Alexander De Man

Laboratory of Pharmaceutical Process Analytical Technology

Ottergemsesteenweg 460

B-9000 Gent (Belgium) 
Tel.: +32 9 264 80 56
E-mail: Alexander.DeMan@UGent.be

Education: Pharmacist (Master in Pharmaceutical Care)

Development of a surrogate identification and selection tool to perform surrogate development studies using the different unit operations of a continuous direct compression line.

During the early stages of drug development, extensive process and formulation optimization are mostly not feasible due to limited Active Pharmaceutical Ingredient (API) availability or its excessively high price, resulting in sub-optimal final product quality or in the necessity of post-approval changes to the manufacturing process or formulation of a new drug product. Therefore, performing development studies with an easily accessible surrogate material would allow to greatly reduce API consumption during the early research and development stages of a drug product. Additionally, extensive process and formulation optimization would become more feasible as price and availability are of less concern.

The goal of this project is the development of a surrogate identification and selection tool to perform surrogate development studies using the different unit operations of a continuous direct compression line. The unit operations in scope are feeding, blending and tableting. As each unit operation has its geometric characteristics, the surrogate ID & selection tool must be able to distinguish the importance of various material and blend properties for each unit operation, possibly resulting in multiple suitable surrogate materials for an API of interest.