Formulation Development and Evaluation of Kattha-Loaded Rectal Suppository for Hemorrhoidal Management 

Hemorrhoidal disease is a common anorectal disorder associated with local inflammation, irritation, and discomfort, highlighting the need for localized rectal delivery systems capable of providing prolonged residence and therapeutic activity at the site of application. Acacia catechu (Kattha) is a traditionally used medicinal plant rich in polyphenolic constituents and has been reported to possess antioxidant, anti-inflammatory, antimicrobial, and astringent properties. The present study aimed to develop and evaluate a Kattha-loaded polymeric suppository as a potential localized rectal drug delivery system for hemorrhoidal management. Kattha was incorporated into a natural polymer-based suppository matrix, followed by evaluation of its physicochemical, mechanical, structural, and biocompatibility characteristics. The developed suppositories were assessed for visual appearance, organoleptic properties, physical dimensions, weight variation, pH, content uniformity, breaking strength, swelling behavior, erosion, and rheological properties. Advanced characterization techniques, including Fourier-transform infrared spectroscopy (FTIR), X-ray diffraction (XRD), thermogravimetric analysis (TGA), field-emission scanning electron microscopy (FESEM), scanning electron microscopy (SEM), atomic force microscopy (AFM), energy-dispersive X-ray spectroscopy (EDX), dynamic light scattering (DLS), and zeta-potential analysis, were employed to investigate the structural, morphological, thermal, elemental, and surface characteristics of the formulation. The optimized formulation demonstrated pH-responsive swelling, with swelling indices of 16.35%, 29.81%, 41.35%, and 51.92% at pH 4.5, 6.8, 7.4, and 8.0, respectively. The formulation exhibited gradual erosion, with its mass decreasing from 520 mg initially to 415 mg after 8 h, corresponding to approximately 20.2% erosion. Cytotoxicity evaluation using Caco-2 cells demonstrated 93–96% cell viability across 62.5–1000 μg/mL, with no significant morphological alterations. Overall, the findings indicate favorable physicochemical characteristics, hydration behavior, matrix integrity, and preliminary cytocompatibility of the Kattha-loaded suppository, supporting its potential as a localized rectal delivery platform. Further in-vitro drug-release, release-kinetic, mucoadhesion, ex-vivo permeation, stability, and in-vivo studies are required to establish its controlled-release performance and therapeutic efficacy.