A New Ibuprofen Pulsed Release Oral Dosage Form

Abstract

Drug constant release is not always the desired solution for controlled drug administration; some therapeutic situations require consecutive pulses of active principle

A biphasic oral delivery system able to release an immediate dose of therapeutic agent as well as a further pulse of drug after some hours could be interesting

In order to obtain such desired releasing performances, a new system (three layer tablet) has been designed with the following characteristics

- an energy source, able to deliver the two divided doses of drug

- a control element, between the drug layers, able to delay the release of the second dose of drug. This control element acts as a barrier and is made with a mixture of water swellable polymers

- an outer film, which is made of water impermeable polymer, that covers the second dose of drug and the barrier

The new system works through subsequent interactions with aqueous fluids of the three different layers of material in the following order

1 - rapid interaction of the uncoated part of the system, and immediate disintegration of the first dose;

2 - slow interaction of the barrier and its gelation;

3 - interaction of the second drug layer and development of a force able to break the barrier thus promoting the release of the second dose of drug. Preliminary in vivo experiments carried out on this biphasic pulsed release device containing Ibuprofen as a model drug, show two distinct peaks in plasma profiles thus indicating that the in vitro results are in good agreement with the in vivo blood levels