Effect of PVP K-25 on the formation of the naproxen:beta-ciclodextrin complex.

The aim of this study was to investigate the effects of the presence of the water-soluble polymer polyvinylpyrrolidone K-25 (MW=24000g/mol) on the complexation of the AINE naproxen, in its sodium salt form, with the beta-cyclodextrin. The data revealed that the polyvinylpyrrolidone K-25 interacts with the drug as well as with the drug:beta-cyclodextrin inclusion complex. The polymer shows more affinity for the inclusion complex, K=(6.67+/-0.292) x 10(-5)M(-1) than for the free drug, (2.08+/-0.208) x 10(-5)M(-1). The presence of different proportions of polymer, in a range 0-1% (w/w) of polyvinylpyrrolidone, does not increase the ability of drug-cyclodextrin complexation but important changes in the driving force of complex formation were detected, depending on the percentage of polyvinylpyrrolidone K-25 present. At low polymer concentrations, the complexation process is driven entropically, while at higher PVP proportions it is enthalpically favored. In the ternary system, polyvinylpyrrolidone K-25 partially or totally coats the drug:beta-cyclodextrin inclusion complex interacting with the beta-cyclodextrin (through hydrogen bonds), and with the naproxen.