Lightning strikes twice at the same time, 137 miles apart


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

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

About Improved Pharma

Improved Pharma is a research, consulting, and information company dedicated to improving pharmaceutical methods, formulations, and processes. Services include solid-state form studies, formulation design, synchrotron techniques, analytical testing, and expert consulting for the development and defense of intellectual property matters. The company was founded in 2006 by Stephen and Sarah Byrn, who also founded SSCI.

For more information about Improved Pharma’s services, please contact us at 1-765-463-9951 or info@improvedpharma.com.

About Varda Space Industries

Varda is a venture capital-backed company creating the first free-flying space stations and reentry vehicles ready-built for materials processing. Microgravity found in low Earth Orbit (LEO) makes it possible to precisely control the crystallization process during development and manufacturing to create valuable pharmaceutical products that cannot be created on Earth’s surface. Varda has raised $53m+ from a cadre of world-class venture capital firms including, but not limited to: Founders Fund, Lux Capital, Caffeinated Capital, Khosla Ventures, and General Catalyst.

For more information about Varda please contact press@varda.com

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