Volume : 13, Issue : 07, July – 2026

Title:

FORMULATION, CHARACTERIZATION AND EVALUATION OF CEFIXIME TRIHYDRATE NANOEMULSION

Authors :

Mr. Ganesh V. Shinde*, Dr Jadhao U.T, Mr. Rathod D.A., Dr. G.N Dhembare

Abstract :

Background: Cefixime Trihydrate is a third-generation cephalosporin antibiotic with broad-spectrum antibacterial activity; however, its clinical efficacy is limited by poor aqueous solubility and low oral bioavailability. The present study aimed to develop and evaluate a nanoemulsion formulation to enhance the solubility, dissolution, and oral delivery of Cefixime Trihydrate.
Methods: Preformulation studies, including physicochemical characterization, melting point determination, solubility analysis, FTIR, DSC, UV-visible spectrophotometry, and HPLC, were performed. Solubility screening was conducted to select suitable formulation components. Mentha oil, Tween 80, and PEG 200 were selected as the oil phase, surfactant, and co-surfactant, respectively. Pseudo-ternary phase diagrams were constructed to identify the nanoemulsion region, and formulations were optimized based on Smix ratio, Oil:Smix ratio, and physicochemical stability. The optimized nanoemulsion was evaluated for pH, viscosity, density, refractive index, self-emulsification time, drug content, particle size, zeta potential, thermodynamic stability, in vitro drug release, and accelerated stability according to ICH guidelines.
Results: FTIR and DSC analyses confirmed the compatibility of Cefixime Trihydrate with the selected excipients. The optimized formulation (Batch A7) exhibited satisfactory physicochemical properties with a pH of 7.30, viscosity of 1.25 cP, drug content of 99.62 ± 0.147%, particle size of 132.8 nm, and zeta potential of −32.3 mV, indicating excellent colloidal stability. The formulation demonstrated rapid self-emulsification, high transmittance, and good thermodynamic stability. In vitro dissolution studies showed 98.94% cumulative drug release within 60 min, compared with 58.65% for the pure drug. Accelerated stability studies confirmed that the optimized nanoemulsion remained physically and chemically stable for 90 days without significant changes in drug content or appearance.
Conclusion: The developed Cefixime Trihydrate nanoemulsion significantly improved the solubility, dissolution rate, and physicochemical stability of the drug. The optimized formulation exhibited excellent drug loading, nanosized droplets, rapid drug release, and satisfactory stability, indicating its potential as an effective oral drug delivery system for enhancing the bioavailability of Cefixime Trihydrate. Further in vivo pharmacokinetic and pharmacodynamic studies are warranted to establish its clinical applicability.
Keywords:
Cefixime Trihydrate, Nanoemulsion, Oral Drug Delivery, Solubility Enhancement, Tween 80, Mentha Oil, PEG 200, Pseudo-ternary Phase Diagram, In Vitro Drug Release.

Cite This Article:

Please cite this article in press Ganesh V. Shinde et al., Formulation, Characterization And Evaluation Of Cefixime Trihydrate Nanoemulsion, Indo Am. J. P. Sci, 2026; 13(07).

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