Effects of hydrotalcite-like nanostructured compounds on biopharmaceutical properties and release of BCS class II drugs: The case of flurbiprofen

A new approach to improve gastric solubility and control intestinal release of drugs, based on the formation of new nanostructured compounds, is described. The nanostructured system is an inorganic–organic hybrid material constituted by an inorganic material, belonging to the hydrotalcite-like compound (HTlc), and by flurbiprofen (FLUR), a nonsteroidal antiinflammatory drug belonging to class II of BCS. HTlc is an inorganic solid able to lodge molecular anions into its interlayer region. It dissolves in acid conditions releasing the guests in the medium generating a supersaturation state. On the contrary, it is very stable in neutral or slightly alkaline conditions releasing the intercalated anions by ion exchange. This article describes: i) the nanocomposite (HTlc-FLUR) preparation and characterization; ii) the capability of HTlc to modify FLUR release, both in gastric and intestinal media; and iii) the ability of HTlc to modify FLUR gastric mucus permeation. A remarkable improvement of drug apparent solubility in gastric fluid, an enhancement of gastric mucus permeation and a drug controlled release in intestinal environment were observed.