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Question

Posted on: October 20 2017

Can you store a solution (dermal) with tetracaine, cocaine, Adrenaline and Nacl 0.9% 6 months outside the refrigerator?

T and C are powders, they are dissolved in A and N. The solution is filtered sterile afterwards. Adrenaline is shelf-life for 6 months outside the refrigerator. According to UZ Leuven, this preparation lasts for 2 months in a refrigerator; But is there not a chance that she lasts for 2 months on KT, since she is filtered sterile? This is important for storage in emergency cabinet/pharmacy on our pitch.

Answer

We have 1. The Chemical shelf life and 2. The Micobiological shelf life

I suspect that tetracaine and cocaine can be stable for 6 months in solution provided that an optimal pH is possible; although in the latter case the play area is quite limited due to the presence of Adrealine. The Adreanline solution is acidic and I suspect that For both local Anaesthettica an acid pH is not unfavorable.  

But we also have the microbiological shelf life. You speak of sterile filtration and this is an uncertain sterilization method, which the European Pharmacopoeia does not even observe as a sterikisation technique. Taking this into account, I would put the     shelf life with KT of your solution on 2 months.  

On the other hand, all ingredients of your composition in solution can be sterilized using heat.   To reduce the likelihood of a non-sterile preparation, we will still filter the solution beforehand   by a sterile Membrane filter in a vial (Flapul), which is closed. We will place this closed bottle for 30 minutes in the autoclave (10 min Warming up time and 20 min sterilization). Once the 30 minutes passed, we let the whole cool down and then take the vial out of the autoclave. So willing, I would dare to grant a retention period of 6 months.