Posted by ed_uk2010 on November 16, 2011, at 12:57:34
In reply to Re: 2nd MAOI after the first one failed? » ed_uk2010, posted by europerep on November 16, 2011, at 8:51:52
>good to see you here again....
Thanks!
>That must mean that it's not actually the phenelzine that is sensitive to above-fridge temperatures, but something else that's in the tablets.
The stability of drugs (such as phenelzine) can be affected by the excipients which are used, either in the tablet core or the coating. I think it's likely that the stability of phenelzine is improved by the excipients/formulation used in America, and so refrigeration to maintain stability is not needed.
The formulation licensed in the UK requires refrigeration in order to maintain an 18 month expiry date from manufacture. Without refrigeration, the expiry date would be unattractive, especially since it's such a slow-moving product. It can, however, be kept out of the fridge for short periods without a problem.
>I mean, even if the ingredients for the European versions are cheaper, that would most likely be offset by what it costs to have the products sit in a cooled warehouse, no? Do you have any idea why that is?
Although fridge lines are more costly to distribute than ambient products, it would potentially be expensive for Archimedes UK to change the tablet formulation. Any changes would have to be tested and approved by the MHRA or EMEA. Given that sales are very low, I don't think they would consider it worthwhile to make any changes at this stage. The cost of the excipients themselves is not likely to be relevent, they all cost very little.
Sorry not to be of more help.
poster:ed_uk2010
thread:990065
URL: http://www.dr-bob.org/babble/20111110/msgs/1002762.html