Pharmacokinetic, Adhesion and Safety Evaluation
of Transdermal Patches
A Case Study Analysis
Transdermal deliveries offer a number of advantages over conventional routes of administration, which include providing a controlled release over an extended period. For new drug products as well as for second-entry transdermal products, a pharmacokinetic study is required by regulatory agencies in addition to an assessment of adhesion. This can be evaluated and compared in either a pharmacokinetic study, a separate parallel or crossover study design.
Pharmacokinetic studies are generally comprised of single-dose and multiple-dose investigations which include key endpoints such as fluctuation and concentration time profiles, post-patch removal. In this case study, the pharmacokinetic, adhesion and safety profiles of a transdermal patch were compared under normal activities following single and multiple transdermal applications.
The methodology used by Algorithme Pharma in transdermal delivery studies is critical in accurately assessing the pharmacokinetics, safety and tolerability of investigated drugs. This approach can also be applied to the development of a new drug product or for the determination of bioequivalence between two formulations.