DISSOLUTION TESTING ‘CRITICAL’: HOVIONE RESEARCHER ON MONTH-LONG STUDY VISIT TO ISAB LAB

Hovione doctoral researcher Beatriz Noriega returns to ISAB’s labs in Stockholm for her ongoing research into preclinical in vitro dissolution testing. She talks to Lab Blog about why she believes dissolution testing is critical, and how she’s hoping to prove it.

Hovione Ph.D. researcher Beatriz Noriega has been working for two years so far on her doctoral thesis, authoring four well-received posters and with two accepted for the next Respiratory Drug Delivery (RDD) Conference in April 2018. This is Beatriz’s second research visit to ISAB’s labs to use the in vitro simulation tool DissolvIt ^®, as part of her work in the Particle Design and Inhalation Development department of Hovione’s R&D Drug Product Development. Her mission? “No matter how similar formulations may seem, until you analyse dissolution you never really know,” says Beatriz. She took time out from her research to talk to our ISAB Lab Blog.

What will you be testing on this visit?

“I’m here to test my own formulations that right now are screened as similar based on their aerodynamic performance. I want to show how analysing their dissolution early on can prove that actually they’re very different. I’m using particles of the same API that are produced using two different technologies, jet milling and wet polishing, and produce a seemingly similar formulation with similar aerodynamic performance. They look the same—but are they? Sometimes formulations like these can go all the way through to clinical trials before it’s found they behave differently. What I’m trying to prove is that particle engineering technology, whether we jet mill or wet mill particles in formulations, will influence how solutions dissolve in the lung. I’m hoping to prove that dissolution is a critical test in getting the right formulation.”

What’s so special about the lungs?

“I’m really excited by lung science! There’s so much to know, and every time you find something out it makes you realize how much is still left to know. The lungs are tough to access, the thickness of the lung fluid goes from just 2 micrometres to 100 micrometres, and it is a challenge to mimic the its exact composition! So I’m constantly excited and challenged, but I’m realistic too.  I’m not going to be able to construct a whole predictive model in just four years! But I can show how critical it is to analyse dissolution early on, and this could play an important role in later establishing a predictive model that lets us know how it’s going to be when we treat human patients.”