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Question

Posted on: March 6 2013

We are asked to prepare a loco preparation for WARTEC cream. This cream contains podofyllotoxin 1, 5mg/g and a tube contains 5g cream.

Which cream base would we use? Do we solve podophyllin in alcohol beforehand? Or is it better to prepare a solution?

Answer

The most complete composition, which I could find is worded as follows:

Purified water Ph Eur Methylparaben Ph Eur Propylparaben Ph Eur Sorbic acid Ph Eur Phosporic acid Ph Eur Emulsifier E2155 In House 011-000/4 Stearyl alcohol Ph Eur Cetyl alcohol Ph Eur Isopropyl myristate Ph Eur Paraffin, liquid Ph Eur Fractionated coconut oil BP Butylated hydroxyanisole BP

Shelf-life: 2 years from date of manufacture.

Special Precautions for Storage: Store at room temperature (15-25 °C).

Nature and Contents of Container: A collapsible tube of aluminium furnished with an imperforate nozzle membrane and internally coated with A protective lacquer. Tube screw cap of polypropylene with a spike on the upper end aimed to perforate the membrane when opening the tube for the first time. Size 5 or 10g.

Emulsifier E2155 is Steareth-10, which belongs to the series which also includes Cetomacrogol 1000 (or Cetareth-20).

So the buffered Cetomacrogol cream TMF can therefore be recommended for this preparation. Two possibilities can be considered to add the Podophyllin. Prior dissolving in ethanol, in which this product is well soluble, becomes a first possibility. When mixing this solution with the cream, the Podophyllin will hopefully precipitate under a fine form.

But I also read that Podophyllin is to some extent solvent-based in vegetable oils. In the composition, which is mentioned above, fractionated fractionated coconut oil occurs. A better known product, which corresponds to this denomination, is Miglyol. Since the amount of podophyllin to add is limited, it might be possible to solve it in Miglyol. The amount of Miglyol, which we use, is deducted from the amount of liquid paraffin, which in the composition of the Cetomacrogol cream prevent