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Question

Posted on: March 6 2013

How to avoid discoloration of suppositories with 10 mg Omeprazole for a 9 month baby?

We use Wittepsol H15 as suppository Mass and try not to heat it too brightly. The solidified Suppo & #039; s are white but after about a week they start to color to light purple. How can we avoid this?

Answer

Here what a colleague who conducted research on Omeprazole wrote to me:

We have worked with Omeprazole a lot in the past years. However, we have never determined the chemical structure of the violet degradation product/s. The color of this product/s also depends on the solvent in which it is dissolved. In Organic Solutions It turns brown. The only information I can give you on this degradation product/s is that the discoloration appears to be derived from a mixture of different degradation products, at least in an aqueous environment. These colored degradation products must have a very high absorption coefficient, as the actual drug concentration in these intensively colored solutions is still close to 100%.

To My knowledge you cannot prevent this discoloration. It also happens in organic solutions. Even in the dry state the drug powder turns yellow to brown after a while.

so it gets some searching. I would test out three things.
  1. to the suppository mass I would add BHT 0.02%. If no effect perhaps try with propylgallate same concentration;

  2. Add 50 mg per suppository MgCO3;

  3. there are zetpilstrips in plastic, which serve as a casting and packaging form. Maybe use it once?