Controlling Drug Release in Oral Product Development Programs: An Industrial Perspective

Abstract

Most new drugs for oral administration are released rapidly from the dosage form. This may give "peak-trough" plasma profiles not suited to the drug's mode of action or side effect profile. Traditionally, there were few options for better design to optimize rate or time of release. However, advances in many areas of drug evaluation are now identifying opportunities to modify drug release during earlier phases of development to optimize therapeutic efficacy and reduce undesirable effects. It should also result in better success rates in drug development programs as well as better medications for patient treatment.This chapter explores possibilities for modifying release during Preclinical, Phase 1, Phase 2, and Phase 3 programs. Opportunities to improve performance or find new indications for mature drugs, by controlling release continue to emerge. Such possibilities are also considered. The chapter is written, not only for the product design (formulation) specialist but also for scientists involved in all aspects of drug evaluation and development. Consequently, its focus is on the breadth rather than depth of the topic. Other chapters provide more comprehensive accounts of specific approaches, technologies, and modes of evaluation.

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