Posted by europerep on January 18, 2015, at 15:17:32
In reply to Re: Splitting pills. Reliable or not? (@Ed and others), posted by ed_uk2010 on January 17, 2015, at 17:03:17
> Sure, what is it? I'm not aware of that many different products. There's King pharma (which are film coated), NRIM pharma (not film coated) and a blister packed import called Paxtibi. I suspect your tablets are made by NRIM. Correct?
Yes indeed, it's the NRIM. It's really good to hear that these are not coated, so I don't have to worry about this any longer.
> There will always be variation - no quantity can ever be exact. What's important is whether or not the differences are clinically relevant.
Of course, it's clear that no two tablets will even contain the same amount of molecules of the active ingredient. I just meant that I could imagine that there is a variation that, as far as technology is concerned, could easily be reduced, but that this would only make production more expensive without making a real difference for the patient.
> The decision to accept or reject a batch is based on a *statistical calculation*. This is because it's not possible to analyse every tablet..... the tablets are destroyed during the analytical/assay process.
Yeah, I had imagined that this would like that. What I find surprising is that, every now and then, batches of drugs *are* recalled because of excessive variation of the active ingredient. As far as I know, this is only a small part of all the recalls, but it does happen. (It happened recently here with an amitriptyline product I was taking.) Why don't they test the batch beforehand and only distribute it if the tests come out ok? That's not just easier but also so much cheaper than organizing a recall, plus of course the potential impact on patients. Do you have an idea why that is?
But I also have one more follow-up related to my initial question? Will the fact that I cut the tablet change anything about how quickly the active ingredient is released? I would assume that, since my product is an immediate release, there will be no noticeable difference, but is this indeed the case?
Thanks again! :)
poster:europerep
thread:1075154
URL: http://www.dr-bob.org/babble/20150102/msgs/1075241.html