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Posted on: April 8 2014

Shelf life Locoid Crelo with salicylic acid 3%?

In a question about the Locoid Crelo with salicylic acid 3% you indicate that for the stability of the emulsion sodium lauryl sulfate can be added. But what shelf life would you allocate?

Answer

Locoid Crelo is an emulsion milk with 0.1% hydrocortsonbutyrate. This constituent is an ester and therefore subject to hydrolysis. In itself I found in   Rapid high performance liquid chromatography analysis and stability study of Hydrosortisone butyrate in cream PR eparations A great stability   for this product in creams. This product is very little soluble in water like all analogue corticosteroid esters and will probably be reflected in the oil phase. Nevertheless one finds combinations of such esters with salicylic acid only   in water-free ointments. So, deciding that no hydrolysis occurs when water comes to pass, I would not dare to guarantee it.  

I am almost certain of the foregoing that I will not find any scientific stability studies in the presence of salicylic acid. It is therefore impossible to give a concrete shelf-life. The   becomes a wet finger operation. I would gamble on up to 2 months when stored in the refrigerator. Now for a magistal preparation this must be in principle sufficient.