ABSTRACT

The oral route of drug delivery is considered the most convenient and is widely used for drug product development purposes. It has been estimated that approximately 84% of all sales of the top selling commercially available products are delivered via the oral route (1). Therefore it is obvious that drug discovery efforts will necessarily focus on the identification and development of compounds that are readily deliverable via the oral route and will have the most appropriate pharmacokinetic and pharmacodynamic profiles where possible. However the successful development of molecules with these ideal properties is unlikely and many compounds show pharmacokinetic and/or bioavailability deficiencies that may or may not be addressed during lead optimization (2). Consequently there is a need for product life-cycle management of existing molecules in order to maximize returns on the investments made, during the development phases of a drug product. Many of the strategies used by pharmaceutical companies to develop a further market niche for their products include consideration of using different delivery systems and technologies to ensure differentiation including extended, modified, controlled, or rapid release systems among others. The use of molecules with established efficacy will allow reduced development costs thereby providing less expensive therapies for the worldwide market.