Read about challenges faced and overcome by our scientists. See how other companies put CoreRx™ teams to work for them. In one case, our client had already progressed to clinical trials; however, they discovered a problem with the stability of their product. In another case, we reformulated a drug made from two Class II controlled substances within the client's timeline and without infringing on intellectual property.
Unique Product Reformulation
A formulation of the drug candidate that was used because there were many existing patents on the API, was found to have long-term stability problems. Scientists came up with a compound that remained stable in the long-term, could be scaled up for manufacture, and yet did not infringe on existing patents. CoreRx scientists reformulated the compound quickly and effectively to correct the error made in the formulation attempts.
Read more: Unique Product Reformulation
A drug formulation existed with three different dosage levels. Our team deformulated, and then reformulated the compounds quickly so that the client’s schedule did not need to be changed. At CoreRx, we understand the difficulties involved in creating unique formulation compounds on time and getting your compounds ready for FDA applications.
Read more: Multi-Level Deformulation
Anti-viral Drug Developed Into Injectable Product
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.
Read more: Anti-viral Drug Developed Into Injectable Product
Multi-layer, Dual Active Ingredient Re-Formulation
The client had a modified release, multi-layer, dual active pharmaceutical ingredient drug product which needed re-formulation into either a multi-layer or mono-layer tablet. There was substantial intellectual property regarding stabilization of one of the drug molecules, as well as various formulation patents which had to be circumvented. The project was seen as a potential “blockbuster” drug (a drug generating more than $1 billion of revenue for its owner each year).
Read more: Multi-layer, Dual Active Ingredient Re-Formulation