Development and Evaluation of Orally Disintegrating Tablet of Levodopa for Parkinson's Disease

The present study aimed to develop and evaluate a suitable oral dosage form of Levodopa for the effective management of Parkinson’s disease. An Orally Disintegrating Tablet (ODT) of Levodopa was developed using co-processed excipient F-Melt Type C as a filler-disintegrant base, Crospovidone as a superdisintegrant, and Sodium Stearyl Fumarate as a lubricant. A 2³ factorial design was employed to optimize the formulation, considering concentrations of F-Melt, Crospovidone, and Sodium Stearyl Fumarate as independent variables, while tablet hardness, disintegration time, and drug release were selected as dependent variables. Pre-compression parameters including bulk density, tapped density, angle of repose, Carr’s index, and Hausner’s ratio confirmed good flowability of powder blends. Post-compression evaluation revealed acceptable limits for friability, hardness, weight variation, disintegration time, drug content uniformity and wetting time. Studies on in vitro dissolution demonstrated rapid and complete drug release in (SSF) simulated salivary fluid and phosphate buffer. The batch that was optimized showed a DT time of less than 30 seconds with >90% drug release within 15 minutes, ensuring enhanced patient compliance. Stability studies conducted under ICH guidelines confirmed the robustness of the optimized formulation. The study successfully established Levodopa ODT as a patient-friendly dosage form with potential to improve therapeutic results in Parkinson’s disease.