English version

Physico-Chemical Reliability Profiling of Amorphous Solid Dispersions

(Ref. BAP-2017-19)

Tewerkstelling : Voltijds
Duur : Bepaalde duur
Plaats : Leuven
Solliciteren tot en met : 09/02/2017
For Drug Delivery and Disposition we are looking for a highly motivated post-doctoral researcher.The overall goal of this research project is the creation of a knowledge platform that allows a robust design approach to design and guarantee the physical stability of high drug loaded amorphous solid dispersions (ASD) across the entire commercial manufacturing life cycle, and in that way facilitate lower pill burden for patients. The project will be carried out in close collaboration with the pharmaceutical industry.

Physico-Chemical Reliability Profiling of Amorphous Solid Dispersions

The Drug Delivery and Disposition research unit is worldwide recognized for expertise in the field of amorphous materials and solid (molecular) dispersions of poorly soluble drugs. The process development and formulation of these systems are studied with the aim to correlate the physical structure of the drug-carrier (polymer) dispersions to their pharmaceutical performance and stability profile, and to correlate formulation and processing parameters to the resulting physical structure. Processing technologies that are being studied are spray drying, spray congealing, fluidized-bed bead coating, hot-melt extrusion, compression/compaction and mechano-chemical activation. Analytical techniques used for this purpose are thermal analysis (DSC, MDSC, hot-stage microscopy, isothermal microcalorimetry, solution calorimetry), X-ray powder diffraction, infrared spectroscopy, solid state NMR and in vitro (intrinsic) dissolution testing. In addition, Drug Delivery and Disposition is actively involved in the formulation and process development of drug delivery systems for intra-muscular and site-specific (oral) delivery. As part of the Center for Drug Delivery and Analysis of KU Leuven, Drug Delivery and Disposition is also involved in formulation development and preformulation studies for pharmaceutical companies.

Responsibilities

  • Evaluation of latest advanced ways of in-vitro characterization of ASD along with implementation of in-silico modelling tools. Better quantification and understanding of the relation between physico-chemical fundamentals and ASD physical stability will aid in designing high drug loaded and physically stable ASDs.
  • Expand the reliability profile of the ASD by adding the robustness component to the glass formation, drug-carrier mixing (glass solution formation), drug-carrier de-mixing and de-vitrification (= de-stabilization) process. Work out a downscaled high throughput system for testing robustness.
  • Translate the findings to a (semi) quantitative risk/ reliability assessment system of the physical stability of the candidate formulation concepts. This will aid in selecting concepts which stay stable for the entire commercial manufacturing life cycle. Discover and define risky situations (based on physico-chemical fundamentals) where typical ICH physical stability studies can be misleading.
  • Being the liaison between academia and pharmaceutical industry

Profile

PhD in pharmaceutical sciences or physical chemistry. Experience in the domain of amorphous solid dispersions is an asset.

Offer

We offer a post-doc position for two years

Interested?

For more information please contact Prof. dr. Guy Van den Mooter, tel.: +32 16 33 03 04; +32 473 356 132 (mobile); mail: guy.vandenmooter@kuleuven.be.

You can apply for this job no later than February 09, 2017 via the
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