Drug Product Optimisation

An effective drug product must deliver an NCE to the right place, at the right time, at the right concentration to express its beneficial therapeutic effect.  For oral medicines, the increasingly competitive nature of the pharmaceutical industry inevitably means that this must be accomplished in a once- to twice-daily dosing regimen. However, the physicochemical and biopharmaceutical properties of NCEs emerging from the inductry R&D pipeline presenting increasing challenges in achieving this profile, with sub-optimal solubility and/or permeability characteristics often encountered.

The drug development team must transition rudimentary formulations used in the FIH study to formulations suitable for later stage development, and those drug products must be optimised to ensure viability in the marketplace.

Quotient has developed a suite of innovative services which significantly enhance the process to optimise oral drug products. RapidFACT^TM (Rapid Formulation development And Clinical Testing) offers a new paradigm to screen, select and validate new formulations in man. These drug products can then be manufactured at volumes to support further Early Development studies.

Enterion^TM is a proprietary technology that enables us to understand drug absorption, metabolism, and transport within the GI tract and pharmacoscintigraphy is a technique which enables the performance of a drug product to be tracked as it transits through the gut.

All of our approaches are based on a solid understanding of GI physiology and anatomy and their impact on drug absorption.

NCE - new chemical entity; FIH - First-in-Human; GI - gastrointestinal.