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Case Studies

Anti-viral Drug Developed Into Injectable Product

Project: The client had an anti-viral drug molecule requiring development into an injectable product within six months. The drug molecule is an inhibitor of influenza A and B neuraminidases and certain strains of influenza viruses that may be resistant to available neuraminidase inhibitors but are susceptible to the client drug molecule in laboratory tests. 

Assignment: Facing limited time to get formulations into the clinic and facing a possible pandemic avian influenza outbreak in the U.S., the client wanted an injectable product developed rapidly for possible stockpile and distribution to the U.S. government. The client received United States Food and Drug Administration ("FDA") Fast Track designation for the product currently being developed in both intramuscular and intravenous formulations.

Results: Within two months CoreRx, Inc. conducted compatibility, solubility, sedimentation and pH studies leading to formulation matrices for developed solution, suspension and lyophilized formulations in multiple prototypes. Prototype formulations were placed on stability in various packaging configurations including lyophilized vial, syringe and glass bottle. The product is currently in late Phase II development.

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Discover The Benefits Of Working With CoreRx™

• Our scientists have expertise in a virtually every dosage form so you can rest assured we can quickly and effectively create solutions to formulation dilemmas.
• Our staff has over 200 years of combined experience in contract pharmaceutical development giving us a unique insight and deep understanding of the process.
• CoreRx™ is founded on effective communication and active client involvement which ensures your timelines and expectations are met again and again.
• Our facilities and teams are designed to provide you the greatest flexibility while maintaining quality which means even as your project requirements change, our services can keep up with your needs.
• We’re fast! CoreRx™ has the experience to identify the most effective process and keep your project on schedule throughout it. Without sacrificing quality, we’ll get your product through manufacturing and on the market quickly.

Call, email, or complete the form above to learn more about the benefits of partnering with CoreRx™ for your pharmaceutical development project.