Formulation Optimization & Evaluation of Fexofenadine Hydrochloride Capsule

Abstract

The present study focused on the formulation optimization and evaluation of Fexofenadine Hydrochloride immediate-release capsules. Preformulation studies were conducted to characterize and establish the analytical profile of the drug. Organoleptic evaluation confirmed that Fexofenadine Hydrochloride was a white, odorless, and bitter powder consistent with standard specifications. The melting point was found to be 195°C, indicating satisfactory purity and compliance with the reported reference range. A UV-Visible spectrophotometric method was developed using 0.1 N HCl as the solvent system. The maximum absorption wavelength (λmax) was observed at 225 nm. A calibration curve was constructed over the concentration range of 0–25 μg/mL and exhibited excellent linearity with the regression equation y = 0.0385x − 0.0242 and correlation coefficient (R²) of 0.9978. Formulation optimization was performed using Central Composite Design (CCD) under Response Surface Methodology (RSM). Croscarmellose Sodium (X₁) and Crospovidone (X₂) were selected as independent variables, while Disintegration Time (DT) and Percentage Drug Release (%DR) were considered dependent responses. B7 optimized batches (B1–B10) were prepared and evaluated through in-vitro dissolution studies. All formulations demonstrated rapid drug release, achieving 92.34–98.30% release within 60 minutes. Regression analysis indicated that both super disintegrants positively influenced drug release (%DR = 96.95 + 1.83X₁ + 1.11X₂) and negatively affected disintegration time (DT = 4.01 − 0.6051X₁ − 0.6155X₂). ANOVA results confirmed the statistical significance of the developed models (p < 0.05). The optimized formulation exhibited rapid disintegration and enhanced drug release, demonstrating the effectiveness of super disintegrant optimization in immediate-release capsule development.

Keywords