QBD APPROACH IN THE ENHANCEMENT OF ORAL BIOAVAILABILITY TELMISARTAN FAST DISSOLVING TABLETS EMPLOYING STARCH HUMATE AS A NEW SUPERDISINTEGRANT

Objective: This research focuses to enhance the of oral bioavailability of Telmisartan (TMN) by developing Fast Dissolving Tablets (FDTs) using Starch Humate (SH) as a new superdisintegrant. Quality By Design (QbD) method was employed to assess SH for enhancing the Dissolution Efficiency (DE) of Cardio Vascular Drug (CVD)-TMN. Methods: Sorghum starch was isolated through an alkaline treating method from sorghum flour, followed by it reacts humic acid to form SH. Various flow characterization techniques were used, including NMR for structural and functional group analysis. Scanning Electron Microscopy (SEM) and X-Ray Diffraction (XRD) for Surface morphology, Fourier transform infrared (FTIR) spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC) for drug-excipient compatibility and thermal behavior. QbD was applied to assess Disintegration Time (DT), Cumulative Percent Drug Dissolution (CPDD), and Dissolution Efficiency (DE), taking SH, Sodium Starch Glycolate (SSG), and Crospovidone (CP) as variables. TMN-FDTs utilized the approach of 23-factorial design in their formulation by direct compression method. Results: The SS and SH are insoluble in aqueous and organic solvents, with pH shows 5.1-5.8, a good angle of repose. 4.5-5.4 ppm peaks are anomeric protons of glucose, which confirms starch and the 4.8-5.4 ppm region confirms a strong bond in SH through NMR. SEM and XRD confirm crystalline nature, and FTIR and DSC investigations revealed no interaction. Optimized TMN-FDTs with 5% starch humate disintegration time (24±0.06 seconds), %CPDD10 (99.73±0.61%), and %DE (1.31±0.12 to 71.6±0.15%). Pharmacokinetics studies demonstrated improved relative bioavailability (113.09%). Conclusion: This study revealed that SH could potentially be a new superdisintegrant developed into fast-dissolving tablets by QbD in managing hypertension, exhibiting enhanced relative bioavailability and patient acceptance.