Testing of controlled-release transdermal dosage forms. Product development and clinical trials

Area of Science:

• Pharmacology and Pharmaceutical Sciences
• Dermatology and Skin Science
• Drug Delivery Systems

Background:

• Established in vitro techniques predict drug permeation through skin.
• Preclinical methods assess skin irritation potential during transdermal dosage form development.

Purpose of the Study:

• To discuss various aspects of testing transdermal dosage forms.
• To evaluate the correlation between preclinical test results and clinical performance in routine use.

Main Methods:

• Utilized in vitro skin permeation assays.
• Employed preclinical methods for skin irritation assessment.
• Conducted clinical studies evaluating skin irritation, contact sensitization, plasma drug levels, and efficacy.

Main Results:

• In vitro and preclinical tests provide predictive data for drug permeation and irritation.
• Clinical studies assess key parameters like sensitization and efficacy.
• Challenges exist in definitively predicting clinical outcomes, particularly contact sensitization, from animal models.

Conclusions:

• While preclinical tests are valuable, they do not guarantee prediction of all clinical outcomes.
• Contact sensitization remains a significant challenge in predicting transdermal dosage form performance.
• Correlation between preclinical testing and actual clinical use is crucial for successful transdermal drug development.