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Significant research and efforts are directed towards drug delivery systems, which are suited to:

• control the onset time of drug release and/or
• deliver the active ingredient to a distal sites within the gastro-intestinal tract (GIT)

These delivery devices are in particular advantageous for drugs/dosage forms with the following features and/or needs:

• Circadian variations in pharmacokinetics and/or pharmacologic responses
• Requirement of night-time dosing or multiple dosing intervals
• Need to deliver the API to the distal parts of the GIT

GPS has established a platform technology, which is suited to control the onset of drug release (Figure 1) and release rate of oral delivery devices with superior reproducibility and low system variability. Also multiple pulse systems can be realised with this technology (Figure 2). Drug release is pH-independent.

The final dosage form is presented as hard-gelatine capsule, tablet or sachet.

Figure 1: In vitro dissolution profiles of products with differing onset times

Figure 2: In vitro dissolution behaviour of multiple pulse systems

The profiles below (Figure 3-6) illustrate the in vitro and in vivo performance of clinical test preparations with differing delayed release characteristics developed with the proprietary technology. Prototype I exhibits a shorter onset time, Prototype II a prolonged lag-phase in vitro and in vivo as well.

Figure 3: In vitro dissolution of Prototype I

Figure 4: In vivo performance of Prototype I

Figure 5: In vitro dissolution of Prototype II

Figure 6: In vivo performance of Prototype II