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The role of clinical pharmacology in the development and evaluation of oral controlled-release dosage forms.

The major advances in the development of new, more effective, drugs during the last four decades contrast sharply with the limited progress achieved in improving methods of delivering these agents to the body. Only in recent years has the concept of controlled drug delivery achieved some prominence, but much of the innovation and endeavour in this area of research has been concerned with technical aspects of dosage form design rather than with defining drug input rates to achieve 'optimal' therapeutic effects. This paper examines the rationale for rate control in drug therapy and lists the factors which might limit its wider application. It also considers the specific example of 3-adrenoceptor-blocking drugs and proposes an 'ideal' level of ,-adrenoceptor blockade against which the performance of controlled-release systems can be assessed.