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

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

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

• 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 to learn more about the benefits of partnering with CoreRx for your pharmaceutical development project.