Formulation and Evaluation of Immediate-Release Tablets of Edoxaban Tosylate

Abstract

The immediate-release dosage form breaks down quickly and gets dissolved to release the medicaments. Immediate-release drug delivery is suitable for drugs having long biological half-life, high bioavailability, lower clearance, and lower elimination half-life. The basic design of the system consists of a rapid-release core. The core tablets were prepared using rapid Mixer Granulation and Fluidized bed Granulation Technique. The Mixture was blended further with the addition of Crospovidone and Magnesium Stearate. Nine (F1-F9) formulations of the core were prepared using NF Pharma and HPC-L Nippon Soda as binders in different proportions (2, 3 & 4 %w/w) to study the effect of variable concentrations of these on the characteristics of the formulation. The core blend was evaluated for Flow properties, Hardness, Thickness, Friability, and in-vitro drug release. The drug (Edoxaban) is compatible with all excipients. All the parameters were in the optimum range. Among the Nine formulations F8 containing HPC Nippon Soda (2%) as a binder showed a better drug release of 100% over 60 minutes was selected. 400mg of resultant powder blend was manually compressed at a pressure of 100 tablets, with 10.60mm punch and die to obtain the core tablet. Among these, F8 was optimize based percent of drug release (99% of drug release in 60 minutes).