Natural self-emulsifying reversible hybrid-hydrogel delivery (N'SERH) of tocopherol enhances bioavailability and modulates alcohol-induced reproductive toxicity in rats.

Abstract

Alpha-tocopherol (α-Toc), an antioxidant vitamin, has been widely prescribing in the treatment of infertility, in spite of its limited oral bioavailability. The present study describes the enhanced bioavailability and efficacy of a novel 'natural self-emulsifying reversible hydrogel' (N'SERH)-based oral delivery form of α-Toc-rich sunflower oil (Tα-fen) using fenugreek galactomannan hydrogel scaffold (hybrid-FENUMATTM ). Tα-fen was characterised by FTIR, SEM, TEM and DLS as a hybrid-hydrogel powder. The bioavailability study on thirty (n=30) male Sprague Dawley rats randomised into two groups indicated 4.84-fold increase in the oral bioavailability when the formulation was provided at 15mg/kg b. wt. of α-Toc by oral gavage. The efficacy study on 24 animals randomised into four groups as control, ethanol treated (4mg/kg b. wt.), ethanol+unformulated, UTα (15mg/kg b. wt.) and ethanol+formulation, Tα-fen (15mg/kg b. wt.) revealed significant improvement (*p<0.05) and reversal of alcohol-induced reproductive toxicity as evident from the enhanced sperm count, motility and viability parameters, testosterone levels, fructose content, and SDH activity and plasma antioxidant status among Tα-fen-treated rats, compared with unformulated, UTα-treated group. Histopathology further confirmed the reversal of the alterations in the testes morphology of Tα-fen-treated animals, indicating its promising potential in the treatment of reproductive health issues.