Technological Device for Manufacturing Transdermal Films: Possible Applications to the Individualized Treatment for Erectile Dysfunction.

Abstract

Pharmacological advances in erectile dysfunction (ED) treatment have aroused growing interest among health professionals towards sexual dysfunction, generating an increasing demand for dosage forms and drug delivery systems, including tadalafil. This study aimed to develop a device to generate patches that would enable drug dosage individualization and transdermal administration. To create such a mechanical device, technical drawings were made using the CAD software. A functional prototype was built, and a pharmaceutical formulation containing tadalafil (10mgcm-2) was prepared. An analytical method (HPLC) was developed and validated. The average weight of adhesives (n=10) was 241.01mg; the content uniformity for preparations in unit doses (n=10) was 108.93%, and a CV <2% for intraadhesive tadalafil content (n=40) was observed. The ex vivo permeation of patches containing tadalafil was determined in Franz cells (n=6), equipped with human skin and kept for 12h in contact with the patch, by using the tape stripping method. The optimized method showed acceptable confidence limits within the range recommended by regulatory agencies, being validated for use in this ex vivo permeation study. Tadalafil could permeate to the viable epidermis and dermis (5.7%). The created device produced homogeneous patches of tadalafil, showing such technological innovation as to be feasible in individualized therapy for the treatment of ED.