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Gudrun Fridgeirsdottir, Ph.D.
LEAD FORMULATION SCIENTIST

Gudrun Fridgeirsdottir, Ph.D. is a Lead Formulation Scientist in Catalent’s Nottingham UK Facility. She received a Ph.D. from University of Nottingham, UK, a masters degree in Drug Discovery and Development from Uppsala University, Sweden, and achieved a Bachelor of Science degree in Pharmaceutical Sciences at the University of Iceland.

Gudrun specializes in solid dispersions as well as lipid and particle size reduction. Her research involves enabling formulation techniques, improving solubility for poorly soluble compounds, through the aforementioned techniques.

Her work involves early phase formulation development ensuring that each new API has the best chance of succeeding in PK, tox or phase I studies. Her team helps to get new APIs quickly and efficiently to the patients that need them.

Discover what drives her passion for drug formulation. Access her works that include 6 peer reviewed articles and scientific posters to help you understand Catalent’s implementation of formulation development.

Get to know this Catalyst in formulation development.

Key Expertise: Analytical & Formulation Development

Connect with Gudrun Fridgeirsdottir on LinkedIn

A CONVERSATION WITH GUDRUN FRIDGEIRSDOTTIR

Choosing an optimal formulation and manufacturing route for a new API not a straightforward process. Can you elaborate on some tools you use to help accelerate the process?

In early formulation development we extensively use small scale screening experiments as well as some computational modelling in order to obtain maximum information about the molecule and different formulation strategies. Through small scale screening such as film casting, miniature melt granulations and DSC miscibility studies we can assess multiple systems using minimal amount of API and time. Then, there is always a balance to be found between solubility, stability and manufacturability which has to be considered with the target product profile to achieve the best formulation for each molecule.

Catalent’s Nottingham facility focuses on early drug development, can you elaborate on some of the technologies used for formulation there?

With the large amount of poorly soluble drug molecules that we work with we have a good expertise in enabling formulations, that is formulations that can improve solubility. These include particle size reduction both micronisation and nano-milling, lipidic formulations and our most commonly used strategy, solid dispersions. A large proportion of our poorly soluble molecules are incorporated into solid dispersions and through downstream processing made into tablets or filled into capsules.

Can you give us some examples of successful ways your team has enhanced the bioavailability of poorly soluble drugs?

As mentioned above we have worked extensively with solid dispersion, both binary and ternary systems. We have followed several of those projects into late phase clinical studies, where the formulations are showing significantly improved bioavailability compared to the crystalline API. Other strategies we have successfully used are use of precipitation inhibitors e.g. with prodrugs and solid dispersions, to maintain solubility enhancement over an extended time in vivo.

What are some additional projects that you are currently working on at Catalent?

I am currently working on implementing the Catalent OFSS platform in the Nottingham site. Furthermore, looking at new solubility enhancing techniques to add to the OFSS platform. Another interesting project I am currently working on is looking into possible formulation strategies to improve solubility/bioavailability and reduce fed/fasted state difference Other projects we are currently working on at the Nottingham site include a topical gel, mini-tablets, several solid dispersions, and delayed release formulations.

What do you enjoy most about your job as a formulator?

I enjoy the diversity of the projects that we get to work with. There are different problems with each new molecule and no two projects are the same. I particularly enjoy the problem solving aspect of formulation development. Learning and adapting new techniques to overcome challenges that we face.

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