Benign prostatic hyperplasia therapy through liquisolid technology composed of polymer-layered nanocomposites based on silicate that contain babassu oil and copaiba oil-resin

Abstract In a previous article by our research group, the association of babassu oil (BBS) and copaiba oil-resin (COPA) in a nanosystem was verified as a potential phytotherapic alternative for treatment and prophylaxis of benign prostatic hyperplasia (BPH). Since few studies have examined their association with nanosystems, we developed polymeric nanocomposites of lamellar silicates containing BBS and COPA to potentially enhance their anti-hyperplastic activity through a process that would be amenable to larger scale production. Organoclay-based-nanocomposites were prepared by an intercalation method in a polyethyleneimine (PEI) solution of low or high molar weight polymer and BBS alone or together with COPA, aiming to develop a technology capable of transforming liquid or oily active pharmaceutical ingredients into suitable powders for compression. A nanocomposite of Viscogel S7® containing BBS-COPA with low molecular weight PEI, presented the highest intercalation efficiency values of BBS (83.08 ± 0.10%) and COPA (70.14 ± 0.88%) along with the highest values of basal spacing (22.12 ± 0.87 A) and the nanocomposite presented particle diameter suitable for obtaining compactable solids. The produced tablets presented an average weight and hardness within established limits and a rapid dissolution profile in simulated gastric and enteric fluids for both oils. The anti-hyperplasic effect of the BBS-COPA-nanocomposite led to a reduction of the prostate weight (4.53 ± 2.07%), which was similar to results obtained with Finasteride (5.23 ± 2.09%). The histopathological patterns of prostrates from animals treated with the nanocomposite closely matched those observed with control animals. In conclusion, the newly developed nanosystem showed promising potential to reduce the pathological process of BPH and could serve as a natural alternative for treatment.