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L2

Preparation of vesicular phospolipid gels by Twin-Screw Extrusion

Prof. Gerhard Winter, LMU München; Michaela Breitsamer, LMU München; Natalie Deiringer, LMU München

LMU München


Challenge

Vesicular Phospholipid Gels (VPGs) are semisolid drug delivery systems for the sustained release of proteins, peptides and other small molecular drugs. They are composed of up to 50% phospholipids and buffer. This simple and cheap composition, the high biocompatibility and their exceptional functionality with release rates up to several weeks makes them an ideal drug delivery system. Compared to other s.c. depot formulations VPGS provide several advantages and VPGs are universally applicable to almost all drug delivery applications where retardation in the range of 1-4 weeks is desired. Previously VPGs have been prepared either by high pressure homogenization (HPH), magnetic stirring or by dual asymmetric centrifugation (DAC). Over the last few years DAC has qualified as gold standard for the preparation of VPGs. However, all these methods do have several disadvantages like a long duration, limited scale up and high shearing forces. Up-scaling to industrial scale or down-scaling to small lab scale bares difficulties and complications which have to be overcome.


Technology

Twin-screw extrusion (TSE) is a simple and continuous manufacturing technology, which has become an established technology in pharmaceutical industry for the preparation of sophisticated drug product formulations. It has gained great interest in the field of continuous wet and melt granulation as well as in the production of injectable implants. The fast process with well controllable parameters like temperature and shear intensity can easily be scaled up to commercial scale and continuous manufacturing is possible. Liquid and solid components can be addedsimultaneously and a homogenous blend is achieved. This promising manufacturing process for semisolid systems has now been adopted and qualified for the production of VPG and is described in a recent patent application. The properties of TSE made VPGs are even slightly better than those manufactured by the previously described methods despite the easier and faster production process.


Commercial Opportunity

Licensing or Purchase of IP from LMU possible. Background IP also available from the LMU inventors.


Development Status

Proof of Principle, in vitro, prototype; In vivo animal applications published


Patent Situation

DE Priority Patent Appliation (16.03.2018), DE2 patent application within priority year, PCT application pending (March 2019)


Further Reading

DE 10 2018 002 123.9


 

Preparation of vesicular phospolipid gels by Twin-Screw Extrusion