Advancing transdermal drug-delivery systems past development barriers to the clinic: An industry perspective

摘要

In 2010, the transdermal-delivery market was valued at US$21.5 billion, with patches alone reacheing $9.5 billion. By 2015, it is anticipated that the transdermal-delivery market will reach $31.5 billion. The market is poised for continuous growth as innovative technologies are being developed [1,101]. However, in the past, various problems in product quality, from both brand and generic products, have been reported by the US FDA, practitioners and patients. Some of these problems in quality have safety and efficacy implications, which have led to the recall of numerous batches of products (e.g., fentanyl patch and Daytrana patch) and, in some circumstances, the temporary or permanent removal of the product from the market, such as Testoderm(testosterone patch), Neupro (rotigotine patch) and several nitroglycerine products [2]. Transdermal drug-delivery systems (TDDS) are complex in terms of their quality, safety and efficacy.