Formulation and Evaluation of Orally Disintegrating Tablets of Tadalafil and Dapoxetine HCl prepared by Direct Compression and Freeze-Drying Techniques with Taste Masking of Dapoxetine HCl.

Erectile dysfunction (ED) and premature ejaculation (PE) are two common male sexual disorders encountered by clinicians daily. The first-line recommended treatment for ED is the use of phosphodiesterase type 5 (PDE5) inhibitors including Tadalafil (TADA). Dapoxetine (DAPO) has been approved in many countries as an on-demand treatment for PE, but the bitter flavor taste of oral Dapoxetine formulations is a commonly experienced issue. As a result, the taste of Dapoxetine has been effectively masked through encapsulation by Eudragit E100 using a spray-drying method. Production yield and encapsulation efficiency were 77.36%, and 99.03% respectively. The combination of Tadalafil and Dapoxetine are sold in the market as regular tablets. At present, there are no ODTs in the market that contain both Tadalafil and Dapoxetine. This study's goal was to create and describe orally disintegrating tablets (ODTs) that include Tadalafil and Dapoxetine. The ODTs were made through freeze-drying methods and direct compression techniques. Quality controls were conducted. ODTs made using direct compression and freeze-dried methods disintegrated in 62 and 29 sec, respectively. The in vitro dissolution test demonstrated that Tadalafil released from ODTs prepared by freeze-drying occurred more rapidly than from those made by direct compression. Conversely, Dapoxetine released more quickly from ODTs prepared by direct compression compared to those made by freeze-drying. This difference is attributed to the encapsulation of Dapoxetine using Eudragit E100 through spray drying for taste masking. 8.94% of Dapoxetine was released in the phosphate buffer pH 6.8 during the simplified dissolution test from ODTs prepared by freeze-drying in the first three minutes.