Solvates are known as pseudopolymorphs in which solvent like ethanol or isopropyl alcohol is a part of crystalline structure of the drug. when the solvent is water, it can be called as hydrates. Polymorphs are known to have different physical, chemical and may biopharmaceutical properties like dissolution rate and bioavailability. For example, Theophylline anhydrous form has higher bioavailability than theophylline monohydrated form. This is due to water acts as bridge that links two molecules of theophylline that requires energy during dissolution process.
So, if we have hydrated form of drug like pefloxacin mesylate dihydrate (moisture content by Karl Fischer 7.5-8.5%), and is processed by wet granulation and subjected to drying in FBD. The change in moisture content (by KF) can lead to change in the biopharmaceutical properties if the two forms having different properties.
So, in line monitoring by NIR must be designed in FBD to determine the moisture content during drying stage to avoid the bad impact on biopharmaceutical properties of drug.
Crystalline solids
Vippagunta SR1, Brittain HG, Grant DJ
http://www.ncbi.nlm.nih.gov/pubmed/11325474
polymorphs do effect the physicochemical and biopharmaceutical property of the API as they owe different solubility and stability in different solvent and at different pHs/temp. Moisture presence may change the polymorphic state of API that will ultimately effects it bio-availability.
- Badges
- Science topic
- Similar topics
- Phytochemistry
- Extracts