Role of nanotechnology in the prolonged release of drugs by the subcutaneous route.

Although recent academic research and development (R&D) advances in the subcutaneous delivery of nanosystems have exhibited promising results, pharmaceutical industries and regulatory agencies need to catch up. The lack of standardized methodologies for analyzing in vitro data from nanosystems for subcutaneous administration and subsequent in vivo correlation limits their access to clinical trials. There is an urgent need for regulatory agencies to develop methods that faithfully mimic subcutaneous administration and specific guidelines for evaluating nanosystems.