FORMULATION AND IN-VITRO EVALUATION OF SUSTAINED RELEASE TABLETS CONTAINING ETIFOXINE HYDROCHLORIDE

Abstract

The present study was aimed at the formulation and in-vitro evaluation of sustained release floating tablets
containing Etifoxine hydrochloride using Chitosan and Carbopol 940 P as release-retarding polymers.
Sustained release tablets were prepared by direct compression method employing different polymer
compositions to achieve prolonged drug release and enhanced gastric retention. The prepared formulations
were evaluated for pre-compression parameters including bulk density, tapped density, compressibility index,
and Hausner ratio, which indicated acceptable flow properties suitable for compression. Post-compression
evaluation demonstrated satisfactory tablet characteristics such as hardness, friability, thickness, weight
variation, and drug content uniformity within acceptable pharmacopoeial limits.
The buoyancy study revealed that all formulations exhibited floating duration greater than 12 h, while
formulation F8 showed the shortest floating lag time of 28 ± 3 seconds. In-vitro drug release studies indicated
that formulation F8 provided controlled and sustained drug release up to 12 h with 99.25% cumulative drug
release. Drug release kinetic analysis showed that the optimized formulation followed Higuchi and
Korsmeyer–Peppas release models, indicating diffusion-controlled non-Fickian drug release behavior.
Stability studies performed under accelerated conditions for three months confirmed that the optimized
formulation remained stable without significant changes in physical appearance, hardness, drug content, or
drug release profile.
The results of the present investigation demonstrated that sustained release floating tablets of Etifoxine
hydrochloride can be successfully developed using Chitosan and Carbopol 940 P to provide prolonged drug
release, improved gastric retention, and enhanced therapeutic efficacy.