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Question

Posted on: May 31 2016

Latanoprost in Fitalite base in a very low dosage

A dermatologe prescribes: Latanoprost 0.005% in Fitalite basis ad15g. Lanatoprost is supplied in a 5 mg vial. How can this minimum amount of lanatoprost be inserted into the cream base? Is a shelf life known and should additional preservative be added?

Answer

1. This means that for 15 g cream We need 0.75 mg of latanoprost. If we dissolve the 5 mg of Latanoprost   in the vial with 7 g ethanol and add 1 g of this solution to 14   G Fitalite Base then we have in 1 G ethanolic solution 0.714 mg Latanoprost. This obviously does not correspond correctly to 0.005%. But I think we should finish a bit in order not to have to work with small amounts after the comma.  

2. According to the limited amount of information, Fitalite contains preservatives. + Our small amount of ethanol?

3. Stored at room temperature, the shelf life at room temperature is six weeks. Nothing prevents the cream from being stored in the refrigerator  

4. Stability data on latanoprost in aqueous solution can be found on the website of Fagron.be   of a   ethanolic solution from Latanoprost We found no stability data but we suspect that, kept in the refrigerator ( Deep-freezer), the solution is stable for six to nine months.