Optimization of kalmegh and Parijat-based fast dissolving herbal tablets for hyperlipidemia management using a two-level three-factorial design   

Abstract

Hyperlipidemia, characterized by elevated levels of lipids in the blood, is a leading risk factor for cardiovascular diseases such as atherosclerosis, coronary artery disease, and stroke. Conventional pharmacotherapy, including statins and fibrates, though effective, often presents undesirable side effects, such as hepatotoxicity and muscle weakness. In this context, the use of herbal medicines as safer alternatives has gained considerable interest. The present research focuses on the formulation, optimization, and evaluation of fast-dissolving herbal tablets (FDTs) incorporating Kalmegh (Andrographis paniculata) and Parijat (Nyctanthes arbor- tristis)—two plants traditionally known for their antihyperlipidemic, antioxidant, and hepatoprotective properties.The study utilized a two-level, three-factor factorial design (2³) to investigate the influence of three independent variables—binder (microcrystalline cellulose), disintegrant (sodium starch glycolate), and lubricant (magnesium stearate)—on key response variables such as disintegration time, drug release, and assay value. The herbal extracts were obtained via hydroacetone extraction, and a calibration curve was established for standardization. The tablets were prepared using the direct compression method and were evaluated for pre-compression (flow properties, bulk density) and post-compression parameters (hardness, friability, weight variation, disintegration time, wetting time, and dissolution rate).Among the trial batches (T1-T8), the optimized formulation demonstrated a rapid disintegration time (