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Question

Posted on: March 6 2013

How do I make theophylline syrup?

Theolair syrup is out of trade. No other syrup with theophylline available. Can we make a magistal preparation with theophylline? It is administered via a probe feeding (swallowing problems).
What about the stability of theophylline? Does heating not lose stability?
Why is NaOH 2N solution added in the Netherlands (FNA)? For stability or solubility? Or is this not really necessary?

Answer

So We start by looking at the formula of Theolair syrup. I don't see NaOH or am I wrong? So can it be without NaOH? In The FNA NaOH is added for the solubility but then the syrup is certainly alkaline.

If we look at the formula, this does not seem complicated to make a magistal preparation. I would make them based on sorbitol syrup 70% not crystallizable (to buy at Febelco). You try to dissolve the theophylline under heating in e.g. 60 ml of that sorbitol syrup and then gradually try to add water to it watching that nothing crystallizes. If this is the case, add 10 ml of sorbitol again and thus up to 100 ml.

I believe that the theophylline is kept in solution by the sorbitol 70% and that there should not be too much water on the total volume. Therefore my method.