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Posted on: June 30 2016

Atropine 0.01% in Solutio pH 4.8 of benzalkonii Chlorido

Best I was asked by a doctor to prepare an eyedrop with atropine 0.01%. I thought to make this in a solutio pH 4.8 of benzalkonii Chlorido, as can be found in the FN V and FNA. However, is it supposed that this solution is sterilized anyway by steamy water vapour or by methods of the BF V? Is it not enough to filter this vehicular sterile in the preparation of the Eyedrop? I also find a shelf life of 1 month back. I know that this is classic for eyedrops, but is there an option to extend this shelf life anyway? Thanks in advance!

Answer

The sterilisation methods using heat are more secure in the final receptacle than a sterile filtration. The latter is not excluded. But in your hospital pharmacy you may have a LAF cabinet. This is already a bigger improvement, but the method still gives a certain chance of non-sterility. The total solution is filtered in a pre-sterilized collyrevial

There is no method to prolong the retention period, which imposes the pharmacopoeia for eye drops. The month is counted from the first opening of the bottle. .   The short period has to do with the micobiological contamination during use.

Unopen, shielded from light and stored in refrigerator is shelf life 1 year