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ROUNDTABLE


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Controlled Release Technologies and Trends


Dr. Thomas Dürig Sr. R&D Director Ashland


Shaukut Ali, PhD Technical Support Manager BASF


Kyle Kyburz, PhD Senior Research Chemical Engineer Bend Research, a division of Capsugel Dosage Form Solutions


Shrikant N. Khot, PhD Sr. R&D Manager Dow Pharma & Food Solutions


Jasmine Musakhanian Scientifi c and Marketing Director – Pharmaceutical Division Gattefosse


Can you tell us about some of the latest technologies for controlled release? What are their benefi ts?


Dr. Thomas Dürig, Sr. R&D Director, Ashland: Among the promising new oral controlled release technologies are bioavailability enhancing technologies coupled with extended release technologies. An example of these are gastro resident systems which enable the extended delivery of drugs with limited colonic absorption. While older hydrophilic matrix based technologies such as Accuform™ have been in the market for several years, newer technologies are in development that bind to the mucosal membranes and have ability to also repel gastric contents, thus allowing for extended gastric residence. Another promising bioavailability enhancing technological development is the coupling of enabling technologies such as amorphous dispersions with modifi ed release formulation techniques such as matrix tablets, thus enabling the extended delivery of poorly soluble drugs. This can now be readily achieved with the aid of appropriate hot melt extrusion technologies. Existing advances have also been made in manufacturing and process technologies, for instance in the use of 3D printing to engineer devices with complex architecture for precise drug release modulation.


Shaukut Ali, PhD, BASF: Controlled release has been a subject of continued interest in the industry with particular focus on creating a better and smarter dosage that (i) meets the therapeutic index by maintaining the desired plasma concentrations for extended periods, (ii) avoids drug toxicity and (iii) makes patient compliance less burdensome. These can be achieved by selecting appropriate excipients and technologies that are compatible and yield desired release profi les. This can be done by drug layering. For instance, pulsatile release polymeric excipients control the selective delivery when and where it is desired. It off ers a unique advantage because timely release is controlled by coating the drug with polymers having sustained and/or enteric modifi ed release characteristics. While drug layering and pulsatile release is eff ective in releasing the drugs through polymeric barrier layers around APIs, in colon drug delivery, for example, the drug layering may require multiple coatings with diff erent polymers to design the release at a specifi c pH and site in the GI tract. In such cases, polymers with enteric or reverse enteric modifi ed characteristic are often required to mitigate the pH eff ects, while allowing the controlled


58 | | May/June 2016


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