The study aimed to develop and optimize Niacin 500 mg extended release (ER) tablets to address challenges associated with conventional formulations, such as frequent dosing and adverse effect like flushing and hepatotoxicity The novelty of the work lies in designing ER tablets using hydroxypropyl methylcellulose (HPMC) E10M and K15M polymers, comparing direct compression and wet granulation methods. Wet granulation with HPMC E10M was identified as superior based on in vivo dissolution and other evaluation parameters. A systematic formulation approach explored varying concentrations of polymer, binder, and lubricant across different batches (F1 to F13) to obtain optimal drug release profiles. F3 formulation demonstrated a gradual and extended release, closely matching the marketed product (MP) in in vitro dissolution equivalence studies with dissimilarity factor (f1) and similarity factors (f2) of 4.15% and 78.87%, respectively. Stability testing over two months under accelerated conditions confirmed the robustness of the optimized formulation, with consistent in vitro dissolution and physical attributes. Finally, the study successfully established a formulation for Niacin ER tablets (F3) that offers extended release, improved patient compliance, and less side effects, making it promising alternative for dyslipidemia management.
Keywords: Niacin, Extended Release (ER), Hydroxypropyl Methylcellulose (HPMC), Polyethylene Oxide (PEO), Dyslipidemia.
How to cite this article: Kumar KK, Thummala U, Samidala NR, Pulagurtha B, Kumar CSP; Formulation and in Vitro Evaluation of Niacin 500 Mg Extended Release Tablets. Int J Drug Deliv Technol. 2026;16(1): 307-314. DOI: 10.25258/ijddt.16.1.33