Solitek's Newsletter
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Welcome to the June edition of the Solitek newsletter!
As we embark on the summer season, we can't help but feel the excitement in the air. June brings with it longer days, warmer temperatures, and a renewed energy that permeates the world of science. This month, we're thrilled to share the latest developments and insights in the fascinating realm of solid state.
A bit of history
June is a special month for those passionate about crystallography. It was in June 1912, that Max von Laue published his groundbreaking paper on X-ray diffraction by crystals, titled "Interference of X?rays". This paper described von Laue's experiments that demonstrated how X-rays could be diffracted by crystals, revealing their internal structure. This discovery laid the foundation for the field of X-ray crystallography and revolutionized our ability to study the atomic and molecular arrangements in solids. Max von Laue's work earned him the Nobel Prize in Physics in 1914, and his experiments paved the way for countless advancements in crystallography.
By commemorating the publication of Max von Laue's paper in June, we recognize the pivotal role he played in the development of crystallography, enabling us to gain deeper insights into the nature of solid forms.
As the summer season unfolds and we embrace the warmth and energy it brings, let us continue our journey of exploration and discovery in the fascinating world of solid forms.?
TOPIC OF THE MONTH
A new form of Ritonavir after 24 years!
The recall of Ritonavir Form I is not a new story.
Among of the cases of disappearing polymorphs it is probably the most notorious example that dates back to 1998[1],[2].
Given such notoriety, it is surprising to read that a new Form III has been recently identified 24 years after the problems were initially reported![3],[4]
While Form III is a metastable form and the least stable one known so far, the story of Ritonavir goes on to highlight the importance of #polymorph screening in API drug development. As a solid form services provider, the takeaway message is that polymorphs screening methods can always be challenged. Perhaps not many would disagree that a comprehensive screening is extremely valuable, if not a must-do, for drug development. However, it involves a large number of experiments and therefore time and investment, so many companies won′t be keen to perform a comprehensive screening with their early phase assets. Nonetheless, a more focused screening aimed at identifying the most stable form is certainly a key study to ensure the selection of the most suitable solid form for further development.
References
[1] ?Chemburkar SR, Bauer J, Deming K, Spiwek H, Patel K, Morris J, Henry R, Spanton S, Dziki W, Porter W. ’Dealing with the impact of ritonavir polymorphs on the late stages of bulk drug process development’. Org Process Res Dev. 2000;4:413–417.
[2] Bauer J, Spanton S, Henry R, Quick J, Dziki W, Porter W, Morris J.’ Ritonavir: an extraordinary example of conformational polymorphism’. Pharm Res. 2001;18: 859–866.
[3] Yao, X. et al. ‘Ritonavir Form III: A New Polymorph After 24 Years’. Journal of Pharmaceutical Sciences 2023:112:237?242
[4] Parent, Stephan D. et al. ‘Ritonavir Form III: A Coincidental Concurrent Discovery’. Cryst. Growth Des. 2023:23:320?325
CASE STUDIES
Is patentability of new polymorphs under scrutinity? Check out this case!
MEET THE TEAM
Joan Benet,Technical leader
Joan Benet Congost obtained his degree in Chemistry at Universitat Autònoma de Barcelona. His Master′s degree specializing in solid form in the chemical industry and since then has worked in pharma and solid-state CROs in Spain for more than eight years. He is an expert in polymorphism studies, cocrystal and salt formation and additional API physicochemical characterization and is being a valuable member in Solitek′s team for 1.5 year.
What Joan Says...
"I am excited to be part of such an experienced and knowledgeable team in the field of #solidform and drug development. During this 1.5 years I have learned from everyone and I am happy to have contributed, and continue to be doing so, to the growth of this small, but dynamic company."
UPCOMING EVENTS
Join us at CPHI Barcelona!
Contact us in https://solitekpharma.com/