Development and evaluation of prolonged-release dutasteride transdermal delivery system

Title : Development and evaluation of prolonged-release dutasteride transdermal delivery system

Abstract:

Benign prostatic hyperplasia (BPH), an enlargement of the prostate affecting older men, leads to urinary complications. Oral administration of Dutasteride (DTS) is a common treatment, but it poses challenges for the elderly, including difficulty in taking the medication by mouth, sexual side effects, and the need for daily intake. To address these issues, this study aimed at exploring transdermal delivery systems for DTS, offering a non-invasive alternative with potential benefits such as prolonged drug delivery, and improved patient comfort and compliance. Transdermal patches were prepared using a solution casting method and employing ethylene vinyl acetate as backing layer and Eudragit® RL as drug-loaded film. Triethyl citrate was used as plasticizer, and a 1:1 mixture of Capmul® PG-8-70 NF and Captex® 170 EP was incorporated, in different concentrations, as penetration enhancers (PEs). All patches underwent extensive characterization, evaluating parameters such as thickness, weight variation, drug content, folding endurance, and more. Further, the physicochemical properties of the drug and patches were assessed through FTIR, DSC, TGA, XRPD, and SEM analyses. In vitro release and permeation studies were performed using Franz diffusion cells and apparatus. Strat-M® membrane was used for the permeation studies as a highly reliable predictor of human skin permeation. Patches prepared with PEs demonstrated higher drug release than those without PEs. The permeation studies demonstrated increased drug permeation in patches with lower polymer content. The optimal formulation, labelled as patch I, demonstrated an impressive 58.05% drug permeation over a 14-day period, suggesting its potential for sustained DTS delivery and a viable two-week treatment option. This research offers a promising alternative to oral administration, addressing the challenges associated with DTS treatment for BPH. The transdermal patches, characterized by their smooth, clear, and flexible nature, present advantages in terms of patient comfort and convenience. The findings highlight the feasibility of formulating extended-release transdermal patches containing DTS, utilizing Eudragit® RL polymer along with penetration enhancers. Overall, this study opens avenues for improving therapeutic efficacy and patient adherence in the treatment of BPH.

Audience Take Away Notes:

• The audience would appreciate the formulation and optimization strategy used in the transdermal delivery of such highly lipophilic drug, which normally pose challenges in drug delivery across the skin
• The audience can use the information from this study to enhance BPH treatment strategies; they can consider incorporating the transdermal delivery system, into their research or treatment protocols for patients with BPH, thus offering a potential alternative to oral administration, addressing challenges faced by elderly patients, such as difficulty in taking medications by mouth and unwanted sexual side effects, and improve patient outcomes
• The study opens avenues for further research in the field of transdermal drug delivery. Researchers can build upon these findings to explore additional formulations, delivery systems, or combination therapies for BPH treatment or other treatments. This may lead to continuous improvements in therapeutic efficacy and patient adherence
• The research offers valuable insights that other faculty members could potentially use to expand their research or integrate into their teaching. They can use the study's strategies and methodology as a foundation to explore and develop transdermal delivery systems for other drugs or medical conditions. The specific use of Eudragit® RL polymer, Capmul® PG-8-70 NF, and Captex® 170 EP can inspire further studies on the application of these materials in different drug delivery systems
• Hopefully, the interdisciplinary nature of this research can encourage collaboration between faculty members from different departments. This collaboration could lead to more comprehensive studies that address both pharmaceutical and clinical aspects

Biography:

Dr. Shereen M. Assaf is a distinguished pharmaceutical sciences professor. After receiving her PhD from the University of Strathclyde, Glasgow, in 1992, she joined the faculty of pharmacy at Jordan University of Science and Technology. She has nine years of administrative experience and extensive contributions to academia. She is also a consultant and committee member at the Jordanian Food and Drug Administration since 2012. Her research focuses on designing pharmaceutical dosage forms, specializing in microencapsulation, nanocarriers, liposomes, and polymeric drug delivery systems across various administration routes.