Dev Soni, Jashoda Prajapati, Viral A Prajapati, Mayur Bathvar, Patel Harsh, Jani Shreyanshi, Dudhat Aenshi, Panchal Disha and Parmar Vipul
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 (<30 seconds)and cumulative drug release of up to 90% within 5 minutes, indicating excellent performance as a fast-dissolving dosage form. The formulation pharmacopoeial standards, and the observed results confirmed the synergistic lipid-lowering effect of Kalmegh and Parijat. This was likely due to the presence of bioactive compounds such as andrographolide in Kalmegh and flavonoids and phytosterols in Parijat, which have been previously reported to lower LDL, total cholesterol, and triglyceride levels, while promoting HDL cholesterol. The study concludes that the herbal FDTs of Kalmegh and Parijat offer a promising, natural alternative to conventional antihyperlipidemic therapy. Their fast disintegration, high bioavailability, and favorable release profile make them suitable for patients who require quick therapeutic action and enhanced compliance. Additionally, the factorial design approach facilitated the precise optimization of excipient levels to ensure robust tablet performance. Future studies could include in vivo lipid profile testing and stability studies to support further development toward clinical application.
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