Hi, My drug is sensitive to hydrolysis and we are trying to formulate an o/w nanoemulsion of it. In the stability study, we see a degradation of the drug due to hydrolysis which is not acceptable. Please suggest how to overcome the hydrolytic degradation of drug and make the nanoemulsion stable.
Also, what are the critical parameters to look at while formulating. PS: There is no problem of physical instability. Thanks
You have to know the pH of maximum stability. Perform a pH-rate profile and target the proper pH range. Formulate with excipients that squeeze out the water around your API.
you have to consider pH, critical temperature, solubility and of course measuring the leakage of your micelle or nano- microbead would help to prevent the degradation process.
Maybe you could add a conjugate that could prevent degradation like a protein or polymer.
Kratz, F., 2008. Albumin as a drug carrier: design of prodrugs, drug conjugates and nanoparticles. Journal of controlled release, 132(3), pp.171-183.
Khandare, J. and Minko, T., 2006. Polymer–drug conjugates: progress in polymeric prodrugs. Progress in Polymer Science, 31(4), pp.359-397.
The pH of the maximum stability and can add the polymer to overcome this obstacle
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