Fast dissolving film nanocrystal (FDFN) preparation as a new trend for solubility enhancement of poorly soluble class ii drug tenoxicam

Abstract

Objective: This research targeted to prepare, characterize and evaluate fast dissolving film nanocrystals (FDFN) of tenoxicam (TNX) as an innovative system using three different film-former polymers, HPMC E 30, PVP K90 and PVA, for the optimization of BCS class II drug solubility, dissolution rate and bioavailability. Methods: TNX nanocrystals first prepared using acid-base nanoprecipitation method, which further formulated into fifteen FDF using HPMC E 30, PVP K90 and PVA as film-formers. Films were then evaluated for appearance, surface pH, folding endurance, thickness, weight variation, TS, PE, disintegration time and TNX release durations. Results: TNX nanocrystal were prepared successfully with optimized physical properties including solubility due size reduction. Six formulation, F-1, F-2, F-6, F-8, F-11 and F-12, exhibit desired FDF features as indicated by characterization techniques including fast disintegration in less than 30 seconds and in vitro dissolution within two minutes. Conclusion: Six TNX-FDFN formulations were prepared successfully with ideal film properties and improved TNX solubility and hence, can used as an alternative to the oral form thereby avoiding associated limitations of GI irritation and poor solubility of TNX.