistency will be much greater with a re-grind and mix, assuming those two steps are performed thoroughly.
Summary
I highly recommend pulling the batch in the interests of true harm reduction, but if QSC is unwilling to do so, customers should be fully aware that they could be getting a 150% or greater overdosed tablet.