Unlocking the secrets of API stability
I still remember my university days when, after long hours in the lab, I would finally synthesize the target molecule. As in many research projects, this would not be the first attempt to obtain a substance with specific properties. Full of hope (and with a little fear of failure), I would run a DSC experiment. This would show whether the phase transition temperatures of this new material matched my expectations. If not, I would go back to the lab to fine-tune the chemical structure to come closer to my goal. However, if the phase behavior matched the desired profile, I would hurry to the X-ray lab to see whether the XRD pattern contained the right features.
I am a polymer chemist by education. In the past, my research was mainly dedicated to highly elastic liquid crystalline polymers that used to create artificial muscles.
Over the last five years, I have been working with many customers in the pharmaceutical industry. In their labs I see many different analytical instruments sitting next to each other: a calorimeter for phase behavior assessment, a Mastersizer for particle size characterization, a diffractometer for polymorph validation. It is no accident that these instruments are often located in the same laboratories. Analysts often run multiple tests on their substances as they try to understand the behavior of their newly synthesized molecules. Just like I was some years ago.
Collaboration
That’s why I am very excited that Malvern Panalytical is collaborating with NETZSCH Analyzing & Testing. This partnership brings together the technologies our companies have excelled at for many years. Here is what Gabriele Kaiser, of NETZSCH says about this collaboration:
While liquid vaccines are the talk of the town right now, solid dosage formulations remain the most important dosage forms of pharmaceuticals. Thermal analysis provides understanding of the physicochemical properties of drug products. It can be applied to study polymorphism and offers a method for quick assessment of physicochemical incompatibility between active pharmaceutical ingredients (APIs) and excipients. However, and this applies to all analytical techniques, thermal analysis does not follow the concept of universal analysis. Therefore, I am delighted that we now have a partner with whom we can work together on such issues and thus support our customers even more comprehensively.
Gabriele Kaiser, Ph.D.
Business Field Manager Pharma, Cosmetics, Food – NETZSCH
On January 20th, we ran our first collaborative webinar. This session explored a simple system – lactose – to demonstrate how much information can be uncovered by “simple” XRD, DSC and TGA experiments. This widely spread excipient can exhibit amorphous and crystalline phases, and it can also exist in hydrated form.
Our next step is to look at more complex systems to demonstrate how different analytical technologies used in conjunction with each other can reveal much more about the materials under investigation, opposed to common sequential analysis.
Stay tuned for more in-depth analysis from the Malvern Panalytical / NETZSCH collaboration!