Design, Optimization, And Hepatoprotective Evaluation of a Novel Herbal Capsule Using Factorial Design

Abstract

The present study explores the formulation and evaluation of a polyherbal capsule comprising equal ratios of Ludwigia adscendens, Launaea pinnatifida, and Carica papaya extracts. Granules were prepared using a wet granulation method and encapsulated in size "00" hard gelatin capsules. A 3² full factorial design was employed to optimize the concentrations of ethyl cellulose and microcrystalline cellulose. The optimized formulation demonstrated acceptable pre-compression parameters (bulk density: 0.38 ± 0.05 g/cm³, angle of repose: 39.36 ± 2.67°) and capsule characteristics (disintegration time: 11 ± 0.34 min, moisture content: 3.6 ± 0.22%). Stability studies confirmed formulation integrity over three months. In vivo evaluations revealed no acute toxicity at doses up to 2000 mg/kg. The polyherbal formulation showed significant hepatoprotective effects against paracetamol and CCl₄-induced hepatotoxicity in Wistar rats, evidenced by normalized serum markers (AST, ALT, ALP, bilirubin), improved antioxidant status (SOD, GSH), reduced lipid peroxidation (MDA), and histological restoration of liver architecture. These findings suggest the formulation as a promising hepatoprotective agent with good stability and safety profiles.