WEST LAFAYETTE, Ind. (PRWEB)September 13, 2022
Developing new tools and advancing pharmaceutical development is a key part of Improved Pharma’s mission. In 2021, Improved Pharma had the unique opportunity to start polymorph screening research projects in close collaboration with Varda Space Industries with the intent of advancing pharmaceutical product manufacturing. As a result, the Improved Pharma/Varda team has developed a process to prepare Form III of Ritonavir using a faster nucleation method.
In 1998, the recall of ritonavir upon the unexpected appearance of the more stable Form II polymorph, still remains a notorious case of disappearing polymorphs as the presence of Form II inhibited the ability to grow the original Form I. The current research presents the characterization of Form III of ritonavir grown from melt/cool crystallization. While Form III has been observed by researchers in 2014 and 2022, this study presents a thorough characterization and novel thermal profile for quicker nucleation and crystallization of the new form. In this current study, past thermal methods are expanded upon by examining the polymorphic landscape of ritonavir to shed light on the crystallization of Form III from the melt.
“This ongoing research effort in collaboration with Varda Space Industries has been very exciting for the entire Improved Pharma team,” exclaims Dr. Stephen Byrn, CSO of Improved Pharma. “We’re grateful to our collaborators for all they are doing to advance pharmaceutical development in space and are thrilled to be a part of these studies that may alter the future development of pharmaceutical products as we know it.”
Ritonavir Form III: Lightning strikes twice at the same time, 137 miles apart
Stephan D. Parent1, Pamela A. Smith1, Dale K. Purcell1, Daniel T. Smith1, Susan J. Bogdanowich-
Knipp1, Ami S. Bhavsar2, Larry R. Chan2, Jordan M. Croom2, Haley C. Bauser2, Andrew McCalip2,
Stephen R. Byrn1, Adrian Radocea2*
1. Improved Pharma LLC, West Lafayette, IN 47906
2. Varda Space Industries, El Segundo, CA 90245
*Corresponding Author: adrian@varda.com
https://doi.org/10.26434/chemrxiv-2022-49tzw