"Introduction to Hot Melt Extrusion for Pharmaceutical Applications"
Dr. Margarethe Richter
Pharma Application Specialist
Thermo Fisher Scientific
As a well-known process in polymer industry hot melt extrusion (HME) is approaching pharmaceutical manufacturing. HME allows innovative formulations of solid oral dosage forms. Its main advantage in pharmaceutical applications is the possibility to enhance bioavailability of a drug, i.e., to produce solid dispersions of the active pharmaceutical ingredient (API) in the polymer matrix. Regarding solid oral dosage forms, typical edible polymers are copovidone, copolymers derived from esters of acrylic and methacrylic acid, HPC, HPMC, PEG or PEO. The main concern of the formulator is to achieve the appropriate release profile (immediate or sustained release) or improved bioavailability of the API. The following material properties play a major role in pharmaceutical HME applications:
* The polymer dissolution/swelling in water, or at a certain pH, at a defined rate in order to control the release of the active ingredient (the API)
* The ability of the API to form a solid dispersion or solution in the polymer in order to enhance solubility and bioavailability.
* The rheology and thermal stability of the formulation.
The presentation includes several case studies related to HME for solid oral dosage forms from formulation, through process development, to analysis of the products. In addition, novel delivery methods will be discussed, e.g. injectable implants that allow a site specific drug delivery. These polymers can be biodegradable, e.g. PLGA or HPC or biocompatible e.g. EVA. Also in this case the release profile of the active ingredient is the crucial point. Examples covering injectable implants as well as transmucosal delivery systems will be covered in the talk.
Of course all pharmaceutical HME processes have to be compliant to Good Manufacturing Practice (GMP). A summary of the special considerations related to manufacturing equipment e.g. requirements for material contact parts and software will be given in the talk.
Margarethe Richter is a Pharma Application Specialist at Thermo Fisher Scientific, where she develops new applications for pharmaceutical hot melt extrusion and twin screw granulation. The publication of her findings as well as the worldwide support for Thermo Fisher’s customers are her main responsibilities. Margarethe (Magi) was a researcher at the German Aerospace Center (DLR), Institute of Engineering Thermodynamics, in Stuttgart, Germany. There she focused on thermochemical energy storage, heat transformation, thermal analysis, and thermodynamic and kinetic reaction models. In that position, she earned her PhD degree (Dr.-Ing.) from the University of Stuttgart. Magi is a chemical engineer by training and graduated from the Karsruhe Institute of Technology (KIT). She did several international research stays at the CIC energigune in Victoria, Spain, and the Hong Kong University of Science and Technology (HKUST).
Wednesday, October 3
Michael’s at Shoreline
2960 N Shoreline Blvd
Mountain View, CA