Jukka Rantanen
Professor
E-mail: jtr(at)farma.ku.dk
Telefon: 35 33 65 85
Rum: 13/709

 Process analytical technology and Quality by Design, PAT/QbD
Quality by Design, QbD, is a new way to look into pharmaceutical formulation. The main aim is to build the quality into products, to achieve relevant information during processing, and by this means increase the level of safety of medication. Current projects in this area cover the unit operations related to solid dosage forms, specifically the implementation of non-invasive spectroscopic methods for process monitoring and control purposes. Students have a possibility for industrial and academic projects in both Denmark and outside of Denmark (UK, USA, and Sweden).
Supervisor: Jukka Rantanen

Development of novel formulations with advanced processing technologies, at LifeCycle Pharma, Hørsholm
LCP (LifeCycle Pharma) is an emerging specialty pharmaceutical company focused on certain cardiovascular indications and organ transplantation in particular. LCP has developed a patented technology called MeltDose®. Unlike more costly and complex technologies, MeltDose® is a one-step process designed to enhance the absorption of drug substances by incorporation a more soluble form of the drug in the tablet matrix. We have two specific projects:
1) Solid state characterization of melts and MeltDose® granules. Focus: Solid state characterization of MeltDose granules using e.g. NIR, Raman, X-ray powder diffraction, Hot-State microscopy, laser diffraction.
2) Preparation of Solid Dispersion by controlled agglomeration using MeltDose® technology. Focus: MeltDose® granulation and compression, effect of process and formulation variables, granule and tablet characterization.
Supervisor: Jukka Rantanen and Jakob Kristensen, LifeCycle Pharma A/S

Effect of excipient in powder blends on segregation, at Lundbeck
Over the last years the pharmaceutical industry is moving towards a more risk and science based approach for product development and manufacturing. The changes are facilitated by new guidance from FDA e.g “Pharmaceutical cGMPs for the 21st Century – A risk-based approach” and the ICH guidance’s Q8, Q9 and Q10. The new approach is referred to as Quality-by-Design (QbD), which emphasizes targeting development against a predefined product profile, designing quality into the product by identifying the factors influencing product performance, and establishing control strategies to ensure that product can be manufactured with appropriate quality.
Focus for this thesis is to investigate the relation between powder-blends characteristics, in-process performance (e.g. segregation) and tablet uniformity of dose. The experimental part of the project will be based on Design of Experiments (DoE) to quantify the effect of excipients in powder-blends with different API concentrations and characteristics. Powder blend characteristics will primarily be based on measurements on a FT4 powder rheometer. Performance of the different powder blends could be evaluated from measurements on a Jenike Fluidization Segregation Tester, from small-scale tablet batches in development and from existing manufacturing experience in Lundbeck production (large scale).
Supervisor: Jukka Rantanen and Mette Bryder, Lundbeck

Probing the amorphous state of pharmaceuticals
Pharmaceutical materials may exist in various crystalline forms or in an amorphous state. The use of amorphous form of the substance can be helpful in solving problems related to solubility and bioavailability of drugs. This project is aiming to develop approaches to identify and quantify amorphous content in solid state pharmaceutics.
This project is a co-operation project with New Zealand's National School of Pharmacy (University of Otago, New Zealand). All the experimental work will be performed in the Southern Hemisphere (Dunedin, New Zealand) with professor Thomas Rades. Dunedin (Ōtepoti in Maori) is the second-largest city in the South Island of New Zealand.
Supervisor: Jukka Rantanen  and Thomas Rades (University of Otago, New Zealand)