Formulation and Evaluation of Extended-Release Matrix Tablets of Pramipexole Dihydrochloride Monohydrate Using Hydrophilic and Hydrophobic Polymers

Abstract

The present study focuses on the formulation and evaluation of extended-release matrix tablets of Pramipexole Dihydrochloride Monohydrate, a dopamine agonist used in the treatment of Parkinson’s disease. Due to its short half-life and frequent dosing requirement, an extended-release formulation was developed to enhance patient compliance and provide sustained therapeutic action. The tablets were prepared using the wet granulation technique with varying concentrations of hydrophilic (Hydroxypropyl Methylcellulose – HPMC) and hydrophobic (Ethyl Cellulose) polymers to modulate the drug release profile. Pre-compression parameters such as angle of repose, bulk density, and compressibility index indicated satisfactory flow properties of the granules. Post-compression evaluations including hardness, friability, drug content, and in vitro dissolution were within pharmacopeial limits. The optimized formulations demonstrated a sustained release of Pramipexole over a 24-hour period. Drug release kinetics followed zero-order and Higuchi models, indicating a diffusion-controlled mechanism, while Korsmeyer-Peppas modeling suggested a non-Fickian release profile. Stability studies conducted under ICH guidelines confirmed the physical and chemical stability of the formulations. The results suggest that the developed matrix tablets provide a reliable extended-release profile, offering an effective once-daily alternative to conventional Pramipexole therapy. This can potentially improve therapeutic outcomes and patient adherence in Parkinson’s disease management.