Hello Everyone!
I have prepared liposomal formulation using Rotary Evaporator method followed by dialyzed the liposomal Suspension in Phosphate buffer to remove the un-encapsulated drug. After dialysis I have stored the formulation at 2-8C for stability analysis. Issue is upon analyzing day 2 or 3 sample concentration of sample observed to be more than double to what i have observed on day 0. Have anyone experienced this kind of problem before? Any recommendation or suggestion to find what might be wrong here! Thanks!
*Please note - i have prepared two batches separately and similar problem is there in both batches. Also, did observe same problem with hydrophilic as well as hydrophobic drug.
About the evaporation method: did you extrude the resulting heterogenic suspension upon hydration? If yes, did you observe any size changes after the give time period?
How do you analyze the concentration? The increase of the concentration could be caused by releasing of the "drug/API" from your liposomes (If the concentration determination method analyzing only "free" drug in suspension).
Thanks @ jan kotoucek for replying! Unfortunately, I wasn’t able to extrude the suspension. I did dialysis only to remove the free drug. Though i did wash the stability samples (after observing this issue) with phosphate buffer using centrifugation. In supernatant i have observed only traces (0.01mg) of API. Is there any recommendations from your side?@jan kotoucek
The increase in drug concentration may not be due to the substance, it may be due to the interpretation of the result obtained by the quantification method you use.
Since by pure matter and energy analysis, you cannot create extra matter to what you added, you would only transform it if there was a reaction.
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