Cyclodextrin-based oral dissolving films formulation of taste-masked meloxicam

Abstract

This work deals with fast-dissolving drug delivery systems of meloxicam (MX) derived from electrospun polyvinylpyrrolidone (PVP)/2-hydroxypropyl-β-cyclodextrin (HPβCD) nanofiber mats. Electrospinning of solutions with different solvent systems [dimethylformamide (DMF) and ethyl alcohol (EtOH)] was performed. Prepared films were evaluated for morphology, physical, and mechanical properties. MX content, dissolving time, MX release, and cytotoxicity of films were investigated. In vivo studies were also performed in healthy human volunteers. The results showed that MX/HPβCD complexes improved the solubility of MX. PVP also increased MX solubility and the stability of MX/HPβCD complexes. Films were successfully prepared by two solvent systems with fiber in the nanometer range. MX was well incorporated into the films (100% efficiency). The X-ray patterns and DSC experiment indicated an amorphous form of MX. A fast disintegration time and burst release of MX was obtained from EtOH system. Cytotoxicity testing of the films produced by EtOH system proved safer than the DMF system. In vivo studies revealed that films rapidly dissolved in the mouth and had a less bitter taste than MX. These results suggest that electospun films from EtOH system may be a good candidate for fast-dissolving drug delivery systems to increase palatability of dosage forms.

Keywords:

• Oral dissolving films
• electrospinning
• meloxicam
• ethyl alcohol
• dimethylformamide

Acknowledgements

Authors thank Areerut Sripattanaporn for cytotoxicity test and technical guidance.

Disclosure statement

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Funding

The authors would like to acknowledge Faculty of Pharmacy, Silpakorn University and the Silpakorn University Research and Development Institute for the financial support.