Two-Minute Mysteries: BioPharm Stories - Episode 1: A Mysterious Low Reading

*Full transcript available below.

In this inaugural episode of the “Two-Minute Mysteries: BioPharma Stories” video series, Ken Boda, a dissolution product specialist at Agilent Technologies, shares the story of a mysterious low reading.

About the Expert

Ken Boda
Dissolution Product Specialist
Agilent Technologies

Ken works primarily with customers in the US and Canada. He has a wide knowledge of analytical methods, method development, validation, and regulations in the pharmaceutical environment. He enjoys educating people on the science of dissolution and helping customers work through their method challenges.

Specialties: Dissolution Method Development and Validation, Dissolution Failure Investigations, HPLC, UV, Physical Testers, well-versed in USP, FDA, and ASTM regulations in regard to pharmaceuticals, nutritional supplements, and medical devices.

Find Ken on LinkedIn.

Transcript

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Hi, my name is Ken Boda. I'm a dissolution product specialist with Agilent Technologies. I wanted to share a little, scientific mystery with you. Oftentimes, when we're working with dissolution and we have a failure, these can present as little mini mysteries to try to do a failure investigation, determine what's going on.

One example of a quick mystery is a customer of ours who had a dissolution with baskets and a disintegrant dosage form, and they had unexplained low results on a particular dissolution bath. They asked us to come out and take a look at it. We brought our 280-DS mechanical qualification system to the site to evaluate the system.

We found that the alignment of the system was good. However, we did note that there was some interesting spikes in vibration over time, and it turned out that the vibration was coming from a refrigerator that was on the same bench top as the dissolution. So what was going on? What was causing those low results?

Well, when we have spikes in vibration in a disintegrant dosage form in basket, we can shake that basket out and we end up having the powder land on the bottom of the vessel, and at the bottom of the vessel, we don't have much mixing. And so, as a result, we have a large amount of drugs sitting at the bottom of the vessel where it can't dissolve.

And that leads us to having low results. This is really important to monitor vibration and dissolution, because it can have a lot of interesting effects. We usually think of vibration causing higher and more variable results, but that's not always the case as evidenced by this basket study. So, thank you, and hope you