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Research Article Open access CC BY 4.0

Oral Gentamicin Sulphate Nanoemulsion for Systemic Indication: Formulation and Evaluation

Somtochukwu R Ewuzie, Calistus D Nwakile, Emmanuel M Uronnachi, Chukwuebuka E Umeyor, Henrietta I Obi, Ifeanyi E Okoye, Ogechukwu C Dozie-Nwakile, Anthony A Attama, Vincent C Okore

Asian Journal of Research in Medical and Pharmaceutical Sciences · pp. 129–139 · Published 3 Aug 2024

10.9734/ajrimps/2024/v13i3268

Abstract

Aim: To achieve systemic availability of an oral dosage form of gentamicin sulfate (GS), typically impermeable via the gastrointestinal tract. Study Design: Formulation and physical characterization of GS nanoemulsion. Stability studies and ex vivo bioavailability evaluation of the emulsion. Place and Duration of Study: Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University Awka, Anambra State, Nigeria; between January 2021 and May 2023. Methodology: Pre-formulation experiments were conducted with adjuvants for use for the formulation. Using a homogenizer, an aquaphilic GS nanoemulsion was prepared with the adjuvants, including polysorbate 80 and span 80, as permeation enhancers. The emulsion was evaluated for its globule size and polydispersity index, and real-time physical stability parameters using pH and relative viscosity. The bioavailability of gentamicin sulphate was assessed as ex vivo anti-E. coli activity after oral administration of the emulsion to Wister rats and a confirmatory test was done using gas chromatograph-flame ionization detection (GC-FID) analysis. Results: The emulsion had an average globule size of 66.55 nm, and is monodispersed with a polydispersity index of 0.45. The pH and viscosity values measured for 60 days ranged from 6.60±0.00 to 6.80±0.00 and .03±0.00 to .03±0.01 respectively (P = .05). The ex vivo antibacterial activity of the GS emulsion was significant at 3.00±0.00 mm 1 –hr post-administration to the Wistar rats, indicating systemic availability of the antibiotic. The GC-FID analysis confirmed the presence of the drug in the serum. Conclusion: The bioavailability of oral GS is achievable through simple specialized formulations containing adjuvants which contributes to an improved gastrointestinal permeability of the drug.

Gentamicin sulphate oral gentamicin bioavailability nanoemulsion oral administration permeation enhancer

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