EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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ISSN 2394-3211

Impact Factor: 7.065

ICV - 79.57

Abstract

FORMULATION AND EVALUATION OF GENTAMICIN SULPHATE OPHTHALMIC MICROEMULSION

Aswathi Panayanthatta* and Dr. Suja C.

ABSTRACT

Microemulsions are thermodynamically stable-phase transition systems. They exhibit small particle size (1-100nm) with lower surface tension which facilitates higher drug absorption and permeation. The present study involves the formulation and evaluation of gentamicin sulphate ophthalmic microemulsion for the treatment of bacterial infection of eye. Gentamicin sulphate is an aminoglycoside antibiotic. It is a BCS class III drug with high solubility, low permeability and poor biological half-life of 2 to 3hours. The solution and ointment of gentamicin sulphate for ophthalmic treatment is available, but it has been found that, ophthalmic microemulsions shows better permeability and corneal residence time compared to solutions and ointments. The study is also aimed to find which cosurfactant is more effective with the penetration enhancer. Ethanol and PEG400 are the cosurfactants and tween 80 as the surfactant (penetration enhancer). The primary evaluations are carried out to find the compatibility of gentamicin sulphate with other excipients and further studies to find out the effect of penetration enhancer with different cosurfactants. Optimization studies have been done by Design Expert Software using optimal design and 14 formulations were prepared. All the formulations where evaluated for physical appearance, viscosity, pH,globule size,zetapotential,drug content and in vitro release study. All the formulations showed results with acceptable range of the evaluation tests. The optimized formulation F9 showed drug release 88.8% and globule size 10.34nm. Kinetic studies, microbiological studies and stability studies were conducted on the optimized formulation. The mechanism of drug release was found to be zero order and non-fickian case II transport. The optimized formulation was found to be stable and sufficient antimicrobial effect.

Keywords: Gentamicin sulphate, Microemulsion, Phase titration, Design Expert.

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