Drug Product Optimisation
In order to express its beneficial therapeutic effect, an effective drug product must deliver a new chemical entity (NCE) to the right place, at the right time and at the right concentration. For oral medicines, the increasingly competitive nature of the pharmaceutical industry means that this must be accomplished in a once- to twice-daily dosing regimen. The physicochemical and biopharmaceutical properties of NCEs emerging from the industry R&D pipeline present increasing challenges achieving this profile. Sub-optimal solubility and/or permeability characteristics are often encountered.
The drug development team must transition rudimentary formulations used in the First-in-Human (FIH) study to formulations suitable for later stage development. Drug products must be optimised to ensure viability in the marketplace.
We have developed a suite of innovative services which significantly enhance the process of optimising oral drug products.
- EnterionTM is a proprietary technology that enables us to understand drug absorption, metabolism and transport within the gastrointestinal (GI) tract.
- RapidFACTTM (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.
- 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 sound understanding of GI physiology and anatomy and their impact on drug absorption.