Paul E. Trusty

Paul Trusty Ph.D. (University of Surrey), is a Senior Technical Director in Pharma Supply Chain for GlaxoSmithKline based at Ware, UK.  He is a Materials Scientist by training, with over 30 years’ experience of applying this approach to different manufacturing industries. 

Most of his early research focused on the fabrication and properties of engineering ceramics for aerospace applications.  He then worked for 9 years in the Food Industry (Unilever Research) where he headed Product Characterisation and Development groups in both the UK and Latin America.

For the past 13 years Paul has worked in the Pharmaceutical Industry for GSK in various positions in New Product Development, Process Design and Development, and HIV Supply Chain.  With each role, the aim has been to ensure the launch and maintenance of robust dosage forms that have been designed with a level of quality that will persist throughout the whole product lifecycle (Quality by Design).

USE OF A MICROSTRUCTURE-PROPERTY APPROACH TO DE-RISK

ORAL SOLID DOSE FORMULATIONS

Paul A. Trusty

As the Regulatory Agencies have continued to adopt the principles of Quality by Design (QbD), reviews have become more question-based, and pharmaceutical companies have been required to demonstrate their understanding of their raw materials, products and processes at a level that is scientifically sound, feasible and justifiable.  In order to effectively demonstrate such understanding, a more prominent use of disciplines such as Materials Science and Engineering can be of great use. 

Materials Science is traditionally known as the science of metals, polymers and ceramics.  It attempts to improve the performance of these ‘standard’ materials and also to design and fabricate new, higher performance materials that have not previously existed in nature.  It is proposed in this work that the adoption of a Materials Science approach within pharmaceutical drug development at the micro scale can aid with our understanding of the input raw materials of solid oral dosage forms and how they achieve their functionality.  By interrogating formulations in a 3D virtual space, one can hypothesise about which microstructure-property relationships will be key to the assurance of drug product quality.  This can be something as basic as the virtual assessment of segregation potential when using different grades of excipients, or as complex as the assessment of the potential effect of changes in drug particle size/shape on drug release kinetics. 

Ultimately this approach seeks to risk assess the ‘lifecycle robustness’ of a formulation from a materials and manufacturability perspective.  By interrogating the formulation at this level, the observed product performance can be readily related back to the microstructure, which in turn is a manifestation of how the raw materials have been transformed during processing.  This approach is also a relatively straightforward way for the pharmaceutical industry to more readily demonstrate its scientific understanding of its dosage forms.