Abstract

DEVELOPMENT AND CHARACTERIZATION OF FAST DISSOLVING ORAL FILMS OF FENSPIRIDE HYDROCHLORIDE

Priyanka Ojha*, Dr. Satkar Prasad

RKDF School of Pharmaceutical Sciences, Bhabha University, NH-12, Jatkhedi, Hoshangabad Road, Bhopal- 462026

ABSTRACT

Fenspiride hydrochloride is a bronchodilator and anti-inflammatory agent used in respiratory disorders. Conventional oral formulations face challenges such as delayed onset of action and poor patient compliance, particularly in pediatric and geriatric populations. The present study aimed to develop and characterize fast dissolving oral films (FDOFs) of fenspiride hydrochloride to enhance patient acceptability, improve onset of action, and ensure uniform drug delivery. FDOFs were prepared using the solvent casting method with different concentrations of polymers and plasticizers. The films were evaluated for general appearance, thickness, weight, folding endurance, tensile strength, disintegration time, moisture content, drug content, and in-vitro drug release. The optimized formulation was subjected to stability studies over three months. All films were transparent with uniform thickness (52–72 µm) and weight (110–145 mg). Folding endurance ranged from 157–220, disintegration time from 28–70 seconds, tensile strength 0.64–0.78 kg/cm², and drug content 95.9–99.5%. The optimized formulation (F6) exhibited rapid drug release (98.85% in 10 min) and followed first-order release kinetics. Stability studies confirmed minimal drug degradation over three months. The optimized FDOFs of fenspiride hydrochloride demonstrated rapid disintegration, satisfactory mechanical properties, uniform drug content, and enhanced drug release, making them a promising dosage form for improving patient compliance and therapeutic efficacy in respiratory disorders.

Keywords: Fenspiride hydrochloride, Fast dissolving oral films, Solvent casting, Disintegration time, Drug release, Patient compliance.