Formulation of Double-layer Tadalafil and Amlodipine Complex Tablets to Treat Erectile Dysfunction and Hypertension

Abstract

Many men over the age of 40 suffer from erectile dysfunction (ED) for a variety of reasons. In addition, more than 40% of ED patients have hypertensive disease at the same time. Tadalafil (TD) is a selective and reversible inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase type 5 (cGMP-specific PDE-5). It is an insoluble drug with biopharmaceutics classification system class-II and was prepared by wet granulation with a solubilizing agent. Amlodipine besylate (AM) is a calcium channel antagonist that is effective in preventing systolic hypertension and stroke, and is manufactured using physical mix method. We used TD and AM to fabricate a double-layer complex tablet that can prevent or treat two diseases at the same time. Scanning electron microscope (SEM), Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimeter (DSC), X-ray diffraction (XRD) were analyzed for confirming chemical and physical characterization. Also, in vitro dissolution test was conducted to evaluate the dissolution rate of tablet at pH=1.2. In conclusion, the rapid release of two drugs in the double layer tablet was confirmed and could be applied as a pharmaceutical therapeutic agent.

Relationship Between Hypertension, Antihypertensive Drugs and Sexual Dysfunction in Men and Women: A Literature Review

“… 56 Tadalafil, a compound that selectively and reversibly inhibits cyclic guanosine monophosphate-specific phosphodiesterase type 5, can help prevent systolic hypertension and stroke, and is also used to treat erectile dysfunction and pulmonary arterial hypertension. 23 Phosphodiesterase-5 inhibitors (PDE5i), such as sildenafil, vardenafil, tadalafil, and avanafil, are considered the primary medical therapies for erectile dysfunction. Recently, sildenafil and tadalafil have been recommended as first-line therapies for patients with pulmonary hypertension.…”

“…Hypertension is strongly associated with erectile dysfunction since arteriolar smooth muscle cells of the cavernous bodies are related to blood flow. 7,[21][22][23] Other authors have pointed out that erectile dysfunction is related to atherosclerotic changes that lead to reduced blood perfusion to the pelvis and penis gland, resulting in erectile dysfunction and overall deterioration of sexual function. 24 Erectile dysfunction can cause severe psychological distress and humiliation among most men, making it a health problem that needs to be considered clinically.…”

“…24 Erectile dysfunction can cause severe psychological distress and humiliation among most men, making it a health problem that needs to be considered clinically. 7,[21][22][23] Sexual Dysfunction in Women Sexual desire and arousal were highly correlated in both men and women. Women are aroused under conditions of continuous physical stimulation, which further reinforces sexual desire.…”