Question
Posted on: October 20 2017Can you store a solution (dermal) with tetracaine, cocaine, Adrenaline and Nacl 0.9% 6 months outside the refrigerator?
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.