I have developed polymeric patch by incorporating polymers and drugs and characterized by different analytical tools including SEM, DSC and others. The product is undergone accelerated stability testing for six months at 40 degree temperature and 75 relative humidity. The physical property have been evaluated at different time points. The drug content was also dtermined at different time points. But I don't have exact idea to detrmine chemical stability of the product during the course stability testing. Whether thermogravimetric analysis will be sufficient to confirm the chemical stability or is there any other technique to confirm chemical stability of the product. Please explain.
Hello dear TGA is not enough for your chemical stability you can make infrared analysis, because sometimes the drugs may suffer oxidation process.
Dear Johirul Islam
Please go through the ICH guidelines for the stability studies. Please have a look of ICH Q1C guidelines. I also recommend AFM studies for the surface roughness and XRD for any crystal changes in the patches.
with best wishes
The way to make a first guess at a shelf life is to perform an Arrhenius plot with stability at different temperatures.
The other stuff, DSC, TGA only tell you that there IS a chemical reaction (i.e. thermodynamic change) This could be an irreversible decomposition you only see at high temperature or it may be as harmless as change in crystalline isoform.) Texture analysis is really what you want to characterize a patch deliver system. AFM is microscale and may or may not give useful information.
Beyond that, you have to have ICH guidelines to pass. What you have described here, I believe is adequate for first production with obligation for further points under future review. The CRT and intermediate levels 35/70 are also CRITICAL for stability. So much degrdation has to do with water first, and secondly temperature. Is your primary packaging adequate? You also have the added challenge, I presume, of working with a hydrogel. Your product is essentially liquid. You probably need sealed foil pouches to prevent changes to your product. This kind of product could also be sensitive to cold temperature as freeze/thaw could possibly damage large weight excipients in an aqueous environment. I would be sure to write a cold storage test into the stability protocol.
Good luck. It's challenging work!
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