Abstract

Benign Prostatic Hyperplasia (BPH) is a common progressive condition that affects the quality of life of older men. Since current pharmacological interventions can cause severe side effects, this study aimed to develop, characterize and evaluate a natural alternative based on the use of babassu oil (BBS) and copaiba oil-resin (COP) incorporated into self-emulsifying drug delivery systems (SEDDS). Initially, the major components of each of the natural oils were analyzed by gas chromatography/mass spectrometry to provide a means to track their incorporation into nanoformulations. An effective analytical methodology was developed to detect lauric acid and β-caryophyllene as chemical tracers for BBS and COP, respectively. The physical characteristics of the resulting nanoemulsions were next analyzed to identify preparations suitable for in vitro toxicity and in vivo tests. The two most promising SEDDS formulations, containing BBS with and without COP, were thermodynamically stable with a zeta potential less than −20 mv and droplet size around 30 nm. In addition, both were non-cytotoxic and genotoxic. These formulations, in rat model of BPH, showed promising potential to reduce the onset of this pathological process. In conclusion, SEDDS containing BBS and COP were successfully developed that could serve as natural alternatives for the prevention of BPH.

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