Ottergemsesteenweg 460 B-9000 Gent (Belgium) Tel.: +32-9-264.83.55 E-mail : Glenn.Verstraete@UGent.be Education : Pharmacist (Master of Science in Drug Development)
Hydrophilic thermoplastic polyurethanes for the manufacturing of highly dosed oral sustained release matrices via hot melt extrusion and injection molding
Sustained release dosage forms have been successfully developed via HME using different polymers; the drug load in these formulations is often low. With high drug loads burst release or processing issues are observed. Therefore the design of novel sustained release dosage forms using innovative polymeric materials with improved characteristics for controlled drug release is continuously under investigation. A more rational design/use of polymer matrix excipients for drug formulation is needed.
Recently Thermoplastic Polyurethanes (TPUs) were found to be promising matrix formers for the production of high drug loaded oral sustained release formulations via Hot Melt Extrusion and Injection Molding, thereby diminishing the amount of excipient needed and creating a major advantage for the patient’s compliance. In addition Hot Melt Extrusion/Injection Molding is a continuous production process, which offers several advantages such as reduction of cost, reduction of waste, improved process efficiency, optimal use of equipment and flexibility in production capacity.
Although high dosed hydrophobic TPU matrices were successfully produced via HME/IM, drug release modifiers were needed to ensure a complete release of drugs with lower aqueous solubility. The investigation of other (i.e. hydrophilic) TPUs is essential to provide manufacturers with a flexible polymer platform that allows sustained release of a wide range of APIs.
