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Surface Modified Self-Nanoemulsifying Formulations (SNEFs) For Oral Delivery of Gentamicin: In Vivo Toxicological and Pre- Clinical Chemistry Evaluations

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Objective: This study aims to investigate the in vivo toxicological profile and pre-clinical safety of surface modified self-nanoemulsifying formulations (SNEFs) for oral delivery of a broad spectrum, anti-bacterial agent, gentamicin.

Method: SNEFs which were surface modified using PEG 4000, were formulated through water titration method using appropriate mixtures of soybean oil, a combination of Kolliphor ® EL and Kolliphor® P188 as surfactants, and Transcutol® HP as co-surfactant, and encapsulating gentamicin. SNEFs were characterized by measuring the droplet sizes, size distribution and surface charges using a Zetasizer. The effects of the SNEFs on body weight, haematological, biochemical, and histopathological factors of rats after oral administration were determined.

Results: Physicochemical characterization showed that the nanoformulations had droplet sizes ranging from 96 - 121 nm with surface charges of -32 to -36 mV. SNEFs did not show net suppression of body weights of rats. There were no clear indications of haematologic, hepatic and renal injuries in the study rats due to flip-flops in the levels of haematologic, hepatic and nephritic biomarkers evaluated. Histopathological organ examinations corroborated findings from the effect of SNEFs on the liver and kidney but revealed possible induction of astrocytosis in the cerebral cortex of rats.

Conclusion: Results of the study indicate that surface modified SNEFs of gentamicin have a promising pre-clinical safety potential with minimum toxicity effects.
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Keywords: Pre-clinical chemistry; gentamicin; haematological; histopathological; self-nanoemulsifying formulations; toxicological

Document Type: Research Article

Publication date: December 1, 2017

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