Regulatory challenges for new formulations of controlled substances in today's environment.

Abstract

The pharmaceutical industry has made substantial innovations in the area of targeted drug delivery and optimization of pharmacokinetics for existing drugs to try to maximize therapeutic effect while simultaneously minimizing adverse consequences of medication abuse. These innovations, however, have not come without a price. Designer drugs and high content modified release formulations have been exploited both in casual recreational drug abuse as well as, on a much larger scale, by the criminal diversion of these products for profit. In this paper we will consider the challenges before manufacturers and regulators as they approach the problem of abuse potential of these new drug products and some of the solutions specifically designed to counteract abuse.