Abstract

DEVELOPMENT AND IN-VITRO ASSESSMENT OF CONTROLLED POROSITY OSMOTIC PUMP TABLETS FOR SUSTAINED RELEASE OF EMTRICITABINE

Abilash S.*, Dr. G. Mariyappan, Dr. J. Karthi, Prakash Murugan

ABSTRACT

The current study focused on developing and assessing a controlled porosity osmotic tablet of Emtricitabine to achieve sustained drug release. The linearity and accuracy of the analytical method was established throughout a concentration spectrum ranging from 50–150% making use of a standard calibration curve. Compatibility was confirmed by FT-IR spectroscopy, which exhibited no best known drug-excipient interactions. A semipermeable membrane of cellulose acetate and sodium lauryl sulphate (SLS) as a pore-forming agent was applied to the tablets after they had been prepared by direct compression. Excellent flow, compressibility, and mechanical strength were discovered, and both pre- and post-compression parameters satisfied pharmacopeial criteria. Studies on swelling in 0.1N HCl concluded that swelling behaviour was impacted by membrane thickness and higher concentrations of HPMC K100M and HPMCK15M. Formulations F7, F8, and F9 were selected for coating at 3%, 6%, and 9% weight growth because they showed the best swelling. Considering a cumulative release of 96.90% after 8 hours, F8C2 (6% coating) had the best in vitro drug release among them as well. With a faster release in acidic conditions (pH 1.2), drug release was comparable over a range of paddle speeds and dissolving media. A homogeneous and porous membrane structure in F8C2 was confirmed by SEM assessments. According to kinetic studies, osmotic pressure and membrane erosion prompt drug release with respect to Zero-order and Hixson-Crowell kinetics. The formulation's durability was proven by stability tests conducted over a three-month period. To sum up, F8C2 successfully achieved the requirements of a controlled porosity osmotic delivery system for emtricitabine through the implementation of sodium chloride and mannitol as osmogens and 1% SLS in the membrane.

Keywords: Emtricitabine, Controlled Porosity Osmotic Tablet, Sustained Drug Release, Semipermeable Membrane, Release Kinetics.