Preparation and Characterization of Febuxostat Nanosuspension as Fast Dissolving Oral Film

Zahraa Salim Alwan; Nawal Ayash Rajab

doi:10.54133/ajms.v6i2.873

Authors

Zahraa Salim Alwan Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Baghdad, Iraq https://orcid.org/0000-0002-1633-422X
Nawal Ayash Rajab Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Baghdad, Iraq.

DOI:

https://doi.org/10.54133/ajms.v6i2.873

Keywords:

Febuxostat, Fast-dissolving oral films, Nanosuspension, Solvent casting method

Abstract

Background: Quickly dissolved oral films are a widely accepted method of delivering drugs and help patients adhere to treatment regimens. Nanosuspensions (NS) are colloidal dispersions of drug particles with a submicron size, and their large surface area enhances the solubility and dissolution of low-water-soluble drugs. Febuxostat (FXT) is a non-purine xanthine oxidase inhibitor with a low dissolution rate that limits its absorption. Objective: To develop fast-dissolving oral films (FDOFs) containing FXT NS and convert NS into solid dosage forms to ease administration and accelerate drug release. Methods: FXT NS was prepared using Soluplus as a stabilizer and Tween80 as a co-stabilizer through an anti-solvent precipitation technique. We prepared FDOFs using a solvent casting method, utilizing hydrophilic polymers like pullulan, polyvinyl alcohol (PVA), gelatin, and plasticizers like polyethylene glycol (PEG400) and glycerin. The study assessed the film's thickness, weight, folding endurance, drug content, disintegration time, and drug release. We validated the drug's compatibility using FTIR, and conducted a crystallinity study using DSC and X-ray powder diffraction. Results: F4 was the optimized formula prepared using PVA and PEG400. In just three minutes, the F4 dissolution rate increased significantly (99.63% vs. 11.23%) compared to the FXT ordinary film. Also, it had good mechanical properties. Conclusions: FXT NS were successfully loaded into FDOFs with accepted properties.

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