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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