Abstract
The FDA has approved tadalafil (TDL) for the treatment of benign prostatic hyperplasia (BPH)-associated symptoms. Pumpkin seed oil (PSO) has shown promise for the relief of prostatitis-related lower urinary tract symptoms. The aim was to improve TDL delivery to the prostate and assess the combined effect of TDL with a PSO-based formula in the management of BPH. PSO, Tween 80, and polyethylene glycol 200 were selected for the optimization of self nano-emulsified drug delivery system (SNEDDS). The formed vesicles were assessed for their globule size and zeta potential. A rat in vivo study was carried out to investigate prostate weight and index, histopathology, and pharmacokinetics. The average globule size for the optimized TDL-PSO SNEDDS was 204.8 ± 18.76 nm, with a zeta-potential value of 7.86 ± 1.21 mV. TDL-PSO SNEDDS produced a marked drop in prostate weight by 35.51% and prostate index by 36.71% compared to the testosterone-only group. Pharmacokinetic data revealed a 2.3-fold increase of TDL concentration, from optimized TDL-PSO SNEDDS, in the prostate compared with the raw TDL group. This study indicated that the combination of TDL and PSO in an optimized TDL PSO SNEDDS formula improved the efficacy of TDL in the management of BPH.
Highlights
Benign prostatic hyperplasia (BPH) is characterized by the non-cancerous enlargement of the prostate
This study aimed to optimize the tadalafil-pumpkin seed oil-self nano-emulsified drug delivery system (TDL-Pumpkin seed oil (PSO) SNEDDS) formulation with a minimum globule size and maximum zeta potential to enhance TDL delivery to the prostate and to evaluate the joint impact of TDL and PSO when used in BPH-management
This was based on using PSO, with its established activity in prostate tissues, as the oil component for TDL SNEDDS instead of using an inactive oil formula component
Summary
Benign prostatic hyperplasia (BPH) is characterized by the non-cancerous enlargement of the prostate. The benign and enlarged prostate places a pushing pressure on the urethra and leads to the thickening of the bladder wall. This may lead to the weakening of the bladder and a loss of complete emptying of the bladder, resulting in urine retention. These changes include overactivity of the autonomic nervous system, pelvic ischemia, a decrease in pelvic nitric oxide (NO)/cyclic guanosine monophosphate (cGMP) signaling, atherosclerosis, and elevated Rho-kinase activity (which results in control of myosin phosphatase activity and, facilitates smooth prostatic muscle contractions) [3]. Inhibition of PDE5 has been observed to decrease the proliferation of prostate cells, while decreasing the number of smooth muscle cells (SMCs) in the prostate, bladder, neck, and supporting vasculature
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