Dissolution testing ’critical’: Hovione researcher on month-long study visit to ISAB labs

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.

Beatriz Noriega with DissolvIt ^®.

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?

Working with samples for DissolvIt ^®’s cover slips..

“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 micrometers to 100 micrometers, and it is a challenge to mimic 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.”

You describe dissolution testing as ‘critical’. Why?

“The faster and more safely you can develop drugs the faster patients can get new treatments. Dissolution testing is critical to making drug development take fewer steps and less risk. At Hovione we are at the cutting edge of developing formulations for inhaled drugs. What we saw was missing in this field today is the dissolution study. There are other technologies that simulate drug dissolution – but right now DissolvIt ^® is the one which best mimics what happens in the lung. I’ve used other dissolution tools, ones that adapt tools to simulate dissolution from oral delivery using pills for example, but whilst they mimic dissolution they don’t do it for the real environment of the lung. These simulation tools can be used for discrimination, or do quality control. But not to predict what happens in the lung. For predicting how particles dissolve in the lungs—DissolvIt ^® is currently the system we should use.”

What’s it like living and working in a different environment for a month?

”Great! You learn a lot and grow a lot. It’s liberating to be in a different place and do things in a different way. It’s always good to talk to new minds and get new ideas and perspectives. Here at the ISAB labs you have physics engineers and mechanics as well as chemistry and biology experts, so you look at things from a different perspective. The ISAB team are always very open to change, developing new things fast and taking in new input. There are a lot of great minds here. When you give them an idea they just do it. That’s the perfect way of making the equipment change and improve, the best science is a Work in Progress, there’s always room for improvement!”