Nanostructured hybrids for the improvement of folic acid biopharmaceutical properties

Objectives Folic acid (FA) is an important source for the prevention of many diseases. However, its use is limited because the very low solubility (<10 mg/l particularly in the gastric environment) responsible for the incomplete adsorption of the administered dose. This study proposes a technological strategy to overcome this problem enhancing FA dissolution rate by means of a formulation able to make completely bioavailable the whole administered dose. Methods Folic acid was intercalated in the layered double hydroxides (LDHs) MgAl-LDH and ZnAl-LDH. The obtained inorganic–organic nanostructured hybrids MgAl-LDH-FA and ZnAl-LDH-FA were deeply characterized and used to prepare immediate release tablets presenting very simple compositions. The hybrids, both as simple powders and as tablets, were submitted to in-vitro release studies mimic the gastric environment conducted both in sink and non-sink conditions. Key findings Folic acid release from hybrids, as single powders or as tablets, resulted enhanced in both experiments in comparison with crystalline FA. Conclusions Obtained results showed that FA-LDH nanostructured hybrids are a promising strategy able to enhance the active ingredient dissolution at low pH values representing a promising approach suitable to realize innovative and effective nutraceutical products.