Delivery systems with a pulsatile-release pattern are receiving increasing
interest for the development of drugs for which conventional controlled dru
g-release systems with a continuous release are not ideal. These drugs ofte
n have a high first-pass effect or special chronopharmacological needs. A p
ulsatile-release profile is characterized by a time period of no release (l
ag time) followed by a rapid and complete drug release. Pulsatile drug-deli
very systems can be classified into site-specific systems in which the drug
is released at the desired site within the intestinal tract (e.g., the col
on), or time-controlled devices in which the drug is released after a well-
defined time period. Site-controlled release is usually controlled by envir
onmental factors, Eke the pH or enzymes present in the intestinal tract, wh
ereas the drug release from time-controlled systems is controlled primarily
by the delivery system and, ideally, not by the environment. This review c
overs various single- and multiple-unit oral pulsatile drug-delivery system
s with an emphasis on time-controlled drug-release systems.