Elan Drug Technologies

 

Elan Drug Technologies’ DUal RElease Drug Absorption System (DUREDAS^™ Technology) is a bilayer tablet which can provide immediate or sustained release of two drugs or different release rates of the same drug in one dosage form. The tabletting process can provide an immediate-release granulate and a modified-release hydrophilic matrix complex as separate layers within the one tablet. The modified-release properties of the dosage form are provided by a combination of hydrophilic polymers.

Benefits offered by the DUREDAS™ Technology include:

• bilayer tabletting technology
• tailored release rate of two drug components
• capability of two different CR formulations combined
• capability for immediate release and modified release components in one tablet
• unit dose, tablet presentation

 

The DUREDAS™ system can easily be manipulated to allow incorporation of two controlled release formulations in the bilayer. Two different release rates can be achieved from each side. In this way greater prolongation of sustained release can be achieved. Typically an immediate release granulate is first compressed followed by the addition of a controlled release element which is compressed onto the initial tablet. This gives the characteristic bilayer effect to the final dosage form.

A further extension of the DUREDAS™ technology is the production of controlled release combination dosage forms whereby two different drugs are incorporated into the different layers and drug release of each is controlled to maximise the therapeutic effect of the combination. Again both immediate release and controlled release combinations of the two drugs are possible. A number of combination products utilising this technology approach have been evaluated.

The DUREDAS™ technology was initially employed in the development of a number of OTC controlled release analgesics. In this case a rapid release of analgesic is necessary for a fast onset of therapeutic effect. Hence one layer of the tablets is formulated as an immediate release granulate. By contrast, the second layer of the tablet, through use of hydrophilic polymers, releases drug in a controlled manner. The controlled release is due to a combination of diffusion and erosion through the hydrophilic polymer matrix.