Hi all.
I am interested in the possibility of replacing the technology for producing tablets with the preliminary production of a solid dispersion by spray drying. My task is to develop a generic drug, while the patent for the originator states that the first stage is to obtain a solid dispersion of the API in a polymer matrix using the spray drying method. Class 2 drug BCS. How realistic do you think it would be to try using surfactants/soluilizers/complexing agents instead of making a solid dispersion? Is it likely that a change in the method of increasing solubility/bioavailability will affect the pharmacokinetics? In this case, how indicative will the results of the dissolution test be?
For a BCS2 drug, dissolution is the rate-limiting step that determines its absorption in vivo and dissolution testing is considered indicative. Dissolution enhancers such as solubilisers/surfactants may be limited when a large percentage of the drug is prescribed. Solid dispersion techniques are still recommended to maintain a consistent release profile. Other solid dispersion techniques such as hot melt extrusion and co-precipitation can be tried if patents are to be avoided. I wish you success!
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