Multi-layer, Dual Active Ingredient Re-formulation Project: 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).
Assignment: Facing decreasing investor resources from the early phase of the project it was imperative that CoreRx, Inc. develop the drug product into various forms quickly and efficiently (for clinical trials) to ensure investors the project was on the right path to enhance future capital investment into the project from both private and public domain.
Results: Within one year CoreRx, Inc. formulated various prototypes in tri-layer, bi-layer and mono-layer tablet form, each with characteristic release profile in an attempt to “mimic” phase I in-vivo clinical release of each of the active pharmaceutical ingredients. These prototype formulations and processes were manufactured into an “experimental design” matrix to over-lay the phase I clinical data. The product is currently in Phase III development.
|
