Ritonavir Form III: A Coincidental Concurrent Discovery

(pubs.acs.org)

29 points | by f1shy 6 days ago ago

7 comments

  • refurb 3 days ago

    Polymorphs are actually super interesting scientific challenges in pharmaceutical manufacturing.

    I remember one drug was about to be launched, they had settled on polymorph A, but then during trial manufacturing runs polymorph B started to showed up. They couldn't use polymorph B because it messed up the absorption of the drug.

    So they tried a ton of different methods to see if they could force the drug to polymorph A, but to no avail since it was the more thermodynamically stable version.

    They thought they were ok because another plant was successfully still making A. However, after a few months polymorph B started to pop up, likely due to cross-contamination of some sample or even some microscopic type B crystals falling off a notebook page. Once B showed up, the entire plant was useless for making type A.

    In the end, they were able to identify yet another polymorph, type C, which could be reproducibly created even from type B. The resubmitted their manufacturing protocol to the FDA and it was approved. It delayed launch by over a year.

    • unavoidable 2 days ago

      That is literally the drug in the article (ritonavir).

    • chromatin 2 days ago

      I believe you're thinking of ritonovir, which is exactly the story in the linked article.

  • magicalhippo 3 days ago

    Paper from 2022. Wikipedia has some relevant context[1], with more details here[2].

    [1]: https://en.wikipedia.org/wiki/Ritonavir#Polymorphism_and_tem...

    [2]: https://www.cmbe.engr.uga.edu/bche4520/Other/Ch9/Bauer%20200...

  • plmpsu 3 days ago

    Asianometry has recently covered Rionavir here:

    https://m.youtube.com/watch?v=_xPhxtuA_Qc

  • jakedata 3 days ago

    I just finished re-reading Cat's Cradle by Kurt Vonnegut. Ice-nine is probably the reason non-chemists (with a literary bent anyway) know anything about alternate forms of crystallization.

  • aaron695 3 days ago

    [dead]