Question
Posted on: March 6 2013How 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%.so it gets some searching. I would test out three things.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.
- to the suppository mass I would add BHT 0.02%. If no effect perhaps try with propylgallate same concentration;
- Add 50 mg per suppository MgCO3;
- there are zetpilstrips in plastic, which serve as a casting and packaging form. Maybe use it once?