Abstract

Kalyani Narendra Deshpande, Dr. Aijaz Sheikh, Dr. Kailash R. Biyani

ABSTRACT

The development of controlled release drug delivery systems has emerged as a promising strategy to enhance therapeutic efficacy, reduce dosing frequency, and improve patient compliance in antiviral therapy. Lumividine, a nucleoside analogue antiviral agent, is conventionally administered in immediate-release formulations that require multiple daily doses, often leading to poor adherence and fluctuating plasma drug concentrations. The present study focuses on the formulation and evaluation of controlled release matrix tablets of Lumividine using hydrophilic and hydrophobic polymers to achieve sustained drug release over a 12-hour period. Matrix tablets were prepared by direct compression employing Hydroxypropyl Methylcellulose (HPMC K15M), Ethyl Cellulose, and Carbopol 934P in varying concentrations. Pre-compression parameters such as angle of repose, bulk density, and compressibility index confirmed good flow properties of the powder blend. Post-compression studies revealed acceptable hardness, friability, weight variation, and uniform drug content across all formulations. In vitro dissolution studies were conducted using USP dissolution apparatus II in simulated gastric fluid (pH 1.2) for 2 hours, followed by phosphate buffer (pH 6.8) up to 12 hours. Results indicated that formulations with lower polymer concentrations released the drug rapidly, while those with higher hydrophobic polymer content exhibited incomplete release. Optimized formulations containing balanced ratios of HPMC and Ethyl Cellulose demonstrated sustained release of approximately 80% of Lumividine over 12 hours. Kinetic modeling revealed that drug release followed the Higuchi model with non-Fickian diffusion, suggesting a combination of diffusion and erosion mechanisms. The study concludes that controlled release matrix tablets of Lumividine can be successfully formulated using polymeric blends, achieving prolonged drug release and potentially enabling once-daily dosing. This approach may significantly improve patient adherence and therapeutic outcomes in antiviral therapy. Further in vivo pharmacokinetic studies are warranted to validate clinical applicability and establish bioequivalence with conventional formulations.